«The first cause of recurrent infections in children is... childhood itself.» (J. Gary Wheeler)
Is it possibe to treat and prevent recurrent respiratory infections (RTIs) in pediatric age? Some studies have shown that immunostimulants/immunomodulators can reduce and prevent RTIs in children.
To learn more please visit www.waidid.org
1. This document summarizes recent developments in sublingual immunotherapy (SLIT), including updated practice parameters from 2017.
2. SLIT involves holding allergen extracts under the tongue to induce tolerance and has been shown to effectively treat allergic rhinitis and asthma symptoms.
3. The 2017 parameter outlines efficacy evidence for house dust mite SLIT tablets in asthma treatment and safety guidelines for SLIT administration and management of adverse events.
Congenital CMV infection is a leading cause of sensorineural hearing loss and mental retardation. Approximately 0.15-2% of live births are affected. While most infections are asymptomatic, 10% of symptomatic newborns die and survivors often have lifelong disabilities. Congenital CMV is transmitted from mother to fetus via the placenta or during birth if the mother is infected. Young children are the primary transmitters of CMV through bodily fluids. Treatment with ganciclovir may help reduce hearing loss in symptomatic newborns but is associated with significant toxicity. Prevention through hygiene and education is important since there is no vaccine.
Bullous myringitis is a condition where fluid-filled blisters form on the eardrum, caused by viruses like influenza or bacteria like mycoplasma pneumoniae. It presents with sudden, severe pain in one ear following an upper respiratory infection, along with blood-stained discharge from the ear canal and hearing loss. On examination, blisters can be seen on the eardrum and inner ear canal. It is usually diagnosed based on symptoms and examination findings. While the eardrum heals within days, sensorineural hearing loss affects between 15-67% of patients, though often improves within 3 months with antibiotics.
Ear barotrauma causes, symptoms and treatmentmishramanali
Ear barotrauma is discomfort or damage to the ear caused by pressure differences between the inside and outside of the eardrum. It occurs when the Eustachian tube becomes blocked, preventing equalization of pressure changes that happen with altitude changes like flying or scuba diving. Symptoms include ear pain, fullness, bleeding, and hearing loss. Treatment involves relieving nasal congestion to open the Eustachian tube through decongestants, yawning, chewing gum, or ear tubes inserted during surgery for chronic cases. Preventive measures consist of descending slowly, breathing exercises, and avoiding earplugs during pressure changes.
This document provides an overview of allergic rhinitis. It defines allergic rhinitis as an IgE-mediated hypersensitivity disease characterized by sneezing, nasal discharge and obstruction. The document notes that allergic rhinitis prevalence is 15-20% globally, with higher rates in children. It affects quality of life by impacting school/work performance. Risk factors include genetics, family history of atopy, environmental irritants and allergens. Diagnosis involves history, exam, skin prick tests and blood tests. Management includes environmental control, nasal irrigation, medications like antihistamines, decongestants, steroids and immunotherapy.
This document summarizes key aspects of immunotherapy. It discusses the history and mechanisms of immunotherapy, indications for its use, types of allergen extracts, administration schedules, safety considerations, and special populations. Specifically, it notes that immunotherapy involves administering allergens to desensitize patients, works by altering the immune response, and is effective for respiratory allergies and insect venom. Safety monitoring and premedication can reduce risks of local and systemic reactions.
This document discusses the differential diagnosis of nasal masses. It begins by listing common symptoms that may indicate a nasal mass such as nasal obstruction, rhinorrhea, congestion, and hyposmia. Physical examination findings related to different locations and extensions of masses are described. Nasal masses are then categorized anatomically as normal variants, congenital/developmental, inflammatory/infectious, and neoplasms. Specific conditions are discussed in detail, providing information on symptoms, appearance, relevant test findings, and other characteristics. Incidence data from one study on common nasal masses is presented. The document concludes with a brief overview of malignant nasal masses.
Hepatomegaly, diarrhea and failure to thriveSanjeev Kumar
This document summarizes the case of a child presenting with hepatomegaly, diarrhea, and failure to thrive. Initial treatment with antibiotics showed no improvement. Further investigation with MRCP and liver biopsy revealed Caroli's disease, with atypical findings of Langerhans cell histiocytosis on special staining of biopsy samples. The key learning points were that an unusual clinical progression may indicate an evolving immunological disorder, non-response to antibiotics requires considering alternative diagnoses, and tissue diagnosis is important in obscure cases to obtain answers.
1. This document summarizes recent developments in sublingual immunotherapy (SLIT), including updated practice parameters from 2017.
2. SLIT involves holding allergen extracts under the tongue to induce tolerance and has been shown to effectively treat allergic rhinitis and asthma symptoms.
3. The 2017 parameter outlines efficacy evidence for house dust mite SLIT tablets in asthma treatment and safety guidelines for SLIT administration and management of adverse events.
Congenital CMV infection is a leading cause of sensorineural hearing loss and mental retardation. Approximately 0.15-2% of live births are affected. While most infections are asymptomatic, 10% of symptomatic newborns die and survivors often have lifelong disabilities. Congenital CMV is transmitted from mother to fetus via the placenta or during birth if the mother is infected. Young children are the primary transmitters of CMV through bodily fluids. Treatment with ganciclovir may help reduce hearing loss in symptomatic newborns but is associated with significant toxicity. Prevention through hygiene and education is important since there is no vaccine.
Bullous myringitis is a condition where fluid-filled blisters form on the eardrum, caused by viruses like influenza or bacteria like mycoplasma pneumoniae. It presents with sudden, severe pain in one ear following an upper respiratory infection, along with blood-stained discharge from the ear canal and hearing loss. On examination, blisters can be seen on the eardrum and inner ear canal. It is usually diagnosed based on symptoms and examination findings. While the eardrum heals within days, sensorineural hearing loss affects between 15-67% of patients, though often improves within 3 months with antibiotics.
Ear barotrauma causes, symptoms and treatmentmishramanali
Ear barotrauma is discomfort or damage to the ear caused by pressure differences between the inside and outside of the eardrum. It occurs when the Eustachian tube becomes blocked, preventing equalization of pressure changes that happen with altitude changes like flying or scuba diving. Symptoms include ear pain, fullness, bleeding, and hearing loss. Treatment involves relieving nasal congestion to open the Eustachian tube through decongestants, yawning, chewing gum, or ear tubes inserted during surgery for chronic cases. Preventive measures consist of descending slowly, breathing exercises, and avoiding earplugs during pressure changes.
This document provides an overview of allergic rhinitis. It defines allergic rhinitis as an IgE-mediated hypersensitivity disease characterized by sneezing, nasal discharge and obstruction. The document notes that allergic rhinitis prevalence is 15-20% globally, with higher rates in children. It affects quality of life by impacting school/work performance. Risk factors include genetics, family history of atopy, environmental irritants and allergens. Diagnosis involves history, exam, skin prick tests and blood tests. Management includes environmental control, nasal irrigation, medications like antihistamines, decongestants, steroids and immunotherapy.
This document summarizes key aspects of immunotherapy. It discusses the history and mechanisms of immunotherapy, indications for its use, types of allergen extracts, administration schedules, safety considerations, and special populations. Specifically, it notes that immunotherapy involves administering allergens to desensitize patients, works by altering the immune response, and is effective for respiratory allergies and insect venom. Safety monitoring and premedication can reduce risks of local and systemic reactions.
This document discusses the differential diagnosis of nasal masses. It begins by listing common symptoms that may indicate a nasal mass such as nasal obstruction, rhinorrhea, congestion, and hyposmia. Physical examination findings related to different locations and extensions of masses are described. Nasal masses are then categorized anatomically as normal variants, congenital/developmental, inflammatory/infectious, and neoplasms. Specific conditions are discussed in detail, providing information on symptoms, appearance, relevant test findings, and other characteristics. Incidence data from one study on common nasal masses is presented. The document concludes with a brief overview of malignant nasal masses.
Hepatomegaly, diarrhea and failure to thriveSanjeev Kumar
This document summarizes the case of a child presenting with hepatomegaly, diarrhea, and failure to thrive. Initial treatment with antibiotics showed no improvement. Further investigation with MRCP and liver biopsy revealed Caroli's disease, with atypical findings of Langerhans cell histiocytosis on special staining of biopsy samples. The key learning points were that an unusual clinical progression may indicate an evolving immunological disorder, non-response to antibiotics requires considering alternative diagnoses, and tissue diagnosis is important in obscure cases to obtain answers.
The document discusses various pharmacological treatments for vertigo, including vestibular suppressants that reduce vertigo symptoms but also vestibular function, as well as anticholinergics, antihistamines, benzodiazepines, calcium channel blockers, and other drugs that modify neurotransmitter action in the vestibular system. Intratympanic therapies for conditions like Meniere's disease and gentamicin ablation of the vestibular system are also covered. Treatment depends on identifying the underlying pathomechanism through a detailed history, exam, tests and imaging.
