십이지장 궤양 치료에 있어서 라베프라졸 10 mg 과 오메프라졸 20 mg 의 효과 비교 - 다기관 비교 연구

Abstract

Background/Aims: To compare efficacy and tolerability of rabeprazole (RAB) 10 ㎎ versus omeprazole (OME) 20 ㎎ in patients with duodenal ulcer. Methods: This randomized, comparative, multicenter study was conducted at 10 centers in Korea, from February to September in 1999. Patients with active duodenal ulcer as proven by endoscopy were randomized to RAB (n=123) or OME (n=123) groups. One hundred-twenty-three patients received RAB 10 ㎎ once daily, and 123 patients received OME 20 ㎎ once daily for 2 or 4 weeks. Primary efficacy parameter was complete healing by endoscopy and secondary parameter was the improvement in the severity of clinical symptoms after the therapy. Results: After 2 weeks, complete healing was achieved in 81.7% (85/104) of patients given RAB 10㎎ and in 81.1% (77/95) of patients given OME 20 ㎎ (p=0.902). After 4 weeks, complete healing was documented in 97.1% (101/104) of patients given RAB 10 ㎎ and in 93.7% (89/95) of patients given OME 20 ㎎ (p=0.315). The percentages of patients resolved daytime pain and night-time pain at Day 4 were 87.5% and 90.1% in RAB group and 79.0% and 80.5% in OME group (p=0.138 and p=0.087 for day-time k night-time pain, respectively). No clinically meaningful changes or other between-group differences were observed in laboratory parameters and adverse events which were evaluated to be related with medication. Conclusions: In this study, rabeprazole 10 ㎎ produced healing rates and symptom relief equivalent to omeprazole 20 ㎎ at weeks 2 and 4 in patients with active duodenal ulcer and provided a tendency of faster symptom relief than omeprazole 20 mg, although it didn't reach statistical significance. Both the treatments were well tolerated.