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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。
Objective: To evaluate the clinical efficacy and safety of bismuth sub salicylate in the treatment of acute digestive symptoms. METHODS: A multicenter, randomized, double-blind, double-dummy, controlled trial was conducted to investigate the effects of imported salicylic acid oral solution and homemade bismuth sub salicylate suspension on 131 cases with two or more Clinical Efficacy and Safety of Patients with Acute Digestive System Symptoms. . Results: The cure rate of oral solution was 67.2%, the total effective rate was 88.1%. The cure rate of dry suspension was 62.5% and the total effective rate was 85.9%. Oral liquid adverse drug reaction rate was 3.0%, mainly as nausea, belching; dry suspension drug adverse reaction rate was 6.2%, mainly for nausea and diarrhea. There was no significant difference in the clinical efficacy and adverse drug reaction between the two groups (P> 0.05). Conclusion: The efficacy of bismuth sub salicylate oral liquid and dry suspension in the treatment of acute dyspeptic symptoms is similar, and the incidence of adverse drug reactions is low. Bismuth sub salicylate oral solution is safe and effective treatment of acute digestive symptoms of drugs.