The Multi-evidence Integration Methodology for Traditional Chinese Medicine: the MERGE Framework
-
摘要:
在循证医学时代下,依托规范的技术方法和标准化的操作规程发掘中医药独特优势,是实现中医药现代化、国际化发展并惠泽人类的必由之路。中医理论、人用经验和研究证据三结合证据体系的提出标志着中医药特色评价体系思维方法取得了重要进步,经过恰当方法整合后的多元证据体是中医药临床指南推荐意见和循证卫生决策的有力支撑。本文基于当前国际证据合成与分级方法学前沿与进展,初步提出中医药多元证据整合方法:MERGE,以期为该方法学走向成熟奠定基础,并为中医药循证医学方法学体系的发展提供借鉴。
Abstract:In the era of evidence-based medicine, it is necessary to explore the unique advantages of traditional Chinese medicine (TCM) based on standardized technical methods and operating procedures in order to achieve the modernization and internationalization of TCM and benefit humanity. The proposal of a three-pronged evidence system combining TCM theory, human experience and experimental evidence marks an important progress in the thinking method of the TCM evaluation system. The multi-evidence body integrated through appropriate methods is a strong support for the clinical guideline recommendations and evidence-based health decisionmaking in TCM. Based on the current methodological progress of international evidence synthesis and grading, this paper proposes a novel approach for integrating multi-evidence in traditional Chinese medicine: the MERGE framework. The aim is to establish a solid foundation for the development of this methodology and to provide guidance for the advancement of the evidencebased medicine framework in traditional Chinese medicine.
-
[1] 喻佳洁, 李琰, 陈雯雯, 等.循证医学的产生与发展:社会需求、学科发展和人文反思共同推动[J]. 中国循证医学杂志, 2019, 19:108-113. [2] Tian G, Zhao C, Zhang X, et al. Evidence-based traditional Chinese medicine research:Two decades of development, its impact, and breakthrough[J].J Evid Based Med, 2021, 14:65-74. [3] 国务院关于印发中医药发展战略规划纲要(2016-2030年)的通知[J].中华人民共和国国务院公报. 2016(08):21-29. [4] 余艳红.在中国中医药循证医学中心成立仪式上的讲话[J].中国中西医结合杂志, 2019, 39:389. [5] 邢冬梅, 刘新灿, 张俊华, 等.循证中医药学进展[J].中华中医药杂志, 2022, 37:3319-3323. [6] Chen Y, Wang C, Shang H, et al. Clinical practice guidelines in China[J].BMJ, 2018, 360:j5158. [7] 中华人民共和国中央人民政府.中共中央国务院关于促进中医药传承创新发展的意见[EB/OL].(2019-10-26)[2023-02-10].http://www.gov.cn/zhengce/2019-10/26/content_5445336.htm. [8] Guyatt G, Rennie D, Meade M, et al. Users' Guides to the Medical Literature:A Manual for Evidence-Based Clinical Practice[M].New York:McGraw-Hill Education, 2002. [9] 张越伦, 吴东, 李乃适, 等.试论循证医学的哲学基础[J].协和医学杂志, 2021, 12:401-406. [10] Toon P. What is evidence?[J].London J Prim Care (Abingdon), 2014, 6:95-97. [11] Mowat R, Subramanian SV, Kawachi I. Randomized controlled trials and evidence-based policy:A multidisciplinary dialogue[J].Soc Sci Med, 2018, 210:1. [12] Sun X, Tan J, Tang L, et al.Real world evidence:experience and lessons from China[J].BMJ, 2018, 360:j5262. [13] Gokhale M, Stürmer T, Buse JB.Real-world evidence:the devil is in the detail[J].Diabetologia, 2020, 63:1694-1705. [14] Cuello-Garcia CA, Santesso N, Morgan RL, et al.GRADE guidance 24 optimizing the integration of randomized and non-randomized studies of interventions in evidence syntheses and health guidelines[J].J Clin Epidemiol, 2022, 142:200-208. [15] 赖鸿皓, 田晨, 朱鸿飞, 等.如何整合随机与非随机干预研究[J].中国循证医学杂志, 2022, 22:836-841. [16] 陈曦, 张宇鹏, 于智敏, 等.关于中医理论体系框架研究的若干思考[J].中国中医基础医学杂志, 2013, 19:3-5, 14. [17] 苏鹏丽, 刘骏, 于亚南, 等.中医药证据体系及评价要素研究现状分析[J].中医杂志, 2022, 63:288-292. [18] 李琰, 喻佳洁, 陈雯雯, 等.循证医学的科学观和人文观[J].中国循证医学杂志, 2019, 19:114- 118. [19] 杨其霖,田思胜,马梅青.中医药古籍文献数据库建设研究与思考[J].中国医药导报,2018,15:119-122. [20] 赵雪, 戴国华, 管慧, 等.中医临床疗效评价指标的选择与应用[J].中华中医药杂志, 2022, 37:1863-1867. [21] Guyatt GH, Oxman AD, Kunz R, et al.What is "quality of evidence" and why is it important to clinicians?