复方芩兰口服液治疗急性上呼吸道感染外感风热证的多中心临床评价  

A multi-center clinical evaluation trial of Fufang Qinlan Oral Liquid in the treatment of cold(acute upper respiratory tract infection)with external invaded wind heat syndrome

作　　者：石存忠[1] 甄会 刘新桥[1] SHI Cun-zhong;ZHEN Hui;LIU Xin-qiao(First Teaching Hospital of Tianjin University of TCM, Tianjin 300193, China;Beijing COMPETE Pharmaceutical Research and Clinical Evaluation Center, Beijing 100101, China)

机构地区：[1]天津中医药大学第一附属医院,天津300193 [2]北京康派特药物研究与临床评价中心,北京100101

出　　处：《中国新药杂志》2018年第9期1012-1018,共7页Chinese Journal of New Drugs

摘　　要：目的:临床评价复方芩兰口服液治疗急性上呼吸道感染外感风热证的有效性和安全性。方法:采用随机、双盲、阳性药对照、多中心临床研究的方法。共入组464例受试者,随机入选试验组348例,对照组116例,分别口服复方芩兰口服液和双黄连口服液,疗程3 d。结果:试验组和对照组疾病综合疗效愈显率分别为83.14%和73.04%(FAS分析),中医证候疗效愈显率分别为84.59%和70.43%(FAS分析),试验组均显著高于对照组(P<0.05);试验期间,试验组和对照组均无不良事件发生。结论:复方芩兰口服液治疗感冒(急性上呼吸道感染)外感风热证的整体疗效较好,优于双黄连口服液,且具有较好的安全性。Objective： To evaluate the clinical effectiveness and safety of Fufang Qinlan Oral Liquid in the treatment of cold(acute upper respiratory tract infection） with external invaded wind heat syndrome. Methods： A randomized,double-blinded,positive drug parallel controlled,multi-center clinical trial was conducted. Totally464 subjects were enrolled and divided into two group randomly,348 subjects in the experiment group and 116 subjects in the control group. The subjects in experiment group received Fufang Qinlan Oral Liquid for 3 days,and those in control group received Shuanghuanglian Oral Liquid for 3 days. Results： In respect of disease comprehensive curative effect,the cured and marked effective rates were 83. 14% and 73. 04% in experiment and control groups(FAS analysis）,respectively. For traditional Chinese medicine syndrome curative effect,the cured and marked effective rates were 84. 59% and 70. 43% in experiment and control groups(FAS analysis）,respectively. These rates were significantly higher in experiment group than in control group. During the trial,no adverse event occurred in both groups. Conclusion： The overall curative effect of Fufang Qinlan Oral Liquid is better than Shuanghuanglian Oral Liquid in treating cold(acute upper respiratory tract infect） with external invaded wind heat syndrome. Furthermore,it has better safety.

关 键 词：感冒 复方芩兰口服液 外感风热证 双黄连口服液 药物评价 

分 类 号：R969.4[医药卫生—药理学]