Penelitian ini untuk mengevaluasi efek obat penghambat pompa proton (esomeprazol), penggunaan bronkodilator inhaler dan arus puncak ekspirasi (APE) pada pasien asma persisten sedang dengan penyakit refluks gastroesofagus (PRGE). Penelitian ini adalah uji klinis terbuka dengan kontrol di RS Persahabatan Jakarta dari Juli 2004 sampai Oktober 2005. Diagnosis PRGE ditegakkan jika ditemukan gejala PRGE dan gambaran esofagitis pada endoskopi dan atau pada pemeriksaan histopatologi hasil biopsi esofagus. Pada fase 1 (periode run in) selama 2 minggu, pasien mendapat pengobatan budesonid inhalasi dosis 2x200 ug/hari. Pada fase 2, pasien diacak menjadi 2 kelompok dan mendapat pengobatan budesonid inhalasi dosis 2 x 400 ug/hari dengan esomeprazol 40 mg/hari atau tanpa esomeprazol (kelompok kontrol) selama 8 minggu. Fase 3 (periode wash out) pasien mendapat pengobatan budesonid inhalasi dosis 2 x 200 ug/hari. Catatan harian dilakukan pada periode run in, setelah pengobatan 4 minggu, 8 minggu dan periode wash out. Sebanyak 32 pasien (23 perempuan dan 9 laki-laki) menyelesaikan penelitian ini. Rata-rata skor gejala asma total harian berkurang secara bermakna pada kelompok esomeprazol dibanding tanpa esomeprazol setelah pengobatan 8 minggu (-2,29 vs -0,90; p < 0,05). Rata-rata penggunaan bronkodilator inhaler berkurang secara bermakna pada kelompok esomeprazol dibanding tanpa esomeprazol setelah pengobatan 8 minggu (- 1,09 vs - 0,42; p < 0,05). Nilai APE pagi dan sore meningkat lebih besar pada kelompok esomeprazol dibanding tanpa esomeprazol tetapi tidak berbeda bermakna. Disimpulkan bahwa pemberian esomeprazol 40 mg perhari memperbaiki gejala asma dan penggunaan bronkodilator inhalasi pada asma persisten sedang dengan PRGE.
Abstract
This study aimed to evaluate effect of proton pump inhibitor (esomeprazole) on asthma symptoms, use of inhaled bronchodilator and peak expiratory flow rate (PEFR) in moderate persistent asthma with gastroesofageal refluks disease (GERD). This randomized single blind, controlled clinical trial study was conducted at Persahabatan Hospital, Jakarta from July 2004 until October 2005. Samples were moderate persistent asthma patients with GERD. GERD is diagnosed GERD symptoms and proof of oesophagitis from endoscopy and or histapatologic examination from oesophagus biopsy. Phase 1:2 week run-in period patient received inhaled budesonide 2x200 ug/day. Phase 2: patient randomised to receive inhaled budesonide 2 x 400 ug/day with esomeprazole 40 mg/day or without esomeprazole (control group) for 8 weeks. Phase 3: 4 week wash out period, patient receive inhaled budesonide 2 x 200 ug/day. Diary cards were assessed at run-in periode, after treatment 4 weeks, 8 weeks and wash out. There were 32 patients (23 female and 9 male) completed the study. Mean total asthma symptoms score daily were significantly decreased on esomeprazole vs without esomeprazole after 8 weeks (-2.29 vs -0.90; p < 0.05). Mean use of inhaled bronchodilator was significantly decreased on esomeprazole vs without esomeprazole after 8 weeks (-1.09 vs -0.42; p < 0.05). Morning and evening PEFR improved higher on esomeprazole than without esomeprazol but were not significantly difference. In conclusion, administration esomeprazole 40 mg daily improved asthma symptoms and lower the use of inhaled bronchodilator in moderate persistent asthma patients with GERD. |
