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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。
Objective: To compare the curative effect of domestic pantoprazole and pantoprazole on duodenal ulcer; domestic pantoprazole, clarithromycin plus amoxicillin triple anti-helicobacter pylori (HP) Refers to the efficacy of intestinal ulcer with HP infection. Methods: One hundred and twelve patients were enrolled in the trial and 105 cases were evaluated. The experiment consisted of two parts: single drug use (45 cases) were randomly divided into three groups: domestic pantoprazole and imported pantoprazole 40mg once daily , Medication for 2 weeks to compare the rate of ulcer healing; triple drug part of duodenal ulcer were infected with HP, were randomly divided into groups, respectively, with domestic pantoprazole and clarithromycin plus amoxicillin and imported Pantola Azole and imported clarithromycin plus amoxicillin. Pantoprazole treatment for 2 weeks, antibiotic treatment for 1 week, compared the HP eradication rate and adverse events during treatment. Results: The two-week healing rates of domestic and imported pantoprazole in treating duodenal ulcer were 84 0% and 80 0% respectively (P 0 05). The pain relief rates on the 3rd day were 70 2% and 6% The average pain relief time was 421 ± 28 and 3393 ± 18 days respectively. The eradication rates of domestic triple and triple HP were 73 3% and 83 3%, respectively (P 0 05). There was no significant difference in the incidences of adverse events between domestic drug groups and imported drug groups of 34.0% and 320.0% respectively. Conclusion: Domestic pantoprazole and clarithromycin in the treatment of duodenal ulcer with HP infection compared with similar imported products, the same effect, the same security and lower prices, suitable for domestic applications.