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OA北大核心CSTPCD

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 effectondiarrhea,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),including 122 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 the 95％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.