宣肺止嗽合剂治疗急性支气管炎(风邪犯肺证)随机双盲多中心研究  

Randomized Double-Blind Multicenter Study on Xuanfei Zhisou Mixture(宣肺止嗽合剂)in Treatment of Acute Bronchitis(Wind Evil Invading Lung Type)

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 康永红 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;KANG Yonghong(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,Jiangsu,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,Chi

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]甘肃普安制药股份有限公司,甘肃武威733006

出　　处：《中华中医药学刊》2024年第8期7-11,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：目的观察宣肺止嗽合剂对急性支气管炎(风邪犯肺证)患者中医证候及生活质量的影响。方法采用随机、双盲、安慰剂对照研究,在19个平行中心进行观察,将240例急性支气管炎(风邪犯肺证)患者分为试验组和对照组,每组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,疗程均为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(the Leicester cough questionnaire,LCQ)评分。结果最终完成试验者232例,其中试验组118例,对照组114例。治疗后,两组中医证候积分降低,LCQ中生理性得分、心理性得分、社会性得分和总分均升高,试验组改变更为明显(P<0.01)。两组上述指标在治疗后、治疗后较基线的差值均有统计学意义(P<0.01)。全分析集(full analysis set,FAS)及符合方案集(per protocol set,PPS)结果一致。结论宣肺止嗽合剂可以明显改善急性支气管炎(风邪犯肺证)患者中医证候,提高其生活质量。Objective To observe the impacts of Xuanfei Zhisou Mixture(宣肺止嗽合剂)on TCM syndromes and quality of life of patients with acute bronchitis of wind evil invading lung type.Methods Randomized,controlled and placebo-controlled parallel trial design was adopted.The observation was conducted in 19 parallel centers,and 240 cases were randomly divided into trial group and control group,with 120 cases in each group.The trial group was administered with Xuanfei Zhisou Mixture,while the control group was given Xuanfei Zhisou Mixture simulation agent.The treatment course was 7 days.The scores of TCM syndromes(daytime cough,night cough,expectoration,itchy throat)and Leicester cough quality of life questionnaire(LCQ)were compared.Results There were 232 cases completed this trial,including 118 cases in the trial group and 114 cases in the control group.After treatment,the TCM syndromes scores decreased,and physiological score,psychological score,social score and total score of LCQ increased in both groups,and the trial group showed more significant changes(P<0.01).The difference between the two groups of the above indicators after treatment and baseline was statistically significant(P<0.01).The results of the full analysis set(FAS)and per protocol set(PPS)were consistent.Conclusion Xuanfei Zhisou Mixture could significantly improve the TCM syndromes of patients with acute bronchitis(wind evil invading lung type)and increase the quality of life of the patients.

关 键 词：宣肺止嗽合剂 急性支气管炎 风邪犯肺 中医证候 生活质量 

分 类 号：R256.1[医药卫生—中医内科学]