This document discusses the importance of influenza vaccination during pregnancy. It notes that while major health organizations like CDC and WHO recommend the flu vaccine for pregnant women, only about 20% comply with this recommendation. It then outlines the rationale for vaccinating pregnant women, including that influenza poses a significant burden and can increase risks of complications during pregnancy like hospitalization, preterm birth, and fetal distress. Vaccinating pregnant women can help reduce the risk of influenza in young infants who are not yet eligible for the vaccine. The document provides background on influenza viruses, seasonal variation, impact on high-risk groups like pregnant women, and evidence from clinical trials on quadrivalent influenza vaccines.
This document discusses various methods for objectively measuring nasal patency and airflow, which is important for accurately assessing complaints of nasal obstruction. It describes rhinomanometry, which measures nasal resistance, and acoustic rhinomanometry, which provides anatomical data on nasal cross-sectional area. Several other tests are also mentioned, including peak nasal inspiratory flow, body plethysmography, and questionnaires. Overall, the document provides an overview of existing objective methods for evaluating nasal function and structure to help diagnose the cause of a blocked nose.
Steroids and their use in ENT
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YouTube Channel :
https://www.youtube.com/channel/UCu-oR9V3OdFNTJW5yqXWXxA
BY:
DR RAI M. AMMAR MADNI
Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Common triggers include foods, medications, insect stings, latex, and exercise. Symptoms involve multiple organ systems and include skin issues like hives, respiratory problems, gastrointestinal distress, cardiovascular or neurological issues. Diagnosis is based on acute onset of symptoms after exposure to a known or suspected allergen. Treatment involves supporting airway, breathing, and circulation. Epinephrine is given intramuscularly as first line treatment along with antihistamines and corticosteroids. Close monitoring is required and additional epinephrine or other vasopressors may be needed if hypotension persists.
Chronic tonsillitis refers to chronic inflammation of the palatine tonsils. It is characterized by (1) complaints reported by the patient such as recurring sore throats, (2) disruption of the tonsils' drainage function, and (3) morphological changes seen on histological examination. Compensated chronic tonsillitis presents with no complaints but local signs of inflammation, while decompensated chronic tonsillitis results in frequent sore throats, abscesses, and possible complications affecting other organs. Adenoid hypertrophy involves enlargement of the lymphoid tissue in the nasopharynx and can partially or fully block the nasal cavity, leading to various respiratory, ear, facial, dental, sleep
The document discusses various causes of dizziness and balance problems, including peripheral vestibular disorders like benign paroxysmal positional vertigo (BPPV) and vestibular neuritis, central causes like multiple sclerosis and migraines, and systemic issues. It provides details on evaluating patients, potential diagnoses based on history and exam findings, and management strategies for different conditions.
The document discusses balance disorders and how the balance system works. It describes how the inner ear, eyes, and skeletal systems interact to maintain balance. It provides details on different types of balance disorders like BPPV and Meniere's disease. It also discusses medical treatments for balance disorders like vestibular suppressants and vasodilators as well as procedures like Epley's maneuver.
- A 70 year old male presented with 10 years of dyspnea and white productive sputum without fever or other URI symptoms. Skin tests were positive for allergens.
- He has been prescribed several inhalers but was referred to determine if he has COPD or asthma.
- The document discusses the differences and similarities between the inflammation seen in COPD versus asthma. COPD typically involves neutrophilic inflammation in small airways and parenchyma while asthma usually shows eosinophilic inflammation, but there can be overlap between the conditions.
Neonatal herpes is caused by herpes simplex viruses HSV-1 and HSV-2. It can be transmitted to newborns during childbirth if the mother is shedding the virus asymptomatically or symptomatically. There are three main forms of neonatal herpes: disseminated disease affecting multiple organs, CNS disease presenting as encephalitis, and skin/eye/mouth disease limited to those areas. Prompt diagnosis via viral culture and PCR testing and treatment with intravenous acyclovir for 3 weeks can help prevent death and disabilities, which are more common in disseminated and CNS disease. Caesarean delivery and maternal antiviral suppression therapy during late pregnancy can help reduce the
The translabrynthine approach is used to surgically remove vestibular schwannomas. It provides the most direct exposure of the cerebellopontine angle but results in total hearing loss. The key steps involve complete mastoidectomy and labyrinthectomy to access the internal auditory canal. This allows for identification and preservation of the facial nerve while fully exposing the tumor for removal. Though it sacrifices any residual hearing, it allows for quick recovery and excellent postoperative facial nerve function outcomes.
The maxillary sinus is the largest and most commonly involved sinus in malignancies. Maxillary sinus carcinoma arises from the sinus lining and spreads locally through bone destruction and invasion of surrounding structures. Distant metastases occasionally occur in the lungs. Diagnosis involves radiography, CT scan, and biopsy. Treatment depends on tumor stage and may involve surgery, radiation therapy, or chemoradiation. Prognosis diminishes with increased stage, with a 5-year survival rate of 40-50% even with advances in multimodal therapy.
Allergen-specific immunotherapy involves administering increasing doses of allergens to induce tolerance. It works by inducing regulatory T cells that reduce the allergic response. Immunotherapy is effective for allergic rhinitis, asthma, and insect sensitivity. The goals are to eliminate symptoms or reduce medication needs. It is a safe and effective therapy when administered properly to suitable candidates.
This document discusses the evaluation and management of fever without source in infants and children. It defines fever without source and outlines the differential diagnosis. Key points include:
- Fever accounts for 20-35% of pediatric visits and 5-20% will have no apparent source after examination.
- Fever is regulated by the hypothalamus and results from pyrogens stimulating an increased set point.
- For infants under 3 months, a full sepsis workup is considered. Criteria like Rochester can help determine low risk for outpatient management.
- For children 3-36 months, the Yale Observation Scale can identify toxic-appearing children needing admission versus low-risk children who can be treated as out
1. Granulomatous lesions of the nose can be caused by infections, inflammation, or neoplasms. Common infectious causes include tuberculosis, leprosy, rhinoscleroma, and fungal infections like aspergillosis.
2. Sarcoidosis is a common inflammatory cause of nasal granulomas. It is a systemic condition of unknown etiology characterized by non-caseating granulomas. Nasal manifestations include crusting, bleeding, and septal perforation.
3. Wegener's granulomatosis is a necrotizing vasculitis that causes granulomatous inflammation in the respiratory tract and kidneys. In the nose it can cause septal destruction
1) Otitis media with effusion (OME), also known as glue ear, is a chronic accumulation of fluid in the middle ear behind an intact but retracted eardrum that can cause hearing loss.
2) It commonly affects young children, with the highest prevalence between ages 2-5 years old. Risk factors include age, male gender, family history, and exposure to smoke.
3) The fluid is caused by eustachian tube dysfunction preventing drainage and ventilation of the middle ear, which can be due to infections, allergies, or adenoid hypertrophy among other factors.
The Walgreen Timetable predicts that pulmonary tuberculosis can manifest within months of primary infection, while miliary and meningeal tuberculosis typically occur 2-6 months later. TB adenitis usually develops 3-9 months after infection, while bones and joints tuberculosis can take several years, and renal and genital tuberculosis may take over a decade to manifest. Pulmonary lesions from reactivation of dormant foci take years after primary infection.
Paranasal sinuses are air-filled spaces located around the nose. This document discusses the anatomy, physiology, development, and pathologies of the paranasal sinuses. It describes the examination and investigations used to evaluate sinus diseases. The major classifications of sinus pathologies discussed are developmental variations, inflammatory/infectious diseases, cysts, tumors, and other surgically relevant conditions. Specific conditions like polyps, sinusitis, and granulomatous diseases are described in more detail.
This document summarizes research on vaccination in children with chronic diseases. It discusses issues with influenza and pneumococcal vaccinations in high-risk groups. It reviews studies examining the immunogenicity, safety and efficacy of influenza and pneumococcal vaccines in various chronic conditions like asthma, cancer, and immunosuppression. It also discusses gaps in knowledge around the impact of influenza in different at-risk groups and the need for more data on vaccine immunogenicity, safety and efficacy in each high-risk population. The document emphasizes the importance of recommending influenza vaccination for children with chronic diseases and implementing strategies to increase vaccination coverage.
The document discusses various pharmacological treatments for vertigo, including vestibular suppressants that reduce vertigo symptoms but also vestibular function, as well as anticholinergics, antihistamines, benzodiazepines, calcium channel blockers, and other drugs that modify neurotransmitter action in the vestibular system. Intratympanic therapies for conditions like Meniere's disease and gentamicin ablation of the vestibular system are also covered. Treatment depends on identifying the underlying pathomechanism through a detailed history, exam, tests and imaging.
This document discusses the importance of influenza vaccination during pregnancy. It notes that while major health organizations like CDC and WHO recommend the flu vaccine for pregnant women, only about 20% comply with this recommendation. It then outlines the rationale for vaccinating pregnant women, including that influenza poses a significant burden and can increase risks of complications during pregnancy like hospitalization, preterm birth, and fetal distress. Vaccinating pregnant women can help reduce the risk of influenza in young infants who are not yet eligible for the vaccine. The document provides background on influenza viruses, seasonal variation, impact on high-risk groups like pregnant women, and evidence from clinical trials on quadrivalent influenza vaccines.
