抗病毒颗粒治疗流行性感冒有效性和安全性的多中心随机对照研究  

Efficacy and safety of Kangbingdu granules in the treatment of influenza:a randomized,double-blind,double-dummy,positive-drug parallel control multicenter clinical trial

作　　者：农英[1] 林江涛[1] 孙绪武 王珺[3] 麻晓 柳小平 王惠琴 查日田 沈大鹏 姜淑娟[9] 罗世坤 赵琦 孟玲 王晚萍 房洁 韩利梅[15] 陆光兵 张伟[17] 李贵芳 王宏 赵志英[20] 周玮[21] 魏葆琳[22] 袁雅冬[23] 彭丽萍[24] 卢献灵[25] 庞桂芬[26] 李复红 李磊[28] 甄会[28] Nong Ying;Lin Jiangtao;Sun Xuwu;Wang Jun;Ma Xiao;Liu Xiaoping;Wang Huiqin;Zha Ritian;Shen Dapeng;Jiang Shujuan;Luo Shikun;Zhao Qi;Meng Ling;Wang Wanping;Fang Jie;Han Limei;Lu Guangbing;Zhang Wei;Li Guifang;Wang Hong;Zhao Zhiying;Zhou Wei;Wei Baolin;Yuan Yadong;Peng Liping;Lu Xianling;Pang Guifen;Li Fuhong;Li Lei;Zhen Hui(Department of Pulmonary and Critical Care Medicine,China-Japan Friendship Hospital,Beijing 100029,China;Department of Lung Diseases,Mudanjiang Hospital of Traditional Chinese Medicine,Mudanjiang 157009,China;Department of Pulmonary and Critical Care Medicine,the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 250001,China;Emergency Department,Luohe Hospital of traditional Chinese Medicine,Luohe 462000,China;Department of Pulmonary and Critical Care Medicine,the Second People's Hospital of Gansu Province,Lanzhou 730030,China;Respiratory Department,the Second Affiliated Hospital of Shanxi University of traditional Chinese Medicine,Xianyang 712021,China;Respiratory Department of Wuhu First people's Hospital,Wuhu 241000,China;Department of Internal Medicine,Zaozhuang Maternal and Child Health Hospital,Zaozhuang 277800,China;Department of Pulmonary and Critical Care Medicine,Shandong Provincial Hospital,Jinan 250021,China;Department of Internal Medicine,Urumqi Hospital of Traditional Chinese Medicine,Urumqi 830000,China;Department of Respiratory Medicine,Heilongjiang Red Cross(Forest Industry General)Hospital,Haerbin 150040,China;Department of Pulmonary and Critical Care medicine,the Second Affiliated Hospital of Shandong First Medical University,Taian 271000,China;Department of Respiratory Medicine,Changzhi People's Hospital,Changzhi 046000,China;Department of Respiratory Medicine,Dezhou People's Hospital,Dezhou 253020,China;Department of Respiratory Medicine,the Second Affiliated Hospital of Xinjiang Medical University,Urumqi 830063,China;Department of Pulmonary and Critical Care Medicine,Meishan Hospital of Traditional Chinese Medicine,Meishan 620010,China;De

机构地区：[1]中日友好医院呼吸与危重症医学科,北京100029 [2]牡丹江市中医医院肺病科,牡丹江157009 [3]山东中医药大学第二附属医院呼吸与危重症医学科,济南250001 [4]漯河市中医院急诊科,漯河462000 [5]甘肃省第二人民医院呼吸与危重症医学科,兰州730030 [6]陕西中医药大学第二附属医院呼吸科,咸阳712021 [7]芜湖市第一人民医院呼吸内科,芜湖241000 [8]枣庄妇幼保健院内科,枣庄277800 [9]山东省立医院呼吸与危重症医学科,济南250021 [10]乌鲁木齐市中医医院内科,乌鲁木齐830000 [11]黑龙江红十字(森工总)医院呼吸内科,哈尔滨150040 [12]山东第一医科大学第二附属医院呼吸科与危重症医学科,泰安271000 [13]长治市人民医院呼吸内科,长治046000 [14]德州市人民医院呼吸科,德州253020 [15]新疆医科大学第二附属医院呼吸科,乌鲁木齐830063 [16]眉山市中医院呼吸与危重症医学科,眉山620010 [17]山东中医药大学附属医院肺病科,济南250011 [18]冀州能源峰峰集团有限公司总医院呼吸科,邯郸056011 [19]牡丹江第一人民医院呼吸内科,牡丹江157011 [20]保定市第二医院呼吸科,保定071051 [21]宁夏医科大学总医院呼吸与危重症医学科,银川750003 [22]天津中医药大学附属第二医院呼吸与危重症医学科,天津300250 [23]河北医科大学第二医院呼吸与危重症医学二科,石家庄050000 [24]吉林大学第一医院呼吸与危重症医学科,长春130021 [25]石河子大学医学院第一附属医院呼吸科,石河子832008 [26]承德医学院附属医院呼吸与危重症医学科,承德067000 [27]渭南市中心医院呼吸科,渭南714000 [28]中国中药协会药物研究评价技术中心,北京100101

