摘要
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 2 0mg/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 6 7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 2 0mg ,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 .0 5 )。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 2 6 .0 %和 94.0 % ,两组间差异无显著性 (P均 >0 .0 5 )。胃溃疡病人中 ,治疗组痊愈率和愈合率分别为 5 0 .0 %和 10 0 .0 % ,对照组分别为 35 .3%和 94.1% ,两组间差异无显著性 (P均 >0 .0 5 )。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 =1.0 0 0 )。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 2 0mg相当。
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.
出处
《中华消化杂志》
CAS
CSCD
北大核心
2001年第7期404-405,共2页
Chinese Journal of Digestion