This document discusses various methods for objectively measuring nasal patency and airflow, which is important for accurately assessing complaints of nasal obstruction. It describes rhinomanometry, which measures nasal resistance, and acoustic rhinomanometry, which provides anatomical data on nasal cross-sectional area. Several other tests are also mentioned, including peak nasal inspiratory flow, body plethysmography, and questionnaires. Overall, the document provides an overview of existing objective methods for evaluating nasal function and structure to help diagnose the cause of a blocked nose.
Steroids and their use in ENT
Get in touch with us at:
www.facebook.com/drraiammar
www.twitter.com/drraiammar
www.instagram.com/drraiammar
www.linkedin.com/in/drraiammar
www.themedicall.com/blog/auther/drraiammar/
For Any Book or Notes Visit Our Website:
www.allmedicaldata.wordpress.com
www.drraiammar.blogspot.com
YouTube Channel :
https://www.youtube.com/channel/UCu-oR9V3OdFNTJW5yqXWXxA
BY:
DR RAI M. AMMAR MADNI
Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Common triggers include foods, medications, insect stings, latex, and exercise. Symptoms involve multiple organ systems and include skin issues like hives, respiratory problems, gastrointestinal distress, cardiovascular or neurological issues. Diagnosis is based on acute onset of symptoms after exposure to a known or suspected allergen. Treatment involves supporting airway, breathing, and circulation. Epinephrine is given intramuscularly as first line treatment along with antihistamines and corticosteroids. Close monitoring is required and additional epinephrine or other vasopressors may be needed if hypotension persists.
Chronic tonsillitis refers to chronic inflammation of the palatine tonsils. It is characterized by (1) complaints reported by the patient such as recurring sore throats, (2) disruption of the tonsils' drainage function, and (3) morphological changes seen on histological examination. Compensated chronic tonsillitis presents with no complaints but local signs of inflammation, while decompensated chronic tonsillitis results in frequent sore throats, abscesses, and possible complications affecting other organs. Adenoid hypertrophy involves enlargement of the lymphoid tissue in the nasopharynx and can partially or fully block the nasal cavity, leading to various respiratory, ear, facial, dental, sleep
The document discusses various causes of dizziness and balance problems, including peripheral vestibular disorders like benign paroxysmal positional vertigo (BPPV) and vestibular neuritis, central causes like multiple sclerosis and migraines, and systemic issues. It provides details on evaluating patients, potential diagnoses based on history and exam findings, and management strategies for different conditions.
The document discusses balance disorders and how the balance system works. It describes how the inner ear, eyes, and skeletal systems interact to maintain balance. It provides details on different types of balance disorders like BPPV and Meniere's disease. It also discusses medical treatments for balance disorders like vestibular suppressants and vasodilators as well as procedures like Epley's maneuver.
- A 70 year old male presented with 10 years of dyspnea and white productive sputum without fever or other URI symptoms. Skin tests were positive for allergens.
- He has been prescribed several inhalers but was referred to determine if he has COPD or asthma.
- The document discusses the differences and similarities between the inflammation seen in COPD versus asthma. COPD typically involves neutrophilic inflammation in small airways and parenchyma while asthma usually shows eosinophilic inflammation, but there can be overlap between the conditions.
Neonatal herpes is caused by herpes simplex viruses HSV-1 and HSV-2. It can be transmitted to newborns during childbirth if the mother is shedding the virus asymptomatically or symptomatically. There are three main forms of neonatal herpes: disseminated disease affecting multiple organs, CNS disease presenting as encephalitis, and skin/eye/mouth disease limited to those areas. Prompt diagnosis via viral culture and PCR testing and treatment with intravenous acyclovir for 3 weeks can help prevent death and disabilities, which are more common in disseminated and CNS disease. Caesarean delivery and maternal antiviral suppression therapy during late pregnancy can help reduce the
The translabrynthine approach is used to surgically remove vestibular schwannomas. It provides the most direct exposure of the cerebellopontine angle but results in total hearing loss. The key steps involve complete mastoidectomy and labyrinthectomy to access the internal auditory canal. This allows for identification and preservation of the facial nerve while fully exposing the tumor for removal. Though it sacrifices any residual hearing, it allows for quick recovery and excellent postoperative facial nerve function outcomes.
The maxillary sinus is the largest and most commonly involved sinus in malignancies. Maxillary sinus carcinoma arises from the sinus lining and spreads locally through bone destruction and invasion of surrounding structures. Distant metastases occasionally occur in the lungs. Diagnosis involves radiography, CT scan, and biopsy. Treatment depends on tumor stage and may involve surgery, radiation therapy, or chemoradiation. Prognosis diminishes with increased stage, with a 5-year survival rate of 40-50% even with advances in multimodal therapy.
Allergen-specific immunotherapy involves administering increasing doses of allergens to induce tolerance. It works by inducing regulatory T cells that reduce the allergic response. Immunotherapy is effective for allergic rhinitis, asthma, and insect sensitivity. The goals are to eliminate symptoms or reduce medication needs. It is a safe and effective therapy when administered properly to suitable candidates.
This document discusses the evaluation and management of fever without source in infants and children. It defines fever without source and outlines the differential diagnosis. Key points include:
- Fever accounts for 20-35% of pediatric visits and 5-20% will have no apparent source after examination.
- Fever is regulated by the hypothalamus and results from pyrogens stimulating an increased set point.
- For infants under 3 months, a full sepsis workup is considered. Criteria like Rochester can help determine low risk for outpatient management.
- For children 3-36 months, the Yale Observation Scale can identify toxic-appearing children needing admission versus low-risk children who can be treated as out
1. Granulomatous lesions of the nose can be caused by infections, inflammation, or neoplasms. Common infectious causes include tuberculosis, leprosy, rhinoscleroma, and fungal infections like aspergillosis.
2. Sarcoidosis is a common inflammatory cause of nasal granulomas. It is a systemic condition of unknown etiology characterized by non-caseating granulomas. Nasal manifestations include crusting, bleeding, and septal perforation.
3. Wegener's granulomatosis is a necrotizing vasculitis that causes granulomatous inflammation in the respiratory tract and kidneys. In the nose it can cause septal destruction
1) Otitis media with effusion (OME), also known as glue ear, is a chronic accumulation of fluid in the middle ear behind an intact but retracted eardrum that can cause hearing loss.
2) It commonly affects young children, with the highest prevalence between ages 2-5 years old. Risk factors include age, male gender, family history, and exposure to smoke.
3) The fluid is caused by eustachian tube dysfunction preventing drainage and ventilation of the middle ear, which can be due to infections, allergies, or adenoid hypertrophy among other factors.
The Walgreen Timetable predicts that pulmonary tuberculosis can manifest within months of primary infection, while miliary and meningeal tuberculosis typically occur 2-6 months later. TB adenitis usually develops 3-9 months after infection, while bones and joints tuberculosis can take several years, and renal and genital tuberculosis may take over a decade to manifest. Pulmonary lesions from reactivation of dormant foci take years after primary infection.
Paranasal sinuses are air-filled spaces located around the nose. This document discusses the anatomy, physiology, development, and pathologies of the paranasal sinuses. It describes the examination and investigations used to evaluate sinus diseases. The major classifications of sinus pathologies discussed are developmental variations, inflammatory/infectious diseases, cysts, tumors, and other surgically relevant conditions. Specific conditions like polyps, sinusitis, and granulomatous diseases are described in more detail.
This document summarizes research on vaccination in children with chronic diseases. It discusses issues with influenza and pneumococcal vaccinations in high-risk groups. It reviews studies examining the immunogenicity, safety and efficacy of influenza and pneumococcal vaccines in various chronic conditions like asthma, cancer, and immunosuppression. It also discusses gaps in knowledge around the impact of influenza in different at-risk groups and the need for more data on vaccine immunogenicity, safety and efficacy in each high-risk population. The document emphasizes the importance of recommending influenza vaccination for children with chronic diseases and implementing strategies to increase vaccination coverage.
Bacterial meningitis in infants under 90 days old remains a significant burden in the UK and Ireland, with approximately 250 cases reported annually. While mortality has decreased over time to around 12%, long-term neurological complications and disabilities persist in around 20-25% of survivors. Effective diagnosis relies on lumbar puncture since clinical signs are non-specific, but many infants do not receive timely lumbar punctures. There is a lack of evidence regarding optimal antibiotic treatment duration and adjunctive therapies. Two ongoing studies aim to better define the current disease burden and identify opportunities to improve outcomes through earlier recognition, management, and prevention.
Emerging concepts in pneumococcal disease prevention in India sept 2011Gaurav Gupta
Latest information about Pneumococcal disease and its prevention from Indian perspective - as of sept 2011.
Covers latest Pneumonet data, and review from other studies like IBIS, ANSORP etc.
