痰热清胶囊治疗急性气管-支气管炎(风热袭肺证)随机双盲单模拟多中心临床研究  

A Randomized,Double-Blind,Single-Dummy and Multil-Center Clinical Study of Tanreqing Capsules in the Treatment of Acute Tracheo-BronChitis(Fengrexifei)

作　　者：范小会 杜学航 范军铭[3] 范伏元[4] 毛兵[5] 田正鉴 林炳辉[7] Fan Xiaohui;Du Xuehang;Fan Junming;Fan Fuyuan;Mao Bing;Tian Zhengjian;Lin Binghui(Henan Provincial Acdemy of Traditional Chinese Medicine,Zhengzhou 450004;Shanghai Kaibao Pharmaceutical C.,Ltd,Shanghai 201401;Henan Provincial Acdemy of Traditional Chinese Medicine affiliated hospital,Zhengzhou 450004;The First Affiliated Hospital of Hunan University of Traditional Chinese Medicin,Changsha 410007;West China Hospital of Sichuan University,Chengdu 610041;Hubei University of Traditional Chinese Medicine,Changsha 410000;Fujian Provincial Acdemy of Traditional Chinese Medicine,Fuzhou 410007)

机构地区：[1]河南省中医药研究院,郑州450004 [2]上海凯宝药业股份有限公司,上海201401 [3]河南省中医药研究院附属医院,郑州450004 [4]湖南中医药大学第一附属医院,长沙410007 [5]四川大学华西医院,成都610041 [6]湖北中医学院附属医院,长沙410000 [7]福建省中医药研究院,福州350000

出　　处：《中药药理与临床》2020年第2期245-248,共4页Pharmacology and Clinics of Chinese Materia Medica

基　　金：国家自然科学基金资助项目(No.81273877);河南省中医药科学研究专项重点项目(No.2013ZY01006);河南省中医临床学科领军人才(NO.2013-10)。

摘　　要：目的:观察痰热清胶囊治疗急性气管-支气管炎(风热袭肺证)的临床疗效及安全性。方法:选用随机、双盲单模拟、阳性平行对照、多中心的临床研究方法。中医辨证为风热袭肺证患者240例,按照1∶1的比例分为试验组和对照组两组。试验组给予痰热清胶囊及模拟剂胶囊,对照组给予双黄连胶囊。两组治疗疗程均为7 d。结果:FAS分析人群,痰热清胶囊治疗急性气管-支气管炎(风热袭肺证)的显愈率试验组为79.31%,对照组为66.39%,两组显愈率比较有显著差异(P<0.05或P<0.01),中医证候的显愈率试验组为78.44%,对照组为70.58%,两组显愈率比较有显著差异,咳嗽、身楚、口渴等单项症状试验组的改善明显优于对照组(P<0.05或P<0.01)。结论:痰热清胶囊治疗急性气管-支气管炎(风热袭肺证),具有良好的临床疗效,且无毒副作用。Objective:To observe the efficacy and safety of Tanreqing capsules on acute broncho-bronchitis(Fengrexifei).Methods:A multi-center,randomized,double-blinded,single-dummy and positive drug parallel controlled trial was adopted.240 cases of patients were selected by TCM Fengrexifei syndrome,then they were divided into the treatment group and the control group with the ratio 1:1.Patients in the treatment group were treated with Tanreqing capsules and simulated capsules,patients in the control group were treated with Shuanghuanglian capsule,for seven days.Results:FAS analysis showed,the effective rate of Tanreqing capsules in acute broncho-bronchitis(Fengrexifei)was 79.31%and 66.39%in the treatment group and the control group respectively,which had significant difference.The effective rates of TCM syndrome in the treatment group and the control group were 78.44%and 70.58%,respectively,which also had significant difference.The improvement in the single symptom group such as cough,body,thirst was obviously better than that in the control group.Conclusion:Tanreqing capsule has a good clinical effect on acute broncho-bronchitis(Fengrexifei),and has no toxic and side effects.

关 键 词：痰热清胶囊 风热袭肺证 急性气管-支气管炎 

分 类 号：R259[医药卫生—中西医结合]