出　　处：《中华医学杂志》2021年第3期205-211,共7页National Medical Journal of China

摘　　要：目的观察抗病毒颗粒治疗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、阳性药平行对照试验设计,在中国27家三级甲等医院筛选流行性感冒患者,按1∶1随机分配至抗病毒颗粒试验组或磷酸奥司他韦胶囊对照组,每组计划入组受试者200例。试验组给予抗病毒颗粒(每次18 g,每日3次)及磷酸奥司他韦模拟剂口服,对照组给予磷酸奥司他韦胶囊(每次75 mg,每日2次)及抗病毒颗粒模拟剂口服,疗程均为5 d。主要疗效指标包括临床主要症状缓解时间和完全退热时间。次要疗效指标包括对乙酰氨基酚使用剂量、中医证候积分改变、其他重要临床症状缓解时间。对比抗病毒颗粒试验组和磷酸奥司他韦对照组疗效指标差异,同时监测不良事件或不良反应评估抗病毒颗粒的安全性。结果共入组受试者393例,抗病毒颗粒试验组195例,完成试验191例(97.95%)。磷酸奥司他韦对照组198例,完成试验195例(98.48%),两组脱落率和剔除率差异无统计学意义(P>0.05)。全分析数据集(FAS)中试验组年龄(34.9±14.4)岁,男性83例(42.78%);对照组年龄(33.3±13.5)岁,男性78例(39.59%)。两组受试者人口学资料、体格检查、病毒病原学检测、基线中医证候总分及各单项症状评分等比较差异均无统计学意义(P>0.05)。FAS中试验组临床主要症状缓解时间M(Q1,Q3)为3.0(3.0,4.0)d,对照组为3.0(3.0,4.0)d,差异无统计学意义(P>0.05)。完全退热时间M(Q1,Q3)试验组为34.0(20.3,49.0)h,对照组为36.5(19.6,48.8)h,差异无统计学意义(P>0.05)。抗病毒颗粒在对乙酰氨基酚使用剂量、中医证候疗效、多数重要临床症状消失率等方面与磷酸奥司他韦胶囊疗效相当(P>0.05),且抗病毒颗粒组第3天的头昏、胸闷症状消失率优于磷酸奥司他韦胶囊组(P<0.05)。结论抗病毒颗粒治疗流行性感冒疗效与磷酸奥司他韦胶囊相当,且药物安全性良好。Objective To observe the efficacy and safety of Kangbingdu granules(KBD)in the treatment of influenza.Methods A multicenter,randomized,double-blind,double-dummy,and positive-drug parallel control trial was conducted in 27 GradeⅢA hospitals in China and the subjects were randomly assigned to the KBD test group or the oseltamivir phosphate capsule control group at a ratio of 1∶1.200 subjects were planned to be enrolled in each group.The experimental group was given KBD(18g each time,3 times a day)and oseltamivir phosphate simulator orally,while the control group was given oseltamivir phosphate capsule(75 mg each time,twice a day)and KBD simulator orally for 5 days.The primary efficacy indicators included the remission time of major clinical symptoms and the time of complete defervescence.The secondary efficacy indicators included dosage of acetaminophen,the change of traditional Chinese medicine(TCM)syndrome score and the remission time of other important clinical symptoms.The efficacy of KBD in the test group and Oseltamivir phosphate control group were compared.Adverse events or adverse reactions were observed at the same time to evaluate the safety of KBD Granules.Results A total of 393 subjects from 27 GradeⅢA hospitals in China were enrolled.The experimental group included 195 subjects and 191 subjects(97.95%)completed the trial,While the control group included 198 subjects and 195 subjects(98.48%)completed the trial.There was no significant difference in the shedding rate and rejection rate between the two groups(P>0.05).In the Full Analysis Set(FAS),the mean age of the experimental group was(34.9±14.4)years old,with 83 males(42.78%).The mean age of the control group was(33.3±13.5)years old,with 78 males(39.59%).There were no statistically significant differences between the two groups in demographic data,physical examination,viral pathogen detection,total score of TCM syndromes and scores of each symptom at baseline(P>0.05).In the FAS,the remission time M(Q1,Q3)of major clinical symptoms was 3.0(3.0,

关 键 词：流感 人 抗病毒颗粒 有效性 安全性 

分 类 号：R254.9[医药卫生—中医内科学]