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目的：评价国产枸橼酸铋雷尼替丁（ＲＢＣ）治疗消化性溃疡的效果和安全性。方法：多中心临床试验采用随机双盲平行对照的试验方法评价临床疗效，以雷尼替丁作对照；以开放性试验评价安全性。共有４３２例消化性溃疡患者入选本研究，２６例失访（６．０３％），可评价病例４０６例。在双盲试验中，入选国产枸橼酸铋雷尼替丁组１０４例，包括胃溃疡３０例、十二指肠溃疡７４例；入选雷尼替丁组１０５例，其中胃溃疡３１例、十二指肠溃疡７４例。开放性试验组可评价病例１９７例，胃溃疡６１例、十二指肠溃疡１３６例。国产枸橼酸铋雷尼替丁用量为３５０ｍｇ，每日２次；雷尼替丁用量为１５０ｍｇ，每日２次。胃溃疡疗程６周，十二指肠溃疡疗程４周。以用药后疼痛的消失率、溃疡愈合率、幽门螺杆菌根除率以及药物不良反应的发生率作为疗效和安全性评价指标。结果：国产枸橼酸铋雷尼替丁对消化性溃疡疼痛的消失率与雷尼替丁无差异。国产枸橼酸铋雷尼替丁对胃溃疡的６周愈合率为８６．６７０（２６／３０），明显高于雷尼替丁组（５４．８４０，Ｐ＜０．０５）；国产枸橼酸铋雷尼替丁对十二指肠溃疡的４周愈合率（６９．８６％，５１／７３）与雷尼替丁（６２．１６％，４６／７４）无显著差异（Ｐ＞０．０?
Objective: To evaluate the efficacy and safety of domestic made bismuth citrate bilirudin (RBC) in the treatment of peptic ulcer. Methods: The multi-center clinical trial randomized double-blind parallel control test to evaluate the clinical efficacy of ranitidine as a control; an open-ended test to evaluate the safety. A total of 432 patients with peptic ulcer were enrolled in the study, 26 were lost to follow-up (6.03%) and 406 were evaluable. In a double-blind trial, 104 cases of ranitidine bismuth citrate were enrolled, including 30 cases of gastric ulcer and 74 cases of duodenal ulcer; 105 cases of ranitidine were enrolled, including 31 cases of gastric ulcer 74 cases of duodenal ulcer. 197 cases of open test group evaluable cases, 61 cases of gastric ulcer, 136 cases of duodenal ulcer. Domestic bismuth citrate dosage ranitidine 350mg, 2 times a day; amount of ranitidine 150mg, 2 times a day. Gastric ulcer treatment for 6 weeks, duodenal ulcer treatment for 4 weeks. The rate of disappearance of the pain, healing rate of ulcer, eradication rate of Helicobacter pylori and the incidence of adverse drug reactions were taken as the evaluation indexes of efficacy and safety. Results: Domestic ranitidine bismuth citrate peptic ulcer pain disappearance rate and ranitidine no difference. The healing rate of ranitidine bismuth citrate in patients with gastric ulcer at 6 weeks was 86.670 (26/30), which was significantly higher than that of ranitidine (54.840, P <0.05). The domestic citron The healing rate of ranitidine bismuth to duodenal ulcer in 4 weeks (69.86%, 51/73) and ranitidine (62.16%, 46/74) was no significant difference (P> 0. 0?