雷贝拉唑治疗消化性溃疡的临床研究

目的 :评价雷贝拉唑 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进行对比。方法 :采用随机对照临床研究 ,患者随机进入雷贝拉唑组 (治疗组 )或奥美拉唑组 (对照组 ) ,共有 10 2例病人完成治疗 ,其中治疗组 5 2例 ,对照组 5 0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 (DU)疗程 4周 ,胃溃疡 (GU)为 6周。结果 :两组治疗前后疼痛症状的改善及总的缓解率无明显差异 (P >0 .0 5 ) ,但服药第一天时治疗组的腹痛缓解率在DU和GU分别为 5 8%和 4 5 % ,明显高于对照组的 38%和 2 4 % (P <0 .0 5 ) ,其于各天内两组间无差异。十二指肠球部溃疡病人中 ,治疗组愈合率、有效率、总有效率分别为 91%、9%、10 0 % ,对照组分别为 87.9%、9%、97% ,两组间差异无显著性 (P均 >0 .0 5 ) ;胃溃疡病人中 ,治疗组愈合率、有效率、总有效率分别为 84 .2 %、10 .5 %、94 .7% ,对照组分别为 76 .5 %、17.6 %和 94 .1% ,两组间无显著性差异 (P均 >0 .0 5 ) ;治疗组和对照组不良反应发生率分别为 1.92 %和 2 % ,两组间无显著性差异 (P >0 .0 5 )。结论 :雷贝拉唑 10mg d能有效地治疗消化性溃疡 ,其腹痛总的缓解率、促进溃疡愈合的疗效、不

CLINICAL STUDY OF RABEPRAZOLE IN THE TREATMENT OF PEPTIC ULCER

Objective: To evaluate the effect and safety of rabeprazole at the dose of 10mg per day on peptic ulcer, in comparison with omeprazole at the dose of 20mg per day. Methods: in this randomized,controlled clinical trial,102 patients with duodenal or gastric ulcer were randomized into two groups:rabeprazole 10mg qd and omeprazole 20mg qd.There were 52 patients in rabeprazole group and 50 patients in omeprazole group.The treatment lasted 4 weeks in the duodenal ulcer(DU)group,and 6 weeks in the gastric ulcer(GU)group. Results: For the patients with duodenal ulcer or gastric ulcer,there were no statistical differences between these two groups in improving pain symptoms and total complete pain relief rates(P>0.05),but the pain relief rate for DU and GU on the first day was higher in rabeprazole group(58%,45% respectively)than that in omeprazole group(38%,24% respectively),P<0.05,Among patients with duodenal ulcer,the healing rate,effective rate and total effective rate in rabeprazole group were not significantly different from those in omeprazole group(91%?9%and100%,respectively ,versus 87.9%?9%and 97%,P>0.05).Among patients with gatric ulcer,the healing rate,effective rate and total effective rate in rabeprazole group were not significantly different from those in omeprazole group either (84.2%?10.5%and 94.7%respectively,versus 76.5%?17.6% and 94.1%,P>0.05).The incidence of adverse events in rabeprazole group was 1.92%,which was not significantly different from that of omeprazole group(2%).Conclusion: Rabeprazole at the dose of 10mg per day was able to cure peptic ulcer effectively which was equivalent to omeprazole at the dose of 20mg per day in terms of pain relief and ulcer healing and adverse events,but it was higher than omeprazole in the pain relief rate on the first day.