Li Yulin, Xu Haonan, Lang Hui, Li Jing, Bi Lin, Li Yanqing, Dong Liang, Zhang Lin, Liang Xin, Zhu Hongqiu
Department of Andrology, The Reproductive and Women-Children Hospital, Chengdu University of Traditional Chinese Medicine, Sichuan.
Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University.
Medicine (Baltimore). 2020 Jul 31;99(31):e21024. doi: 10.1097/MD.0000000000021024.
The pandemic caused by the coronavirus disease 2019 (COVID-19) infection has exposed vulnerable populations to an unprecedented global health crisis. Research reported that Chinese traditional medicine injections were used in patients with COVID-19 infection and showed significant effects, and there have been no systematic review and meta-analyses to investigate the effects and safety of Chinese traditional medicine injections.
This systematic review and meta-analysis protocol is based on the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 statement. The literature search will involve Cochran library, Web of science, PubMed, MEDLINE, Embase, China Biology Medicine Database, China National Knowledge Infrastructure Database, VIP, Wang Fang database, and China Clinical Trial Registration Center for articles and research published form December 2019. This search will include randomized controlled trials and nonrandomized studies. The Cochrane Collaboration's tool for randomized controlled trial studies and the Quality Assessment Tool for Quantitative Studies for nonrandomized studies will be used to assess the risk of bias among the studies included in the systematic review. Review Manager 5.3 software will be used for the meta-analysis, and odds ratio are calculated as the primary outcomes. Subgroup analyses will then be performed based on the characteristics of the interventions and populations included in the studies examined.
This systematic review protocol is designed to provide evidence regarding the effects and safety of Chinese traditional medicine injections on patients with COVID-19, such evidence may be useful and important for clinical treatment decisions. The results should be disseminated through publication in a peer-reviewed journal. Since the data and results used in the systematic review will be extracted exclusively from published studies, approval from an ethics committee will not be required.
2019年冠状病毒病（COVID-19）感染引发的大流行使弱势群体面临前所未有的全球健康危机。研究报告称，COVID-19感染患者使用了中药注射剂，且显示出显著效果，但尚无系统评价和荟萃分析来调查中药注射剂的疗效和安全性。
本系统评价和荟萃分析方案基于《系统评价和荟萃分析方案首选报告项目2015声明》。文献检索将涉及考克兰图书馆、科学网、PubMed、MEDLINE、Embase、中国生物医学数据库、中国知网数据库、维普、万方数据库以及中国临床试验注册中心，检索2019年12月以来发表的文章和研究。该检索将包括随机对照试验和非随机研究。将使用Cochrane协作网的随机对照试验研究工具和非随机研究定量研究质量评估工具来评估纳入系统评价的研究中的偏倚风险。将使用Review Manager 5.3软件进行荟萃分析，并计算比值比作为主要结局。然后将根据所审查研究中纳入的干预措施和人群的特征进行亚组分析。
本系统评价方案旨在提供关于中药注射剂对COVID-19患者疗效和安全性的证据，此类证据对于临床治疗决策可能有用且重要。研究结果应通过在同行评审期刊上发表进行传播。由于系统评价中使用的数据和结果将仅从已发表的研究中提取，因此无需伦理委员会批准。
