柴胡滴丸治疗普通感冒的多中心随机对照临床试验  

Chaihu Drop-pill in Treatment of Common Cold:A Multi-center and Randomized Controlled Trial

作　　者：常静[1] 唐方[2] 闫凤杰[3] 蔡鸿彦[4] 乔世举[5] 熊旭东[6] 薛汉荣[7] 陈志斌[8] 毛兵[1] 

机构地区：[1]四川大学华西医院中西医结合科,成都610041 [2]天津医科大学总医院呼吸科 [3]长春中医药大学附属医院呼吸科 [4]吉林省中西医结合医院呼吸科 [5]辽宁中医药大学附属第二医院呼吸科 [6]上海中医药大学附属曙光医院呼吸科 [7]江西中医学院附属医院呼吸科 [8]福建省中医药研究院呼吸科

出　　处：《华西医学》2015年第4期635-639,共5页West China Medical Journal

摘　　要：目的评价柴胡滴丸治疗普通感冒(风热证)的安全性和有效性。方法 2011年2月-8月采用随机、双盲双模拟、阳性药对照、多中心临床试验方法。共入组普通感冒(风热证)患者479例,随机分为试验组(柴胡滴丸+银柴颗粒模拟剂)359例和对照组(银柴颗粒+柴胡滴丸模拟剂)120例。疗程均为3 d。观察治疗前后症状、体征变化和有无不良反应,并进行血、尿、大便常规、肝肾功能及心电图检查。结果完成观察的合格病例试验组344例,对照组117例。试验组和对照组的痊愈率分别为32.4%、20.2%(全分析集)和32.6%、20.5%(符合方案集),总有效率分别为96.3%、87.4%(全分析集)和96.5%、87.2%(符合方案集),两组比较差异有统计学意义(P<0.01)。在用药过程中,未发现柴胡滴丸的明显不良反应。结论柴胡滴丸是治疗普通感冒(风热证)的安全有效药物。Objective To evaluate the safety and efficacy of Chaihu drop-pill in the treatment of common cold（wind-heat syndrome）.Methods A multi-center,double blind,double dummy,randomized controlled trial was conducted.A total of 479 patients with common cold（wind-heat syndrome） diagnosed between February and August,2011,were randomly divided into two groups：the trial group（n=359） and the control group（n=120）.The trial group received Chaihu drop-pill and Yinchai granule analogue three times a day,while the control group received Yinchai granule and Chaihu drop-pill analogue.The therapeutic courses of both groups were 3 days.Clinical symptoms,syndromes,and adverse effects were observed before and after the treatment.Furthermore,blood,urine and stool test,hepatorenal function test and electrocardiogram were also carried out before and after treatment.Results After treatment,the healing rates of the trial group and the control group were 32.4%,20.2%（for full analysis set） and 32.6%,20.5%（for per protocol set）,and the overall response rates were 96.3%,87.4%（for full analysis set） and 96.5%,87.2%（for per protocol set）.There were significant differences between the two groups（P〈0.01）.No adverse effects were found in the trial.Conclusion Chaihu drop-pill is effective and safe in the treatment of common cold（wind-heat syndrome）.

关 键 词：中草药制剂 随机对照试验 普通感冒 风热证 中医 

分 类 号：R259[医药卫生—中西医结合]