Immunotherapy in children SCIT or SLIT. Dra. Desirée Larenas WISC Dec2014 ...Juan Carlos Ivancevich
Symposium: Immunotherapy in Latin America - WISC 2014- Rio de Janeiro
Symposium 5: Latin American Society of Allergy and Immunology (SLAAI) Symposium: Immunotherapy in Latin America Sala 1 & 2 (Sul America)
The document discusses the RTS,S/AS01 malaria vaccine candidate. It provides details on the development of RTS,S from initial designs incorporating the circumsporozoite protein to clinical trials demonstrating safety and efficacy. Phase 3 trials in African children showed RTS,S/AS01 reduced clinical malaria by approximately 50% and severe malaria by approximately 50% over 12 months. While the vaccine provided benefit, it also caused some adverse side effects and deaths. Ongoing research continues to improve vaccine design and development for a highly effective malaria vaccine.
Rotavirus vaccine presentation Rotateq 28 june 2013Gaurav Gupta
This document discusses rotavirus, a leading cause of severe diarrhea among children under 5 years old globally. It provides an overview of the disease burden in India, differences between the two available rotavirus vaccines (Rotarix and RotaTeq), challenges with vaccine serotype diversity and efficacy, and recommendations from WHO and IAPCOI to include rotavirus vaccination in national immunization programs in developing countries due to the potential for significant impact even with moderate vaccine efficacy.
Recent Advances in the Treatment of Childhood Asthma - Robert LemanskeJuan Carlos Ivancevich
Congreso Latinoamericano de Alergia, Asma e Inmunología 2015
Presidente: Alfonso Mario Cepeda Sarabia
Comité Organizador Local: Edgardo Jares, Anahí Yañez, Estrella Asayag
Presidentes Sociedad Latinoamericana de Alergia, Asma e Inmunología, Slaai:
2013-2015: Alfonso Mario Cepeda Sarabia - 2015-2017: Juan Carlos Sisul Alvariza
Buenos Aires, marzo 14-16, 2015
Antibiotics in the management of chronic periodontitis.pptmalti19
This document summarizes evidence on the use of adjunctive antibiotics for chronic periodontitis. A systematic review of 25 studies found some additional benefits of antibiotics in deep pockets, including 0.2-0.6 mm more attachment gain and 0.2-0.8 mm more probing depth reduction. However, the clinical relevance is uncertain given limitations in defining chronic periodontitis and its microbiota. Overall, current studies have not conclusively established benefits of adjunctive antibiotics, so they cannot be routinely indicated as adjuncts for chronic periodontitis.
Immunogenicity – i.e. immune response generated in the mother.
Transfer of antibodies to fetus Split –Vision Vaccine
Clinical efficacy in mother
Clinical efficacy in newborn
( up to 6 months of age )
Effectiveness of the Influenza vaccine . Dr. Sharda Jain , Lifecare Cent...Lifecare Centre
Effectiveness of vaccine can be judged in 4 ways
Immunogenicity – i.e. immune response generated in the mother.
Transfer of antibodies to fetus
Clinical efficacy in mother
Clinical efficacy in newborn
( up to 6 months of age )
This document discusses immunotherapy options for children with allergic rhinitis and asthma. It reviews evidence from clinical trials on the safety and efficacy of sublingual immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) using the GRADE approach. Regarding safety, SLIT has caused few severe reactions while SCIT trials in children have reported no fatalities. Efficacy evidence is mixed, with some moderate-quality evidence that SCIT reduces seasonal asthma and rhinitis symptoms, but lower quality evidence for SLIT improving asthma. The document concludes the choice between SLIT and SCIT depends on factors like diagnosis, long-term efficacy, adherence, and patient preference.
This document summarizes evidence and guidelines around the evaluation and management of possible early-onset neonatal sepsis. It finds that restricting unnecessary evaluation and antibiotics is important. Clinical monitoring can identify red flags and is often sufficient for well-appearing late preterm and term infants, especially with serial exams over 12 hours. While tests have limited predictive value, stopping antibiotics by 36 hours for reassuring infants is recommended. Several adjuvant therapies like exchange transfusions, immunoglobulins, and colony stimulating factors show promise but require more research before routine use.
Enteric Fever in Paediatrics Age group ExplainedSurajPatel777270
This study compared the efficacy of 5 days versus 14 days of ceftriaxone therapy in children with typhoid fever. 90 children between ages 3-12 were randomly divided into two groups. The first group received ceftriaxone intravenously at 100mg/kg/day for 5 days, while the second group received ceftriaxone intravenously at 75mg/kg/day for 14 days. Results showed that clinical cure was achieved in 84.5% of patients in the 5 day group compared to 97.8% in the 14 day group. Relapse occurred in 15.5% of patients in the 5 day group compared to only 2.2% in the 14 day group. The
2013 August - Pearls in Allergy and ImmunologyJuan Aldave
This summary discusses two articles from the Annals of Allergy, Asthma & Immunology. The first article reports a case of relapsing polychondritis, an immune-mediated cartilage inflammation, in a patient who also had hypogammaglobulinemia of unknown origin. The patient's polychondritis significantly improved with corticosteroids and methotrexate. The second article reviews advances in the diagnosis and management of insect sting allergy, noting epidemiology, risk stratification of patients, diagnostic tests and their limitations, and novel diagnostic approaches such as basophil activation testing.
Zyvac tcv the Indian typhoid conjugate vaccination - Yamunanagar aug 2018Gaurav Gupta
Zyvac TCV by Zydus Vaccines is the Indian Typhoid Conjugate vaccination with Indian Carrier TT protein.
Recent data from Lancet regarding TCV efficacy is featured in this presentation
A Comparative Study of the Efficacy of 5 Days and 14 Days Ceftriaxone Therapy...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
The document discusses the time interval for booster vaccination following re-exposure to rabies in previously vaccinated individuals. It reviews 19 studies involving over 3300 vaccinees to examine antibody response over time. The results showed that 0.07-0.14% of individuals had an inadequate antibody response at 1-3 months after initial vaccination. Therefore, the document concludes that a booster dose is recommended 3 months after the primary vaccination course for individuals re-exposed to rabies. This time interval is proposed to the WHO expert group for consideration in updating guidelines.
Current challenges in pertussis prevention gaurav gupta - sept 2016Gaurav Gupta
Pentaxim, Hexaxim, India, pertussis, whooping cough, vaccine, 2 component, 5 component.
Talk for Chandigarh, India about whole cell pertussis versus acellular pertussis vaccine -
Similar to Efficacy and safety of immunomodulators in pediatric age - Slideset by Professor Susanna Esposito (20)
Designing vaccines for specific populations and germs - Slides by Professor E...WAidid
The presentation given by Professor Susanna Esposito at ECCMID 2019. A view on vaccines recommendations, combined vaccinations and impact of vaccination practices in the eradication of major infectious diseases.
To learn more, please visit www.waidid.org
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The lecture presented by Professor Susanna Esposito at AMR 2019 on influenza vaccination and abuse of available antimicrobials.
To learn more, please visit www.waidid.org.
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This document discusses point-of-care and point-of-impact molecular diagnostic testing from a European perspective. It describes how molecular diagnostics is moving towards more commercial multiplex assays and automation. Near-patient testing provides results faster but challenges include defining quality indicators for new rapid assays and ensuring clinical relevance. Standards like ISO15189 and ISO22870 provide guidelines for quality control of centralized and decentralized testing. The changing regulatory landscape in Europe aims to improve safety and transparency for in vitro diagnostics.
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In this study Professor Kathryn M. Edwards (Sarah H. Sell and Cornelius Vanderbilt Professor - Division of Pediatric Infectious Diseases - Vanderbilt University Medical Center) provides an update on measles and its prevention.
To learn more, please visit www.waidid.org!
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Are we running out of antibiotics? - Slideset by Professor EspositoWAidid
How does antibiotic resistance happen?
This work, edited by the professor Susanna Esposito, tries to answer this question underlining the importance of prescribing the right drug with the right dose and duration, to avoid any kind of abuse that may cause or increase antibiotic resistance.
To learn more please visit www.waidid.org
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To learn more please visit www.waidid.org
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To learn more please visit www.waidid.org
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To learn more, please visit www.waidid.org.
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3. Influenza vaccination is recommended annually for all immunosuppressed adults. Other common vaccines include pneumococcal, tetanus, hepatitis B, and human papillomavirus depending on the individual's
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There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
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Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler Community Health Nursing A Canadian Perspective, 5th Edition TEST BANK by Stamler Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Study Guide Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Studocu Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Course Hero Community Health Nursing A Canadian Perspective, 5th Edition Answers Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Course hero Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Studocu Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Study Guide Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Ebook Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Questions Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Studocu Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Stuvia
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Tests for analysis of different pharmaceutical.pptx
Efficacy and safety of immunomodulators in pediatric age - Slideset by Professor Susanna Esposito
1. EFFICACY AND SAFETY OF
IMMUNOMODULATORS IN
PEDIATRIC AGE
Susanna Esposito
Pediatric Clinic & Pediatric
Section
Università degli Studi di Perugia
Perugia
2. DEFINITION OF RECURENT RESPIRATORY TRACT
INFECTIONS (RTIs)
«THE FIRST CAUSE OF RECURRENT INFECTIONS IN CHILDREN
IS...CHILDHOOD ITSELF»2
Absence of any pathological underlying condition that may
justify that may justify the recurrence of infections1
1. Gruppo di studio di immunologia della società Italiana di pediatria. Le infezioni ricorrenti nel bambino: definizione ed approccio
diagnostico. Riv Immunol Allergol Pediatrica 1988; 2: 127–34. 2. J. Gary Wheeler Evaluating the child with recurrent infections - includes
patient information sheet. Nov 15, 1996.
