摘要
目的 :比较国产潘托拉唑与进口潘托拉唑对十二指肠球部溃疡的疗效 ;国产潘托拉唑、克拉霉素加羟氨苄青霉素三联抗幽门螺杆菌 (HP)方案对十二指肠球部溃疡合并HP感染的疗效。方法 :112例患者进入试验 ,可评价病例10 5例 ,试验包括两部分 :单用药部分 ( 4 5例 )随机分组 ,分别使用国产潘托拉唑和进口潘托拉唑 40mg ,每日 1次 ,用药 2周 ,比较溃疡愈合率 ;三联用药部分均为十二指肠球部溃疡合并HP感染者 ,随机分组 ,分别使用国产潘托拉唑和克拉霉素加羟氨苄青霉素与进口潘托拉唑和进口克拉霉素加羟氨苄青霉素。潘托拉唑疗程 2周 ,抗生素疗程 1周 ,比较HP根除率及用药期间的不良事件。结果 :国产和进口潘托拉唑治疗十二指肠球部溃疡 2周愈合率分别为 84 0 %和 80 0 % (P>0 0 5 ) ,3日疼痛缓解率分别为 70 2 %和 6 6 7% ,平均疼痛缓解时间分别为 4 2 1± 2 8天和 3 93± 1 8天 ;国产三联和进口三联HP根除率分别为 73 3 %和 83 3 % (P >0 0 5 ) ;国产药组与进口药组不良事件发生率分别为 3 4 0 %和3 2 0 % ,无显著性差异。结论 :国产潘托拉唑和克拉霉素在治疗十二指肠球部溃疡合并HP感染方面与进口同类产品相比疗效相当、同样安全而且价格较低 ,适合国内应用。
Purpose: To compare the efficacy and safety of Chinese produced pantoprazole with imparted for treating duodenal ulcer and triple regimens composed by Chinese produced clarithromycin and pantoprazole plus amoxycillin similar imported triple regimens for treating duodenal ulcer with helicobacter pylori(HP) infection. Methods: 105 complete cases were divided into two parts, one part (45 cases) treated by Chinese produced and imported pantoprazole respectively to observe ulcer healing rate; another part (60 cases) treated by Chinese produced and imported pantoprazole, clarithromycin plus amoxycillin respectively to observe HP eradicating rate, pain and other symptoms relief, and adverse event. Results: Our study shows that there are no significant differences between the Chinese produced medicine group and imported medicine group in ulcer healing rate(84.0% and 80.0%), percentage of disappearance of pain at third days(70.2% and 66.7%) and mean time(4.21±2.8 d and 3.93±1.8 d),HP eradicating rate(73.3% and 83.3%) (P>0.05) and adverse events which are minor and relief after finishing treatment. Conclusion: Our results suggest that Chinese produced pantoprazole and clarithromycin provide similar effects in treating duodenal ulcer and that with HP infection. It was implied that they would replace same kind imported medicine in treating duodenal ulcer patients with HP infection according no pharmacoeconomics.
出处
《临床消化病杂志》
2001年第5期197-200,共4页
Chinese Journal of Clinical Gastroenterology
