双清合剂治疗卫气同病证流行性感冒有效性和安全性多中心随机对照非劣效性试验  

Efficacy and Safety of Shuangqing Mixture in the Treatment of Both Defense and Qi Syndrome of Influenza:A Multicenter,Randomized,Controlled,Non-inferiority

作　　者：林江涛[1] 孙增涛[2] 封继宏[3] 吴建华 陆光兵 郭瑞斌 麻晓 李月荣 申云红 王光恩[10] 马晓斌 黄滔[12] 郭安 张常喜 赵小兵 孙绪武 江柏华[17] 甄会[18] 陈红平 丁俊平 LIN Jiang-tao;SUN Zeng-tao;FENG Ji-hong;WU Jian-hua;LU Guang-bing;GUO Rui-bin;MA Xiao;LI Yue-rong;SHEN Hong-yun;WANG Guang-en;MA Xiao-bin;HUANG Tao;GUO An;ZHANG Chang-xi;ZHAO Xiaobing;SUN Xu-wu;JIANG Bai-hua;ZHEN Hui;CHEN Hong-ping;DING Jun-ping(Pulmonary and Critical Care Medicine,China-Japan Friendship Hospital,Beijing 100029;Institute of Pyreticosis and Respiratory Diseases,Tianjin University of Traditional Chinese Medicine,Tianjin 300250;Pulmonary and Critical Care Medicine,The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300250;Pulmonary and Critical Care Medicine,Fenyang Hospital,Shanxi 032200;Pulmonary and Critical Care Medicine,Meishan Traditional Chinese Medicine Hospital,Sichuan 620000;Pulmonary and Critical Care Medicine,Yangquan Coal Industry Group Co.,Ltd.General Hospital,Shanxi 045000;Emergency Department,Luohe Traditional Chinese Medicine Hospital,Henan 462000;Infectious Disease Department,Jinan Zhangqiu District People's Hospital,Jinan 250200;Infectious Disease Department,The Second People's Hospital of Changzhi,Shanxi 046000;Pneumology Department,HanDan TCM Hospital,Hebei 056001;Pulmonary and Critical Care Medicine,Shandong Provincial Hospital,Jinan 250000;Fever Outpatients,Meishan People's Hospital,Sichuan 620000;Graduate School,Tianjin University of Traditional Chinese Medicine,Tianjin 300250;Pulmonary Disease Department,Ningxia Chinese medicine Research Cent,Ningxia Hui Autonomous Region,Yinchuan 750000;Respiratory Department,Maternity and Child Health Care of Zaozhuang,Shandong 277000;Respiratory Department,Mudanjiang Traditional Chinese Medicine Hospital,Heilongjiang 157000;Pulmonary Disease Department,Heilongjiang Provincial Traditional Chinese Medicine Hospital,Harbin 150036;Respiratory Disease Research Committee of China As-sociation of Traditional Chinese Medicine,Beijing 100061;Beijing Yaohai Ningkang Pharmaceutical Technology Co.,LTD,Beijing 100101;Harbin Kangsaisi Medical Technology Development Co.,LTD,Harbin 150001)

机构地区：[1]中日友好医院呼吸与危重症医学科,北京100029 [2]天津中医药大学热病与呼吸疾病研究所,天津300250 [3]天津中医药大学第二附属医院呼吸与危重症医学科,天津300250 [4]山西省汾阳医院呼吸与危重症医学科,山西032200 [5]眉山市中医医院呼吸与危重症医学科,四川620000 [6]阳煤集团总医院呼吸与危重症医学科,四川620000 [7]漯河市中医院急诊科,河南462000 [8]济南市章丘区人民医院感染性疾病科,济南250200 [9]长治市第二人民医院感染疾病科,山西046000 [10]邯郸市中医院呼吸科,河北056001 [11]山东省立医院呼吸与危重症医学科,济南250000 [12]眉山市人民医院发热门诊,四川620000 [13]天津中医药大学研究生院,天津300250 [14]宁夏回族自治区中医医院肺病科,银川750000 [15]枣庄妇幼保健院呼吸科,山东277000 [16]牡丹江市中医医院呼吸科,黑龙江157000 [17]黑龙江省中医医院肺病科,哈尔滨150036 [18]中国中药协会呼吸病药物研究专业委员会,北京100061 [19]北京药海宁康医药科技有限公司,北京100101 [20]哈尔滨康赛思医药科技开发有限公司,哈尔滨150001