4. RISK FACTORS FOR RRTI IN 286 CHILDREN 3 TO 6 YEARS
DE MARTINO M, GALLI L, VIERUCCI A. THE CHILD WITH RECURRENT RESPIRATORY INFECTIONS.
IN: “PATHOGENESIS AND CONTROL OF VIRAL INFECTIONS”, RAVEN PRESS: NEW YORK 1989
5. EPIDEMIOLOGY AND ETIOLOGY OF RRTIs
• RRTIs affect up to 25% of children aged <1 year
and 18% of children aged 1-4 years in developed
countries1
• Bacteria such as Streptococcus pneumoniae,
Mycoplasma pneumoniae, Haemophilus
influenzae and Streptococcus pyogenes may play
a role3
• Viruses (mainly respiratory syncytial virus,
rhinovirus and influenza viruses) are the main
etiological agents of RRTIs2
1. Bellanti et al. Drugs 1997 2. Esposito et al. Eur J Clin Microbiol Infect Dis 2012 3. Purushothama V. Et al. Chapter 93.
Infections of the Respiratory System. Medical Microbiology. 4th edition. Baron S, editor. Galveston (TX): University of Texas
Medical Branch at Galveston; 1996.
6. 6
• Treatment
limited role of antibiotics
role of symptomatic measures
• PREVENTION
Firstly, based on risk factors
Secondly, based on past history
What can be done?
8. THE FIRST CAUSE OF
RECURRENT RESPIRATORY
INFECTIONS IN CHILDREN IS...
CHILDHOOD ITSELF
(J.G. Wheeler 1996)
9. New complexities in CD4+ T cell differentiation
Z. Chen et al, Immunol Res, 2007
10. Dominguez-Bello MG et al. Gastroenterology 2011;140:1713–1719
Initial gut bacteria (founder species)
depends upon delivery mode
Vaginal delivery:
-Lactobacillus,
Prevotella spp
-Vertical
inheritance
from mother
C-section:
Staphylococcus
Corynebaterium
Propionibacterium spp
-Higher susceptibility
to certain pathogens
-Higher risk of atopic
disease
New strains (less certain in
origin) outcompete old ones
-Rapid increase in diversity
-Early microbiota in
development=high instability
-Shifts in response to diet,
illness
-Highly distinct,
differentiate microbiota
-Microbial community
may continue to change,
but at a slower rate than
in childhood
Substantially different
gut communities than in
younger adults
11. De Martino, Pediatr Allergy Immunol 2007:18: 3
Infezioni
virali
Immunodeficit
transitorio
secondario
Aumentata
suscettibilità
Fattori
di rischio
OMA
CAP
2 settimane
13. Suckling on a
pacifier increases
the reflux of
nasopharyngeal
secretions into
the middle ear
Changes in the
dental structure
can cause
dysfunction of the
Eustachian Tube
14. EFFECTIVENESS FOR INFLUENZA VACCINATED
AND UNVACCINATED CHILDREN WITH
RECURRENT RESPIRATORY TRACT INFECTIONS
STUDY CHILDREN VACCINATED
(N=64)
CONTROLS
(N=63)
P VALUE
NO. OF URTI 1.68 + 1.62 4.52 + 2.43 <0.0001
NO. OF LRTI 0.68 + 0.88 1.24 + 1.32 0.0042
NO. OF FEBRILE
RESPIRATORY
ILLNESSES
1.59 + 1.49 3.87 + 2.74 <0.0001
NO. OF
HOSPITALIZATIONS
0.05 + 0.23 0.10 + 0.25 0.417
NO. OF ANTIBIOTIC
PRESCRIPTIONS
1.32 + 1.28 2.35 + 1.59 <0.0001
NO. OF ANTIPYRETIC
PRESCRIPTIONS
2.21 + 2.03 3.98 + 2.37 <0.0001
MISSED SCHOOL
DAYS
3.10 + 6.23 13.83 + 12.50 <0.0001
Esposito S et al., Vaccine 2003.
15. 0.000.250.500.751.00
0 30 60 90 120 150 180
Time (days after randomisation)
Controls
Treated with vitamin D
complicated
with othorrea AOM episodes
0.000.250.500.751.00
0 30 60 90 120 150 180Time (days after randomisation)
Controls
Treated with vitamin D
0.000.250.500.751.00
0 30 60 90 120 150 180
Time (days after randomisation)
Controls
Treated with vitamin D
uncomplicated
AOM episodes
Efficacy of vitamin D3 1,000 U/day in children
1 – 5 yrs with a history of rAOM
ALL episodes
Marchisio P et al. PIDJ 2013
16. THE FIRST CAUSE OF
RECURRENT RESPIRATORY
INFECTIONS IN CHILDREN IS...
CHILDHOOD ITSELF
(J.G. Wheeler 1996)
WAIT : lets age do its job
REDUCTION OF RISK FACTORS
USE OF IMMUNOSTIMULANTS/
IMMUNOMODULANTS
19. 19
-100 -50 0 50
Study or Subgroup
Mean difference
(IV, Random, 95% CI)
Favours OM-85 Favours placebo
100
Ahrens, 1984
Del-Rio-Navarro, 2003
Gutiérrez-Barreto, 1998
Gómez-Barreto, 1998
Jara-Pérez, 2000
Maestroni, 1984
Schaad, 1986
Schaad, 2002
Zagar, 1988
Total (95% CI)
Percentage difference and 95% CI between OM-85 and placebo
OM-85 reduce total number of ARTIs
in children by 35.9%
-35.9% reduction
[95% CI: –49.5%, 22.4%]
Del-Rio-Navarro et al. Cochrane Database Syst Rev 2012
20. 20
OM-85 in children with recurrence of
upper RTIs*
Schaad UB et al. Chest 2002
Upper RTI was defined as the presence of at least 2 of the following:
• rhinitis, pharyngitis, cough, hoarseness, temperature ≥38.5°C or upper
RTI-related prescription of antibiotic
21. 21
• Double-blind, randomised, placebo-controlled trial
• 220 patients with recurrent upper RTIs* (aged 3–6 years) – prone to
infections
• Study duration: 6 months
• Primary endpoint: incidence of upper RTIs
• Other endpoints: symptoms, other infections, prescribed medication,
school absence, subjective assessment of efficacy, safety
• Dosage regimen: OM-85 (3.5mg) or placebo, 1 capsule/day
Study design
* Upper RRTI: ≥3 episodes of URTIs in the last 12 months. URTI: rhinitis, pharyngitis, cough,
hoarseness, temperature ≥38.5°C or upper RTI-related prescription of an antibiotic.
