This randomized controlled trial evaluated the effects of adjunctive prednisolone and Mycobacterium indicus pranii immunotherapy in 1400 adults with definite or probable tuberculous pericarditis in Africa. Patients were assigned to receive either prednisolone or placebo for 6 weeks, and M. indicus pranii or placebo in 5 injections over 3 months, in addition to antituberculosis therapy. The primary outcome was a composite of death, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis. The trial found that neither prednisolone nor M. indicus pranii had a significant effect on the primary outcome. However, predn
British Medical Journal study on Oral ContraceptivesHarvey Diaz
This study analyzed mortality data from over 46,000 women in the Royal College of General Practitioners' Oral Contraception Study, which began in 1968. The study found that ever users of oral contraceptives had a 12% lower risk of death from any cause compared to never users. Ever users also had lower risks of death from cancers, circulatory diseases, and other specific causes. No clear association was found between duration of oral contraceptive use and overall mortality risk, though some disease-specific relationships were seen.
Autologous Bone Marrow Mononuclear Cell Therapy for Autism: An Open Label Pro...DrAlokSharma
Autism spectrum disorders (ASD) are a group of heterogeneous neurodevelopmental disorders characterized by
deficits in verbal and nonverbal communication, social
interaction, and presence of stereotypical repetitive behavior.
Correlation of Estrogen and Progesterone Receptor expression in Breast Canceriosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
1) The study retrospectively reviewed 57 cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) treated at a hospital in Indonesia from 2009-2013.
2) All cases were treated with systemic corticosteroids alone, with dosages varying based on the severity of SJS or TEN.
3) Outcomes were generally positive, with 87.7% of patients improving, though the mortality rate was higher for TEN (36.4%) than SJS (7.7%). The most common causes were drug reactions like paracetamol.
The document provides information on several professors and their research areas at College of Pharmacy. It includes the names and areas of research for Professors Jing-Ping Liou, Chieh-Hsi Wu, Shawn Hsiang-Yin Chen, Wei-Chiao Chang, Jen-Ai Lee, David Hui-Wen Cheng, and Tzu-Hua Wu. The research areas include medicinal and organic chemistry, cardiovascular and cancer pharmacology, clinical pharmacy, pharmacogenomics, bioanalytical chemistry, pharmaceutical management and regulatory affairs, and clinical pharmacy and therapeutics. It also lists some representative publications for each professor.
Evaluation the efficacy of IVIgG in treatment of Hemolytic Disease of Newborniosrphr_editor
Hemolytic disease of newborn (HDN) is an important cause of hyperbilirubinemia in the
neonatal period,and delayed diagnosis and treatment may lead to permanent brain damage. Traditional
neonatal treatment of HDN is intensive phototherapy and exchange transfusion.Intravenous
immunoglobulin(IVIgG) has been introduced as an alternative therapy to exchange transfusion. This study was
conducted to assess the effect of IVIG in HDN .
The similarities and differences of the recommendations of azithromycin ther...WAidid
The document discusses recommendations for antibiotic therapy for community-acquired pneumonia (CAP) in different patient populations. It finds that for children hospitalized with CAP, combination therapy with a beta-lactam and macrolide was not significantly more effective than beta-lactam monotherapy. For adults hospitalized with CAP, combination therapy was associated with a lower 30-day mortality compared to beta-lactam monotherapy alone, especially for patients with moderate severity based on CURB-65 scores. A randomized controlled trial found no significant difference in clinical stability at day 7 between beta-lactam monotherapy and beta-lactam-macrolide combination therapy for moderately severe CAP in adults.
This document provides guidelines for the diagnosis and treatment of bacterial meningitis. It recommends that patients suspected of having bacterial meningitis receive a lumbar puncture and blood cultures immediately to determine if the CSF formula is consistent with meningitis. It also recommends empirical antibiotic therapy be started before diagnostic tests if lumbar puncture is delayed. The guidelines review evidence on which patients should receive a CT scan before lumbar puncture due to risk of brain herniation. Gram stain, culture and latex agglutination of CSF are recommended diagnostic tests to determine the bacterial etiology of meningitis.
British Medical Journal study on Oral ContraceptivesHarvey Diaz
This study analyzed mortality data from over 46,000 women in the Royal College of General Practitioners' Oral Contraception Study, which began in 1968. The study found that ever users of oral contraceptives had a 12% lower risk of death from any cause compared to never users. Ever users also had lower risks of death from cancers, circulatory diseases, and other specific causes. No clear association was found between duration of oral contraceptive use and overall mortality risk, though some disease-specific relationships were seen.
Autologous Bone Marrow Mononuclear Cell Therapy for Autism: An Open Label Pro...DrAlokSharma
Autism spectrum disorders (ASD) are a group of heterogeneous neurodevelopmental disorders characterized by
deficits in verbal and nonverbal communication, social
interaction, and presence of stereotypical repetitive behavior.
Correlation of Estrogen and Progesterone Receptor expression in Breast Canceriosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
1) The study retrospectively reviewed 57 cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) treated at a hospital in Indonesia from 2009-2013.
2) All cases were treated with systemic corticosteroids alone, with dosages varying based on the severity of SJS or TEN.
3) Outcomes were generally positive, with 87.7% of patients improving, though the mortality rate was higher for TEN (36.4%) than SJS (7.7%). The most common causes were drug reactions like paracetamol.
The document provides information on several professors and their research areas at College of Pharmacy. It includes the names and areas of research for Professors Jing-Ping Liou, Chieh-Hsi Wu, Shawn Hsiang-Yin Chen, Wei-Chiao Chang, Jen-Ai Lee, David Hui-Wen Cheng, and Tzu-Hua Wu. The research areas include medicinal and organic chemistry, cardiovascular and cancer pharmacology, clinical pharmacy, pharmacogenomics, bioanalytical chemistry, pharmaceutical management and regulatory affairs, and clinical pharmacy and therapeutics. It also lists some representative publications for each professor.
Evaluation the efficacy of IVIgG in treatment of Hemolytic Disease of Newborniosrphr_editor
Hemolytic disease of newborn (HDN) is an important cause of hyperbilirubinemia in the
neonatal period,and delayed diagnosis and treatment may lead to permanent brain damage. Traditional
neonatal treatment of HDN is intensive phototherapy and exchange transfusion.Intravenous
immunoglobulin(IVIgG) has been introduced as an alternative therapy to exchange transfusion. This study was
conducted to assess the effect of IVIG in HDN .
The similarities and differences of the recommendations of azithromycin ther...WAidid
The document discusses recommendations for antibiotic therapy for community-acquired pneumonia (CAP) in different patient populations. It finds that for children hospitalized with CAP, combination therapy with a beta-lactam and macrolide was not significantly more effective than beta-lactam monotherapy. For adults hospitalized with CAP, combination therapy was associated with a lower 30-day mortality compared to beta-lactam monotherapy alone, especially for patients with moderate severity based on CURB-65 scores. A randomized controlled trial found no significant difference in clinical stability at day 7 between beta-lactam monotherapy and beta-lactam-macrolide combination therapy for moderately severe CAP in adults.
This document provides guidelines for the diagnosis and treatment of bacterial meningitis. It recommends that patients suspected of having bacterial meningitis receive a lumbar puncture and blood cultures immediately to determine if the CSF formula is consistent with meningitis. It also recommends empirical antibiotic therapy be started before diagnostic tests if lumbar puncture is delayed. The guidelines review evidence on which patients should receive a CT scan before lumbar puncture due to risk of brain herniation. Gram stain, culture and latex agglutination of CSF are recommended diagnostic tests to determine the bacterial etiology of meningitis.
This study evaluated the efficacy of isoniazid preventive therapy (IPT) in combination with antiretroviral therapy (ART) in preventing tuberculosis (TB) among 200 HIV-infected Thai patients who received IPT and 200 patients who did not. The 4-year incidence of pulmonary TB was not significantly different between the groups. However, the incidence was significantly higher in the non-IPT group during the first 6 months, especially among those with initial CD4 counts <200 cells/μl. IPT plus ART was protective against early TB. Retention in HIV care, ART adherence, and CD4 counts were similar between the groups over 4 years. This study suggests that tuberculin skin test-guided
This document discusses dual bronchodilation with tiotropium/olodaterol for the treatment of COPD. It begins with an overview of the prevalence and magnitude of COPD globally and in Spain. It then discusses the 2017 Spanish COPD treatment guidelines and algorithms. It aims to dispel myths around the use of inhaled corticosteroids (ICS) for COPD, looking at risks of pneumonia, exacerbations, withdrawal effects, and mitigating factors. Tiotropium is identified as the most studied bronchodilator. Results are presented showing that combining tiotropium with olodaterol provides superior bronchodilation to either agent alone. The document concludes by discussing the Respimat inhal
Among patients with relapsing-remitting multiple sclerosis (MS) who underwent nonmyeloablative hematopoietic stem cell transplantation (HSCT), the following results were observed:
1) Scores on the Expanded Disability Status Scale (EDSS) and Neurologic Rating Scale (NRS) improved significantly from pre-transplant levels at 2-year and 4-year follow-ups, indicating reduced neurological disability.
2) Fifty percent of patients showed at least a 1-point improvement on the EDSS at 2 years, increasing to 64% at 4 years.
3) Secondary outcomes including quality of life, walking ability, and lesion volume also significantly improved from pre-transplant
The document summarizes the research of Prof. Chieh-Hsi Wu, who focuses on pathological mechanisms involved in restenosis progression and evaluations of bioactive compounds for treating restenosis, hyperlipidemia, and cancer. His laboratory uses genomic and proteomic analyses to identify molecules involved in restenosis development and potential therapeutic targets. He evaluates natural compounds for preventing restenosis and hyperlipidemia.
Who 2019-n cov-corticosteroids-2020.1-engCIkumparan
This document provides recommendations from the WHO on the use of corticosteroids for the treatment of COVID-19. It recommends the use of systemic corticosteroids for patients with severe or critical COVID-19 based on moderate certainty evidence showing benefits. It conditionally recommends against the use of corticosteroids for non-severe COVID-19 based on low certainty evidence. The document was developed in collaboration with experts and reviews evidence on corticosteroid use from multiple clinical trials. It provides the background, methods, evidence and practical considerations regarding the recommendations.
- The document summarizes a study of 68 children with hereditary spherocytosis (HS).
- The main findings were that the median age at diagnosis was 5.6 years, the most common clinical manifestations were anemia in 59 patients, splenomegaly in 49 patients, and jaundice in 33 patients.
- Laboratory tests including complete blood count, blood smear, and osmotic fragility test were used to diagnose HS.
This document is a PhD thesis that examines molecular profiling of endometriosis and related malignancies. It includes 3 studies on this topic. The first study profiles miRNA expression in endometriosis and ovarian cancer samples to identify differently expressed miRNAs and generate miRNA networks. The second study examines the effects of caffeic acid phenethyl ester on ovarian cancer cells and related gene expression. The third study explores the therapeutic potential of RNA interference for modulating gene expression in ovarian and cervical cancers. The thesis aims to further the understanding of molecular mechanisms in endometriosis and related cancers to inform diagnostic and treatment approaches.
Outcomes of Fibrinolytic Therapy Versus PCIPeachy Essay
Several studies have been conducted to analyze the relative benefits of Percutaneous Coronary Intervention (PCI) and fibrinolytic therapy in the treatment of ST-Segment Elevation Myocardial Infarction (STEMI). The timely severity associated with STEMI has made it essential to identify the better of the two interventions. A successful intervention of STEMI depends on the thorough decision to either use PCI or fibrinolytic therapy. A study was conducted by Armstrong et al. (2013), comparing fibrinolytic therapy and primary PCI; a randomized control trial was administered to a sample of 1892 patients. The patients
underwent either fibrinolytic therapy or primary PCI, within 3 hours of presentation of symptoms of STEMI. The assigning of the patients to either undergo fibrinolytic therapy and primary PCI was done randomly.
Case #1.
