宣肺止嗽合剂对感染后咳嗽(风邪犯肺证)中医证候和生活质量的影响观察:一项随机、安慰剂对照、双盲、多中心临床研究  

Influence of Xuanfei Zhisou Mixture(宣肺止嗽合剂)on Traditional Chinese Medicine Symptoms and Quality of Life for Post Infectious Cough(Wind Evil Invading Lung Type):A Randomized,Double-Blinded,Placebo,Parallel-Controlled Multicenter Trial

作　　者：张洪春[1] 杨道文[1] 崔红生 高峰[3] 封继宏[4] 杨佩兰[5] 罗光伟[6] 朱佳[7] 李明[8] 郭栋伟 梁爱武[10] 何咏 耿立梅[12] 林志成 黄燕 刘杰军[15] 赵建清[16] 邝敏[17] 苏海华[18] 李兴芳[19] 吕红霞 钱双喜 ZHANG Hongchun;YANG Daowen;CUI Hongsheng;GAO Feng;FENG Jihong;YANG Peilan;LUO Guangwei;ZHU Jia;LI Ming;GUO Dongwei;LIANG Aiwu;HE Yong;GENG Limei;LIN Zhicheng;HUANG Yan;LIU Jiejun;ZHAO Jianqing;KUANG Min;SU Haihua;LI Xingfang;LYU Hongxia;QIAN Shuangxi(Sino-Japanese Friendship Hospital,Beijing 100029,China;The Third Affiliated Hospital of Beijing University of Chinese Medicine,Beijing 100029,China;Wangjing Hospital of Chinese Academy of Traditional Chinese Medicine,Beijing 100102,China;The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300150,China;Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Wuhan Integrated Traditional Chinese and Western Medicine Hospital,Wuhan 430030,Hubei,China;Jiangsu Provincial Hospital of Traditional Chinese Medicine,Nanjing 210004,Jiangshu,China;Tonghua Central Hospital,Tonghua 134099,Jilin,China;Liuzhou Traditional Chinese Medicine Hospital,Liuzhou 545026,Guangxi,China;Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine,Nanning 530011,Guangxi,China;Zhengzhou Traditional Chinese Medicine Hospital,Zhengzhou 450006,Henan,China;Hebei Provincial Hospital of Traditional Chinese Medicine,Shijiazhuang 050013,Hebei,China;Baishan Traditional Chinese Medicine Hospital,Baishan 134399,Jilin,China;Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine,Hohhot 010020,Inner Mongolia,China;Dezhou People's Hospital,Dezhou 253052,Shandong,China;The First Affiliated Hospital of Hebei North University,Zhangjiakou 050051,Hebei,China;The Second People's Hospital of Nanning,Nanning 530031,Guangxi,China;Xinjiang Production and Construction Corps Hospital,Urumqi 830002,Xinjiang,China;Gansu Provincial Hospital of Traditional Chinese Medicine,Lanzhou 730050,Gansu,China;Beijing Kangyitang Institute of Traditional Chinese Medicine,Beijing 100070,China;Beijing Kangzhong Times Pharmaceutical Technology Group Co.,Ltd,Beijing 100070,Ch

机构地区：[1]中日友好医院,北京100029 [2]北京中医药大学第三附属医院,北京100029 [3]中国中医科学院望京医院,北京100102 [4]天津中医药大学第二附属医院,天津300150 [5]上海中医药大学附属岳阳中西医结合医院,上海200437 [6]武汉市中西医结合医院,湖北武汉430030 [7]江苏省中医院,江苏南京210004 [8]通化市中心医院,吉林通化134099 [9]柳州市中医医院,广西柳州545026 [10]广西中医药大学附属瑞康医院,广西南宁530011 [11]郑州市中医院,河南郑州450006 [12]河北省中医院,河北石家庄050013 [13]白山市中医院,吉林白山134399 [14]内蒙古自治区中医医院,内蒙古呼和浩特010020 [15]德州市人民医院,山东德州253052 [16]河北北方学院附属第一医院,河北张家口050051 [17]南宁市第二人民医院,广西南宁530031 [18]新疆生产建设兵团医院,新疆乌鲁木齐830002 [19]甘肃省中医院,甘肃兰州730050 [20]北京康义堂中医研究院,北京100070 [21]北京康众时代医药科技集团有限公司,北京100070 [22]甘肃陇神戎发药业股份有限公司,甘肃兰州730101

出　　处：《中华中医药学刊》2024年第7期1-5,共5页Chinese Archives of Traditional Chinese Medicine

基　　金：甘肃省科技计划项目(22ZD6FA021-2);武威市科技计划项目(WW2201ZDS001)。

摘　　要：目的评价宣肺止嗽合剂对感染后咳嗽(风邪犯肺证)中医证候和生活质量的影响。方法采用随机、双盲、安慰剂对照、多中心的试验,纳入240例患者,按1∶1的比例分为试验组120例和对照组120例。试验组口服宣肺止嗽合剂,对照组口服宣肺止嗽合剂模拟剂,两组均20 mL/次,每日3次,疗程7 d。比较两组中医证候(日间咳嗽、夜间咳嗽、咳痰、咽痒)积分和莱塞斯特咳嗽生命质量问卷(生理性得分、心理性得分、社会性得分和总分)评分,并采用全分析(full analysis set,FAS)集及符合方案(per protocol set,PPS)集进行分析。结果238例进入FAS集(试验组和对照组均为119例),227例进入PPS集(试验组114例、对照组113例)。PPS与FAS分析均显示,治疗后,两组中医证候积分降低,莱塞斯特咳嗽生命质量问卷评分升高,试验组改变更为明显(P<0.01)。两组上述指标在治疗后、治疗后-基线的差值均有统计学意义(P<0.01)。结论宣肺止嗽合剂可以明显改善感染后咳嗽(风邪犯肺型)患者中医证候,提高其生活质量。Objective To observe the influence of Xuanfei Zhisou Mixture(宣肺止嗽合剂)on traditional Chinese medicine symptoms and quality of life for post infectious cough of wind evil invading lung type.Methods A randomized,controlled,placebo-controlled,multi-center clinical trial was conducted.A total of 240 cases were divided into trial group(120 cases)and control group(120 cases)at a ratio of 1∶1.The trial group was administered with Xuanfei Zhisou Mixture,while the control group was given Xuanfei Zhisou Mixture simulation agent,both with 20 mL each time,three times a day,and the treatment course was 7 days.The TCM syndromes(daytime cough,night cough,expectoration,itchy throat)scores,and Leicester cough quality of life questionnaire(physiological score,psychological score,social score and total score)were compared.Full analysis set(FAS)and per protocol set(PPS)were used for the analysis.Results There were 238 subjects in the FAS(with 119 cases in each group),and 227 subjects in the PPS(with 114 cases in trial group and 113 cases in control group).PPS and FAS analyses showed that after treatment,the TCM syndromes scores decreased,while LCQ scores increased in both groups,and the trial group showed more significant changes(P<0.01).Between groups,the differences after treatment and the differences from baseline after treatment all showed statistical significance(P<0.01).Conclusion Xuanfei Zhisou Mixture could significantly improve the TCM syndromes of patients with wind evil invading lung type,and increase their quality of life.

关 键 词：感染后咳嗽 风邪犯肺 宣肺止嗽合剂 中医证候 生活质量 

分 类 号：R256.11[医药卫生—中医内科学]