一清双解胶囊和片剂治疗急性上呼吸道感染风温病热在肺卫证的多中心随机对照双盲双模拟Ⅱ期临床试验

A multiple center,randomized,controlled,double-blinded and double-dummy trial of Yiqing Shuangjie Capsule and Tablet in treating acute upper respiratory tract infection with the syndrome of heat attacking the lung and Weifen

目的:观察一清双解胶囊和片剂治疗急性上呼吸道感染(风温病热在肺卫证)的疗效,并对其安全性作出评价。方法:采用多中心随机对照双盲双模拟试验,对急性上呼吸道感染(风温病热在肺卫证)患者360例,按1∶1∶1比例随机分为一清双解胶囊组(治疗组A)120例,一清双解片剂组(治疗组B)120例及柴黄片组(对照组)120例。治疗组分别给予一清双解胶囊或片剂,每次3粒(片),每日3次;对照组给予柴黄片,每次3片,每日3次。疗程均为5d。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:纳入患者360例,剔除3例,脱落18例,最终进入意向性(intention-to-treat,ITT)分析343例,符合方案集(per-protocol population set,PPS)分析339例。其中上呼吸道感染疗效:ITT显示,治疗组A总显效率84.96%,总有效率为96.46%;治疗组B分别为85.48%,97.45%;对照组分别为72.58%,99.12%。PPS显示,治疗组A总显效率87.27%,总有效率97.27%;治疗组B分别为86.20%,97.41%;对照组分别为72.58%,99.12%。试验组(胶囊、片剂)疾病疗效优于对照组(P<0.05),ITT与PPS结果一致。中医证候疗效:ITT显示,治疗组A愈显率84.07%,总有效率96.46%;治疗组B分别为88.89%,97.44%;对照组分别为72.58%,99.12%。PPS显示,治疗组A愈显率85.46%,总有效率97.27%;治疗组B分别为89.65%,97.41%;对照组分别为72.58%,99.12%。试验组(胶囊、片剂)中医证候疗效优于对照组(P<0.05),ITT与PPS结果一致。观察中未发现明显不良反应。结论:一清双解胶囊和片剂治疗急性上呼吸道感染热在肺卫证疗效确切,未发现明显毒副作用。

Objective：To evaluate the efficacy and safety of Yiqing Shuangjie Capsule and Tablet in treating acute upper respiratory tract infection with wind-warm syndrome.Methods：The multiple center,double-blinded,double-dummy and randomized controlled method was conducted.Three hundred and sixty patients were randomly divided into the treatment group A（n=120,treated with Yiqing Shuangjie Capsule and Chaihuang analogues）,treatment group B（n=120,treated with Yiqing Shuangjie Tablet and Chaihuang analogues）and the control group（n=120,treated with Chaihuang Tablet and Yiqing Shuangjie Capsule analogues）.Every drug was administered 3 pills each time.Patients in the three groups were all treated for 5 days and three times daily.The accumulated scores of syndrome,clinical symptoms,adverse effect and body temperature were recorded before and after the treatment.The safety indexes,such as routine tests of blood,urine and stool,hepatic and renal function tests and electrocardiogram（ECG）were taken before and after the treatment.Results：Three cases were excluded and eighteen cases lost to follow-up.There were 343 patients who entered to the intention-to-treat（ITT）analysis and 339 patients fitted in the per-protocol population set（PPS）analysis.After treatment,the therapeutic effects of respiratory tract infection were calculated by ITT and PPS analysis respectively.The rates of total obvious effect were 84.96% and 87.27% respectively in the treatment group A,and the total response rates were 96.46% and 97.27% respectively.The rates of total obvious effect were 85.47% and 86.20% respectively in the treatment group B,and the total response rates were 97.45% and 97.41% respectively.In the control group,the rates of total obvious effect both were 72.57%,and the total response rates both were 99.12%.There was significant difference among the three groups（P〈0.05）.The effects of traditional Chinese medicine syndrome were also detected by ITT and PPS analysis respectively.In the treatment group A,the total obvious effect rates were 84.07% and 85.46% respectively,and the total response rates were 96.46% and 97.27% respectively.In the treatment group B,the rates of total obvious effect were 88.89% and 89.65% respectively,and the total response rates were 97.44% and 97.41% respectively.In the control group,the rates of total obvious effect both were 72.57%,and total response rates both were 99.12%.There was also statistical significant difference among the three groups（P〈0.05）.ITT and PPS analysis had the same results.No adverse effect was found in the trial.Conclusion：Yiqing Shuangjie Capsule and Tablet are effective and safe in treating acute upper respiratory tract infection of wind heat syndrome without obvious adverse effect.