Azathioprine에 의한 심한 골수부전 환자를 소개 하였습니다.
실제로 소개드린 첫번째 문헌(GUT)에 의하면 골수 억제의 부작용은 초기 치료 기간에 집중되어 있지만 전 치료 기간에 발생될 수 있는 것으로 되어 있습니다. 문헌들에 의하면 TPMT 활성이 저하된 환자에게 많이 발생하고 투여 전 TPMT 활성을 검사 한 후 치료를 시작 하여야 한다는 내용들이 많습니다. 그러나 TPMT 검사는 고가에 오랜 검사기간이 걸리는 검사입니다(비보험 225,750원, 20일). 또한 슬라이드에 소개드린 두번째 문헌(DDS)에는 스크리닝 검사의 효용성에 대하여 회의적인 결과를 보고 하였습니다.
면역 억제제 투여시 첫 약물로써 가장 간단하게 투여할 수 있는 이뮤란(Azathioprine)이라는 이름의 약물 역시도 주의하며 투여 해야 할 약물 이라 생각 됩니다. 심각한 혈액학적 합병증의 발생률은 약 6% 정도로 보고되고 있으며, 류마티스질환 치료 하시는 분들 역시도 오랜 치료기간 한두번의 경험을 할 수 있는 정도라고 합니다. 사용을 안할 수 없는 약물인 만큼 투여 전 환자와 보호자에게 발생 가능한 부작용에 대한 충분한 설명이 필요 하다고 생각 합니다.
Case #2.
Hepatic enz. elevation 주소로 오신 분이고, non-A, non-B hepatitis로써 ANA 검사상 high titer 소견을 보였습니다. 그런데 ANA 보고시 간과할 수 있는 ANA pattern이 'Discrete speckled' 로 보고되고 Anti Centromere Ab. 양성소견 이었습니다. 다시 병력 청취 하였더니 Raynaud disease가 의심 되었던 case 입니다. ANA 검사 결과를 볼때 titer 뿐 아니라 pattern도 챙겨 보아야 한다는 교훈을 얻었던 case 입니다.
Cryptic Disseminated Tuberculosis: a Secondary Analysis of Previous Hospital-...fahmi khan
The main purpose of this study was to describe the demographic and clinical features of cryptic disseminated TB; it was also aimed to shed light on diagnostic test, procedure results, organ involvement, and outcomes of cryptic disseminated TB in patients with confirmed disseminated TB.
Austin Journal of Clinical Cardiology is an open access, peer reviewed, scholarly journal dedicated to publish articles in all areas of cardiology and angiology. The aim of the journal is to provide a forum for cardiologists, researchers, physicians, and other health professionals to find most recent advances in the areas of cardiology and cardiovascular diseases.
Austin Journal of Clinical Cardiology accepts original research articles, review articles, case reports, clinical images and rapid communication on all the aspects of cardiology and circulatory system.
Austin Journal of Clinical Cardiology strongly supports the scientific upgradation and fortification in related scientific research community by enhancing access to peer reviewed scientific literary works. Austin Publishing Group also brings universally peer reviewed journals under one roof thereby promoting knowledge sharing, mutual promotion of multidisciplinary science.
Austin Journal of Clinical Cardiology is an open access, peer reviewed, scholarly journal dedicated to publish articles in all areas of cardiology and angiology
This document provides guidelines for the diagnosis, treatment and prevention of Clostridium difficile infections (CDI). It summarizes key recommendations with evidence grading. For diagnosis, it recommends nucleic acid amplification tests over toxin enzyme immunoassays, and only testing diarrheal stool samples. It stratifies treatment based on disease severity into mild-moderate (treat with metronidazole), severe (vancomycin with/without metronidazole), and complicated (vancomycin orally and rectally with intravenous metronidazole). It also covers recurrent CDI treatment, managing CDI in patients with comorbidities, and infection control practices like contact precautions and environmental disinfection. The guidelines
Population-based resistance of Mycobacterium tuberculosis
isolates to pyrazinamide and fl uoroquinolones: results from
a multicountry surveillance project
Updated National Guidelines for Pediatric Tuberculosis in India, 2012†mandar haval
The document summarizes updated national guidelines for pediatric tuberculosis in India from 2012. Some key points:
- A national consultation was held in 2012 to reconcile global and national guidelines and update RNTCP guidelines based on consensus with the Indian Academy of Pediatrics.
- New diagnostic algorithms were developed for pulmonary TB and lymph node TB, emphasizing demonstrating bacteriological evidence for diagnosis when possible. Loss of weight over 5% in 3 months is defined.
- Intermittent therapy remains the mainstay for treatment, but select severely ill children can receive daily therapy initially while hospitalized. Drug dosages were rationalized into 6 weight bands.
- Treatment categories were simplified to new cases and previously treated cases. Extending
This document describes a case report of a successful treatment of disseminated strongyloidiasis in an immunocompromised patient using subcutaneous ivermectin. A 56-year-old man being treated with corticosteroids developed sepsis and respiratory failure due to strongyloidiasis. Oral ivermectin treatment was ineffective, so the patient was treated with subcutaneous ivermectin, which successfully cured the infection. The patient was removed from life support and discharged from the hospital. While parenteral ivermectin treatment has not been approved, this case suggests it may be an effective salvage therapy for disseminated strongyloidiasis when oral treatment fails or cannot
Carbamazepine induced steven johnson syndrome a case reportpharmaindexing
1) A 25-year-old female patient developed Steven Johnson Syndrome approximately one month after starting treatment with carbamazepine for seizures.
2) She had a previous history of developing Steven Johnson Syndrome after treatment with phenytoin.
3) Her symptoms improved after discontinuing carbamazepine and starting treatment with levetiracetam instead, along with supportive care including calosoft lotion, antibiotics, and paracetamol.
NON-STEROIDAL ANTI INFLAMMATORY DRUGS AND GASTROINTESTINAL TOXICITYApollo Hospitals
Non-steroidal anti inflammatory drugs (NSAIDs) because of their high efficacy as both anti-inflammatory and analgesic agents, are one of the most commonly prescribed drugs world-wide. They are used in treatment of many commonly occurring disorders such as chronic arthropathies, headache and low back pain. Their widespread and uncontrolled use is promoted by their over the counter availability. This acts as a double edge sword. One of the most common adverse effects that add largely to its morbidity and mortality
is the gastrointestinal tract damage.
A Study to Assess the Effectiveness of Planned Teaching Program on the Knowle...ijtsrd
Malnutrition and Tuberculosis chronic infectious disease are both problems of considerable magnitude in the most underdeveloped regions of the world. Malnutrition can leads to secondary immunodeficiency that increase the host susceptibility to infection. The aim of the study was to assess the effectiveness of planned teaching program on the knowledge and practice regarding dietary pattern among mothers of children with tuberculosis admitted in pediatric ward. Quasi experimental with two groups pre test post test design was used for 60 mothers at IPD and OPD of pediatric department and purposive sampling technique was used. Self structured questionnaire was used to assess knowledge and checklist for practice. In post test experimental group mothers have 63.3 average knowledge, 26.6 poor knowledge and 10 good knowledge while in the control group, 53.3 poor knowledge, 46.6 average knowledge and non hove good knowledge. In experimental group mean score was 17.9 1.96 while in control group mean score was 11.8 2.99. At the “p” value 0.05, the calculated t value 3.21 was compared with the tabulated value 2.01 . In post test experimental group, mothers have 53.3 good practice, 46.6 average practice and none have poor practice while in the control group, 63.33 average practice, 23.3 poor practice and 13.3 good practice. In experimental group mean score was 19.13 1.99 while in the control group, mean score was 14.06 2.85.At the “p” value 0.05, the calculated t value 3.28 was compared with the tabulated value 2.01 . These finding reveals that the planned teaching program on dietary pattern was effective. Mrs. Anchal Tiwari | Mrs. Anugrah Charan | Dr. Sarika Gupta "A Study to Assess the Effectiveness of Planned Teaching Program on the Knowledge and Practice Regarding Dietary Pattern among Mothers of Children with Tuberculosis Admitted in Pediatric Ward at KGMU Hospital, Lucknowv" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-2 , February 2021, URL: https://www.ijtsrd.com/papers/ijtsrd38591.pdf Paper Url: https://www.ijtsrd.com/medicine/nursing/38591/a-study-to-assess-the-effectiveness-of-planned-teaching-program-on-the-knowledge-and-practice-regarding-dietary-pattern-among-mothers-of-children-with-tuberculosis-admitted-in-pediatric-ward-at-kgmu-hospital-lucknowv/mrs-anchal-tiwari
Total and Cause-Specific Mortality of U.S. Nurses Working Rotating Night ShiftsEmergency Live
Know more on http://www.emergency-live.com
Total and Cause-Specific Mortality of U.S.
Nurses Working Rotating Night Shifts
Fangyi Gu, MD, ScD, Jiali Han, PhD, Francine Laden, ScD, An Pan, PhD, Neil E. Caporaso, MD,
Meir J. Stampfer, MD, DrPH, Ichiro Kawachi, MD, PhD, Kathryn M. Rexrode, MD, MPH,
Walter C. Willett,MD, DrPH, Susan E. Hankinson, ScD, Frank E. Speizer,MD, Eva S. Schernhammer,MD, DrPH
Background: Rotating night shift work imposes circadian strain and is linked to the risk of several
chronic diseases.
Purpose: To examine associations between rotating night shift work and all-cause; cardiovascular
disease (CVD); and cancer mortality in a prospective cohort study of 74,862 registered U.S. nurses
from the Nurses’ Health Study.
Methods: Lifetime rotating night shift work (defined as Z3 nights/month) information was
collected in 1988. During 22 years (1988–2010) of follow-up, 14,181 deaths were documented,
including 3,062 CVD and 5,413 cancer deaths. Cox proportional hazards models estimated
multivariable-adjusted hazard ratios (HRs) and 95% CIs.
Results: All-cause and CVD mortality were significantly increased among women withZ5 years of
rotating night shift work, compared to women who never worked night shifts. Specifically, for
women with 6–14 and Z15 years of rotating night shift work, the HRs were 1.11 (95% CI¼1.06,
1.17) and 1.11 (95% CI¼1.05, 1.18) for all-cause mortality and 1.19 (95% CI¼1.07, 1.33) and 1.23
(95% CI¼1.09, 1.38) for CVD mortality. There was no significant association between rotating night
shift work and all-cancer mortality (HRZ15years¼1.08, 95% CI¼0.98, 1.19) or mortality of any
individual cancer, with the exception of lung cancer (HRZ15years¼1.25, 95% CI¼1.04, 1.51).
Conclusions: Women working rotating night shifts for Z5 years have a modest increase in allcause
and CVD mortality; those working Z15 years of rotating night shift work have a modest
increase in lung cancer mortality. These results add to prior evidence of a potentially detrimental
effect of rotating night shift work on health and longevity.
(Am J Prev Med 2015;](]):]]]–]]]) & 2015 American Journal of Preventive Medicine. All rights reserved.
Context—Proton pump inhibitors (PPIs) are among the most commonly used drugs worldwide, and have been linked to acute interstitial nephritis. Less is known about the relationship between PPI use and chronic kidney disease (CKD).
Objective—To quantify the association between PPI use and incident CKD in a population based cohort.
In total, 144,032 participants in Communities study with an estimated glomerular filtration rate of at least 60 mL/min/1.73 m2 were followed from a baseline visit between February 1, 1996, and January 30, 1999, to December 31, 2011. The data was analysed from May 2015 to October 2015.
Prednisolone and Mycobacterium indicus pranii in Tuberculous Pericarditis (IMPI) was a randomized controlled trial that investigated whether adjunctive prednisolone or M. indicus pranii injections improved outcomes in 1,400 patients with tuberculous pericarditis, many of whom also had HIV. The trial found no significant difference in the primary outcome but prednisolone reduced the risk of constrictive pericarditis and hospitalization. However, prednisolone and M. indicus pranii both significantly increased the risk of cancer in these immunosuppressed patients.
