肠舒止泻胶囊治疗脾虚湿热型慢性泄泻的多中心随机双盲对照临床试验

目的 评价肠舒止泻胶囊(鸡矢藤、砂仁、人参、山药、苍术、黄柏、黄连等)治疗脾虚湿热型慢性泄泻的有效性与安全性.方法 将440患者按3∶1随机分为试验组和对照组,分别给予肠舒止泻胶囊和参苓白术胶囊,疗程10 d,根据大便次数、止泻时间、证候积分和综合疗效进行疗效评价.结果 全分析集(FAS)结果表明,试验组综合疗效的显效率、总有效率高于对照组(P＜0.01)；治疗后试验组证候积分低于对照组,治疗前后积分差和变化率高于对照组(P＜0.01)；试验组的中位止泻时间6.00d,对照组中位止泻时间7.00d,差异有显著性意义(P＜0.01).试验组大便泄泻、腹痛腹胀、肠鸣和口渴治疗前后的积分差大于对照组(P＜0.05).在试验过程中,试验组有1例病例出现烧心恶心欲呕,对照组未出现不良事件.结论 肠舒止泻胶囊治疗脾虚湿热型慢性泄泻疗效显著,安全性好.

Changshu Zhixie Capsules in treatment of chronic diarrhea due to spleen deficiency and damp-heat:a multi-center,randomized,double-blind,controlled clinical trial

AIM To evaluate the efficacy and the safety of Changshu Zhixie Capsules(Paederiae Caulis,Amomi Fructus,Ginseng Radix et Rhizoma,Dioscoreae Rhizoma,Atractylodis Rhizoma,Phellodendri chinensis Cortex,Coptidis Rhizoma etc.) in the treatment of chronic diarrhea due to spleen deficiency and damp-heat.METHODS Four hundred and forty patients were randomly divided into two groups(experiment group and control group) in a ratio of 3∶ 1.The participants in the experiment group were given Changshu Zhixie Capsules for ten days and those in the control group were given Shenling Baizhu Capsules.The efficacy was evaluated according to stool frequency,duration of diarrhea,syndrome scores,and overall effects.RESULTS The results for the full analysis set showed that the excellent rate of overall effects and the total effective rate in the experiment group were higher than those in the control group(P<0.01).After treatment,the total syndrome score in the experiment group was lower than that in the control group,and the change in the total syndrome score and the rate of change in the experiment group were respectively higher than those in the control group(P<0.01).The median duration of diarrhea in the experiment group was 6.00 days,shorter than 7.00 days in the control group(P<0.01).The changes of scores in diarrhea,bellyache and bloating,borborygmus,and thirst in the experiment group were respectively higher than those in the control group(P<0.05).One patient experienced symptoms of heartburn and nausea during the trial.No adverse event appeared in the control group.CONCLUSION Changshu Zhixie Capsules have notable efficacy and good safety in treating chronic diarrhea due to spleen deficiency and damp-heat.