Schaad UB et al. Chest 2002
22. 22
Significant reduction in cumulative mean rate (-0.40; -16%) of
upper RTIs was seen in patients receiving OM-85 vs placebo
Cumulativemeanrate
Time (months)
1 632
OM-85 (n=118)
Placebo (n=99)
54
3
2
1
0
p<0.05
OM-85 reduces cumulative mean rate
of upper RTIs in children
Schaad UB et al. Chest 2002
23. 23
Higher the risk, higher the
benefit
This beneficial effect is proportional to the number of RTIs in the
previous 12 months and is larger in younger children a
a= data not shownSchaad UB et al. World J Pediatr 2010;6(1):5-12
24. 24
OM-85 effects on type and incidence
of RTIs* over 12 months
Gutiérrez-Tarango MD et al. Chest 2001 * Both upper RTIs (URTIs) and lower RTIs (LRTIs)
25. 25
• Double-blind, randomised, placebo-controlled trial
• 54 children with recurrent acute RTIs* (aged
1–12 years) living in metropolitan polluted area of Mexico
• Study duration: 1 year
• Primary endpoints: incidence of acute RTIs
• Other endpoints: type of RTI, school absenteeism, antibiotic/other
therapy, safety
• Dosage regimen: OM-85 (3.5mg) or placebo, 1 capsule/day
Study design
*RRTIs: ≥ 3 in the previous 6 months; of note: mean ARTIs rate in the previous year: 12
Gutiérrez-Tarango MD et al. Chest 2001
26. 26
%ofpatientswith<6RTI
Time (months)
40
20
0 126
60
100
OM-85
Placebo
3 9
80
p<0.001
Higher % of patients with <6 ARTI in
12-month period with OM-85
• Higher percentage of patients with no recurrence
• RR for ≥6 ARTIs : 0.37 in favor of OM-85 (95% CI, 0.20-0.68)
Gutiérrez-Tarango MD et al. Chest 2001
27. 27
Meanno.ofAbcourses
Antibiotic courses
Drug courses
(including antibiotics)
p<0.001
p<0.001
12
8
4
0
OM-85
Placebo
Significant reduction in antibiotic
consumption in OM-85 group
• Mean 2.46 courses in OM-85 vs 4.46 in placebo (p<0.001)
• Total duration of acute RTIs was significantly lower in OM-85 (median
30.5 vs 55.0; p<0.01)
Gutiérrez-Tarango MD et al. Chest 2001
28. 28
Prevention of acute otitis media
in children
Gutiérrez-Tarango MD et al. Chest 2001
Jara-Perez JV and Berber A, Clinical Therapeutics, 2000, 22, 6, 748-759
-68%
p<0.001
0
5
10
15
20
25
30
Jara Perez Gutierrez
Placebo
OM-85p< 0.01
-75%
Over 6 months Over 12 months
TotalnumberofAOM
29. 29
OM-85 in recurrence of acute
tonsillitis in children
Bitar MA et al. Int J Pediatr Otorhinolaryngol 2013;77:670-673
30. 30
• A retrospective 5-year observational study
• From 1 Jan 2006 – 31 Dec 2010
• 177 children with recurrent acute tonsillitis (≥3 episodes previous
year) - aged 1–15 yrs
• Typical dosing regimen: OM-85, 1 capsule (3.5mg) /day
• Study duration: 3 months of treatment plus up to 45 months of
follow-up (median 9 months)
• Primary outcome: response to therapy after 3 months (reduction in
tonsillitis - >50% or ≤ compared to same period previous year)
• Secondary long-term outcome for responders: no tonsillectomy (<3
RTIs/year)
Study design
Bitar MA et al. Int J Pediatr Otorhinolaryngol 2013;77:670-673
31. 31
75.6
51.2
24.4 24.4
Any response
(99/131)
Total response
(67/131)
Partial response
(32/131)
No response
(32/131)
Percentageofpatients(%)
100
0
20
40
60
80
Total response: >50% decrease in acute tonsillitis episodes at the
end of treatment (3 months)
Partial response: ≤50%
OM-85 reduced the frequency of
acute tonsillitis in children
75,6% patients responders
Bitar MA et al. Int J Pediatr Otorhinolaryngol 2013;77:670-673
No tonsillectomy required
Median 9 months up to 45 months
Only 11% patients required
tonsillectomy
32. OM-85 in children with wheezing
Razi C et al. J Allergy Clin Immunol 2010;126:763-9
33. 33
Study design
• Randomized, double-blind, placebo-controlled, parallel-group study
• 75 children (aged 1–6 years) with recurrent wheezing (≥3 in 6 months)
• Duration of study: 1 year
• Primary endpoint: number of wheezing attacks
• Other endpoints: acute RTI incidence, acute nasopharyngitis
incidence, wheezing attacks duration, hospitalization rate, safety
• Dosage regimen: OM-85 (3.5mg) or placebo, 1 capsule/day
Razi C et al. J Allergy Clin Immunol 2010;126:763-9
34. 34
Cumulativenumberof
wheezingattacksperpatient
37.9%
p<0.001 36%
p=0.001
34.3%
p=0.003
30.4%
p=0.013
6
4
2
0 3 6 9 12
OM-85
Placebo
Months after start of study
OM-85 prevented wheezing attacks in
pre-school children
The cumulative difference in wheezing attacks between the 2
groups was 2.18 wheezing attacks per patient in 12 months; there
was a 37.9% reduction in the group given OM-85 compared with
the group given placebo (P < 0.001)
35. 35
OM-85 reduced the number of RTIs
0 3 6 9 12
31.4%
p<0.001 29.4%
p<0.001
27.9%
p<0.001
21.6%
p=0.009
8
6
4
2
0
OM-85
Placebo
Cumulativenumberof
RTIsperpatient
Months after start of study
The main difference in RTIs between the 2 groups was 2.5 per
patient in 12 months (7.8 vs 5.3); there was a 31.4% cumulative
reduction in the group given OM-85 compared with the group
given placebo (p< 0.001)
36. 36
OM-85 reduced the number of
nasopharyngitis
37.5%
p<0.001 35.5%
p<0.001
32.9%
p<0.001 26.4%
p=0.032
0 3 6 9 12
8
6
4
2
0
Cumulativenumberof
nasopharyngitiscasesperpatient
OM-85
Placebo
Months after start of study
The main difference in nasopharyngitis between the 2 groups was 2.11 per
patient in 12 months (5.62 vs to 3.51);
there was a cumulative 37.5% reduction in the group given OM-85
compared with the group given placebo (p < 0.001)
37. 37
OM-85 in prevention of RTIs* in
combination with IIV
• Assess the immune response towards a combined prevention (IIV and
OM-85) and IIV only
• Evaluate efficacy and tolerability of combined preventative strategies
Esposito S et al. Vaccine 2014;32:2546-2552
*Both URTIs and LRTIs
38. 38
Study design
• Prospective randomized single blind study (1 October 2012 and 31
March 2013)
• 68 children included (36-59 months)
• ≥6 practitioner-attended episodes in 1 years
• At least 1 previous IIV
• Single-blind: the patients and their parents were asked not to mention
the treatment assignment to their pediatricians
Esposito S et al. Vaccine 2014;32:2546-2552
39. 39
Higher reduction in RTIs and Ab
use in OM-85 and IIV group
Significant reduction versus IIV only arm:
• number of patients with ≥ URTI* (-35%)
• number of patients with ≥ LRTI* (-67%)
• mean number of antibiotics courses (-72%)
• mean number of days lost from school (-52%)
Esposito S et al. Vaccine 2014;32:2546-2552
40. 40
Humoral and cellular immune
response to IIV was not affected
• No between-group differences in the humoral (antibodies
against each of the three influenza strains) and cellular (dendritic and
memory B cells in peripheral blood) immune responses
• Low dose of administration compared to that used in the mouse model
• Measurement in blood (i.e. BAL measurements more relevant but limited in young
children)
Administration of IIV about 15 days after the start of the
first course of OM-85 does not affect humoral or cell-
mediated immunity to the vaccine
Esposito S et al. Vaccine 2014;32:2546-2552
41. 41
OM-85 administered with flu vaccine was well
tolerated in the short-term
Esposito S et al. Vaccine 2014;32:2546-2552
42. 42
Signal detection and
pharmacovigilance
• 35 years of marketing experience
• > 79 million patients treated, including 34 million children since 1996
• Mean 3.6 million treated patients/year worldwide
Well-tolerated therapy with known and manageable risks
Data on file – PSUR 2015
43. 43
Cost effectiveness of OM-85 in
RRTIs prevention in children
• URTI are mainly viral but secondary bacterial infections
are frequent
• ARTI: acute respiratory infections defined as bacterial
infections
– Otitis media, bacterial sinusitis, tonsillitis, bronchitis/pneumonia
• Cost-Consequence Analysis (CCA)
– Assess costs and effectiveness of therapeutic choices (including
prophylaxis with OM-85)
– Perspectives: 1. patient 2. Health System 3. Society – in Italy
Ravasio R. Global & Regional Health Technology Assessment 2015 ; 0 (0): 00--00I: 10.5301/GRHTA.5000200
44. 44
Main assumptions
• Number of ARTI with OM-85:
– -35.9% versus PB (Cochrane)
• Probability of 1 ARTI in children is:
– 31% in not treated (Zaniolo)
– 19.9 % in OM-85 (based on -35.9%, Cochrane)
• Probability of 1 URTI (that is not ARTIs):
– 69% in not treated [(100-31)%]
– 80.1% in OM-85 [(100-19.9)%]
• Mean 2,4 RTIs in OM-85 and 3,6 in case of no prophylaxis
– -1,20 [95% CI -1,75 – -0,66]) in 6 months (Cochrane)
Ravasio R. Global & Regional Health Technology Assessment 2015 ; 0 (0): 00--00I: 10.5301/GRHTA.5000200
45. 45
Results on costs based on therapeutic
options and probabilities
€ 0.00
€ 100.00
€ 200.00
€ 300.00
€ 400.00
€ 500.00
€ 600.00
€ 700.00
Community NHS Patient
OM-85
Placebo
Difference:
€182.99
(-31.4%)
Cost
Stakeholder
Difference:
€40.30
(-43.0%)
Difference:
€7.73
(+20.6%)
Ravasio R. Global & Regional Health Technology Assessment 2015 ; 0 (0): 00—00 DOI: 10.5301/GRHTA.5000200
• Cost of OM-85 for one cycle: Euro 20.99 Euro
• This is largely compensated by the societal cost saving
• Saving for HCS will be sufficient to cover also OM-85 price
+1.29 €/month
OM-85 is cost effective for Society… and for HCS
47. 47
Esposito S et al., unpublished data
A Randomized, Placebo-Controlled, Double-Blinded,
Single Centre, Phase IV trial to assess the efficacy
and safety of OM-85 in children with RRTIs - I
• Phase IV, randomized (3:3:1), double-blind, placebo-
controlled, single-centre trial
• Population of otherwise healthy children 1-6 yrs old with
a history of RRTIs
• Treatment administered per os as either 3.5 mg OM-85
(active, n=100) or placebo (n=109), once a day for the
first 10 days of the first 3 months of the 6-month study
or once a day for the first 10 days of the 6-months
(n=37)
48. 48
Esposito S et al., unpublished data
A Randomized, Placebo-Controlled, Double-Blinded,
Single Centre, Phase IV trial to assess the efficacy
and safety of OM-85 in children with RRTIs - II
• Reduction of 33% in ARTIs
• Reduction of 21% of AOM
• Reduction of 25% of antibiotic prescriptions
• Decrease of 22% of the days of absence from day-care
• Decrease of 18% of the working days lost by parents
• No difference in efficacy between 3 vs 6 months of
treatment
• Good safety profile in the treated population
49. 49
Esposito S et al., unpublished data
REtrospective controlled study of Broncho-Vaxom®
(OM-85) use in PEdiatric patients with recurrent
Respiratory Tract Infections - I
• Phase IV, retrospective, controlled study in pediatric
patients 1-6 yrs old receiving (n=203), or not receiving
(n=201) preventive treatment with OM-85 for the
management of RRTIs during the study period
• Treatment received for at least 2 consecutive years
• The aim was to review and describe the effectiveness
and safety of OM-85 in children in the prevention of
RRTIs
50. 50
Esposito S et al., unpublished data
REtrospective controlled study of Broncho-Vaxom®
(OM-85) use in PEdiatric patients with recurrent
Respiratory Tract Infections - II
• Reduction of 28% of RTIs
• Reduction of 24% URTIs
• Reduction of 21% of antibiotic prescriptions
• Reduction of 31% of outpatient medical visits (visits to
ERs or to a physician/health care provider)
• Good safety profile in the treated population
• No difference between the impact in year 1 and year 2
51. 5151
Concept of the "ideal" time window with the
largest absolute efficacy of OM-85 in pediatric
RTIs
L’impossibilità a contenere completamente i fattori di rischio fa perpetuare il processo, con innesco di nuove infezioni virali che conducono ad un immunodeficit transitorio secondario, con può perdurare per 2- 4 settimane. In questo periodo è inevitabile la possibilità di nuove infezioni.
