痰热清口服液治疗急性气管-支气管炎(风热袭肺证)随机双盲多中心临床研究(Ⅲ期)  

A Randomized,Double-Blind,Multicenter Clinical Study of Tanreqing Oral Liquid Treating Acute Tracheobronchitis(Fengrexifei Symptom)

作　　者：范小会 叶静 杜学航 毕巧莲[1] 范军铭[1] Fan Xiaohui;Ye Jing;Du Xuehang;Bi Qiaolian;Fan Junming(Henan Academy of Traditional Chinese Medicine,Zhengzhou 450004;2019 graduate student of Henan University of Chinese Medicine,Zhengzhou 450046;Shanghai Kaibao Pharmaceutical C.,Ltd,Shanghai 201401)

机构地区：[1]河南省中医药研究院,郑州450004 [2]河南中医药大学,郑州450046 [3]上海凯宝药业股份有限公司,上海201401

出　　处：《中药药理与临床》2020年第5期179-183,共5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:观察痰热清口服液与双黄连口服液对照治疗急性气管-支气管炎(风热袭肺证),评价痰热清口服液有效性和安全性。方法:选用随机、双盲、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440例,按照3∶1的比例分为试验组和对照组两组。试验组给予痰热清口服液,对照组给予双黄连口服液。两组用药时间均为7 d。结果:FAS分析人群,痰热清口服液治疗急性气管-支气管炎(风热袭肺证)的显愈率试验组为86.54%,对照组为72.47%,两组显愈率比较差异有统计学意义(P<0.01),中医证候积分的有效率试验组为86.85%,对照组为79.81%,两组显愈率比较差异有统计学意义(P<0.01),咳嗽、咳痰等单项症状试验组的改善明显优于对照组。结论:痰热清口服液治疗急性气管-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 of Tanreqing Oral Liquid and Shuanghuanglian Oral Liquid in the treatment of acute tracheobronchiolitis(Fengrexifei symptom),and to evaluate the effectiveness and safety of Tanreqing Oral Liquid.Methods:A randomized,double-blind,positive parallel control,multi-center clinical research method was selected.440 patients with Fengrexifei syndrome by TCM syndrome differentiation were selected,which were divided into the experimental group and the control group(allocation ratio 3:1).The patients in the experimental group were given Tanreqing oral solution,and those in the control group were given Shuanghuanglian oral solution,for 7 days in both groups.Results:FAS analysis showed,that the healing rate of Tanreqing Oral Liquid in the treatment of acute tracheobronchitis(Fengrexifei)was 86.54%in the experimental group and 72.47%in the control group.There was a statistical significant difference in the healing rates between the two groups(P<0.01).The efficacy rate of TCM syndromes scores was 86.85%in the treatment group,and that was 79.81%in the control group.There was a statistically significant difference in the efficacy rate between the two groups(P<0.01).The improvement of cough,sputum and other single symptom in the treatment group was significantly better than that in the control group.Conclusion:Tanreqing Oral Liquid has a good clinical efficacy on acute tracheobronchitis(Fengrexifei),and has no toxic side effects.

关 键 词：痰热清口服液 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]