《中西医结合预防与治疗COVID-19的动态循证指南》计划书  

Proposal of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19

作　　者：王琪 后亮瑛 朱鸿飞 栗梦婷 张迁[3] 周奇[4,5,6,7] 陈耀龙 杨克虎[4,5,6,7] 商洪才 郭新峰[9] 吴大嵘 葛龙[1,2,5,6,7] WANG Qi;HOU Liang-ying;ZHU Hong-fei;LI Meng-ting;ZHANG Qian;ZHOU Qi;CHEN Yao-long;YANG Ke-hu;SHANG Hong-cai;GUO Xin-feng;WU Da-rong;GE Long(Evidence-based Social Science Research Center,School of Public Health,Lanzhou University,Lanzhou 730000,China;Department of Social Science and Health Management,School of Public Healthy Lanzhou University,Lanzhou 730000,China;School of Nursing,Lanzhou University,Lanzhou 730000,China;Evidence-based Medicine Center,School of Basic Medical Sciences y Lanzhou University,Lanzhou 730000,China;Key Laboratory of Evidence Based Medicine and Knowledge Translation oj Gansu Province,ImozHou 730000,China;WHO Collaborating Center for Guideline Implementation and Knowledge Translation,Lanzhou 730000,China;GRADE Chinese Center,Lanzhou 730000,China;Key Laboratory of Chinese Internal Medicine of Ministry of Education,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;the Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,China)

机构地区：[1]兰州大学公共卫生学院循证社会科学研究中心,甘肃兰州730000 [2]兰州大学公共卫生学院社会医学与卫生事业管理研究所,甘肃兰州730000 [3]兰州大学护理学院,甘肃兰州730000 [4]兰州大学基础医学院循证医学中心,甘肃兰州730000 [5]甘肃省循证医学与临床转化重点实验室,甘肃兰州730000 [6]世界卫生组织指南实施与知识转化合作中心,甘肃兰州730000 [7]GRADE中国中心,甘肃兰州730000 [8]北京中医药大学东直门医院中医内科学教育部重点实验室,北京100700 [9]广州中医药大学第二附属医院/广东省中医院,广东广州510120

出　　处：《中国中药杂志》2021年第19期5117-5122,共6页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划“中医药现代化研究”项目(2019YFC1709805)。

摘　　要：为进一步规范新型冠状病毒肺炎(COVID-19)患者的中医药临床诊疗决策,将最新临床研究证据转化为临床实践,基于WHO指南制订手册、GRADE系统及卫生保健实践指南的报告条目(RIGHT)的标准和要求,采用动态指南制订的方法,国际中医药推荐意见(international trustworthy traditional Chinese medicine recommendations,TCM Recs)工作组启动了《中西医结合预防与治疗COVID-19的动态循证指南》编制工作。计划书详细介绍了该动态指南的工作组构成、临床问题和结局指标的收集与确定、动态系统评价的制作以及推荐意见的共识等动态指南制订方法和过程。该指南将持续监测中医药防治COVID-19的临床研究证据,定期进行证据更新检索和筛选,当存在新的研究证据时,指导委员会对证据改变临床实践或既往推荐意见的可能性进行评估,以决定是否启动或更新指南的推荐意见,指南更新主要考虑的标准为(1)上版指南中未涉及的中医药存在新的高质量随机对照试验(RCT)证据;(2)指南中已关注的中医药,经动态系统评价证据显示新证据可能改变现有推荐意见的方向或强度。动态循证指南具体实施将以该计划书为研究依据和框架,保障制订过程与方法的标准化,这将是动态指南方法学在中医药领域的首次探索。In order to standardize the clinical diagnosis and treatment decision-making with traditional Chinese medicine for pa-tients of coronavirus disease 2019(COVID-19) and put the latest clinical study evidence into clinical practice, the international trust-worthy traditional Chinese medicine recommendations( TCM Recs) working group started the compilation of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19 on the basis of the standards and re-quirements of WHO handbook, GRADE and RIGHT. This proposal mainly introduces the formulation methods and processes of the living guidelines in details, such as the composition of the working group, the collection and identification of clinical issues and out-comes, the production of the living systematic review and the consensus of recommendations. The guidelines will continue to monitor the clinical study evidences of TCM in the prevention and treatment of COVID-19, and conduct regular evidence updating, retrieval and screening. When there is new study evidence, the steering committee will evaluate the possibility of the evidence to change clinical practice or previous recommendations, so as to decide whether the recommendations for the guidelines shall be implemented or upda-ted. The main criteria considered in the guideline updating are as follows:(1) There are new high-quality randomized controlled trial(RCT) evidences for TCM uninvolved in the previous edition of the guidelines;(2) as for the TCM involved in the guidelines, living sys-tematic review shows that new evidence may change the direction or strength of the existing recommendations. The specific implementation of the living evidence-based guidelines will take this proposal as the study basis and framework, in order to ensure the standardization of the formulation process and methods. This will be the first exploration of the methodology for living guidelines in the field of TCM.

关 键 词：中西医结合 新型冠状病毒肺炎 动态指南 

分 类 号：R563.1[医药卫生—呼吸系统]