中药治疗新型冠状病毒肺炎临床研究文献的质量评价  

Quality evaluation of clinical trial literatures on the COVID-19 treatment with traditional Chinese medicine(TCM)

作　　者：金江炜 施建荣 蔡建[4] 李桂花 陆赛花 徐峰 JIN Jiangwei;SHI Jianrong;CAI Jian;LI Guihua;LU Saihua;XU Feng(Sixth People’s Hospital South Campus Affiliated to Shanghai University of Medicine&Health Sciences,Shanghai 201400,China;School of Pharmacy,Shanghai University of Medicine&Health Sciences,Shanghai 201318,China;Chongming Baozhen Community Health Center,Shanghai 202159,China;Fengxian Mental Health Center,Shanghai 201499,China)

机构地区：[1]上海健康医学院附属第六人民医院南院,上海201400 [2]上海健康医学院药学院,上海201318 [3]上海市崇明区堡镇社区卫生服务中心,上海202159 [4]上海市奉贤区精神卫生中心,上海201499

出　　处：《药学实践杂志》2021年第3期206-210,共5页Journal of Pharmaceutical Practice

基　　金：上海医院药学科研项目(2017-YY-02-17);上海市临床药学重点专科建设项目(2018-2020)。

摘　　要：目的对迄今发表的中药治疗新型冠状病毒肺炎临床研究文献进行质量评价,找出其中的不足并提出相应的建议,以期推广中药在新冠肺炎治疗中的应用。方法检索中国知网和PubMed数据库,用“COVID-19”“新冠病毒肺炎”“TCM”“中医药”“Clinical trial”“临床试验”“Lianhua Qingwen”“连花清瘟”“Huoxiang Zhengqi”“藿香正气”“Jinhua Qinggan”“金花清感”等关键词进行搜索,获得所有有关中药治疗新冠肺炎的相关文献,通过对比实验方法、临床疗效、主要症状消失率、体征消失率等指标,对其质量进行评价。结果共得到中药治疗新冠肺炎相关论文463篇,剔除441篇中药治疗新冠肺炎的网络药理学理论研究文献。在纳入质量分析的22篇中药临床试验研究文献中,有随机对照研究3篇,多中心前瞻性随机对照试验1篇,病例报告2篇,无对照单臂研究5篇,对照试验4篇,回顾性研究7篇。疫情发生至今,虽然已经陆续发表了不少中药治疗新冠肺炎的临床试验文献,但多数工作不够规范,存在着部分试验没有设计对照组、样本量过低、没有设盲等问题,这些问题还需进一步改进和完善。结论中药治疗新冠肺炎仍然需要进行更多的、设计规范的临床试验验证,产生强有力的循证医学证据,例如,增设对照组、增加样本量、采用盲法等,以此增加临床试验的可信度。Objective To evaluate the quality of the clinical trial literatures published on the treatment of COVID-19 with TCM,find out the shortcomings and put forward corresponding suggestions,in order to promote TCM against COVID-19.Methods"COVID-19","New Coronavirus Pneumonia","TCM","Chinese Medicine","Clinical Trial","Lianhua Qingwen","Huoxiang Zhengqi","Jinhua Qinggan",and other keywords were used to search relevant literatures in CNKI and PubMed database.Among the all the screened relevant literatures on the treatment of COVID-19 with TCM,the literature quality was assessed according to evaluation criteria of clinical trial literatures.Results A total of 463 papers related to the treatment of COVID-19 with TCM were obtained.440 papers on theoretical research on the network pharmacology mechanism of Chinese medicine treatment of COVID-19 were excluded.Among the 23 articles included in the quality analysis,there are 3 randomized controlled studies,1 multi-center prospective randomized controlled trial,2 disease case report trials,and 5 uncontrolled single arm studies,5 controlled trials and 7 retrospective studies.In the period of more than half a year,although many clinical trial documents of TCM for the treatment of COVID-19 have been published,the clinical trial design reflected in most TCM clinical trials were not standardized.There are problems in"randomness and rationality",such as no control group,no randomization design,only case studies,no blinding method in controlling bias,and insufficient objectivity in the evaluation criteria of efficacy.All of these need to be improved.Conclusion The treatment of new coronavirus pneumonia with TCM still requires more and standardized clinical trial verifications and publications to generate strong evidence-based results,such as adding control groups,increasing sample size,and using blinding methods to increase the credibility of clinical trials.

关 键 词：中药 新型冠状病毒肺炎 临床试验 文献质量评价 

分 类 号：R259[医药卫生—中西医结合]