Post covid pulmonary fibrosis , atypical covid19 sequeleDr-Ajay Tripathi
1) COVID-19 can cause persistent radiological changes and lung function abnormalities even after discharge from the hospital. Regular follow-up is recommended, especially for severe cases.
2) COVID-19 has been shown to cause multi-system involvement beyond the lungs, including cardiovascular, neurological, renal and other organ systems. It can present atypically without respiratory symptoms.
3) Post-COVID care including pulmonary rehabilitation is important as many patients have long-term effects. Emerging treatments like anti-fibrotics are being studied to prevent long-term pulmonary fibrosis in severe cases.
This study evaluated the efficacy of isoniazid preventive therapy (IPT) in combination with antiretroviral therapy (ART) in preventing tuberculosis (TB) among 200 HIV-infected Thai patients who received IPT and 200 patients who did not. The 4-year incidence of pulmonary TB was not significantly different between the groups. However, the incidence was significantly higher in the non-IPT group during the first 6 months, especially among those with initial CD4 counts <200 cells/μl. IPT plus ART was protective against early TB. Retention in HIV care, ART adherence, and CD4 counts were similar between the groups over 4 years. This study suggests that tuberculin skin test-guided
This document discusses dual bronchodilation with tiotropium/olodaterol for the treatment of COPD. It begins with an overview of the prevalence and magnitude of COPD globally and in Spain. It then discusses the 2017 Spanish COPD treatment guidelines and algorithms. It aims to dispel myths around the use of inhaled corticosteroids (ICS) for COPD, looking at risks of pneumonia, exacerbations, withdrawal effects, and mitigating factors. Tiotropium is identified as the most studied bronchodilator. Results are presented showing that combining tiotropium with olodaterol provides superior bronchodilation to either agent alone. The document concludes by discussing the Respimat inhal
Among patients with relapsing-remitting multiple sclerosis (MS) who underwent nonmyeloablative hematopoietic stem cell transplantation (HSCT), the following results were observed:
1) Scores on the Expanded Disability Status Scale (EDSS) and Neurologic Rating Scale (NRS) improved significantly from pre-transplant levels at 2-year and 4-year follow-ups, indicating reduced neurological disability.
2) Fifty percent of patients showed at least a 1-point improvement on the EDSS at 2 years, increasing to 64% at 4 years.
3) Secondary outcomes including quality of life, walking ability, and lesion volume also significantly improved from pre-transplant
The document summarizes the research of Prof. Chieh-Hsi Wu, who focuses on pathological mechanisms involved in restenosis progression and evaluations of bioactive compounds for treating restenosis, hyperlipidemia, and cancer. His laboratory uses genomic and proteomic analyses to identify molecules involved in restenosis development and potential therapeutic targets. He evaluates natural compounds for preventing restenosis and hyperlipidemia.
Who 2019-n cov-corticosteroids-2020.1-engCIkumparan
This document provides recommendations from the WHO on the use of corticosteroids for the treatment of COVID-19. It recommends the use of systemic corticosteroids for patients with severe or critical COVID-19 based on moderate certainty evidence showing benefits. It conditionally recommends against the use of corticosteroids for non-severe COVID-19 based on low certainty evidence. The document was developed in collaboration with experts and reviews evidence on corticosteroid use from multiple clinical trials. It provides the background, methods, evidence and practical considerations regarding the recommendations.
- The document summarizes a study of 68 children with hereditary spherocytosis (HS).
- The main findings were that the median age at diagnosis was 5.6 years, the most common clinical manifestations were anemia in 59 patients, splenomegaly in 49 patients, and jaundice in 33 patients.
- Laboratory tests including complete blood count, blood smear, and osmotic fragility test were used to diagnose HS.
This document is a PhD thesis that examines molecular profiling of endometriosis and related malignancies. It includes 3 studies on this topic. The first study profiles miRNA expression in endometriosis and ovarian cancer samples to identify differently expressed miRNAs and generate miRNA networks. The second study examines the effects of caffeic acid phenethyl ester on ovarian cancer cells and related gene expression. The third study explores the therapeutic potential of RNA interference for modulating gene expression in ovarian and cervical cancers. The thesis aims to further the understanding of molecular mechanisms in endometriosis and related cancers to inform diagnostic and treatment approaches.
Outcomes of Fibrinolytic Therapy Versus PCIPeachy Essay
Several studies have been conducted to analyze the relative benefits of Percutaneous Coronary Intervention (PCI) and fibrinolytic therapy in the treatment of ST-Segment Elevation Myocardial Infarction (STEMI). The timely severity associated with STEMI has made it essential to identify the better of the two interventions. A successful intervention of STEMI depends on the thorough decision to either use PCI or fibrinolytic therapy. A study was conducted by Armstrong et al. (2013), comparing fibrinolytic therapy and primary PCI; a randomized control trial was administered to a sample of 1892 patients. The patients
underwent either fibrinolytic therapy or primary PCI, within 3 hours of presentation of symptoms of STEMI. The assigning of the patients to either undergo fibrinolytic therapy and primary PCI was done randomly.
Case #1.
Azathioprine에 의한 심한 골수부전 환자를 소개 하였습니다.
실제로 소개드린 첫번째 문헌(GUT)에 의하면 골수 억제의 부작용은 초기 치료 기간에 집중되어 있지만 전 치료 기간에 발생될 수 있는 것으로 되어 있습니다. 문헌들에 의하면 TPMT 활성이 저하된 환자에게 많이 발생하고 투여 전 TPMT 활성을 검사 한 후 치료를 시작 하여야 한다는 내용들이 많습니다. 그러나 TPMT 검사는 고가에 오랜 검사기간이 걸리는 검사입니다(비보험 225,750원, 20일). 또한 슬라이드에 소개드린 두번째 문헌(DDS)에는 스크리닝 검사의 효용성에 대하여 회의적인 결과를 보고 하였습니다.
면역 억제제 투여시 첫 약물로써 가장 간단하게 투여할 수 있는 이뮤란(Azathioprine)이라는 이름의 약물 역시도 주의하며 투여 해야 할 약물 이라 생각 됩니다. 심각한 혈액학적 합병증의 발생률은 약 6% 정도로 보고되고 있으며, 류마티스질환 치료 하시는 분들 역시도 오랜 치료기간 한두번의 경험을 할 수 있는 정도라고 합니다. 사용을 안할 수 없는 약물인 만큼 투여 전 환자와 보호자에게 발생 가능한 부작용에 대한 충분한 설명이 필요 하다고 생각 합니다.
Case #2.
Hepatic enz. elevation 주소로 오신 분이고, non-A, non-B hepatitis로써 ANA 검사상 high titer 소견을 보였습니다. 그런데 ANA 보고시 간과할 수 있는 ANA pattern이 'Discrete speckled' 로 보고되고 Anti Centromere Ab. 양성소견 이었습니다. 다시 병력 청취 하였더니 Raynaud disease가 의심 되었던 case 입니다. ANA 검사 결과를 볼때 titer 뿐 아니라 pattern도 챙겨 보아야 한다는 교훈을 얻었던 case 입니다.
Cryptic Disseminated Tuberculosis: a Secondary Analysis of Previous Hospital-...fahmi khan
The main purpose of this study was to describe the demographic and clinical features of cryptic disseminated TB; it was also aimed to shed light on diagnostic test, procedure results, organ involvement, and outcomes of cryptic disseminated TB in patients with confirmed disseminated TB.
Austin Journal of Clinical Cardiology is an open access, peer reviewed, scholarly journal dedicated to publish articles in all areas of cardiology and angiology. The aim of the journal is to provide a forum for cardiologists, researchers, physicians, and other health professionals to find most recent advances in the areas of cardiology and cardiovascular diseases.
Austin Journal of Clinical Cardiology accepts original research articles, review articles, case reports, clinical images and rapid communication on all the aspects of cardiology and circulatory system.
Austin Journal of Clinical Cardiology strongly supports the scientific upgradation and fortification in related scientific research community by enhancing access to peer reviewed scientific literary works. Austin Publishing Group also brings universally peer reviewed journals under one roof thereby promoting knowledge sharing, mutual promotion of multidisciplinary science.
Austin Journal of Clinical Cardiology is an open access, peer reviewed, scholarly journal dedicated to publish articles in all areas of cardiology and angiology
This document provides guidelines for the diagnosis, treatment and prevention of Clostridium difficile infections (CDI). It summarizes key recommendations with evidence grading. For diagnosis, it recommends nucleic acid amplification tests over toxin enzyme immunoassays, and only testing diarrheal stool samples. It stratifies treatment based on disease severity into mild-moderate (treat with metronidazole), severe (vancomycin with/without metronidazole), and complicated (vancomycin orally and rectally with intravenous metronidazole). It also covers recurrent CDI treatment, managing CDI in patients with comorbidities, and infection control practices like contact precautions and environmental disinfection. The guidelines
Population-based resistance of Mycobacterium tuberculosis
isolates to pyrazinamide and fl uoroquinolones: results from
a multicountry surveillance project
Updated National Guidelines for Pediatric Tuberculosis in India, 2012†mandar haval
The document summarizes updated national guidelines for pediatric tuberculosis in India from 2012. Some key points:
- A national consultation was held in 2012 to reconcile global and national guidelines and update RNTCP guidelines based on consensus with the Indian Academy of Pediatrics.
- New diagnostic algorithms were developed for pulmonary TB and lymph node TB, emphasizing demonstrating bacteriological evidence for diagnosis when possible. Loss of weight over 5% in 3 months is defined.
- Intermittent therapy remains the mainstay for treatment, but select severely ill children can receive daily therapy initially while hospitalized. Drug dosages were rationalized into 6 weight bands.
- Treatment categories were simplified to new cases and previously treated cases. Extending
This document describes a case report of a successful treatment of disseminated strongyloidiasis in an immunocompromised patient using subcutaneous ivermectin. A 56-year-old man being treated with corticosteroids developed sepsis and respiratory failure due to strongyloidiasis. Oral ivermectin treatment was ineffective, so the patient was treated with subcutaneous ivermectin, which successfully cured the infection. The patient was removed from life support and discharged from the hospital. While parenteral ivermectin treatment has not been approved, this case suggests it may be an effective salvage therapy for disseminated strongyloidiasis when oral treatment fails or cannot
Carbamazepine induced steven johnson syndrome a case reportpharmaindexing
1) A 25-year-old female patient developed Steven Johnson Syndrome approximately one month after starting treatment with carbamazepine for seizures.
2) She had a previous history of developing Steven Johnson Syndrome after treatment with phenytoin.
3) Her symptoms improved after discontinuing carbamazepine and starting treatment with levetiracetam instead, along with supportive care including calosoft lotion, antibiotics, and paracetamol.
NON-STEROIDAL ANTI INFLAMMATORY DRUGS AND GASTROINTESTINAL TOXICITYApollo Hospitals
Non-steroidal anti inflammatory drugs (NSAIDs) because of their high efficacy as both anti-inflammatory and analgesic agents, are one of the most commonly prescribed drugs world-wide. They are used in treatment of many commonly occurring disorders such as chronic arthropathies, headache and low back pain. Their widespread and uncontrolled use is promoted by their over the counter availability. This acts as a double edge sword. One of the most common adverse effects that add largely to its morbidity and mortality
is the gastrointestinal tract damage.
