中医药治疗新型冠状病毒感染临床研究证据的范围综述

A scoping review of clinical research evidence for traditional Chinese medicine in the reatment of coronavirus disease 2019

目的 对中医药治疗新型冠状病毒感染(coronavirus disease 2019, COVID-19)的临床研究证据进行范围综述,确定文献中存在的相关问题,为后续开展新的研究提供思路。方法 检索PubMed、Embase、Cochrane Library、中国知网、万方数字化期刊全文数据库、中国生物医学文献服务系统,检索时限为自建库至2022年7月21日,纳入中医药治疗COVID-19的临床研究证据,整理资料信息,并对结果进行描述性分析。结果共纳入132篇研究,包括随机对照试验53篇,非随机对照试验17篇,回顾性队列研究62篇;研究发表于2020年-2022年;研究地点分布在全国19个省市自治区,其中以湖北省的研究数量最多(49.2%,65/132);研究样本量大都集中在50~100例(43.2%, 57/132);疗程在0~14 d的研究居多(50.0%,66/132);干预措施比较类型最多的为中药+常规治疗vs.常规治疗,文献占比为75.0%(99/132)。研究纳入的COVID-19患者以轻型、普通型为主;结局指标包括症状/体征变化情况、实验室指标、影像学指标、临床转归、安全性指标、功能量表等;干预/暴露组的不良反应/事件主要表现为胃肠道反应等。结论 中医药在治疗COVID-19方面已有较多的临床研究证据,未来需要更多大样本、国际合作的临床试验研究,为中医药治疗COVID-19提供强有力的证据支撑。

Objective To conduct a scoping review on the clinical research evidence for the treatment of coronavirus disease 2019(COVID-19)with traditional Chinese medicine,identify relevant problems in the literature,and provide ideas for the follow-up research.Methods PubMed,Embase,the Cochrane Library,China National Knowledge Infrastructure,Wanfang Digital Journal Full-text Database,and China Biomedical Literature Database were searched from inception to July 21st,2022.The clinical research evidence for the treatment of COVID-19 with traditional Chinese medicine was included,the data information was sorted out,and the results were descriptively analyzed.ResultsA total of 132 studies were included,including 53 randomized controlled trials,17 non-randomized controlled trials,and 62 retrospective cohort studies,all of which were published between 2020 and 2022.The clinical studies were carried out in 19 provincial level regions,among which Hubei province had the largest number of studies(49.2%,65/132).The sample sizes of the studies were mostly between 50 and 100 cases(43.2%,57/132).Most of the studies had a treatment course of 0-14 days(50.0%,66/132).The most compared intervention measures were traditional Chinese medicine+conventional western medicine treatment vs.conventional western medicine treatment,accounting for 75.0%(99/132)of the studies.The COVID-19 patients included in the studies were mainly mild and moderate.Outcome indicators included changes in symptoms/signs,laboratory indicators,CT indicators,clinical outcomes,safety indicators,functional scales,etc.The main adverse reactions/events in intervention/exposure groups were gastrointestinal reactions.Conclusions There has been a lot of clinical research evidence on the treatment of COVID-19 by traditional Chinese medicine.To provide strong evidence support for the treatment of COVID-19 by traditional Chinese medicine,more clinical trials with large samples and international collaboration are needed in the future.