出　　处：《中国中西医结合杂志》2024年第9期1036-1043,共8页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的观察双清合剂治疗卫气同病证流行性感冒的有效性及安全性。方法采用多中心、随机、双盲、双模拟平行对照、非劣效性试验设计,将240例卫气同病证流行性感冒患者采用分层区组随机化方法,使用SAS软件按1:1随机分为试验组和对照组,每组120例。试验组服用双清合剂和磷酸奥司他韦胶囊模拟剂,对照组服用磷酸奥司他韦胶囊和双清合剂模拟剂,两组疗程均为5日。分别于治疗前、治疗3日、治疗5日时进行访视,评价其主要临床症状缓解时间、完全退热时间、退热起效时间、对乙酰氨基酚使用量、中医证候积分、中医证候疗效、重要临床症状缓解时间、重症/危重流感发生率及安全性。结果试验期间,共脱落/剔除16例(试验组8例、对照组8例),最终纳入符合方案集224例,其中试验组112例,对照组112例。与对照组比较,试验组可缩短头痛缓解时间[28.00(17.75,42.99)h vs.41.00(18.75,59.00)h]、减少肌肉或关节酸痛缓解时间[37.83(12.88,52.77)h vs.38.07(13.50,69.25)h](P<0.05)。与对照组比较,试验组在主要临床症状缓解时间、完全退热时间、对乙酰氨基酚缓释片使用率及使用量、中医证候疗效显愈率方面比较,差异无统计学意义(P>0.05)。两组患者不良反应发生率,试验组为4.17%和对照组为1.67%,差异无统计学意义(χ^(2)=1.36,P>0.05)。结论双清合剂可有效缓解卫气同病证流行性感冒的头痛、肌肉或关节酸痛症状,效果优于磷酸奥司他韦胶囊;在改善发热、咳嗽、汗出、面赤、咳黄痰临床症状,减少对乙酰氨基酚使用量,降低中医证候积分方面与磷酸奥司他韦胶囊疗效相当;安全性与磷酸奥司他韦胶囊相当。(中国临床试验注册中心注册No.ChiCTR2400087831)。Objective To observe the effectiveness and safety of Shuangqing Mixture(SQM)in treating pattern of both defense and qi syndrome of influenza. Methods A multicenter, randomized, doubleblind, double-dummy,parallel controlled,non-inferiority trial design was used. Totally 240 patients with influenza of pattern of both defense and qi syndrome were randomly assigned to the experimental group and the control group using SAS software in a 1 :1 ratio, 120 in each group. The experimental group received SQM and Oseltamivir Capsules simulant, while the control group received Oseltamivir Capsules and SQM simulant. The therapeutic course for all 5 days. The main clinical symptom relief time, complete fever resolution time, fever onset time, usage of acetaminophen, Chinese medicine(CM)syndrome scores, efficacy of CM syndrome treatment, important clinical symptom relief time, incidence of severe/critical influenza, and safety were observed before treatment, and on the 3rd and 5th days of treatment. Results The trentment course, 16 patients dropped out(8 in the experimental group and 8 in the control group),224 patients were finally include in analyses,with 112 individuals in each group. Compared with the control group, the experimental group showed a shorter time for headache relief [28.00(17.75, 42.99)h vs. 41.00(18.75,59.00)h] and reduced muscle or joint pain relief time [37.83(12.88,52.77)h vs. 38.07(13.50,69.25) h](P<0.05). There was no statistically significant difference in the main clinical symptom relief time, complete fever resolution time, usage rate and amount of acetaminophen, and the rate of marked improvement in CM syndrome efficacy(P>0.05). The incidence of adverse reactions in the experimental group was 4.17%,and 1.67% in the control group, showing no significant difference (χ^(2)=1.36, P>0.05). Conclusions The clinical efficacy of SQM in the treatment of headache and muscle or joint pain in patients with influenza of both defense and qi syndrome was better than use of Oseltamivir Capsules. In terms of improvin

关 键 词：流行性感冒 卫气同病 双清合剂 随机对照试验 中西医结合 

分 类 号：R259[医药卫生—中西医结合]