1. Hwang, J. J., Lee, D. H., Yoon, H., Shin, C.
M., Park, Y. S., & Kim, N. (2016). Gut and
liver, 10(3), 356–361.
Presentan:
2. • Helicobacter pylori telah ditemukan berhubungan
dengan penyakit non-gastrointestinal seperti PJK,
autoimun, dan anemia pernisiosa
• H. pylori menunjukkan potensi sebagai faktor
etiologik idiopathic thrombocytopenic purpura (ITP)
meningkatnya angka trombosit pasca eradikasi
H.pylori
PENDAHULUAN
2
3. Immune thrombocytopenic
purpura
• Gangguan autoantibodi atau
kompleks imun
menghancurkan trombosit
dan bermanifestasi sebagai
perdarahan mukokutan.
PENDAHULUAN
3
• Steroid merupakan terapi
efektif untuk ITP
• Penghentian steroid
menyebabkan relapse
hanya 10-30% berhasil
mempertahankan remisi
• Terapi eradikasi H.pylori
memiliki keunggulan berupa
efek samping lebih sedikit
dan durasi terapi lebih
singkat
5. Metode Penelitian
5
Populasi studi
• Penelitian dilakukan di Seoul National University Bundang
Hospital pada Januari 2003-Desember 2013
• Dilakukan peninjauan retrospektif pada rekam medis pasien
terdiagnosis ITP kronis
• Protokol studi telah disetujui Ethics Committee Seoul National
University Bundang Hospital
6. Metode Penelitian
6
Kriteria eksklusi
Usia <18 tahun
Trombositopenia berhubungan dengan
gangguan autoimun, obat-obatan,
riwayat keluarga trombositopenia
herediter, infeksi HIV, hepatitis, atau
pseudotrombositopenia
Riwayat eradikasi H.pylori
Riwayat pengobatan dengan PPI,
antagonis reseptor H2, atau antibiotik 4
minggu sebelumnya
Kriteria inklusi
Usia >18 tahun
Terdiagnosis ITP berdasarkan kriteria
American Society of Hematology
dengan angka trombosit awal
<100x103/μL
7. Metode Penelitian
7
Terapi eradikasi (triple therapy)
- Rabeprazole 2x20 mg
- Amoxicillin 2x1000 mg
- Clarithromycin 2x500 mg
13C-urea breath
test
Positif infeksi
H.pylori
Negatif
Terapi eradikasi*
Tidak menerima
terapi eradikasi
Evaluasi 13C-urea breath
test 4 minggu pasca
inisiasi terapi
8. Metode Penelitian
8
Outcome
• Peningkatan angka trombosit
berdasarkan infeksi H. pylori atau
keberhasilan eradikasi
Kriteria utama
• Peningkatan angka trombosit
berdasarkan respons terapi
Kriteria sekunder
10. Metode Penelitian
10
Analisis statistik
• SPSS versi 20.0
• Variabel kontinu student t-test dan analisis variansi
• Variabel non-kontinu Pearson chi-square dan Fisher exact
test
15. Diskusi
15
Terdapat hubungan keberhasilan eradikasi
H.pylori dan peningkatan angka trombosit
▪ Faktor yang memengaruhi respons terapi
yaitu jarak antara diagnosis ITP sebelum
terapi dan angka trombosit sebelum terapi
(Rostami et al., 2008; Stasi et al., 2009)
▪ Gasbarrini et al. : autoantibodi trombosit
menghilang pada 6 dari 11 pasien
trombositopenia autoimun yang menjalani
eradikasi H.pylori
▪ Emilia et al.: AT meningkat pada 6 dari 12
(50%) pasien ITP yang menjalani eradikasi
H.pylori
Prevalensi infeksi H.pylori pada
populasi studi: 41.1% (42/102)
39 subjek menunjukkan
peningkatan AT (92.9%)
16. Diskusi
16
▪ Arnold et al. : hanya 8,8% pasien ITP negatif H.pylori menunjukkan
peningkatan AT dibandingkan 51,2% pasien ITP positif H.pylori (OR
14,5, 95%CI 4,2-83,2)
▪ Fujimura et al.: studi skala besar di Jepang menunjukkan trombosit
meningkat pada 63% pasien pasca terapi eradikasi
Terapi eradikasi H.pylori direkomendasikan untuk
pasien ITP positif H.pylori
17. Kesimpulan
17
Terapi eradikasi H.pylori berhubungan dengan peningkatan angka
trombosit, dan keberhasilan eradikasi memengaruhi peningkatan
angka trombosit pada pasien Korea dengan ITP kronis.
