米曲菌胰酶片联合马来酸曲美布汀片治疗功能性腹泻的临床疗效

Clinical efficacy observation of oryz-aspergillus enzyme and pancreatin tablet combined with trimebutine maleate tablet on functional diarrhea

目的:评价米曲菌胰酶片联合马来酸曲美布汀片治疗功能性腹泻的疗效和安全性。方法:将复旦大学附属中山医院消化科门诊功能性腹泻患者随机分为联合用药组和单药治疗组,联合用药组给予米曲菌胰酶片2片(餐中服用,3次/d)和马来酸曲美布汀片1片(3次/d),单药治疗组给予马来酸曲美布汀片1片(3次/d)。治疗4周后评估不同治疗方案对功能性腹泻的疗效和安全性。结果:经过4周的治疗后,联合用药组的总有效率显著优于单药治疗组(88.9%vs 80.9%,P=0.01),且联合用药组的治愈率和显效率均明显优于单药治疗组(29.6%vs 14.9%,51.9%vs 31.9%,P<0.01)。停药4周后,联合用药组腹泻再发率明显低于单药治疗组(4.3%vs 18.4%,P=0.002)。2组未观察到与研究方法和研究药物相关的不良反应。结论:米曲菌胰酶片可提高马来酸曲美布汀片治疗功能性腹泻的效果,二者联合可更有效治疗功能性腹泻。

Objective:To investigate the efficacy and safety of oryz aspergillus enzyme and pancreatin tablet combined with trimebutine maleate tablet on functional diarrhea(FD).Methods:According to the RomeⅢDiagnostic Criteria for FD,the patients were recruited from Zhongshan Hospital,affiliated to Fudan University,Shanghai,China.These patients were randomly divided into the combination therapy group and the monotherapy group.The patients in the combination group were prescribed with oryz aspergillus enzyme and pancreatin tablet(2pellets with a meal,three times a day)and trimebutine maleate tablet(1pellet post meal,three times a day)for4weeks,and the patients in the monotherapy group were prescribed with trimebutine maleate tablet(1pellet post meal,three times a day)for4weeks.The efficacy and safety of the drugs were evaluated.Results:After4weeks,the overall efficacy rate of the combination therapy on FD was superior to that of the monotherapy(88.9%vs80.9%,P=0.01).Additionally,the cure rate and the significant efficiency rate of the combination therapy on FD were also both superior to that of the monotherapy(29.6%vs14.9%and51.9%vs31.9%,P<0.01).After withdrew,the recurrence rate of diarrhea was significantly higher in the monotherapy group than in the combination group(4.3%vs18.4%,P=0.002).None of the patients reported the drug related adverse effects during the study.Conclusions: The oryz aspergillus enzyme and pancreatin tablet can improve the effect of trimebutine maleate tablet on FD.FD can be effectively treated by the combination with these two drugs.