国产枸橼酸铋雷尼替丁治疗消化性溃疡的临床研究

A Clinical Study of Ranitidine Bismuth Citrate in the Treatment of Peptic Ulcer

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 clinical efficacy and safety of Chinaproduced ranitidine bismuth citrate(RBC) in treatment of peptic ulcer. METHODS: A randomized, double-blind,controlled trial, as well as opened trial was carried out in multicentfe clinics. Four hundred and thirty two patients with peptic ulcer were enrolled in the study, a total of 26 cases were withdrawal from the study (6.03%). In double- blind trial, 104 patients (30 with gastric ulcer and 74 with duodenal ulcer) were enrolled in RBCgroup (350mg, bid) and 105 cases (31 with gastric ulcer and 74 with duodenal ulcer) in controlled group (ranitidine, 150mg, bid). RESULTS: The percentage of disappearance for abdominal pain in RBC group and ranitidine group was 94.95% and 95.96% respectively (P>0.05). Comparing with ranihdine group, the gastric ulcer healing rate of RBC group in 6 week was significant higher (86.67%, 26/30 vs. 54.84%, 17/31, P<0.05). The similar healing rate for duodenal ulcer in 4 week was achieved in both RBC and ranitidine group (69.86%, 51/73 and 62. 16%, 46/74, respectively, P>0.05). Three of 301 cases treated with RBC for 4-6weeks had adverse effects, the incidence rate was 1%. CONCLUSION: Chinese-produced RBC was effective and safe in treatment peptic ulcers, especially for gastric ulcer, it had potential effect in eradication for Hp infection.