小儿金翘颗粒治疗儿童轻型流行性感冒风热证多中心随机对照临床研究  

Multi-centered,Randomize-Controlled Clinical Study on Xiaoer Jinqiao Granules(小儿金翘颗粒)in Treating Children with Mild Influenza with Wind-heat Syndrome

作　　者：马融[1] 胡思源[1] 许雅倩 辛德莉[2] 冯自威 赵爱利 孙力 代如民 全惜春 王永莉 薛萍[9] 黄建玲 张晓霞 钟成梁[1] 郭圣璇 MA Rong;HU Siyuan;XU Yaqian;XIN Deli;FENG Ziwei;ZHAO Aili;SUN Li;DAI Rumin;QUAN Xichun;WANG Yongli;XUE Ping;HUANG Jianling;ZHANG Xiaoxia;ZHONG Chengliang;GUO Shengxuan(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381;Beijing Friendship Hospital,Capital Medical University;Luohe Hospital of Chinese Medicine,Henan;Xianyang Central Hospital,Shaanxi;Dandon First Hospital,Liaoning;The Second Hospital of Qinhuangdao,Hebei;Nanyang Traditional Chinese Medicine Hospital,Henan;Tongchuan Kuangwuju Central Hospital,Shaanxi;Taiyuan Maternal and Child Health Hospital,Shanxi;3201 Hospital in Hanzhong,Shaanxi;Benxi Hospital of Traditional Chinese Medicine,Liaoning)

机构地区：[1]天津中医药大学第一附属医院,天津市300381 [2]首都医科大学附属北京友谊医院 [3]河南省漯河市中医院 [4]陕西省咸阳市中心医院 [5]辽宁省丹东市第一医院 [6]河北省秦皇岛市第二医院 [7]河南省南阳市中医院 [8]陕西省铜川矿务局中心医院 [9]山西省太原市妇幼保健院 [10]陕西省汉中市三二0一医院 [11]辽宁省本溪市中医院

出　　处：《中医杂志》2020年第14期1242-1246,共5页Journal of Traditional Chinese Medicine

基　　金：中华中医药学会标准化项目(2018-5-16)。

摘　　要：目的评价小儿金翘颗粒治疗儿童轻型流行性感冒风热证的疗效及其安全性。方法采用分层区组随机、阳性药平行对照、非劣效检验、多中心临床试验设计。计划纳入240例受试儿童,按1∶1比例随机分为治疗组和对照组。治疗组予小儿金翘颗粒,对照组予磷酸奥司他韦颗粒,疗程5天并随访2天。比较两组疾病临床痊愈时间,完全退热时间,CARIFS症状维度分与时间的曲线下面积,并发症、重症及危重症发生率,中医证候疗效(痊愈率)和安全性指标。结果共纳入临床诊断患儿240例,其中229例进入全分析数据集(FAS),200例进入符合方案数据集(PPS),233例进入安全性数据集(SS)。治疗后,主要指标疾病临床痊愈中位时间,治疗组与对照组均为3天,组间比较差异均无统计学意义(P>0.05),采用加速失效-对数正态模型,按0.75的非劣标准,治疗组非劣效于对照组,PPS与FAS分析结论一致。次要指标,治疗组和对照组的完全退热中位时间分别为42h、36h,组间比较,FAS分析差异有统计学意义(P<0.05),PPS分析差异无统计学意义(P>0.05);CARIFS症状维度评分与时间曲线下面积,并发症、重症及危重症发生率,以及中医证候疗效(痊愈率)组间比较差异均无统计学意义(P>0.05)。治疗中,治疗组与对照组分别发现23例次、18例次不良事件。治疗组不良反应9例次、对照组10例次。不良事件与不良反应发生率的组间比较,差异均无统计学意义(P>0.05)。结论小儿金翘颗粒治疗儿童轻型流行性感冒具有缩短病程作用,疗效非劣于磷酸奥司他韦颗粒,临床应用的安全性较好。Objective To evaluate the efficacy and safety of Xiaoer Jinqiao Granules(小儿金翘颗粒)for mild influenza in the treatment of children with influenza of wind-heat syndrome.Methods Randomized layered block,parallel control of positive drugs,non-inferiority test,and multi-center clinical trial design were used.A total of 240 children were included as the subjects and were randomly divided into treatment group and control group equally.The treatment group was given Xiaoer Jinqiao Granules and the control group was given Oseltamivir Phosphate Granules for 5 days and 2 days for follow-up.The clinical recovery time,complete antipyretic time,area under the curve of CARIFS symptom dimension and time,incidence of complications,incidence of severe and critical illness,efficacy of traditional Chinese medicine syndromes(curative rate)and safety indicators were compared between the 2 groups.Results A total of 240 children were enrolled.Among of them,the full analysis set(FAS)included 229 cases,perprotocol set(PPS)included 200 cases,and safety set(SS)included 233 cases.After treatment,the median time of clinical recovery in the treatment group and the control group were 3 days.There was no significant difference between the 2 groups(P>0.05).The accelerated failure time model was used.According to the non-inferior standard of 0.75,the treatment group was not inferior to the control group.The conclusions of PPS and FAS analysis were consistent.For the secondary indicators,the antipyretic time of treatment group the and control group were 42 hours and 36 hours respectively.Compared between the 2 groups,there was significantly difference in FAS(P<0.05),but there was no significantly difference in PPS(P>0.05).There was no significant difference between the groups in the area under curve of CARIFS symptom dimension score,the incidence of complications,severe cases and critical illness,as well as TCM syndrome efficacy(curative rates)(P>0.05).In the process of treatment,there were 23 cases of adverse events in the treatment group

关 键 词：小儿金翘颗粒 流行性感冒 风热证 儿童 随机对照试验 

分 类 号：R272[医药卫生—中医儿科学]