宣肺止嗽合剂治疗感染后咳嗽(风邪犯肺证)的有效性及安全性的随机、安慰剂对照、双盲、多中心临床研究  

Efficacy and Safety of Xuanfei Zhisou Mixture(宣肺止嗽合剂)for Post Infectious Cough(Wind Evil Invading Lung Type):A Randomized,Double-Blinded,Placebo,Parallel-Controlled Multicenter Trial

作　　者：杨道文[1] 张洪春[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] 李珺飞 吕红霞 YANG Daowen;ZHANG Hongchun;CUI Hongsheng;GAO Feng;FENG Jihong;YANG Peilan;LUO Guangwei;ZHU Jia;LI Ming;GUO Dognwei;LIANG Aiwu;HE Yong;GENG Limei;LIN Zhicheng;HUANG Yan;LIU Jiejun;ZHAO Jianqing;KUANG Min;SU Haihua;LI Xingfang;LI Junfei;LYU Hongxia(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 Chinese Medical Sciences,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 830092,Xinjiang,China;Gansu Provincial Hospital of Traditional Chinese Medicine,Lanzhou 730050,Gansu,China;Gansu Pu′an Pharmaceutical Co.,Ltd,Wuwei 733006,Gansu,China;Beijing Kangyitang Institute of Traditional Chinese Medicine,Beijing 101100,China;Beijing Kangzhong Times

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830092 [19]甘肃省中医院,甘肃兰州730050 [20]甘肃普安制药股份有限公司,甘肃武威733006 [21]北京康义堂中医研究院,北京101100 [22]北京康众时代医药科技集团有限公司,北京100070

出　　处：《辽宁中医杂志》2024年第12期72-78,共7页Liaoning Journal 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(WW220/ZDS001)。

摘　　要：目的评价宣肺止嗽合剂治疗感染后咳嗽(风邪犯肺证)的安全性和有效性。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。比较两组患者咳嗽视觉模拟(visual analogue scale,VAS)评分、咳嗽缓解和消失情况、临床疗效及用药安全性。结果有效性评价采用全分析(full analysis set,FAS)集及符合方案(per protocol set,PPS)集分析,安全性指标以安全性(safety set,SS)集进行分析。结果240例患者均进入SS集,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分析均显示两组咳嗽VAS评分治疗后均较本组基线下降,且试验组下降更为明显(P<0.01)。试验组咳嗽缓解率及消失率、治疗有效率均明显高于对照组(P<0.01),试验组咳嗽缓解时间短于对照组(P<0.05)。试验组2例患者发生2例次不良事件,对照组3例患者发生5例次不良事件,组间差异无统计学意义(P>0.05)。经分析,上述不良事件与试验药物可能无关或肯定无关。结论宣肺止嗽合剂治疗感染后咳嗽(风邪犯肺证)疗效确切,安全性较高。Objective To evaluate the safety and efficacy of Mixture(宣肺止嗽合剂)for post infectious cough of wind evil invading lung type.Methods A randomized,double-blind,placebo-controlled and 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,20 mL for each time,three times a day,and the treatment course was 7 days.The cough visual analogue scale(VAS),cough relief and disappearance,clinical efficacy and safety were compared.Full analysis set(FAS)and per protocol set(PPS)were used for effectiveness analysis,while safety set(SS)was used for safety analysis.Results All 240 cases were included in the SS,and there were 238 subjects in the FAS(with 119 in each group),and 227 subjects in the PPS(with 114 in trial group and 113 in control group).PPS and FAS analyses showed that cough VAS decreased in both groups(P<0.01),and the trial group had more significant changes than the control group(P<0.05 or P<0.01).The cough relief rate and disappearance rate and treatment efficacy in the trial group was higher than those in the control group(P<0.01),and the cough relief time was shorter in the trial group(P<0.01).There was 2 adverse events occurred in 2 subjects of the trial group,while 5 adverse events occurred in 4 subjects of the control group,and there were no statistical difference between the two groups(P>0.05).After analysis,the above adverse events probably not or definitely not be related to the test drug.Conclusion Xuanfei Zhisou Mixture had good clinical effect and high safety for patients with post infectious cough(wind evil invading lung type).

关 键 词：宣肺止嗽合剂 感染后咳嗽 风邪犯肺 安全性 有效性 

分 类 号：R256.11[医药卫生—中医内科学]