A Study to Assess the Effectiveness of Planned Teaching Program on the Knowle...ijtsrd
Malnutrition and Tuberculosis chronic infectious disease are both problems of considerable magnitude in the most underdeveloped regions of the world. Malnutrition can leads to secondary immunodeficiency that increase the host susceptibility to infection. The aim of the study was to assess the effectiveness of planned teaching program on the knowledge and practice regarding dietary pattern among mothers of children with tuberculosis admitted in pediatric ward. Quasi experimental with two groups pre test post test design was used for 60 mothers at IPD and OPD of pediatric department and purposive sampling technique was used. Self structured questionnaire was used to assess knowledge and checklist for practice. In post test experimental group mothers have 63.3 average knowledge, 26.6 poor knowledge and 10 good knowledge while in the control group, 53.3 poor knowledge, 46.6 average knowledge and non hove good knowledge. In experimental group mean score was 17.9 1.96 while in control group mean score was 11.8 2.99. At the “p” value 0.05, the calculated t value 3.21 was compared with the tabulated value 2.01 . In post test experimental group, mothers have 53.3 good practice, 46.6 average practice and none have poor practice while in the control group, 63.33 average practice, 23.3 poor practice and 13.3 good practice. In experimental group mean score was 19.13 1.99 while in the control group, mean score was 14.06 2.85.At the “p” value 0.05, the calculated t value 3.28 was compared with the tabulated value 2.01 . These finding reveals that the planned teaching program on dietary pattern was effective. Mrs. Anchal Tiwari | Mrs. Anugrah Charan | Dr. Sarika Gupta "A Study to Assess the Effectiveness of Planned Teaching Program on the Knowledge and Practice Regarding Dietary Pattern among Mothers of Children with Tuberculosis Admitted in Pediatric Ward at KGMU Hospital, Lucknowv" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-2 , February 2021, URL: https://www.ijtsrd.com/papers/ijtsrd38591.pdf Paper Url: https://www.ijtsrd.com/medicine/nursing/38591/a-study-to-assess-the-effectiveness-of-planned-teaching-program-on-the-knowledge-and-practice-regarding-dietary-pattern-among-mothers-of-children-with-tuberculosis-admitted-in-pediatric-ward-at-kgmu-hospital-lucknowv/mrs-anchal-tiwari
Total and Cause-Specific Mortality of U.S. Nurses Working Rotating Night ShiftsEmergency Live
Know more on http://www.emergency-live.com
Total and Cause-Specific Mortality of U.S.
Nurses Working Rotating Night Shifts
Fangyi Gu, MD, ScD, Jiali Han, PhD, Francine Laden, ScD, An Pan, PhD, Neil E. Caporaso, MD,
Meir J. Stampfer, MD, DrPH, Ichiro Kawachi, MD, PhD, Kathryn M. Rexrode, MD, MPH,
Walter C. Willett,MD, DrPH, Susan E. Hankinson, ScD, Frank E. Speizer,MD, Eva S. Schernhammer,MD, DrPH
Background: Rotating night shift work imposes circadian strain and is linked to the risk of several
chronic diseases.
Purpose: To examine associations between rotating night shift work and all-cause; cardiovascular
disease (CVD); and cancer mortality in a prospective cohort study of 74,862 registered U.S. nurses
from the Nurses’ Health Study.
Methods: Lifetime rotating night shift work (defined as Z3 nights/month) information was
collected in 1988. During 22 years (1988–2010) of follow-up, 14,181 deaths were documented,
including 3,062 CVD and 5,413 cancer deaths. Cox proportional hazards models estimated
multivariable-adjusted hazard ratios (HRs) and 95% CIs.
Results: All-cause and CVD mortality were significantly increased among women withZ5 years of
rotating night shift work, compared to women who never worked night shifts. Specifically, for
women with 6–14 and Z15 years of rotating night shift work, the HRs were 1.11 (95% CI¼1.06,
1.17) and 1.11 (95% CI¼1.05, 1.18) for all-cause mortality and 1.19 (95% CI¼1.07, 1.33) and 1.23
(95% CI¼1.09, 1.38) for CVD mortality. There was no significant association between rotating night
shift work and all-cancer mortality (HRZ15years¼1.08, 95% CI¼0.98, 1.19) or mortality of any
individual cancer, with the exception of lung cancer (HRZ15years¼1.25, 95% CI¼1.04, 1.51).
Conclusions: Women working rotating night shifts for Z5 years have a modest increase in allcause
and CVD mortality; those working Z15 years of rotating night shift work have a modest
increase in lung cancer mortality. These results add to prior evidence of a potentially detrimental
effect of rotating night shift work on health and longevity.
(Am J Prev Med 2015;](]):]]]–]]]) & 2015 American Journal of Preventive Medicine. All rights reserved.
Context—Proton pump inhibitors (PPIs) are among the most commonly used drugs worldwide, and have been linked to acute interstitial nephritis. Less is known about the relationship between PPI use and chronic kidney disease (CKD).
Objective—To quantify the association between PPI use and incident CKD in a population based cohort.
In total, 144,032 participants in Communities study with an estimated glomerular filtration rate of at least 60 mL/min/1.73 m2 were followed from a baseline visit between February 1, 1996, and January 30, 1999, to December 31, 2011. The data was analysed from May 2015 to October 2015.
Prednisolone and Mycobacterium indicus pranii in Tuberculous Pericarditis (IMPI) was a randomized controlled trial that investigated whether adjunctive prednisolone or M. indicus pranii injections improved outcomes in 1,400 patients with tuberculous pericarditis, many of whom also had HIV. The trial found no significant difference in the primary outcome but prednisolone reduced the risk of constrictive pericarditis and hospitalization. However, prednisolone and M. indicus pranii both significantly increased the risk of cancer in these immunosuppressed patients.
Post covid pulmonary fibrosis , atypical covid19 sequeleDr-Ajay Tripathi
1) COVID-19 can cause persistent radiological changes and lung function abnormalities even after discharge from the hospital. Regular follow-up is recommended, especially for severe cases.
2) COVID-19 has been shown to cause multi-system involvement beyond the lungs, including cardiovascular, neurological, renal and other organ systems. It can present atypically without respiratory symptoms.
3) Post-COVID care including pulmonary rehabilitation is important as many patients have long-term effects. Emerging treatments like anti-fibrotics are being studied to prevent long-term pulmonary fibrosis in severe cases.
Yeasts such as Candida are common causes of bloodstream infections in ICU patients. Candida infections in the ICU have a high mortality rate of 15-25% and are the 4th most common cause of hospital-acquired bloodstream infections. Diagnosis can be challenging due to low sensitivity of blood cultures, but newer tests such as PCR, antigen detection assays, and MALDI-TOF mass spectrometry provide more rapid detection of Candida compared to standard culture methods. The presence of risk factors such as abdominal surgery, central venous catheters, antibiotics use, and prolonged ICU stay increase the risk of developing Candida bloodstream infections in critically ill patients.
This study examined the prevalence of cryptococcal meningitis (CM) among people living with HIV/AIDS (PLHAs) at a hospital in southern Odisha, India. Of 112 clinically diagnosed CM patients, 16 cases were confirmed via cerebrospinal fluid analysis, showing a prevalence of 14.3%. Males aged 21-40 were most commonly affected. The most common symptoms were fever, headache, altered sensorium, and neck stiffness. CD4 T-lymphocyte counts were below 100 cells/μl in 93.7% of confirmed cases. All patients responded initially to antifungal therapy but 2 died during hospitalization and 4 were lost to follow up. Early diagnosis and treatment of CM is
Translational medicine aims to expedite the discovery of new diagnostic tools and treatments through a multidisciplinary collaborative approach. It is a bidirectional process that encourages information flow from the laboratory to the clinic and vice versa. This allows for bench-to-bedside factors that test new therapies in clinical trials as well as bedside-to-bench factors that provide feedback to improve treatments. The examples given show how translational medicine has led to repurposing an existing drug to treat Marfan syndrome and developing more sensitive MRI techniques to detect early-stage prostate cancer.
This document summarizes a study that developed a CT-based radiomics score to noninvasively evaluate the tumor immune microenvironment (TIME) in 2272 gastric cancer patients. The radiomics score achieved good performance in predicting the neutrophil-to-lymphocyte ratio (NLR) status in the TIME. Notably, the radiomics score was comparable to the immunohistochemistry-derived NLR status in predicting patient survival outcomes. Furthermore, the study found that objective response rates to anti-PD-1 immunotherapy were significantly higher in patients with a low radiomics score compared to those with a high radiomics score. The radiomics imaging biomarker provides a noninvasive method for evaluating the TIME and its correlation with prognosis and response to
The document discusses treatment of invasive fungal infections. It begins by defining invasive fungal infections and describing the epidemiology. Common fungi that cause invasive infections include Aspergillus and Candida. Risk factors include prolonged neutropenia from chemotherapy or hematopoietic stem cell transplants. Available antifungal drug classes are discussed along with their mechanisms of action including azoles, polyenes, and echinocandins. Treatment recommendations from clinical guidelines are summarized for conditions like candidemia and invasive aspergillosis.
This editorial discusses two notable articles published in the New England Journal of Medicine in February 2020 on treatments for HER2-positive metastatic breast cancer. The first article reports results from the HER2CLIMB trial showing that adding the oral HER2 inhibitor tucatinib to trastuzumab and capecitabine resulted in significantly longer progression-free and overall survival compared to placebo, including among patients with brain metastases. The second article reports results from a study showing activity of the antibody-drug conjugate trastuzumab deruxtecan in heavily pretreated patients. The editorial highlights these studies as major advances in HER2 blockade for metastatic breast cancer, particularly for later lines of therapy when options are limited.
Recent advances in diagnosis and treatment of tuberculosisAdeyemiKayode2
The document summarizes recent advances in the diagnosis and treatment of tuberculosis. It discusses how diagnosis has advanced from identifying the bacteria that causes TB to newer molecular diagnostic tests like Xpert MTB/RIF assay and whole genome sequencing that provide faster results. Treatment has advanced from historical non-antibiotic approaches to the current drug cocktail regimen, though drug resistance poses challenges. Advances in understanding drug mechanisms of action and detecting resistance mutations have also occurred.
This document discusses thromboprophylaxis in ICU patients. It provides information on:
- The risk of venous thromboembolism (VTE) in hospitalized patients and the potential for prophylaxis to reduce this risk
- Common prophylactic options like enoxaparin, fondaparinux, and unfractionated heparin
- Tools to assess patient risk like the PADUA and IMPROVE scores
- Factors to consider when selecting a prophylactic method, including duration of prophylaxis
The document aims to review best practices for preventing VTE in high-risk hospitalized populations through appropriate thromboprophylaxis.
Adverse Events among HIV/MDR-TB Co-Infected Patients Receiving Antiretroviral...Dr.Samsuddin Khan
Abstract
Background
Significant adverse events (AE) have been reported in patients receiving medications for multidrug- and extensively-drug-resistant tuberculosis (MDR-TB & XDR-TB). However, there is little prospective data on AE in MDR- or XDR-TB/HIV co-infected patients on antituberculosis and antiretroviral therapy (ART) in programmatic settings.
Methods
Médecins Sans Frontières (MSF) is supporting a community-based treatment program for drug-resistant tuberculosis in HIV-infected patients in a slum setting in Mumbai, India since 2007. Patients are being treated for both diseases and the management of AE is done on an outpatient basis whenever possible. Prospective data were analysed to determine the occurrence and nature of AE.
Results
Between May 2007 and September 2011, 67 HIV/MDR-TB co-infected patients were being treated with anti-TB treatment and ART; 43.3% were female, median age was 35.5 years (Interquartile Range: 30.5–42) and the median duration of anti-TB treatment was 10 months (range 0.5–30). Overall, AE were common in this cohort: 71%, 63% and 40% of patients experienced one or more mild, moderate or severe AE, respectively. However, they were rarely life-threatening or debilitating. AE occurring most frequently included gastrointestinal symptoms (45% of patients), peripheral neuropathy (38%), hypothyroidism (32%), psychiatric symptoms (29%) and hypokalaemia (23%). Eleven patients were hospitalized for AE and one or more suspect drugs had to be permanently discontinued in 27 (40%). No AE led to indefinite suspension of an entire MDR-TB or ART regimen.