Il ciclo continua
The primary outcome examined in the Cochrane review conducted by Del-Rio-Navarro et al was the number of acute RTIs experienced during the study period1.
Studies of bacterial extracts, including OM-85, were included in the Cochrane review together with synthetic immunostimulants, thymic extracts and plant extracts. A total of 61 placebo-controlled randomised trials were included in the review, of which 40 investigated bacterial extracts and 12 were studies of OM-85.
The overall quality of the studies included in the meta-analysis was deemed poor. Of 40 studies of bacterial extracts, only 4 were of sufficient standard to be graded ‘A’ according to Cochrane criteria. All 4 of the ‘A’ graded studies of bacterial immunostimulants2–5 were clinical trials of OM-85; 2 studies of herbal remedies (echinacea) were also graded ‘A’.
The following domains were assessed when rating the quality of the studies: random sequence generation; allocation concealment; blinding design; blinding of participants and personnel; blinding of outcome assessment; data completeness; selective reporting.
References
Del-Rio-Navarro BE et al. Immunostimulants to prevent acute respiratory tract infections in children. Cochrane Database Syst Rev 2006; 18: CD004974/ Del-Rio-Navarro BE et al, Evid-Bas Child Health (Cochrane Review) 2012 (6):5-12
Collet JP et al. Stimulation of nonspecific immunity to reduce the risk of recurrent infections in children attending day-care centers. The Epicreche Research Group. Ped Infect Dis J 1993; 12: 648–52.
Del-Rio-Navarro BE et al. Use of OM-85 in children suffering from recurrent respiratory tract infections. Allergologia et Immunopathologia 2003; 31: 7–13.
Gutiérrez-Tarango MD et al. Safety and efficacy of two courses of OM-85 in the prevention of respiratory tract infections in children during 12 months. Chest 2001; 119: 1742–8.
Jara-Pèrez JV et al. Primary prevention of acute respiratory tract infections in children using a bacterial immunostimulant: a double-masked, placebo-controlled clinical trial. Clin Ther 2000; 22: 748–59.
Across the 9 studies, there was a significant reduction in total number of acute RTIs with OM-85 vs placebo of –1.20 (95% CI: –1.75, –0.66).
This translates to a percentage reduction of –35.9% (95% CI: –49.5%, –22.4%).
References
Del-Rio-Navarro BE et al. Immunostimulants to prevent acute respiratory tract infections in children. Cochrane Database Syst Rev 2006; 18: CD004974.
Del-Rio-Navarro BE et al, Evid-Bas Child Health (Cochrane Review) 2012 (6):5-12
No notes for this slide
This study, which was published by Schaad et al in Chest in 2002, was conducted at multiple centres in Switzerland (10) and Germany (30) in paediatric patients with recurrent upper RTIs who had presented at hospital with an upper RTI.
Patients received study treatment (3.5 mg OM-85 or placebo) every day for 1 month, then no treatment for 1 month. They then received study treatment on each of the first 10 consecutive days of Months 3, 4 and 5.
Primary endpoint: rate of upper RTIs during treatment and over the study period. Upper RTI was defined as the presence of at least 2 of the following: rhinitis, pharyngitis, cough, hoarseness, temperature ≥38.5°C or upper RTI-related prescription of an antibiotic.
Other endpoints: symptoms (rhinitis, pharyngitis, cough and hoarseness) were graded as none, mild or severe; fever was coded based on temperature (0= <38.5°; 1=38.5°-39.4°; 2= ≥39.5°); school absence was reported as number of days; other infections comprised otitis, sinusitis or other related infections; prescribed medication included use of antibiotics, antiseptics, anti-inflammatories, antitussives or mucolytic agents; subjective assessments were determined by investigators and parent/guardian on a scale of -3 (marked worsening) to +3 (marked improvement); safety was assessed throughout, including at regular and intermittent visits.
Reference
Schaad UB et al. Immunostimulation with OM-85 in children with recurrent infections of the upper respiratory tract. Chest 2002; 122: 2042–9.
OM-85 significantly (p<0.05 by ANOVA) decreased the cumulative rate of upper RTIs in children over 6 months.
OM-85 significantly reduced the incidence of upper RTI over 6 months by 16% vs placebo.
A greater effect of OM-85 vs placebo was observed in those with a greater number of recurrent upper RTIs at baseline:
22% reduction in upper RTI incidence at Month 4 for those with ≥3 recurrent upper RTIs at baseline
22% reduction in cumulative upper RTI rate over 6 months for those with 6−15 recurrent upper RTIs at baseline (exploratory analysis).
Reference
Schaad UB et al. Immunostimulation with OM-85 in children with recurrent infections of the upper respiratory tract. Chest 2002; 122: 2042–9.
The highest benefit was observed in children at highest risk (more infectious episodes in the previous year).
Thus our recommendation to use the product in the overall children population in case of 6 RTIs per year.
No notes for this slide
This study, which was published by Gutierrez-Tarango et al in Chest in 2001, was conducted in Chihuahua City, Mexico. The aim was to investigate the efficacy of OM-85 in reducing the recurrence of RTIs in children ≤12 years of age.
All of the children who participated in the study had a history of three acute RTIs in the six months prior to study start. They also all lived in an environment of high outdoor air pollution, an important contributing factor to vulnerability to RTIs1, particularly in the developing world.
Study treatment (OM-85 or placebo, once daily) was given according to the 10-10-10 dosing regimen (1 capsule per day for each of 10 consecutive days) in the first 3 months of the study, then again in months 7, 8 and 92.
Primary endpoint: type and incidence of acute RTI with OM-85 compared with placebo. Upper acute RTI was defined as ≥1 of: rhinorrhea, or sore throat/cough without signs of lower acute RTI for ≥2 days. Lower acute RTI was defined as ≥1 of: rales or crepitations, wheezing, stridor, respiratory rate >50/min, cyanosis or chest indrawing for ≥2 days. Otitis was defined as acute onset of earache with erythema.
Other endpoints: absenteeism was defined as days out of school due to acute RTI. Antibiotic therapy was recorded as the number and duration of treatments, other therapies comprised a drug course that included antibiotics. Safety was assessed throughout.
References
Cohen AJ et al. The global burden of disease due to outdoor air pollution. J Toxicol Environ Health 2005; 68: 1301–7.
Gutiérrez-Tarango MD et al. Safety and efficacy of two courses of OM-85 in the prevention of respiratory tract infections in children during 12 months. Chest 2001; 119: 1742–8.
At 12 months, the majority of patients receiving OM-85 had experienced <6 acute RTIs whereas most patients receiving placebo had experienced 6 or more acute RTIs.
