扁蕾颗粒治疗小儿急性感染性腹泻多中心随机双盲临床研究

Treatment of Acute Infectious Diarrhea in Children by Bianlei Granule:A Multicenter,Double-blinded,Randomized Clinical Trial

目的评价扁蕾颗粒治疗小儿急性感染性腹泻湿热泻的有效性和安全性。方法采用随机、双盲、阳性药平行对照、多中心、非劣效检验的设计,纳入小儿急性感染性腹泻湿热泻患儿288例,采用SAS 9.3将受试者随机分为试验组和对照组,每组144例。试验组给予扁蕾颗粒,对照组给予小儿泻速停颗粒,疗程5日。以大便次数、大便性状复常率、止泻时间、便常规白细胞、中医证候疗效为疗效指标。结果最终脱落8例,试验组5例,对照组3例,287例受试者纳入全分析集进行分析。试验组大便次数与大便性状的复常率为79.86%,对照组为79.02%(χ^(2)=0.0310,P=0.8602),非劣效界值为δ=-10%,95%CI(-8.51,10.19),扁蕾颗粒非劣于小儿泻速停颗粒成立;中位止泻时间两组均为4.00(4.00,5.00)天,试验组中医证候总有效率为97.92%,对照组为99.30%,两组疗效相当(P=0.6224)。结论扁蕾颗粒对小儿急性感染性腹泻治疗效果与小儿泻速停颗粒相当,且安全性良好。

Objective To evaluate the efficacy and safety of Bianlei Granule(BLG)in treating acute infectious diarrhea children with dampness-heat diarrhea.Methods A randomized,double-blinded,positive-drug parallel control,multi-centered design and non-inferiority test was performed in this study.A total of 288 acute infectious diarrhea children with dampness-heat diarrhea were assigned to the trial group and the control group,144 cases in each group.Patients in the trial group took BLG,while patients in the control group took Xiaoer Xiesuting Granule(XXG).The therapeutic course for all was 5 days.Frequency of stool,rate of stool returning to normal,time for diarrhea to resolve,WBC in stool and effectiveness of Chinese medicine syndrome were uesd as the therapeutic indexes.Results Finally 8 cases dropped out,5 cases in trial group and 3 cases in control group,287 cases were included in full analysis set.The rate of stool returning to normal was 79.86%in the trial group and 79.02%in the control group(χ^(2)=0.0310,P=0.8602).The non-inferiority threshold was-10%and 95%confidence interval of difference was(-8.51,10.19).The results of non-inferiority test indicated that BL was not inferior to XXG.The median time of diarrhea resolution was 4.00(4.00,5.00)days.The effectiveness of CM syndrome was 97.92%in the trial group and 99.30%in the control group(P=0.6224).Conclusion The effect of BLG on acute infectious diarrhea in children is equivalent to that of XXG,and it showed a good safety profile.