Conclusions
AE occurred frequently in this Mumbai HIV/MDR-TB cohort but not more frequently than in non-HIV patients on similar anti-TB treatment. Most AE can be successfully managed on an outpatient basis through a community-based treatment program, even in a resource-limited setting. Concerns about severe AE in the management of co-infected patients are justified, however, they should not cause delays in the urgently needed rapid scale-up of antiretroviral therapy and second-line anti-TB treatment
Corticosteroids for acute bacterial meningitis DR RML DELHI
This Cochrane review analyzed 25 studies with over 4,000 participants to evaluate the effects of corticosteroids for acute bacterial meningitis. The review found that corticosteroids significantly reduced hearing loss and neurological sequelae but did not reduce overall mortality. Corticosteroids were shown to be beneficial in high-income countries by reducing hearing loss, neurological sequelae, and mortality from S. pneumoniae meningitis, but no benefit was seen in low-income countries.
This study aimed to establish a cerebrospinal fluid (CSF) white blood cell (WBC) count cutoff that could distinguish bacterial meningitis from viral and aseptic meningitis in children. The study retrospectively analyzed 295 children admitted with CSF pleocytosis between 2005-2009. Bacterial meningitis was diagnosed in 31 children (10.5%), viral meningitis in 156 (52.9%), and aseptic meningitis in 108 (36.6%). CSF WBC count was significantly higher in bacterial meningitis compared to the other groups. A cutoff of 321 WBC/μL provided the best balance of sensitivity (80.6%) and specificity (81.4%) for diagnosing bacterial
This document discusses sickle cell nephropathy and provides information over several slides. It begins with basic renal anatomy and physiology concepts. It then covers the pathophysiology of sickle cell nephropathy including hyperfiltration, albuminuria, tubular abnormalities, and hematuria. Epidemiology statistics for sickle cell nephropathy are presented. Clinical manifestations such as hematuria, nocturia, polyuria, acute kidney injury, chronic kidney disease, and nephrotic syndrome are outlined. Methods for diagnosis including basic tests, glomerular filtration rate equations, and newer biomarkers are reviewed. Treatment options are explored including hydroxyurea, ACE inhibitors, blood transfusions, erythropoies
Palliative care seeks to manage symptoms of advanced illness through a holistic, multidisciplinary approach. A study found that early palliative care for metastatic lung cancer improved quality of life and mood, and led to less aggressive end-of-life care without negatively impacting survival time. Opioids are effective for dyspnea when appropriately dosed and monitored, while supplemental oxygen and benzodiazepines may also provide relief. Defining standards for palliative care is important for research.
Evaluation factors contributing to the treatment default by tuberculosis pati...PUBLISHERJOURNAL
Tuberculosis (TB) is one of the biggest public health problem and now ranks alongside Human Immunodeficiency Virus (HIV) as the world’s leading infectious cause of death. Globally, patient compliance with anti-TB therapy estimated as low as 40% in developing countries, remains the principle cause of treatment failure. The aim of this study was to establish the factors contributing to treatment default by Tuberculosis patients at ART clinic in Ishaka Adventist Hospital, Bushenyi District. A cross-sectional and descriptive study which employed both qualitative and quantitative approach of data collection were used. The study was conducted in ART clinic at Ishaka Adventist Hospital, Bushenyi District and it took a period of four weeks. A purposive sampling technique was used to select the study participants. Results showed that out of 38 study participants, majority 26 (68%) were of age 30 years and above. A large proportion 24 (63%) of the participants were unemployed compared to the least 14 (37%) who were employed. Majority 21 (55%) travel at a distance of 10km and above to get TB treatment. Out of 38 participants, majority 26 (68%) did not informed the family or friends when they were on TB treatment. Of 26 participants 16 (61.5%) had fear of being isolated and 2 (7.7%) were other reason of no support. A large proportion of participants rated the attitude of staff who attended to them at the health facility to be unfriendly with 21 (55%) while very few 6 (16%) were rude. The ministry should ensure availability of and access to resources for strengthening systems for delivery of quality tuberculosis treatment, prevention and control.
Keywords: treatment, default, tuberculosis, ART, Uganda
Evaluation factors contributing to the treatment default by tuberculosis pati...PUBLISHERJOURNAL
This document summarizes a study that evaluated factors contributing to treatment default among tuberculosis patients at an ART clinic in Uganda. The study found that the majority of participants were over 30 years old, unemployed, and had to travel over 10km to receive treatment. Most participants were not diagnosed with TB more than a year ago. The majority felt that TB treatment is curative but takes longer than 6 months to complete. Fear of isolation was the most common reason patients did not inform family/friends of their TB status. The study concludes that strengthening TB treatment, prevention, and control systems is needed.
This study compared characteristics, outcomes, and cytokine responses in solid organ transplant recipients and non-transplant patients with bacteremia. Transplant patients with gram-negative bacteremia had a lower rate of septic shock but similar 30-day mortality compared to non-transplant patients. Five cytokines were significantly lower in transplant patients, while one cytokine was higher in transplant patients with Staphylococcus aureus bacteremia. The study aims to better understand how immunosuppression impacts the immune response and outcomes of bacteremia in transplant recipients.
Cor pulmonale, also known as pulmonary heart disease, is a type of heart disease where the right side of the heart enlarges and fails over time due to high blood pressure in the lungs or pulmonary hypertension. It is usually caused by lung diseases like chronic obstructive pulmonary disease (COPD) that result in low oxygen levels and resistance within the pulmonary arteries of the lungs. The enlarged right ventricle must work harder to pump blood into the lungs, causing it to thicken and eventually fail if left untreated.
Peptic ulcers develop in the lining of the stomach or small intestine. Common causes are infection by H. pylori bacteria and use of pain medications like ibuprofen. Symptoms include stomach pain that is worse when the stomach is empty. Diagnosis involves tests to detect H. pylori infection and endoscopy to view the digestive tract. Treatment eliminates the bacteria with antibiotics if present, reduces acid production, and promotes healing with proton pump inhibitors or acid blockers. Preventive measures include careful use of pain medications and protecting against infections.
Pancreatitis is inflammation of the pancreas that can be acute or chronic. It occurs when digestive enzymes in the pancreas are activated and damage pancreatic cells. Common causes include alcoholism, gallstones, certain medications, abdominal injuries, and genetic factors. Symptoms vary but often include abdominal pain that worsens with eating as well as nausea and vomiting. Diagnosis involves blood tests, imaging scans, and endoscopy. Treatment focuses on relieving symptoms, treating underlying causes, and managing complications. To prevent pancreatitis, avoiding excessive alcohol consumption and following a low-fat diet can help reduce risk.
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder defined by abdominal pain and changes in bowel habits. The causes are unclear but may involve stress, infection, or brain-gut interactions. Symptoms include abdominal pain, gas, bloating, and diarrhea or constipation. Diagnosis is based on symptoms, and tests rule out other conditions. Treatment focuses on lifestyle changes like diet, exercise, and stress relief. Medications may help control symptoms but no single treatment works for everyone with this common disorder.
Inflammatory bowel disease (IBD) describes disorders that involve chronic inflammation of the digestive tract, including ulcerative colitis and Crohn's disease. The exact cause is unknown but is likely related to malfunctions of the immune system. Symptoms vary in severity from mild to severe and include diarrhea, abdominal pain, bleeding, and weight loss. Diagnosis involves blood tests, endoscopy, imaging, and ruling out other potential causes. Treatment aims to reduce inflammation and includes anti-inflammatory drugs, immunosuppressants, antibiotics, and surgery in some cases.
Helicobacter pylori is a type of bacteria that infects the stomach and is the most common cause of gastritis and peptic ulcers worldwide. Infection is very common and increases with age. H. pylori bacteria can be transmitted through direct contact with infected feces or vomit, or through contaminated food or water. While most infected people never show symptoms, potential symptoms include abdominal pain, nausea, loss of appetite, and weight loss. Diagnosis involves tests of the blood, breath, or stool to detect H. pylori. Treatment consists of antibiotics along with medication to reduce stomach acid in order to kill the bacteria and allow the stomach lining to heal.
Gastroesophageal reflux disease (GERD) occurs when stomach acid returns up into the esophagus and causes irritation. It is common for people to experience acid reflux occasionally, but GERD is when it occurs at least twice a week or more severely once a week. Risk factors include obesity, pregnancy, smoking, and certain medications. Symptoms include heartburn, nausea, coughing, and sore throat. Diagnosis is usually based on symptoms, but tests like endoscopy or pH monitoring can be done. Treatment involves lifestyle changes like losing weight, avoiding foods and drinks that trigger symptoms, and medications to reduce acid production. Surgery may be an option for severe cases that do not improve with other treatments.
Gastroenteritis is inflammation of the stomach and intestines that is usually caused by viruses, bacteria, or parasites. Common symptoms include diarrhea, nausea, vomiting, and abdominal pain. While generally self-limiting, gastroenteritis can cause dehydration, which is more common and dangerous in infants and young children. Oral rehydration solutions are the recommended treatment for mild to moderate dehydration. Prevention involves proper food handling and drinking clean water, especially when traveling.
1. Gastrointestinal stromal tumors (GIST) are rare tumors that can develop in the wall of the gastrointestinal tract and can be cancerous (malignant) or non-cancerous (benign). Risk factors include inherited genetic mutations and rare genetic syndromes.
2. Symptoms of GIST tumors include blood in stool or vomit, abdominal pain, fatigue, difficulty swallowing, and feeling full after eating small amounts of food. Diagnosis involves physical exams, CT scans, MRI scans, endoscopic ultrasounds, and biopsies of suspicious tissue.
3. Treatment depends on the stage and location of the tumor and may involve surgical resection as the only potentially curative treatment
1. Gastritis is inflammation of the lining of the stomach that is usually caused by Helicobacter pylori infection or excessive alcohol or drug use. It can be acute or chronic.
2. Common causes include H. pylori infection, NSAIDs, alcohol, bile reflux, autoimmune disorders, and stress. Symptoms may include abdominal pain, nausea, vomiting, and black stools from bleeding.
3. Diagnosis involves blood tests, endoscopy, and stool tests. Treatment focuses on eliminating the cause, using antacids or other drugs to reduce stomach acid, and antibiotics to treat H. pylori infection. Preventing overuse of NSAIDs and limiting alcohol and sp
1. Esophageal motor disorders are alterations in the peristaltic activity of the esophageal body and/or functioning of the sphincters. There are primary motor disorders that affect the esophageal body and lower esophageal sphincter including achalasia, diffuse esophageal spasm, and hypercontractile disorders.
2. The etiology of spastic motor disorders is divided into primary and secondary causes. The primary causes include diffuse esophageal spasm, nutcracker esophagus, and hypertensive lower esophageal sphincter. The pathophysiology involves alterations in nitric oxide synthesis and degradation affecting normal peristalsis.
3. Symptoms include chest pain, dysphagia
Dyspepsia, also known as indigestion, refers to discomfort or pain in the upper abdomen that is often caused by eating. Common symptoms include pain, swelling, heartburn, and nausea. While the specific cause is unknown in most cases, potential causes include stress, medications like aspirin, Helicobacter pylori bacteria, smoking, alcohol, spicy or greasy foods, and large meal sizes. Diagnosis involves tests like abdominal ultrasounds and endoscopies of the esophagus, stomach, and duodenum. Treatment focuses on diet changes, antibiotics to eliminate H. pylori if present, and medications to reduce acid like omeprazole. Prevention includes relaxing after
This document discusses diseases of the rectum and anus. It begins with definitions and explains that these diseases are commonly seen in primary care. It describes some of the main diseases including their causes, symptoms, and risk factors. Some of the diseases covered include hemorrhoids, anal fissures, abscesses, and anal cancer. The document discusses how these diseases are diagnosed, often through examination with an anoscope or sigmoidoscope. It also outlines treatments for some conditions like surgery, radiation therapy, and chemotherapy for anal cancer. Lastly, it discusses some ways to prevent diseases like avoiding risk factors, screening high risk patients, and vaccinations to prevent HPV infections.
