Difference in Efficacy of Proton Pump Inhibitor Between
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Difference in efficacy of proton pump inhibitor between new-onset and recurrent gastroesophageal
reflux disease: Result from a study of on-demand versus continuous
maintenance therapy in Japan
Retno Dwi Hartati10711112
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Pendahuluan GERD
Angka kejadian 10 – 20 %, Penyakit berulang.
Pada usia 18 – 44 tahun
Cenderung berulang – terap pemeliharaan
Proton pump inhibitor
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Tujuan penelitian Apakah terdapat perbedaan perbaikan gejala
antara GERD onset baru dengan GERD reccurent terhadap terapi omeprazole continue dan terapi bila ada gejala.
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METODEAnalisis post terapi GERD dengan proton pump inhibitor
Paralel, studi acak, open label, RS universitas tunggal april 2009 – april 2013
Diagnosis berdasarkan kriteria Los Angeles
Random : Kelompok GERD onset baru dan reccurent
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evaluasi
Mengisi Gejala setiap hari ke dalam grafik harian
jumlah tablet yang dikonsumsi setiap hari
Endoskopi pada minggu ke 24
Tidak ada gejala selama 6 hari atau 1
minggu
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HASIL
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Pasien GERD onset baru, perbaikan gejala pada kelompok terapi continue pada minggu 4,5,6 17 p<0,05
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pasien GERD berulang,pada kelompok continue, menunjukkan efek signifikan pada 1, 2, 3, 4, 5, 7, 8, 17 dan 18 minggu (Gambar 3).
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Kesimpulan
Terapi continue pada GERD onset baru dan GERD reccurent efektif dalam meringankan
gejala dan penyembuhan mukosa.
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Diskusi
GERD
Penyakit yang cenderung kambuh
tingkat kekambuhan setelah 6 bulan tanpa terapi pemeliharaan 50 – 100%.
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Hasil karateristik pasien pada kelompok GERD reccurent
BMI < 25 tergolong normal,
Konsumsi alkohol lebih sering
Alkohol menginduksi cedera mukosa,
Mengganggu efek farmakologis PPI
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Faktor yang berperan terhadap kekambuhan
Usia muda merokok
Tingkat keparahan
regurgitasi sedang/berat
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Analisis PICO
Patient
:
• pasien GERD onset baru dan recurrent
Intervention
:
• omeprazole 20 mg saat gejala
Comparison
:
• omeprazole 20 mg continue
Outcome
:
• efektifitas omeprazole terhadap perbaikan gejala GERD.
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• Penelitian ini menganalisis apakah terdapat perbedaan perbaikan gejala antara GERD onset baru dan berulang dengan terapi continue dan on demand
Did the trial address a
clearly focused issue?
•responden yang ikut dalam penelitian ini di dilakukan randomisasi menggunakan komputer yang di bagi dalan kelompok pemberIan obat saat gejala dan terus menerus.
Was the assignment of
patients to treatments
randomised?
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• tidak, pada awal penelitian terdapat 118 responden, sementara pada hasil responden yang dianalisis sebanyak 98 orang.
Were all of the patients who entered the trial
properly accounted for at its conclusion?
• Pada penelitian ini tidak di jelaskan apakah petugas kesehatan, pasien dan penelitian blind terhadap intervensi
Were patients, health workers and
study personnel ‘blind’ to treatment?
• Sejak awal penelitian kelompok sama yakni kelompok yang menerima terapi continue dan yang meminum obat saat gejala .
Were the groups similar at the
start of the trial?
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Aside from the experimental intervention, were the groups treated equally?
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• Perbedaan signifikan BMI dan minum alkohol pada kelompok onset baru dan recurrent berpengaruh terhadap terjadinya GERD P<0,05•Pada GERD onset baru terapi continue lebih banyak mendapat perbaikan gejala pada minggu 4,5,6 dan 17. P<0,05•Pada kelompok GERD berulang, pada kelompok terapi continue efektifitas terhadap perbaikan gejala pada minggu 1,2,3,4,5,7.8.17 dan 18. P<0,05•Tidak ada perbedaan konsumsi jumlah tablet pada GERD recurrent dan onset baru.•pasien yang sembuh secara signifikan pada endoskopi minggu ke 24 lebih tinggi pada kelompok onset baru 60/68 (88,2%) dari pada kelompok berulang 17/30 (56,7%) dengan P <0,01•
How large was
the treatment effect?
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• Signifikansi statistik didefinisikan P<0,05.
How precise was the estimate of the treatment effect?
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•Hasil penelitian dapat diamplikasikan di indonesai karena omeprazole tersedia di indonesia.
Can the results be applied in your
context? (or to the local population?)
•Hasil keluaran yang penting telah diikut sertakan dalam analisis penelitian.
Were all clinically important outcomes
considered?
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Terimakasih