The difference was significant (p<0.001) indicating OM-85 exhibited a marked effect in reducing the frequency of acute RTIs.
In a separate analysis, OM-85 therapy was associated with a significantly lower risk of patients experiencing ≥6, ≥7 or ≥8 acute RTIs vs placebo.
Reference
Gutiérrez-Tarango MD et al. Safety and efficacy of two courses of OM-85 in the prevention of respiratory tract infections in children during 12 months. Chest 2001; 119: 1742–8.
Other endpoints that were examined in this study included number of antibiotic courses, total courses of drug treatment, total duration of illness and of treatment, and school or daycare absenteeism.
As shown in the figure, a significant reduction in the number of antibiotic courses and in total drug courses was seen among the children who received OM-85 over the 12 months of study. The mean number of antibiotic courses was reduced to 2.5 in the OM-85 versus 4.5 in the placebo group, and the mean number of drug courses was 5.0 in the OM-85 versus 8.0 in the placebo group.
Mean total duration of illness in the OM-85 group (35 days) was just over half that observed among children receiving placebo (61 days) and represented a significant reduction (p<0.001). The data for mean total duration of drug treatment were similar and a significant treatment difference was also seen.
A numerical reduction in RTI-associated school or daycare absenteeism was observed in the OM-85 group (mean 3.6 days vs 5.8 days in the placebo group); however, this treatment difference did not reach the threshold of statistical significance.
Reference
Gutiérrez-Tarango MD et al. Safety and efficacy of two courses of OM-85 in the prevention of respiratory tract infections in children during 12 months. Chest 2001; 119: 1742–8.
Bitar and colleagues, in a study published in 20131, were the first to investigate the efficacy of OM-85 in preventing recurrent acute tonsillitis.
Occasional bouts of tonsillitis in childhood are very common and in most cases resolved without treatment or with a single course of antibiotics2. In a minority of patients, frequent recurrent episodes has a severe impact on quality of life and schooling3.
Historically, surgery has often been indicated for patients so affected, but tonsillectomy is associated with considerable morbidity, risk and cost4. Hence, a preventive approach that could help reduce the number of patients requiring surgery could be of great interest in the management of patients suffering from recurrent tonsillitis. Based upon the findings of Bitar et al, the use of OM-85 shows promise in this patient population1.
References
Bitar MA et al. The role of OM-85 (OM-85) in preventing recurrent acute tonsillitis in children. Int J Pediatr Otorhinolaryngol 2013; 77: 670–3.
Del Mar CB et al. Antibiotics for sore throat. Cochrane Database Syst Rev 2006; 4: CD000023.
Georgalas CC et al. Tonsillitis. Clin Evid 2009; Oct 26: 0503.
Baugh RF et al. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg 2011; 144: S1–30.
This cohort study was conducted over 4 years in Beirut, Lebanon. The study population comprised children aged 1 to 15 years presenting to the clinic with a diagnosis of recurrent acute tonsillitis (defined as a history of ≥3 episodes in the year prior to study start).
Treatment comprised OM-85, tonsillectomy or antibiotics. OM-85 therapy was given according to the 10-10-10 dosing regimen over 3 months.
Primary endpoint: response to therapy was assessed in terms of change in frequency of acute tonsillitis episodes over 3 months.
Other endpoints: baseline demographic and laboratory variables were assessed in bivariate and multivariate analyses to identify factors associated with response to OM-85 therapy.
Reference
Bitar MA et al. The role of OM-85 (OM-85) in preventing recurrent acute tonsillitis in children. Int J Pediatr Otorhinolaryngol 2013; 77: 670–3.
Patients who experienced a decrease in tonsillitis episodes of >50% were classed as total responders; those who experienced a decrease of ≤50% as partial responders; all others were classed as no response. In total responders, long-term outcome of recurrent infection (≥3 times/year) necessitating tonsillectomy was also assessed.
Of a total of 177 participating children, 131 (74%) received OM-85.
Of the 131 children who received OM-85, 99 (76%) showed a decrease in the frequency of acute tonsillitis episodes 6 months after start of treatment.
The majority of responders were total responders so, overall, 51% of the patients who received OM-85 had a decrease of more than 50% in the frequency of their tonsillitis episodes.
Of the 51% of patients achieving total response, none required tonsillectomy in the subsequent long-term follow-up period.
Reference
Bitar MA et al. The role of OM-85 (OM-85) in preventing recurrent acute tonsillitis in children. Int J Pediatr Otorhinolaryngol 2013; 77: 670–3.
This study was conducted in Ankara, Turkey, in a population of children with recurrent wheezing induced by respiratory tract illness (≥3 events in prior 6 months).
Study treatment (OM-85 BV or placebo, once daily) was given according to the registered 10-10-10 dosing regimen in the first 3 months of the study.
Primary endpoint: number of acute wheezing attacks, defined as episodes of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness (or any combination thereof) lasting for >6 hours in the presence of a normal chest x-ray.
Other endpoints: number of acute RTIs, defined as presence of diagnostic symptoms (acute nasopharyngitis, sinusitis, acute otitis, tonsillitis, viral croup or pneumonia) for >48 hours; number of acute nasopharyngitis events; duration of wheezing attack from diagnosis to assessment of clinical cure by investigator; number/duration of hospitalisations. Safety was recorded throughout.
As with most clinical studies of OM-85 BV, double-blind treatment was administered according to the registered 10-10-10 dosing regimen.
Reference
Razi et al. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol 2010; 126: 763-769.
Benefit on wheezing attacks in children with more the 6 episodes of respiratory infections in the previous year
There was a significant difference in the cumulative number of wheezing attacks from 0−6, 0−9 and 0−12 months for OM-85 vs placebo. The difference at 0−3 months cannot be considered significant because the p-value (p=0.013) exceeded the significance threshold (p=0.0125) required to account for multiplicity of testing (Bonferroni correction).
Over the 12-month period, the mean number of wheezing attacks was 2.18 events lower in the OM-85 arm (3.57 events) vs the placebo arm (5.75 events).
In regression analysis, the difference between OM-85 and placebo was independent of age, wheezing attacks in the prior year, sex, atopy, history of allergy and history of smoking at home; adding acute RTIs and acute nasopharyngitis into the model showed that reduction in wheezing attacks was significantly associated with reduction in acute RTIs.
Reference
Razi et al. The immunostimulant OM-85 prevents wheezing attacks in preschool children. J Allergy Clin Immunol 2010; 126: 763-769.
This correlated with the reduction in URTIs mainly rhinopharingitis.
A reduction in overall number of acute RTIs was observed that paralleled the difference between the treatment groups for the primary outcome; it is likely that these effects are correlated, as a majority of acute RTIs are, like the wheezing attacks, caused by viruses rather than bacteria.
The 31% decrease in cumulative number of RTIs in patients receiving OM-85 compared with placebo after 12 months is equivalent to a reduction of 2.5 episodes per patient per year. Significant treatment effects were observed at all timepoints.
Reference
Razi et al. The immunostimulant OM-85 prevents wheezing attacks in preschool children. J Allergy Clin Immunol 2010; 126: 763-769.
There was a significant difference in the cumulative number of nasopharyngitis cases. A 37.5% decrease in cumulative number of acute nasopharyngitis (a viral infection most commonly caused by rhinoviruses) in patients receiving OM-85 compared with placebo after 12 months.
The main causative agents of wheezing attacks are viruses, rather than bacteria. These findings, which show that OM-85 safely and effectively reduces wheezing attacks in children1, indicate that OM-85 is effective in enhancing the immune response to viral, as well as bacterial, infections.
OM-85’s mode of action, stimulating the innate immune system, means that it has a broad effect that goes beyond the bacteria from which the lysate is produced. This study shows that the broad-ranging efficacy suggested by OM-85’s mode of action2,3 is reflected in clinical data.
References
Razi et al. The immunostimulant OM-85 prevents wheezing attacks in preschool children. J Allergy Clin Immunol 2010; 126: 763-769.
Bessler WG, et al. The bacterial extract Broncho-Vaxom protects against respiratory infections – in vivo and in vitro studies. Microbial pathogens and strategies for combating them: science, technology and education vol. 3 2013 (A. Méndez –Vilas, Ed.).
Parola C et al. Selective activation of human dendritic cells by OM-85 through a NF-kB and MAPK dependent pathway PLoS One 2013; 8: e82867. doi: 10.1371/journal.pone.0082867.
Although virosomal adjuvant preparations are effective for reducing influenza and RTIs as a whole, the
immunogenicity and efficacy of conventional IIVs are not completely satisfactory in young children.
• OM-85 is usually given in the beginning of autumn in children with recurrent RTIs. IIV is administered
some weeks after the first course of OM-85.
• According to previous mouse studies, the immune stimulation induced by OM-85 could potentially
strengthen the influenza antibodies response evoked by IIV.
These results may be explained by several factors, among them:
The low dose of administration compared to that used in the mouse model
The timing of administration
Measurement in blood (i.e. BAL measurements more relevant but limited in young children)