The document discusses diseases of the mouth cavity. It defines the mouth and its functions, and describes common mouth problems like cold sores, canker sores, and infections. Diagnosis involves examination by a dentist, and treatment depends on the specific problem but may include cleaning, surgery, or maintenance visits. Prevention strategies include avoiding tobacco and excessive alcohol, eating fruits and vegetables, protecting lips from sun, and regular dental exams.
The document discusses digestive hemorrhage, also known as gastrointestinal bleeding. It defines high and low hemorrhages based on their origin in the digestive tract. Some common causes of digestive hemorrhage include anal fissures, hemorrhoids, ulcers, and cancers of the digestive system. Symptoms include vomiting blood or black tarry stools. Diagnosis involves endoscopy, imaging tests, or surgery depending on the location of bleeding. Treatment focuses on stabilization, determining the cause through endoscopy, and addressing the specific condition causing the hemorrhage. Prevention strategies target those with risk factors like ulcers, cirrhosis, or who take anti-inflammatory drugs.
1. Diarrhea is defined as more frequent bowel movements with soft and liquid stools. It is usually caused by viruses, bacteria, parasites, certain foods, medications, and other digestive disorders.
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1. Pulmonary tuberculosis is a chronic infectious disease caused by the bacterium Mycobacterium tuberculosis, which usually affects the lungs. It spreads through the air when people who are sick with TB cough, sneeze or speak.
2. Symptoms include a persistent cough lasting more than two weeks, coughing up blood, weight loss, fever, night sweats and fatigue. Diagnosis involves physical exams, chest x-rays, sputum tests and tuberculosis skin tests.
3. Treatment involves a multi-drug regimen administered by a tuberculosis specialist to prevent drug resistance. Patients are advised to rest at home and cover their mouth when coughing to prevent spreading the disease until treatment has reduced their contagious
1. Pulmonary embolism is caused by a blood clot in the lung, usually formed in the deep veins of the lower limbs. It is a leading cause of preventable death in hospitalized patients.
2. Symptoms include shortness of breath, chest pain, increased heart rate, coughing up blood, and fainting. Diagnosis involves assessing risk factors and test like D-dimer and CT scan.
3. Treatment involves anticoagulant drugs to dissolve clots initially by injection and then orally for 3-6 months. Prevention focuses on continuing anticoagulants, lifestyle changes like exercise and diet, wearing compression stockings, and early movement after surgery.
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1. Prednisolone and Mycobacterium indicus pranii in Tuberculous
Pericarditis
Bongani M Mayosi, M.B., Ch.B., D.Phil., Mpiko Ntsekhe, M.D., Ph.D., Jackie Bosch, Ph.D.,
Shaheen Pandie, M.Med. (Med.), Hyejung Jung, M.Sc., Freedom Gumedze, Ph.D., Janice
Pogue, Ph.D., Lehana Thabane, Ph.D., Marek Smieja, M.D., Ph.D., Veronica Francis, R.N.,
Laura Joldersma, B.Sc., Kandithalal M. Thomas, M.B., B.S., Baby Thomas, M.B., B.S.,
Abolade A. Awotedu, M.B., B.S., Nombulelo P. Magula, M.B., Ch.B., Datshana P. Naidoo,
M.B., Ch.B., Ph.D., Albertino Damasceno, M.D., Ph.D., Alfred Chitsa Banda, M.B., Ch.B.,
Basil Brown, M.B., Ch.B., Pravin Manga, M.B., B.Ch., Bruce Kirenga, M.B., Ch.B., Charles
Mondo, M.B., Ch.B., Ph.D., Phindile Mntla, M.B., Ch.B., Jacob M. Tsitsi, M.B., B.Ch.,
Ferande Peters, M.B., B.Ch., Mohammed R. Essop, M.B., B.Ch., James B.W. Russell, M.B.,
Ch.B., James Hakim, M.D., Jonathan Matenga, M.B., Ch.B., Ayub F. Barasa, M.B., Ch.B.,
Mahmoud U. Sani, M.B., B.S., Taiwo Olunuga, M.B., B.Ch., Okechukwu Ogah, M.B., Ch.B.,
Victor Ansa, M.B., Ch.B., Akinyemi Aje, M.B., Ch.B., Solomon Danbauchi, M.B., Ch.B, Dike
Ojji, M.B., B.S., Ph.D., and Salim Yusuf, M.B., B.S., D.Phil. for the IMPI Trial Investigators*
Cardiac Clinic, Department of Medicine, Groote Schuur Hospital and University of Cape Town
(B.M.M., M.N., S.P., V.F.), and Department of Statistical Sciences, University of Cape Town (F.G.),
Cape Town, Department of Internal Medicine, Nelson Mandela Academic Hospital and Walter
Sisulu University, Mthatha (K.M.T., B.T., A.A.A.), Division of Medicine, King Edward VIII Hospital,
and University of KwaZulu Natal, Durban (N.P.M.), Department of Cardiology, Inkosi Albert Luthuli
Central Hospital and University of KwaZulu Natal, Durham (D.P.N.), Department of Cardiology,
Provincial and Livingstone Hospitals, and Walter Sisulu University, Port Elizabeth (B.B.), Division
of Cardiology, Charlotte Maxeke Johannesburg Academic Hospital, and University of the
Witwatersrand, Johannesburg (P. Manga), Division of Cardiology, Dr. George Mukhari Hospital,
and University of Limpopo, Pretoria (P. Mntla), and Division of Cardiology, Chris Hani
Baragwanath Hospital, and University of Witwatersrand, Soweto (J.M.T., F.P., M.R.E.) — all in
South Africa; McMaster University and the Population Health Research Institute, Hamilton Health
Sciences, Hamilton, ON, Canada (J.B., H.J., J.P., L.T., M.S., L.J., S.Y.); Hospital Central de
Maputo, Maputo, Mozambique (A.D.); Malawi Military Health Services, Lilongwe, Malawi (A.C.B.);
New Mulago Hospital, Kampala, Uganda (B.K., C.M.); Connaught Hospital, Free-town, Sierra
Leone (J.B.W.R.); Parirenyatwa Hospital, Harare, Zimbabwe (J.H., J.M.); Moi Hospital, Eldoret,
Kenya (A.F.B.); and Aminu Kano Teaching Hospital, Kano (M.U.S.), Federal Medical Center,
Abeokuta, Ogun State (T.O., O.O.), University of Calabar Teaching Hospital, Calabar (V.A.),
University College Hospital, Ibadan, Oyo State (A.A.), Ahmadu Bello Teaching Hospital, Zaria,
Kaduna State (S.D.), and Abuja Teaching Hospital, Abuja (D.O.) — all in Nigeria
Address reprint requests to Dr. Mayosi at the Department of Medicine, Old Groote Schuur Hospital, J Fl., Rm. J46-53, Groote Schuur
Dr., Observatory, Cape Town, 7925, South Africa, or at bongani.mayosi@uct.ac.za.
*A complete list of the investigators in the Investigation of the Management of Pericarditis (IMPI) trial is provided in the
Supplementary Appendix, available at NEJM.org.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
N Engl J Med. Author manuscript; available in PMC 2016 June 18.
Published in final edited form as:
N Engl J Med. 2014 September 18; 371(12): 1121–1130. doi:10.1056/NEJMoa1407380.
CIHRAuthorManuscriptCIHRAuthorManuscriptCIHRAuthorManuscript
2. Abstract
BACKGROUND—Tuberculous pericarditis is associated with high morbidity and mortality even
if antituberculosis therapy is administered. We evaluated the effects of adjunctive glucocorticoid
therapy and Mycobacterium indicus pranii immunotherapy in patients with tuberculous
pericarditis.
METHODS—Using a 2-by-2 factorial design, we randomly assigned 1400 adults with definite or
probable tuberculous pericarditis to either prednisolone or placebo for 6 weeks and to either M.
indicus pranii or placebo, administered in five injections over the course of 3 months. Two thirds
of the participants had concomitant human immunodeficiency virus (HIV) infection. The primary
efficacy outcome was a composite of death, cardiac tamponade requiring pericardiocentesis, or
constrictive pericarditis.
RESULTS—There was no significant difference in the primary outcome between patients who
received prednisolone and those who received placebo (23.8% and 24.5%, respectively; hazard
ratio, 0.95; 95% confidence interval [CI], 0.77 to 1.18; P = 0.66) or between those who received
M. indicus pranii immunotherapy and those who received placebo (25.0% and 24.3%,
respectively; hazard ratio, 1.03; 95% CI, 0.82 to 1.29; P = 0.81). Prednisolone therapy, as
compared with placebo, was associated with significant reductions in the incidence of constrictive
pericarditis (4.4% vs. 7.8%; hazard ratio, 0.56; 95% CI, 0.36 to 0.87; P = 0.009) and
hospitalization (20.7% vs. 25.2%; hazard ratio, 0.79; 95% CI, 0.63 to 0.99; P = 0.04). Both
prednisolone and M. indicus pranii, each as compared with placebo, were associated with a
significant increase in the incidence of cancer (1.8% vs. 0.6%; hazard ratio, 3.27; 95% CI, 1.07 to
10.03; P = 0.03, and 1.8% vs. 0.5%; hazard ratio, 3.69; 95% CI, 1.03 to 13.24; P = 0.03,
respectively), owing mainly to an increase in HIV-associated cancer.
CONCLUSIONS—In patients with tuberculous pericarditis, neither prednisolone nor M. indicus
pranii had a significant effect on the composite of death, cardiac tamponade requiring
pericardiocentesis, or constrictive pericarditis. (Funded by the Canadian Institutes of Health
Research and others; IMPI ClinicalTrials.gov number, NCT00810849.)
Tuberculous pericarditis is a common cause of pericardial effusion, cardiac tamponade, and
constrictive pericarditis in sub-Saharan Africa and parts of Asia.1–3 Patients with
tuberculous pericarditis often have concomitant human immunodeficiency virus (HIV)
infection.1 Despite antituberculosis therapy, pericardial drainage, or pericardiectomy,
mortality and morbidity remain high.4 Mortality is as high as 26% at 6 months but is even
higher (approximately 40%) among persons with the acquired immunodeficiency syndrome.
5
The use of glucocorticoid therapy in patients with tuberculous pericarditis to attenuate the
inflammatory response may improve outcomes and decrease the risk of death by reducing
cardiac tamponade and pericardial constriction,6 but the clinical effectiveness of adjunctive
glucocorticoids is unclear.7–9 A meta-analysis of randomized, controlled trials of
glucocorticoid therapy for tuberculous pericarditis showed a nonsignificant reduction in
mortality,7,8 but the numbers of events and patients included were very small. A meta-
analysis of all trials of adjunctive glucocorticoid therapy for all forms of tuberculosis also
suggested reduced mortality.10
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3. However, glucocorticoids may increase the risk of cancer in HIV-infected patients,11,12 and
there is scant evidence of the effects of adjunctive glucocorticoid therapy for tuberculosis in
this population.10 These considerations have led to conflicting recommendations in
international guidelines regarding the role of adjunctive glucocorticoid therapy in patients
with tuberculous pericarditis.9,13,14 We hypothesized that there would be an overall benefit
of adjunctive prednisolone for these patients.
Preliminary evidence suggests that repeated doses of intradermal heat-killed Mycobacterium
indicus pranii (formerly known as Mycobacterium w) immunotherapy may reduce
inflammation associated with tuberculosis and increase the CD4+ T-cell count in persons
infected with HIV.15–17 M. indicus pranii is a nonpathogenic, saprophytic, rapidly growing
atypical mycobacterium species that has shown clinical benefit when administered as a heat-
killed intradermal formulation in patients with leprosy and that may have benefits in patients
with pulmonary tuberculosis and HIV infection.16,18–22 We hypothesized that intradermal
M. indicus pranii could be effective in suppressing inflammation and its sequelae in patients
with tuberculous pericarditis. In the Investigation of the Management of Pericarditis (IMPI)
trial, we evaluated the efficacy and safety of adjunctive prednisolone and M. indicus pranii
in patients in Africa who had tuberculous pericarditis.
