碱式水杨酸铋口服液治疗急性消化系统症状的多中心随机双盲双模拟对照临床研究

目的:评价碱式水杨酸铋口服液治疗急性消化系统症状的临床疗效和安全性。方法:用多中心、随机、双盲、双模拟、对照试验方法,研究进口碱式水杨酸秘口服液与国产碱式水杨酸铋干混悬剂对131例具有两项或两项以上急性消化系统症状的患者的临床疗效及安全性。。结果:口服液的痊愈率为67.2％,总有效率为88.1％;干混悬剂的痊愈率为62.5％,总有效率为85.9％。口服液药物不良反应发生率为3.0％,主要表现为恶心、嗳气;干混悬剂药物不良反应发生率为6.2％,主要表现为恶心、腹泻。两组的临床疗效和药物不良反应发生率均无显著差异(P>0.05)。结论:碱式水杨酸铋口服液与干混悬剂治疗急性消化不良症状的疗效相似,药物不良反应发生率低。碱式水杨酸铋口服液是安全和有效的治疗急性消化系统症状的药物。

A Double-blind Double-dummy Randomized Controlled Multicenter Clinical Trial on Bismuth Subsalicylate Oral Solution in The Treatment of Some Gastrointestinal Symptoms

OBJECTIVE: To evaluate the efficacy and safety of bismuth subsalicylate oral solution(BSOS) in the treatment of some gastrointestinal symptoms in Chinese. METHODS: The effects and safety profile of BSOS(trial group) were compared with bismuth subsalicylate suspension produced by a native industry (control group) in double-blind, randomized and controlled clinical trials with double-dummy technique in 131 patients with two or more symptoms. RESULTS: The excellent rates in trial and control groups were 67.2% and 62.5%, respectively. The total effective rates in trial and control groups were 88.1% and 85.9%, respectively. There was not significant difference (P>0.05). The adverse drug reaction rates were 3.0% and 6.2%, respectively with no statistical differences. CONCLUSION: The results suggested both bismuth subsalicylate had the same efficiency and safety for the treatment of some gastrointestinal symptoms. BSOS is a kind of effective and safe drug.