联合清肺抑火胶囊治疗支气管扩张症急性加重的多中心随机对照研究  

Combination treatment of Qingfei Yihuo capsules in brochiectasis exacerbation:a multi-center randomized controlled clinical trial

作　　者：汤葳[1] 周俊[1] 高习文[2] 张亚娟[2] 薛珉[2] 揭志军[3] 杭晶卿[4] 俞烽[4] 鲁立文 宋瑞红 段玉香[6] 金晓燕[6] 程齐俭 蔡晓婷 罗剑锋[8] 瞿介明[1] TANG Wei;ZHOU Jun;GAO Xiwen;ZHANG Yajuan;XUE Min;JIE Zhijun;HANG Jingqing;YU Feng;LU Liwen;SONG Ruihong;DUAN Yuxiang;JIN Xiaoyan;CHENG Qijian;CAI Xiaoting;LUO Jianfeng;QU Jieming(Department of Respiratory and Critical Care Medicine,Ruijin Hospital,Shanghai Jiao Tong University Medical College,Shanghai 200025,P.R.China;Department of Respiratory and Critical Care Medicine,Fudan University Affiliated Minhang Hospital,Shanghai 201199,P.R.China;Department of Respiratory and Critical Care Medicine,Shanghai Fifth People's Hospital Affiliated with Fudan University,Shanghai 200240,P.R.China;Department of Respiratory Medicine,Shanghai Putuo District People's Hospital,Shanghai 200060,P.R.China;Department of Respiratory Medicine,Shanghai Fengxian District Central Hospital,Shanghai 201499,P.R.China;Department of Respiratory Medicine,Tongren Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200336,P.R.China;Department of Respiratory Medicine,Ruijin Hospital North,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,P.R.China;Institute of Biostatistics,School of Public Health,Fudan University,Shanghai 200032,P.R.China)

机构地区：[1]上海交通大学医学院附属瑞金医院呼吸与危重症医学科,上海200025 [2]复旦大学附属闵行医院呼吸与危重症医学科,上海201199 [3]复旦大学附属上海市第五人民医院呼吸与危重症医学科,上海200240 [4]上海市普陀区人民医院呼吸内科,上海200060 [5]上海市奉贤区中心医院呼吸内科,上海201499 [6]上海交通大学医学院附属同仁医院呼吸内科,上海200336 [7]上海交通大学医学院附属瑞金医院北院呼吸内科,上海200025 [8]复旦大学公共卫生学院生物统计教研室,上海200032

出　　处：《中国呼吸与危重监护杂志》2019年第4期352-356,共5页Chinese Journal of Respiratory and Critical Care Medicine

基　　金：上海市科委产学研课题(15DZ1900203)

摘　　要：目的评价在常规抗生素及黏痰溶解剂基础上联合清肺抑火胶囊在减轻支气管扩张症急性加重时的发作症状、缩短急性期天数、减轻病情中的辅助作用。方法本研究为前瞻性、多中心、随机对照临床试验。通过随机双盲的方法,使用清肺抑火胶囊或安慰剂联合抗生素及黏痰溶解剂进行治疗,总治疗天数为10 d。评价患者用药前后咳嗽、咳痰、呼吸困难症状评分和日记卡评分,以及肺功能、圣乔治呼吸问卷评分。结果本项目研究时间为2017年6月至2018年8月,来自上海市6家二级、三级医院的7个中心共190例支气管扩张症急性加重的患者入组了本研究。联合清肺抑火胶囊治疗组较联合安慰剂治疗组可显著改善治疗第9、第10 d的咳嗽、咳痰和呼吸困难症状评分,呼吸系统症状改善更快。结论清肺抑火胶囊对支气管扩张症急性加重的临床症状改善有辅助促进作用。Objective To evaluate the combination efficacy with Qingfei Yihuo capsule and routine antibiotics as well as mucopolytic agents in the treatment of bronchiectasis acute exacerbation. Methods This was a prospective, multicenter, randomized controlled clinical study. The efficacy of Qingfei Yihuo capsule combine with routine antibiotics and mucopolytic agents in the treatment of bronchiectasis acute exacerbation was compared according to the symptom control as well as exacerbation duration. Through randomization, patients received Qingfei Yihuo capsule or placebo combine with routine antibiotics and mucopolytic agents treatment for 10 days. Symptom score of cough, sputum, short of breath pre-and post-treatment as well as the symptom score in daily card were compared between the two groups. The spirometry and St. George respiratory questionnaire(SGRQ) before and after treatment were compared. Results This study was conducted from June 2017 to August 2018. One hundred and ninety patients from 7 centers in 6 hospitals with bronchiectasis acute exacerbation were enrolled in the study. There was statistically improvement of symptom score(including the 9th and 10th treatment days) according to the daily card recording in Qingfei Yihuo capsule group compared to the placebo group, but no statistically significant difference was found in spirometry results or SGRQ. Conclusion Qingfei Yihuo capsule has assistant effect on improving respiratory symptoms of bronchiectasis exacerbation.

关 键 词：清肺抑火胶囊 支气管扩张 急性加重 

分 类 号：R562.22[医药卫生—呼吸系统]