METHODS
STUDY DESIGN, CONDUCT, AND OVERSIGHT
We used a 2-by-2 factorial design to independently evaluate prednisolone and intradermal
M. indicus pranii, as compared with placebo, for the treatment of tuberculous pericarditis
(Fig. S1 in the Supplementary Appendix, available with the full text of this article at
NEJM.org). A detailed description of the design of the trial has been published previously.
4,23–25 The study was approved by the appropriate national regulatory authorities and by the
ethics committee at each participating site. All the participants provided written informed
consent.
Cadila Pharmaceuticals donated the study drugs used in the trial and distributed them to the
research sites but had no role in the design or conduct of the study, in the analysis of the
data, or in the decision to submit the manuscript for publication. The Canadian Institutes of
Health Research reviewed the protocol, and changes were made according to the comments
of the reviewers; the South African Medical Research Council also reviewed the protocol,
but no changes were recommended or made.
The study was coordinated by teams at the University of Cape Town, South Africa, and the
Population Health Research Institute (PHRI) at Hamilton Health Sciences and McMaster
University, Canada. The steering committee (see the Supplementary Appendix) designed the
study, oversaw its conduct, wrote the manuscript, and made the decision to submit it for
publication. An independent trial monitoring committee monitored the trial for safety and
efficacy. Data were collected and analyzed at the PHRI. The first and last authors vouch for
the accuracy of the data and the analyses and for the fidelity of this report to the trial
protocol, which is available at NEJM.org.
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4. ENROLLMENT CRITERIA
Details of the inclusion and exclusion criteria are provided in Table S1 in the Supplementary
Appendix. Patients were eligible for inclusion in the trial if they were 18 years of age or
older, had a pericardial effusion confirmed by echocardiography, had evidence of definite or
probable tuberculous pericarditis (as defined in Tables S2 and S3 in the Supplementary
Appendix), and had begun to receive antituberculosis treatment less than 1 week before
enrollment. Patients were excluded if an alternative cause of pericardial disease could be
identified, if they had used glucocorticoids within the previous month, if they had known
hypersensitivity or allergy to the M. indicus pranii preparation, or if they were pregnant.
STUDY PROCEDURES
Eligible patients who had provided written informed consent were assigned to an active-
treatment or placebo group for each of the two randomized comparisons. Randomization
was performed with the use of a central computer-generated randomization list, with
stratification according to center and with a random block size. For the comparison of
prednisolone with placebo, participants were assigned to receive prednisolone or placebo for
6 weeks at a dose of 120 mg per day in the first week, 90 mg per day in the second week, 60
mg per day in the third week, 30 mg per day in the fourth week, 15 mg per day in the fifth
week, and 5 mg per day in the sixth week. For the comparison of M. indicus pranii with
placebo, participants were assigned to receive the M. indicus pranii preparation (CADI-Mw
injection, Cadila Pharmaceuticals) or placebo in five doses — at the time of enrollment and
at 2 weeks, 4 weeks, 6 weeks, and 3 months. The first dose was given as two injections of
0.1 ml (containing 0.5×109 organisms) in each deltoid region of the upper arm; the four
subsequent doses were given as a single injection of 0.1 ml.
Trial participants received antimicrobial treatment for tuberculosis and antiretroviral
treatment for HIV according to World Health Organization (WHO) guidelines; management
during the course of the trial was revised as recommended treatment practices evolved.
13,26–28 No routine testing for drug resistance of either M. tuberculosis isolates or HIV
isolates was performed before or during treatment.
Follow-up data were collected at the time of hospital discharge; at 2 weeks, 4 weeks, 6
weeks, 3 months, and 6 months; then every 6 months through 2 years; and every 12 months
thereafter. Follow-up visits included assessments of study outcomes, adherence to treatment,
and adverse events. Site monitoring throughout the study was performed through the project
coordinating office according to a standard operating procedure (see the Site Monitoring and
Quality Control Section in the Supplementary Appendix).
OUTCOMES
The primary efficacy outcome was a composite of death or the first occurrence of cardiac
tamponade requiring pericardiocentesis or constrictive pericarditis. Secondary efficacy
outcomes included the individual components of the primary outcome as well as
hospitalization. Safety outcomes included opportunistic infections and cancer, as well as the
effect of interventions on the CD4+ T-lymphocyte cell count (as a measure of
immunosuppression) and the incidence of the immune reconstitution inflammatory
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5. syndrome (in HIV-infected patients). Detailed definitions of outcome events are provided in
Tables S4 through S8 and the Methods section in the Supplementary Appendix.
STATISTICAL ANALYSIS
We based our sample-size calculation on the following assumptions: the event rate among
patients receiving placebos for both interventions would be 35% at a mean follow-up of 2
years; half the patients in the control group for each intervention would receive another
effective intervention, which would result in a 30% relative risk reduction in the event rate;
the nonadherence rate would be 10%; and the rate of loss to follow-up would be 6%. On the
basis of these assumptions, we estimated that with a sample of 1400 patients, the study
would have 90% power to detect a 22.9% reduction in the hazard ratio, with the use of a log-
rank test and a two-sided type I error rate of 5%.
Data were analyzed with the use of SAS software, version 9.1, according to an intention-to-
treat approach (as described in the protocol and the prespecified statistical analysis plan).
Time-to-event curves were constructed by means of product-limit estimation and were
compared with the use of stratified log-rank tests. Cox proportional-hazards models
stratified according to factorial treatment assignment were used to determine hazard ratios
and 95% confidence intervals. We assessed interactions between the two active treatments
by including an interaction term in the model.
We also performed analyses for the primary outcome in subgroups defined according to HIV
status, the strength of the evidence supporting the tuberculous pericarditis diagnosis (definite
or probable diagnosis), exposure of HIV-infected persons to antiretroviral therapy (>6
months, ≤6 months, or no exposure), the CD4+ T-cell count threshold for treatment (≤200
per cubic millimeter vs. >200 per cubic millimeter and ≤350 per cubic millimeter vs. >350
per cubic millimeter), and pericardiocentesis status at baseline (performed vs. not
performed), using the Cox proportional-hazards model, with an interaction term for
treatment effects across the subgroups. For all analyses, P values of less than 0.05 were
considered to indicate statistical significance.
The trial monitoring committee performed seven interim analyses of the primary outcome
data; at the sixth interim analysis, the trial monitoring committee recommended that the M.
indicus pranii randomization be discontinued for reasons of futility.
RESULTS
STUDY POPULATION
The trial was conducted from January 2009 through February 2014 at 19 hospitals in eight
African countries (see the Supplementary Appendix). A total of 1400 patients were enrolled
for the comparison of prednisolone with placebo; 706 were assigned to receive prednisolone
and 694 to receive placebo. The median follow-up period was 636.5 days (interquartile
range, 317.5 to 1085.5); at study end, the primary-outcome status was known for 1371
participants (97.9%) (Fig. S2 in the Supplementary Appendix).
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6. A total of 1250 patients were enrolled for the comparison of M. indicus pranii with placebo,
before this comparison was stopped early for futility (on February 14, 2013); 625 were
assigned to receive M. indicus pranii and 625 to receive placebo. The median follow-up
period was 720.5 days (interquartile range, 368.0 to 1095.0); at study end, the primary-
outcome status was known for 1223 participants (97.8%) (Fig. S3 in the Supplementary
Appendix).
The baseline characteristics were similar across the groups (Table 1, and Table S9 in the
Supplementary Appendix). Approximately two thirds of the participants had a large
pericardial effusion; pericardiocentesis was performed in 60.5%. The diagnosis of
tuberculous pericarditis was considered to be definite in 17.1% of the patients (details are
provided in Table S10 in the Supplementary Appendix). Two thirds of the participants were
HIV-positive.
TREATMENT REGIMENS AND ADHERENCE
For the comparison of prednisolone with placebo, 88.5% of the patients in the prednisolone
group and 88.7% of those in the placebo group adhered to the regimen for the full 6 weeks
of the study treatment. A total of 44 patients (3.1%) received nonstudy glucocorticoids
during the trial; this rate was similar in the prednisolone and placebo groups. For the
comparison of M. indicus pranii with placebo, 75.9% of the patients in the M. indicus pranii
group and 81.4% of those in the placebo group adhered to the regimen for the full 3 months
of the study treatment.
Of the 1400 patients enrolled in the trial, 76.6% were receiving antituberculosis treatment at
the time of randomization, and 14.5% were receiving antiretroviral treatment (Table S11 in
the Supplementary Appendix). The rates of ongoing use of antituberculosis therapy and
antiretroviral therapy during the trial are shown in Tables S12 and S13 in the Supplementary
Appendix. The increasing use of antiretroviral therapy during the course of the trial reflects
the adoption of revised WHO guidelines recommending early initiation of antiretroviral
treatment in HIV-positive patients with tuberculosis.27,28
PREDNISOLONE COMPARISON
The rate of the primary composite outcome (death, cardiac tamponade requiring
pericardiocentesis, or constrictive pericarditis) was 14.3 events per 100 patient-years of
follow-up in the prednisolone group and 14.8 per 100 patient-years in the placebo group
(hazard ratio with prednisolone, 0.95; 95% confidence interval [CI], 0.77 to 1.18; P = 0.66)
(Table 2 and Fig. 1A, and Fig. S4 in the Supplementary Appendix). There was also no
significant difference between the two groups in the rate of death or the rate of cardiac
tamponade requiring pericardiocentesis, when considered individually (Fig. S5 and S6 in the
Supplementary Appendix). The main causes of death were pericarditis (23.8%),
disseminated tuberculosis (18.6%), HIV infection (7.3%), and other cardiovascular causes
(5.7%) (Table S14 in the Supplementary Appendix). The prednisolone group had a lower
rate of constrictive pericarditis and fewer hospitalizations than the placebo group (Table 2,
and Table S15 and Fig. S7 and S8 in the Supplementary Appendix).
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7. The incidence of opportunistic infection was 6.89 cases per 100 patient-years in the
prednisolone group, as compared with 5.91 per 100 patient-years in the placebo group
(hazard ratio, 1.16; 95% CI, 0.84 to 1.61; P = 0.36) (Fig. S9 in the Supplementary
Appendix). The proportion of patients with candidiasis was higher in the prednisolone group
than in the placebo group (7.7% vs. 5.2%, P = 0.05) (Table 3, and Table S16 in the
Supplementary Appendix).
Prednisolone, as compared with placebo, was associated with an increased incidence of
cancer (1.05 vs. 0.32 cases per 100 person-years; hazard ratio, 3.27; 95% CI, 1.07 to 10.03;
P = 0.03) (Table 3, and Fig. S10 in the Supplementary Appendix). This increase was due to a
higher incidence of HIV-related cancers in the prednisolone group than in the placebo group
(0.73 vs. 0.08 per 100 person-years; hazard ratio, 9.04; 95% CI, 1.14 to 71.33; P=0.04).
(Table 3). A list of the causes of cancer is provided in Table S17 in the Supplementary
Appendix.
There were two cases of the immune reconstitution inflammatory syndrome in the
prednisolone group and one in the placebo group. There was a similar increase in CD4+ T-
cell counts in the two groups (Table S18 in the Supplementary Appendix).
M. INDICUS PRANII COMPARISON
The rates of the primary composite outcome and its components, as well as the rates of
hospitalization and opportunistic infection, did not differ significantly between the M.
indicus pranii group and the placebo group (Tables 2 and 3 and Fig. 1B, and Fig. S11
through S16 in the Supplementary Appendix). However, M. indicus pranii was associated
with an increased incidence of cancer, as compared with placebo (0.92 vs. 0.24 cases per
100 person-years; hazard ratio, 3.69; 95% CI, 1.03 to 13.24; P = 0.03) (Table 3, and Fig. S17
in the Supplementary Appendix), which was due mainly to an increase in HIV-associated
cancer. There was one case of the immune reconstitution inflammatory syndrome in each
group. There was a similar increase in CD4+ T-cell counts in the two groups.
