雷贝拉唑钠治疗消化性溃疡的多中心临床研究

目的：评价雷贝拉唑钠10mg/d在消化性溃疡治疗中的疗效及安全性，并与奥美拉唑20mg/d进行比较。方法：采用随机开放对照临床研究，患者随机进入雷贝拉唑钠组（治疗组）或奥美拉唑组（对照组），共有137例病人完成治疗，其中治疗组70例，对照组67例；治疗组口服雷贝拉唑钠片每次10mg,每日1次；对照组口服奥美拉唑胶囊每次20mg，每日1次。十二指肠球部溃疡疗程为4周，胃溃疡为6周。结果：两组治疗前后疼痛症状的改善及疼痛时间的消失，差异无显著性（P＞0．05）。十二指肠溃疡病人中，治疗组痊愈率和愈合率分别为38．5％和98．1％，对照组分别为26．0％和94．0％，两组间差异无显著性（P均＞0．05）。胃溃疡 病人中，治疗组痊愈率和愈合率分别为50．0％和100．0％，对照组分别为35．3％和94．1％，两组间差异无显著性（P均＞0．05）。整个试验过程中，治疗组和对照组不良反应率分别为4．3％和4．5％，两组间不良反应发生率相似（P＝1．000）。结论：雷贝拉唑钠10mg能安全、有效地治疗消化性溃疡，其缓解疼痛、促进溃疡愈合的疗效与奥美拉唑20mg相当。

Multi-center clinical study of rabeprazole in the treatment of peptic ulcer

Objective To evaluate the effect and safety of Rabeprazole at the dose of 10 mg per day on peptic ulcer, comparing with omeprazole at the dose of 20 mg per day. Methods In this randomized, open label, controlled clinical trial, 137 patients with duodenal or gastric ulcers were randomized into two groups: i.e. rabeprazole 10 mg qd, or omeprazole 20 mg qd. There were 70 patients in rabeprazole group and 67 patients in omeprazole group. The treatment lasted 4 weeks in the duodenal ulcer group, and 6 weeks in the gastric ulcer group. Results For patients with duodenal ulcer and gastric ulcer, there were no statistical differneces between these two groups in improving pain symptoms and time of pain resolution after treatment( P >0.05). Among patients with duodenal ulcer, the cure rate and healing rate in the rabeprazole group were not significantly different from those in the omeprazole group(38.5% and 98.1% respectively, versus 26.0% and 94.0% respectively, P >0.05). Among patients with gastric ulcers, the cure and healing rate in the rabeprazole group were also not significanltly different from those of omeprazole (50.0% and 100.0% respectively, versus 35.3% and 94.1% respectively, P >0.05). The incidence of adverse events in the rabeprazole group was 4.3%, which was not significanlty different from that of omeprazole group(4.5%). Conclusion Rabeprazole at the dose of 10 mg per day was able to cure peptic ulcer safely and effectively. It was equivalent to omeprazole at the dose of 20 mg per day in terms of pain resolution and ulcer healing.