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(Ⅲ期)  

Clinical Research of Tanreqing Capsules on Acute Broncho-Bronchitis(Fengrexifei Syndrome) in Multi-Center,Randomized,Double-Blinded,Single-Dummy Trial (Phase Ⅲ)

作　　者：范小会 范军铭[1] 毕巧莲[1] 毛兵[2] 田正鉴 Fan Xiaohui;Fan Junming;Bi Qiaolian;Mao Bing;Tian Zhengjian(Henan Provincial Acdemy of Traditional Chinese Medicine,Zhengzhou 450004;West China Hospital of Sichuan University,Chengdu 610041;Hubei University of Traditional Chinese Medicine,Changsha 410000)

机构地区：[1]河南省中医药研究院,郑州450004 [2]四川大学华西医院,成都610041 [3]湖北中医学院附属医院,长沙410000

出　　处：《中药药理与临床》2020年第3期238-241,共4页Pharmacology and Clinics of Chinese Materia Medica

基　　金：国家自然科学基金资助项目(编号:81273877);河南省中医药科学研究专项重点项目(编号:2013ZY01006);河南省中医临床学科领军人才(编号:2013-10)。

摘　　要：目的:观察痰热清胶囊与双黄连胶囊对照治疗急性气管-支气管炎(风热袭肺证),评价痰热清胶囊有效性和安全性。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264例,按照3∶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。疗程两组均为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)的总有效率试验组为84.62%,对照组为72.31%,治疗组疗效显著优于对照组,中医证候的有效率试验组为83.08%,对照组为72.30%,治疗组证候总有效率显著优于对照组,咳嗽、咳痰等单项症状试验组的改善明显优于对照组。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 treatment with Tanreqing capsules and Shuanghuanglian capsules for acute broncho-bronchitis(Fengrexifei syndrome),and to evaluate the efficacy and safety of Tanreqing capsules.Methods:A multi-center,randomized,double-blinded,single-dummy and positive drug parallel controlled trial was adopted.264 cases of patients with TCM Fengrexifei syndrome were selected and divided into the treatment and the control groups,with 3∶1 ratio.The Patients in the treatment group were treated with Tanreqing capsules and simulated capsules,those in the control group were treated with Shuanghuanglian capsule,for 7 days in both groups.Results:FAS analysis showed,the total effective rates inTanreqing capsules and control groups on acute broncho-bronchitis(Fengrexifei Syndrome)were 84.62%and 72.31%,respectively,the effect of Tanreqing showed significant.The total effective rates in TCM syndrome group and control group were 83.08%and 72.30%,respectively,the TCM syndrome group showed significant difference in total effective rate.Also,the improvement in single symptom group such as cough,spitting sputum was significantly better than that in the control group.Conclusion:Tanreqing capsules has a good clinical effect on acute broncho-bronchitis(cough of wind-heat invading the lung),and shows 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 Ⅲ期临床研究 

分 类 号：R259[医药卫生—中西医结合]