羌竹清感方治疗卫气同病证流行性感冒的多中心随机对照试验  

Qiangzhu Qinggan Decoction in the treatment of influenza with the pattern of plague simultaneously involving weifen and qifen:A multi-center randomized controlled trial

作　　者：邱磊 张少言[1] 吴显伟 晋玉梅 李殿滨 李泽庚[4] 杨珺超[5] 郑培永[6] 张惠勇[1] 鹿振辉[1] QIU Lei;ZHANG Shaoyan;WU Xianwei;JIN Yumei;LI Dianbin;LI Zegeng;YANG Junchao;ZHENG Peiyong;ZHANG Huiyong;LU Zhenhui(Institute of Respiratory Diseases,Longhua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Emergency Department,Shanghai Fengxian District Traditional Chinese Medicine Hospital,Shanghai 201499,China;Emergency Department,Shanghai Changning District Tianshan Hospital of Traditional Chinese Medicine,Shanghai 200051,China;The First Affiliated Hospital of Anhui University of CM,Hefei 230009,China;Respiratory Department,The First Affiliated Hospital of Zhejiang Chinese Medical University,Hangzhou 310018,China;Clinical Research Center,Longhua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China)

机构地区：[1]上海中医药大学附属龙华医院呼吸疾病研究所,上海200032 [2]上海市奉贤区中医医院急诊科,上海201499 [3]上海市长宁区天山中医医院急诊科,上海200051 [4]安徽中医药大学第一附属医院,合肥230009 [5]浙江中医药大学附属第一医院呼吸科,杭州310018 [6]上海中医药大学附属龙华医院临床研究中心,上海200032

出　　处：《中华中医药杂志》2023年第10期5059-5064,共6页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家“十三五”传染病科技重大专项(No.2017ZX10305011);国家中医药多学科交叉创新团队(No.ZYYCXTD-D-202208);上海市科委项目(No.184958106000,No.20Y21900200,No.21Y21920400);上海市申康医院发展中心重大临床研究项目(No.SHDC2020CR2006A);上海中医药大学科研项目(No.2021LK044)。

摘　　要：目的:观察羌竹清感方治疗流行性感冒卫气同病证的临床效果。方法:于2019年1月—2021年3月选择230例流感卫气同病证患者,根据随机数表法分为中药组(116例)和对照组(114例);对照组接受常规对症治疗和奥司他韦(疗程5~7 d),中药组在对照组治疗方案基础上加服羌竹清感方(疗程为7 d);以第7天临床症状恢复率、流感主要症状恢复时间、单项流感症状恢复时间、退热时间和第7天病毒核酸/抗原转阴率为主要疗效指标,同步监测安全性指标。结果:中药组的流感主要症状第7天恢复率显著高于对照组[96.6%(112/116)vs 85.1%(97/114),P<0.01];中药组的流感主要症状中位恢复时间较对照组显著缩短(5.0 d vs 6.0 d,P<0.01);中药组的中位退热时间较对照组显著缩短(22.0 h vs 27.0 h,P<0.05)。中药组的第7天病毒核酸/抗原转阴率与对照组相仿。两组间不良事件比较差异无统计学意义[10.34%(12/116)vs 8.77%(10/114)]。结论:羌竹清感方有助于改善流感卫气同病证患者的临床症状和缩短退热时间,且具有良好的安全性。Objective:To observe the efficacy and safety of Qiangzhu Qinggan Decoction(QZQGD)in influenza of the pattern of plague simultaneously involving weifen and qifen(PSIWF pattern).Methods:A total of 230 patients with influenza of PSIWF pattern from January 2019 to March 2021 were selected and randomly divided into Chinese medicine(CM)group(116 cases)and control group(114 cases).The control group received conventional symptomatic treatment and oseltamivir,while the CM group received conventional symptomatic treatment,oseltamivir(5 to 7 d of intervention)and QZQGD(7 d of intervention).Outcomes mainly included the recovery rate of major influenza symptoms on the 7th day,the recovery time of major influenza symptoms,the recovery time of individual influenza symptoms,time to defervescence(TTD),and the negative conversion ratio of nucleic acid or antigen on the 7th day.Security indicators need to be monitored simultaneously.Results:The recovery rate of the main influenza symptoms in the CM group on day 7 was significantly higher than that in the control group[96.6%(112/116)vs 85.1%(97/114),P<0.01].The median recovery time of the main influenza symptoms in the CM group was significantly shorter than that in the control group(5.0 d vs 6.0 d,P<0.01).The median TTD in the CM group was shorter than that in the control group(22.0 h vs 27.0 h,P<0.05).The negative conversion ratio of nucleic acid or antigen on the 7th day of the CM group was similar to that of the control group.The difference in adverse events between the two groups was not statistically significant[10.34%(12/116)vs 8.77%(10/114)].Conclusion:QZQGD might help effectively improve the clinical symptoms of patients with influenza of PSIWF pattern and shorten TTD,and it also has good safety.

关 键 词：羌竹清感方 中医药 流行性感冒 卫气同病证 多中心 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]