Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China.
Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China.
Am J Chin Med. 2020;48(7):1511-1521. doi: 10.1142/S0192415X20500743. Epub 2020 Nov 5.
The worldwide spread of the 2019 novel coronavirus has become a profound threat to human health. As the use of medication without established effectiveness may result in adverse health consequences, the development of evidence-based guidelines is of critical importance for the clinical management of coronavirus disease (COVID-19). This research presents methods used to develop rapid advice guidelines on treating COVID-19 with traditional Chinese medicine (TCM). We have followed the basic approach for developing WHO rapid guidelines, including preparing, developing, disseminating and updating each process. Compared with general guidelines, this rapid advice guideline is unique in formulating the body of evidence, as the available evidence for the treatment of COVID-19 with TCM is from either indirect or observational studies, clinical first-hand data together with expert experience in patients with COVID-19. Therefore, our search of evidence not only focuses on clinical studies of treating COVID-19 with TCM but also of similar diseases, such as pneumonia and influenza. Grading of recommendations assessment, development and evaluation (GRADE) methodology was adopted to rate the quality of evidence and distinguish the strength of recommendations. The overall certainty of the evidence is graded as either high, moderate, low or very low, and to give either "strong" or "weak" recommendations of each TCM therapy. The output of this paper will produce the guideline on TCM for COVID-19 and will also provide some ideas for evidence collection and synthesis in the future development of rapid guidelines for COVID-19 in TCM as well as other areas.
2019 年新型冠状病毒在全球范围内的传播,对人类健康构成了严重威胁。由于使用未经证实有效的药物可能会导致不良健康后果,因此制定基于证据的指南对于冠状病毒病(COVID-19)的临床管理至关重要。本研究介绍了制定使用中药治疗 COVID-19 的快速建议指南所采用的方法。我们遵循了制定世界卫生组织快速指南的基本方法,包括准备、制定、传播和更新每个过程。与一般指南相比,本快速建议指南在制定证据体方面具有独特性,因为 COVID-19 采用中药治疗的可用证据来自间接或观察性研究、COVID-19 患者的临床第一手数据以及专家经验。因此,我们的证据搜索不仅集中在 COVID-19 采用中药治疗的临床研究上,还集中在类似疾病(如肺炎和流感)的临床研究上。采用推荐评估、制定和评估(GRADE)方法学对证据质量进行评级,并区分推荐建议的强度。证据的总体确定性分为高、中、低或极低,并对每种中药治疗方法给予“强”或“弱”的推荐建议。本文的输出结果将产生针对 COVID-19 的中药指南,并为未来 COVID-19 中药快速指南以及其他领域的证据收集和综合提供一些思路。