马来酸曲美布汀治疗功能性消化不良的临床疗效和安全性评价

Clinical Efficacy and Safety of Trimebutine Malcate in the Treatment of Functional Dyspepsia

目的评价国产马来酸曲美布汀(诺为)治疗功能性消化不良的有效性和安全性。方法采用多中心、随机双盲,阳性药物平行对照设计,治疗组为马来酸曲美布汀,对照组为普瑞博思,治疗组38例,对照组35例,纳入对象为功能性消化不良患者,马来酸曲美布汀用量:每次200mg口服,3次/d;普瑞博思用量:每次100mg口服,3次/d。疗程4周。结果治疗组马来酸曲美布汀临床总有效率及显效率分别为81.6%(31/38)和55.3%(21/38),对照组普瑞博思临床总有效率及显效率分别为82.8%(29/35)和57.1%(20/35),2组经比较无统计学意义(P>0.05);治疗组和对照组不良反应发生率分别为7.9%和11.4%,经比较两组差异无统计学意义(P>0.05)。结论马来酸曲美布汀治疗功能性消化不良是有效安全的药物。

Objective To observe the efficacy and safety of Trimebutine malcate in the treatment of functional dyspepsia. Methods 73 patients with functional dyspepsia were divided into two groups randomly. The treatment group was treated with trimebutine malcate （200mg,t. i. d）, the control group was treated with cisapride （ 100mg,t. i. d）, and the treatment period was 4 weeks. Results The results showed＇that the total effective rate was 81.6% （31/38） and the highly effective rate was 55.3% （21/38） in treatment group, while in control group they were 82.8% （29/35） and 57.1% （20/35） respectively. The adverse reaction rate of treatment group was 7.9% and control group was 11.4%. There were no statistical significant difference between the two groups （P 〉 0.05 ）. Conclusion Trimebutine malcate is a effective and safe drug in treating functional dyspepsia.