Significantly more patients in the M. indicus pranii group than in the placebo group had
injection-site reactions (41.4% vs. 2.9%, P<0.001) (Table S19 and Fig. S18 in the
Supplementary Appendix). Although the majority of these reaction were characterized by
minor symptoms and signs of inflammation (i.e., induration, redness, and pain), there was a
significantly greater proportion of patients with abscess formation in the M. indicus pranii
group than in the placebo group (15.0% vs. 1.0%, P<0.001).
PREDNISOLONE AND M. INDICUS PRANII INTERACTION AND SUBGROUP ANALYSES
There was no significant interaction between the effects of M. indicus pranii and those of
prednisolone on the primary efficacy and safety outcomes (P>0.30 for all interactions),
except for injection-site reactions (P = 0.004) (Fig. S4 and S11 in the Supplementary
Appendix). However, 9 of the 13 cases of cancer in the prednisolone group occurred in
patients who also received M. indicus pranii (Fig. 2). Although a clinical interaction of the
two interventions on cancer cannot be ruled out, the number of cases is small.
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8. The effects of prednisolone and M. indicus pranii immunotherapy on the primary composite
efficacy outcome were similar across prespecified subgroups (Fig. S19 and S20 in the
Supplementary Appendix).
DISCUSSION
In this trial, adjunctive prednisolone therapy and M. indicus pranii immunotherapy were
compared with placebo in patients with definite or probable tuberculous pericarditis. Neither
therapy had a significant effect on the primary composite outcome of death, cardiac
tamponade requiring pericardiocentesis, or constrictive pericarditis. With respect to the
secondary outcomes, adjunctive prednisolone therapy reduced the incidence of constrictive
pericarditis and the incidence of hospitalizations. However, both interventions increased the
incidence of cancer among trial participants.
Previous trials of adjunctive glucocorticoid therapy in patients with tuberculous pericarditis
had relatively small samples (28 to 240 patients) and included few HIV-infected patients,
and there was poor reporting of adverse events.10,29–34 Our trial included 1400 patients, a
substantial number of whom (940 patients) had HIV infection. To our knowledge, M.
indicus pranii immunotherapy has not been studied previously in this population.
For the prednisolone comparison, we used an initiation dose of 120 mg per day, which is
known to have a therapeutic effect when administered in combination with rifampin, an
enzyme inducer that increases the metabolism of glucocorticoids.35 Adherence to
prednisolone therapy was high. The significant reduction in pericardial constriction with
prednisolone indicates that the doses used were sufficient to achieve a substantial
antiinflammatory effect. The reduction in the incidence of constrictive pericarditis translated
to fewer hospitalizations in the prednisolone-treated group. This finding is important
because pericardiectomy, the definitive treatment for chronic pericardial constriction, is
associated with high perioperative mortality and morbidity, and cardiac surgery is not widely
available in Africa.2,36
The marked increase in HIV-related cancer with prednisolone therapy is consistent with the
results of two previous studies of HIV-associated tuberculosis, in which cases of Kaposi’s
sarcoma occurred only in the prednisolone-treated groups.11,12 However, the association of
M. indicus pranii immunotherapy with cancer that we observed in our study has not been
reported previously. It is possible that adjunctive glucocorticoids and M. indicus pranii act
synergistically to increase the risk of cancer in immunosuppressed patients. The available
data on the interaction between adjunctive glucocorticoid therapy and M. indicus pranii
immunotherapy are sparse.23
Our study has a few limitations. First, a definite diagnosis of tuberculosis either in the
pericardium or elsewhere in the body was made in only one quarter of the patients. Thus,
one potential interpretation of the trial result is that the interventions were not effective
because relatively few of the trial participants actually had tuberculous pericarditis.
However, the results were consistent between patients with definite tuberculosis and those
with probable tuberculosis. Furthermore, the diagnosis of extrapulmonary tuberculosis is
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9. challenging, and only a minority of cases of extrapulmonary tuberculosis are treated on the
basis of a definite diagnosis.37 Second, a small proportion of patients (less than 2%) had a
diagnosis other than tuberculosis. However, although the estimation of the sample size
needed for this study was based on the clinical case definition of tuberculous pericarditis,4
we expected that a small proportion of cases (up to 10%) would have an alternative cause of
pericarditis.23 Third, the trial was powered for a rate of nonadherence of 10% in the active-
treatment groups. Although this rate was almost achieved in the prednisolone group (non-
adherence rate of 11%), the nonadherence rate was higher in the M. indicus pranii group
(21%), owing mainly to injection-site side effects. This relatively high nonadherence rate
may have diminished the power of the study with respect to the analysis of the primary
outcome in the M. indicus pranii group. Finally, because prednisolone is immunosuppressive
and M. indicus pranii is immunostimulatory, there may be an interaction between them that
could result in each one either reducing or increasing the effects of the other one.23
In conclusion, adjunctive therapy with prednisolone for 6 weeks and with M. indicus pranii
for 3 months did not have a significant effect on the combined outcome of death from all
causes, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis. Both
therapies were also associated with an increased risk of HIV-associated cancer. However, the
use of adjunctive glucocorticoids reduced the incidences of pericardial constriction and
hospitalization. The beneficial effects of prednisolone with respect to pericardial constriction
and hospitalization were similar in HIV-positive and HIV-negative patients.
Supplementary Material
Refer to Web version on PubMed Central for supplementary material.
Acknowledgments
Supported by grants from the Canadian Institutes of Health Research, the Canadian Network and Centre for Trials
Internationally, the Population Health Research Institute, the South African Medical Research Council, the Lily and
Ernst Hausmann Research Trust, and Cadila Pharma, India.
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12. Figure 1. Kaplan–Meier Estimates of the Time to the Primary Efficacy Outcome, According to
Treatment Group
Data on the time to the primary efficacy outcome of death, cardiac tamponade requiring
pericardiocentesis, or constrictive pericarditis are shown for patients who received
prednisolone or placebo (Panel A) and Mycobacterium indicus pranii or placebo (Panel B).
Mayosi et al. Page 12
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13. Figure 2. Time to Cancer Occurrence
Shown are Kaplan–Meier estimates of the time to cancer occurrence for all four
comparisons in the 2-by-2 factorial trial. The inset shows the same data on an enlarged y
axis.
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Table 1
Baseline Characteristics of the Patients and Diagnosis at 3 Months.*
Variable
Prednisolone (N =
706)
Placebo (N =
694)
Mycobacterium indicus
pranii (N = 625)
Placebo (N =
625)
Age — yr 38.8±13.5 38.5±13.3 37.7±12.5 39.3±14.1
Weight — kg 59.6±12.3 59.2±12.1 58.6±12.2 59.6±12.0
Female sex — no. (%) 317 (44.9) 299 (43.1) 292 (46.7) 263 (42.1)
Size of pericardial effusion — no. (%)
Small, <1 cm 51 (7.2) 56 (8.1) 58 (9.3) 40 (6.4)
Moderate, 1–2 cm 172 (24.4) 159 (22.9) 154 (24.6) 140 (22.4)
Large, >2 cm 462 (65.4) 460 (66.3) 391 (62.6) 428 (68.5)
Not measured 21 (3.0) 19 (2.7) 22 (3.5) 17 (2.7)
Pericardiocentesis — no. (%)
Performed 428 (60.6) 419 (60.4) 372 (59.5) 381 (61.0)
Not performed 278 (39.4) 275 (39.6) 253 (40.5) 244 (39.0)
Diagnosis at 3 months — no. (%)
Definite tuberculous pericarditis 116 (16.4) 122 (17.6) 100 (16.0) 105 (16.8)
Probable tuberculous pericarditis
Tuberculosis proven elsewhere 73 (10.3) 63 (9.1) 67 (10.7) 53 (8.5)
Tuberculosis not proven elsewhere 506 (71.7) 506 (72.9) 450 (72.0) 462 (73.9)
Non-tuberculous cause 11 (1.6) 3 (0.4) 8 (1.3) 5 (0.8)
HIV status — no. (%)
Positive 474 (67.1) 465 (67.0) 437 (69.9) 403 (64.5)
Negative 218 (30.9) 213 (30.7) 175 (28.0) 209 (33.4)
Unknown 14 (2.0) 16 (2.3) 13 (2.1) 13 (2.1)
Antituberculosis medication at randomization
— no. (%)
541 (76.6) 531 (76.5) 460 (73.6) 462 (73.9)
Antiretroviral medication at randomization —
no. (%)
99 (14.0) 104 (15.0) 88 (14.1) 84 (13.4)
*
Plus–minus values are means ±SD. There were no significant differences among the study groups in any of the baseline characteristics listed here.
HIV denotes human immunodeficiency virus.
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Table2
EffectsofPrednisoloneandMycobacteriumindicuspraniiImmunotherapyonEfficacyOutcomes.*
Outcome
Prednisolone(N=
706)Placebo(N=694)
HazardRatio
(95%CI)PValue
Mycobacteriumindicus
pranii(N=625)Placebo(N=625)
HazardRatio
(95%CI)PValue
no.of
patients
(%)
no.of
events/1
00
person-
yr
no.of
patients
(%)
no.of
events/1
00
person-
yr
no.of
patients
(%)
no.of
events/1
00
person-
yr
no.of
patients
(%)
no.of
events/1
00
person-
yr
Primarycomposite
outcome:death,cardiac
tamponade,orconstrictive
pericarditis
168(23.8)14.3170(24.5)14.80.95(0.77–1.18)0.66156(25.0)13.97152(24.3)13.41.03(0.82–1.29)0.81
Secondaryoutcomes
Deathfromanycause133(18.8)10.6115(16.6)9.11.15(0.90–1.48)0.26119(19.0)9.81111(17.8)9.021.07(0.83–1.39)0.59
Cardiactamponade22(3.1)1.828(4.0)2.30.77(0.44–1.35)0.3722(3.5)1.8622(3.5)1.840.99(0.55–1.79)0.98
Constrictivepericarditis31(4.4)2.5854(7.8)4.560.56(0.36–0.87)0.00936(5.8)3.1537(5.9)3.150.97(0.61–1.53)0.89
Hospitalization146(20.7)13.27175(25.2)16.70.79(0.63–0.99)0.04152(24.3)14.90141(22.6)13.31.09(0.87–1.37)0.46
*
PercentageswerecalculatedwiththeuseoftheKaplan–Meiermethod.Hazardratiosarefortheactive-treatmentgroupascomparedwiththeplacebogroup.
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Table3
EffectsofPrednisoloneandMycobacteriumindicuspraniiimmunotherapyonSafetyOutcomes.
Outcome
Prednisolone(N=
706)Placebo(N=694)
HazardRatio
(95%CI)PValue
Mycobacterium
indicuspranii(N=
625)Placebo(N=625)
HazardRatio
(95%CI)PValue
no.of
patients
(%)
no.of
events/1
00
person-
yr
no.of
patients
(%)
no.of
events/1
00
person-
yr
no.of
patients
(%)
no.of
events/10
0
person-
yr
no.of
patients
(%)
no.of
events/1
00
person-
yr
Opportunisticinfection78(11.0)6.8968(9.8)5.911.16(0.84–1.61)0.3675(12.0)6.8661(9.8)5.451.25(0.89–1.75)0.20
Candidainfection54(7.6)4.6836(5.2)3.011.52(1.00–2.32)0.0547(7.5)4.1737(5.9)3.201.28(0.83–1.96)0.26
Cancer13(1.8)1.054(0.6)0.323.27(1.07–10.03)0.0311(1.8)0.923(0.5)0.243.69(1.03–13.24)0.03
HIV-relatedcancer9(1.3)0.731(0.1)0.089.04(1.14–71.33)0.047(1.1)0.582(0.3)0.163.53(0.73–17.01)0.09
Immunereconstitutiondisease2(0.3)0.161(0.1)0.082.02(0.18–22.28)0.561(0.2)0.081(0.2)0.081.00(0.06–16.02)>0.99
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