涩肠止泻散治疗儿童急性水样便腹泻多中心随机对照临床研究

Randomized controlled,multi-center clinical study of Sechangzhixiesan in the treatment of acute watery diarrhea in children

目的评价涩肠止泻散治疗儿童急性水样便腹泻的临床疗效和安全性。方法采用分层区组随机、双盲的研究方法。于2020年12月至2023年3月纳入17家研究中心248例儿童急性水样腹泻患儿,根据使用药物不同分为试验组(123例)和对照组(125例),分别给予涩肠止泻散和蒙脱石散,对药物进行非劣效性检验。比较两组的腹泻疗效、腹泻时间、止泻起效时间、腹痛持续时间、腹痛起效时间及安全性指标。结果共245例进入全分析数据集(FAS),其中试验组122例,对照组123例。主要疗效指标为满3 d腹泻疗效(有效率),试验组为83.61%,对照组为85.37%,两组率比(试验组/对照组)及95%置信区间为0.979(0.879~1.09),经非劣效检验,试验组不劣于对照组,FAS、符合方案集(PPS)分析结论一致。腹泻时间、止泻起效时间组间比较,差异均无统计学意义;腹痛持续时间、腹痛起效时间,试验组均短于对照组,两组间比较差异有统计学意义,FAS、PPS分析结论一致。在安全性方面,两组不良事件或不良反应发生率的比较,差异均无统计学意义,不良反应两组各发生1例,均为便秘,为品种已知的不良反应类型。结论涩肠止泻散治疗儿童急性水样便的腹泻疗效不劣于蒙脱石散,且止痛效果明显,同时安全性良好,具有临床推广价值。

Objective To evaluate the clinical efficacy and safety of Sechangzhixiesan in the treatment of acute watery diarrhea in children.Methods Stratified block randomized,double-blind method was adopted.A total of 248 children with acute watery diarrhea were enrolled in 17 research centers from December 2020 to March 2023.They were divided into an experimental group of 123 cases and a control group of 125 cases.They were given Sechangzhixiesan and montmorillonite powder respectively to test the non-inferiority of the drugs.The effecton diarrhea,duration of diarrhea,abdominal pain duration,onset time of drug effect in stopping diarrhea,onset time of abdominal pain relief,and safety indicators were compared between the two groups.Results A total of 245 cases were included in the full analysis set(FAS),including122 cases in the experimental group and 123 cases in the control group.The main efficacy index was the efficacy(effective rate)of diarrhea for 3 days,which was 83.61%in the experimental group and 85.37%in the control group.The rate ratio of the two groups and the95%CI(experimental group/control group)was 0.979(0.879~1.09);the non-inferiority test was established,the experimental group was not inferior to the control group,and the FAS and PPS analysis conclusions were consistent.There were no statistically significant differences in the duration of diarrheaor or onset time of drug effect in stopping diarrhea;the duration of abdominal pain and the onset time of abdominal pain were shorter in the experimental groups than in the control group,and the difference was statistically significant;the conclusions of FAS and PPS analysis were consistent.In terms of safety,there was no statistically significant difference in the incidence of adverse events/adverse reactions between the two groups.Adverse reactions occurred in 1 case in each group,both of which were constipation,and it was a known adverse reaction in the species.Conclusion Sechangzhixiesan is non-inferior to montmorillonite powder in treating acute watery diarrhea in children,having obvious analgesic effect,and it exhibits good safety,implying its promising clinical application value.