19. 19
P
Pasien didiagnosis dengan ITP kronis
I
Terapi eradikasi Helicobacter pylori
C
Negatif terhadap Helicobacter pylori atau
tidak merespon terhadap terapi eradikasi
O
Peningkatan angka trombosit
20. 20
Was the assignment of patients to
treatments randomized?
▪ Bagian Methods, Diagnosis of H. pylori and eradication therapy,
Paragraf 1:
“All participants were tested for the presence of H. pylori
with a 13C-urea breath test. If the result was positive, the
patient was diagnosed as having H. pylori infection…….
Patients without H. pylori infection received no eradication
therapy.”
▪ Bagian Methods, Assessment of treatment efficacy, Paragraf
1:
“We divided the patients by three groups…”
21. 21
Were the groups similar at the
start of the trial?
▪ Bagian Results, Patient characteristics, Paragraf 1:
“There were no statistical differences in age, gender
distribution, baseline platelet count, WBC count, hemoglobin,
ANC, or previous ITP treatment between three groups.”
22. 22
Aside from the allocated treatment,
were the groups treated equally?
▪ Bagian Methods, Diagnosis of H. pylori and eradication therapy,
Paragraf 1:
“None of the patients received additional concurrent
immunosuppressive treatment or prednisolone except for
previous maintenance treatment over 6 months during the H.
pylori eradication therapy and follow-up periods.”
23. 23
Were all patients who entered the
trial accounted for? And were they
analyzed in the groups to which they
randomized?
▪ Bagian Results, Patient characteristics, Paragraf 1:
“Between 2003 and 2013, a total of 102 patients (HPPE
group, n=39; HPNE group, n=3; HPN group, n=60) were
diagnosed with chronic ITP.”
24. 24
Were measures objective or were
patients and clinicians kept “blind” to
which treatment was being
received?
▪ Bagian Methods, Diagnosis of H. pylori and eradication therapy,
Paragraf 1:
“All participants were tested for the presence of H. pylori
with a 13C-urea breath test. If the result was positive, the
patient was diagnosed as having H. pylori infection…….
Patients without H. pylori infection received no eradication
therapy.”
25. 25
How large was the treatment effect?
>=100 <100 Total
Terapi 39 3 42
Non-terapi 19 41 60
Total 58 44 102
RR : (39/42)/(19/60) =
ARR:
RRR :
NNT :
AT
Terapi
H.pylori
<100 >=100 Total
Terapi 3 39 42
Non-terapi 41 19 60
Total 44 58 102
RR :
Risk Diff. :
RRR :
NNT :
28. How large was
the treatment?
< 85 >=85 Total
DLBS1033 7 35 42
Aspirin 3 39 42
Total 10 74 84
Barthel
Index
Terapi
>=85 < 85 Total
DLBS1033 35 7 42
Clopidogrel 31 11 42
Total 66 18 84
Barthel
Index
Terapi RR : (35/42)/(39/42) =
0,89
Risk Diff. : 0,83 – 0,93= -
0,10
RRR : 1 – 0,89 = 0,11
NNT : 1/-(0,10) = -10
RR : (35/42)/(31/42) =
1,13
Risk Diff. : 0,83 – 0,74=
0,09
RRR : 1 – 1,13 = -0,13
NNT : 1/0,09 = 11,1
RR : Relative risk; RRR : Relative risk reduction; NNT : number needed to treat
29. How precise was the estimate of the treatment
effect?
▪ 95% CI Risk diff. DLBS1033 vs aspirin (BI) : - 0,10 ± 0,137
▪ 95% CI Risk diff. DLBS1033 vs clopidogrel (BI): 0,09 ± 0,174
▪ 95% CI Risk diff. DLBS1033 vs aspirin (SSGM) : 0 ± 0
▪ 95% CI Risk diff. DLBS1033 vs aspirin (SSGM) : - 0,024 ±
0,046
Editor's Notes
Seluruh pasien tidak menerima terapi imunosupresif tambahan selain terapi ruwatan selama 6 bulan terapi eradikasi H,pylori dan periode follow up
Kriteria sekunder
remisi komplit (AT ≥100x103/uL setelah 2 bulan terapi)
Remisi parsial (AT ≥30x103/uL setelah 2 bulan terapi)
Tidak respons (AT <30x103/uL, peningkatan <50% dibandingkan AT baseline, tidak ada peingkatan)