喜炎平注射液治疗急性扁桃体炎的多中心随机单盲安慰剂平行对照临床研究  

A multicenter randomized single-blind placebo controlled clinical study on Xiyanping Injection in treatment of acute tonsillitis

作　　者：丁彦[1] 张奇芬 沈秋莉 张敏[4] 谢绍华 李军[6] 焦深山 李玲波[8] 赵东铭 陈佑生[10] 丁震[11] 张湘华 贾金广 万俐佳[14] 许萍[15] 孟庆伟 冯悦静[17] 张伟[18] DING Yan;ZHANG Qi-fen;SHEN Qiu-li;ZHANG Min;XIE Shao-hua;LI Jun;JIAO Shen-shan;LI Ling-bo;ZHAO Dong-ming;CHEN You-sheng;DING Zhen;ZHANG Xiang-hua;JIA Jin-guang;WAN Li-jia;XU Ping;MENG Qing-wei;FENG Yue-jing;ZHANG Wei(The First Affiliated Hospital of Gannan Medical College,Ganzhou 341000,China;Nanchang Hongdu Hospital of Traditional Chinese Medicine,Nanchang 330000,China;Hangzhou Linping District Maternity and Child Health Care Hospital,Hangzhou 311199,China;Ganzhou People’s Hospital,Ganzhou 341000,China;Yichun People’s Hospital,Yichun 336400,China;Jiujiang First People’s Hospital,Jiujiang 332000,China;Nanchang Third Hospital,Nanchang 330000,China;Liuzhou Workers’Hospital,Liuzhou 545000,China;Luoyang First People’s Hospital,Luoyang 471000,China;Zibo Central Hospital,Zibo 255020,China;The First People’s Hospital of Hefei,Hefei 230000,China;Shijiazhuang People’s Hospital,Shijiazhuang 050000,China;Zhengzhou People’s Hospital,Zhengzhou 450000,China;Jingzhou Central Hospital,Jingzhou 434000,China;The Fourth Affiliated Hospital of Nanchang University,Nanchang 330000,China;Shangrao People’s Hospital,Shangrao 334000,China;The Sixth People’s Hospital of Zhengzhou,Zhengzhou 450000,China;The First Affiliated Hospital of Nanchang University,Nanchang 330006,China)

机构地区：[1]赣南医学院第一附属医院,江西赣州341000 [2]南昌市洪都中医院,江西南昌330000 [3]杭州市临平区妇幼保健院,浙江杭州311199 [4]赣州市人民医院,江西赣州341000 [5]宜春市人民医院,江西宜春336400 [6]九江市第一人民医院,江西九江332000 [7]南昌市第三医院,江西南昌330000 [8]柳州市工人医院,广西柳州545000 [9]洛阳市第一人民医院,河南洛阳471000 [10]淄博市中心医院,山东淄博255020 [11]合肥市第一人民医院,安徽合肥230000 [12]石家庄市人民医院,河北石家庄050000 [13]郑州人民医院,河南郑州450000 [14]荆州市中心医院,湖北荆州434000 [15]南昌大学第四附属医院,江西南昌330000 [16]上饶市人民医院,江西上饶334000 [17]郑州市第六人民医院,河南郑州450000 [18]南昌大学第一附属医院,江西南昌330006

出　　处：《中草药》2023年第11期3586-3593,共8页Chinese Traditional and Herbal Drugs

基　　金：科技部“十二五”重大新药创制专项:抗病毒感染中药“喜炎平注射液”的关键技术研究的延伸性研究课题—中药大品种“喜炎平注射液”上市后再评价(2014ZX09201025)。

摘　　要：目的评价喜炎平注射液治疗急性扁桃体炎的有效性和安全性。方法收集2017年4月16日—2021年5月25日就诊于赣南医学院第一附属医院等18家中心18~65周岁的急性扁桃体炎患者458例,以1∶1的比例随机分配到试验组和安慰剂组中。试验组采用喜炎平注射液联合常规治疗,安慰剂组采用喜炎平模拟注射液联合常规治疗。观察两组的临床疗效,比较两组治疗后急性扁桃体炎病症缓解时间及各项症状缓解时间,评价安全性。结果治疗后,试验组可以使中位扁桃体炎缓解时间显著缩短12.7 h(P<0.05),与安慰剂组比较具有优效性。治疗后,试验组可显著缩短各项症状缓解时间,咽痛、夜咳、日咳、发冷/出汗的中位缓解时间与安慰剂组比较分别缩短13.5、14.2、21.0、3.8 h,差异具有统计学意义(P<0.05)。两组总体不良事件发生率相似,所有不良事件均恢复且无严重不良反应。结论喜炎平注射液可缩短急性扁桃体炎患者的疾病缓解时间,提高临床治愈率,加快缓解各项症状,临床疗效安全可靠。Objective To evaluate the efficacy and safety of Xiyanping Injection(喜炎平注射液)in the treatment of acute tonsillitis.Methods 458 patients aged 18 to 65 years old with acute tonsillitis admitted to 18 centers including the First Affiliated Hospital of Gannan Medical University from April 16,2017 to May 25,2021 were collected and randomly assigned to the experimental group and the placebo group in a 1︰1 ratio.The experimental group was treated with Xiyanping Injection combined with conventional treatment,and the placebo group was treated with Xiyanping simulated injection combined with conventional treatment.The clinical efficacy of the two groups was observed,and the remission time of acute tonsillitis and various symptoms after treatment were compared between the two groups,and the safety was evaluated.Results The median remission time of tonsillitis in the experimental group was significantly shortened by 12.7 h(P<0.05),and had excellent efficacy.The median remission time of pharyngeal pain,night cough,day cough and chiller/sweating was shortened by 13.5,14.2,21.0 and 3.8 h,respectively,in the experimental group compared with the placebo group,and the difference was statistically significant(P<0.05).The overall incidence of adverse events was similar between the two groups,and all adverse events recovered without serious adverse reactions.Conclusion Xiyanping Injection can shorten the remission time of acute tonsillitis,improve the clinical cure rate,accelerate the relief of symptoms,and the clinical efficacy is safe and reliable.

关 键 词：急性扁桃体炎 喜炎平注射液 多中心 安慰剂 扁桃体炎缓解时间 

分 类 号：R285.64[医药卫生—中药学]