[J].BMJ, 2008, 336:995-998. [22] Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines:1. Introduction-GRADE evidence profiles and summary of findings tables[J].J Clin Epidemiol, 2011, 64:383-394. [23] 龙德怀, 尚菊菊, 刘红旭, 等.中医药随机对照试验质量评价文献再评价[J].中华中医药杂志, 2022, 37:5318-5322. [24] 郑玉娇, 逄冰, 刘文科, 等.中医"治未病"临床研究的现状及对策探析[J].环球中医药, 2018, 11:4. [25] 陆玉林, 骆文, 陆丽明.开展真实世界中医药临床研究的机遇与挑战[J].中华中医药杂志, 2021, 36:4. [26] Sherman RE, Anderson SA, Dal Pan GJ, et al.Real-World Evidence-What Is It and What Can It Tell Us?[J]. N Engl J Med, 2016, 375:2293-2297. [27] Jarow JP, LaVange L, Woodcock J.Multidimensional Evidence Generation and FDA Regulatory Decision Making:Defining and Using"Real-World" Data[J].JAMA, 2017, 318:703-704. [28] Schünemann HJ, Cuello C, Akl EA, et al. GRADE guidelines:18. How ROBINS-I and other tools to assess risk of bias in nonrandomized studies should be used to rate the certainty of a body of evidence[J].J Clin Epidemiol, 2019, 111:105-114. [29] Li L, Smith HE, Atun R, et al.Search strategies to identify observational studies in MEDLINE and Embase[J].Cochrane Database Syst Rev, 2019, 3:MR000041. [30] 王志稳, 冷敏敏, 孙月.证据整合研究中文献检索策略的制订[J].中华护理教育, 2021, 18:883- 888. [31] Faber T, Ravaud P, Riveros C, et al.Meta-analyses including non-randomized studies of therapeutic interventions:a methodological review[J].BMC Med Res Methodol, 2016, 16:35. [32] Bilandzic A, Fitzpatrick T, Rosella L, et al.Risk of Bias in Systematic Reviews of Non-Randomized Studies of Adverse Cardiovascular Effects of Thiazolidinediones and Cyclooxygenase-2 Inhibitors:Application of a New Cochrane Risk of Bias Tool[J].PLoS Med, 2016, 13:e1001987. [33] Sanderson S, Tatt ID, Higgins JP.Tools for assessing quality and susceptibility to bias in observational studies in epidemiology:a systematic review and annotated bibliography[J].Int J Epidemiol, 2007, 36:666-676. [34] Deeks JJ, Dinnes J, D' Amico R, et al.Evaluating non-randomised intervention studies[J].Health Technol Assess, 2003, 7:iii-x,1i-173i. [35] 孙凤, 高乐, 杨智荣, 等.偏倚风险评估系列:(五)非随机干预性研究[J].中华流行病学杂志, 2018, 39:374-381. [36] Dreier M, Borutta B, Stahmeyer J, et al.Comparison of tools for assessing the methodological quality of primary and secondary studies in health technology assessment reports in Germany[J].GMS Health Technol Assess, 2010, 6:Doc07. [37] 中医药真实世界研究技术规范:证据质量评价与报告[J].中医杂志, 2022, 63:293-300. [38] 刘建平.传统医学证据体的构成及证据分级的建议[J].中国中西医结合杂志, 2007:1061-1065. [39] 苏鹏丽, 刘骏, 于亚南, 等.中医药证据体系及评价要素研究现状分析[J].中医杂志, 2022, 63:288-292. [40] 钱静华, 郭志丽.构建适合中医药特征的临床证据评价体系[J].中华中医药杂志, 2018, 33:4302-4304. [41] 金锐, 王宇光, 张冰.试论完善传统中医药组方合理性评价技术在中药新药审评中的重要性[J].中药新药与临床药理, 2020, 31:1117-1122. [42] 刘迈兰, 吴曦, 任玉兰, 等.借鉴循证医学实践方法研究中医古籍的思考[J].时珍国医国药, 2010, 21:726-727. [43] 张磊, 佟琳, 曾宪涛, 等.中医古籍证据循证评价标准研究现状[J].中国中医药图书情报杂志, 2021, 45:66-69. [44] 陈薇, 方赛男, 刘建平.基于证据体的中医药临床证据分级标准建议[J].中国中西医结合杂志, 2019, 39:358-364. [45] 李承羽, 赵晨, 陈耀龙, 等.中医药临床指南/共识中推荐意见分级标准的制订[J].中医杂志, 2020, 61:486-492. [46] Richards DA, Bazeley P, Borglin G, et al.Integrating quantitative and qualitative data and findings when undertaking randomised controlled trials[J].BMJ Open, 2019, 9:e032081. [47] Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices[J].Health Serv Res, 2013, 48:2134-2156. [48] Lewin S, Booth A, Glenton C, et al.Applying GRADE-CERQual to qualitative evidence synthesis findings:introduction to the series[J].Implement Sci, 2018, 13:2. [49] 拜争刚, 刘少堃, 黄崇斐, 等.定性系统评价证据分级工具:CERQual简介[J].中国循证医学杂志, 2015, 15:1465-1470. [50] 中华医学会.中医药整体证据研究的标准化操作规程[EB/OL].(2020-03-27)[2023-02- 10].http://www.cacm.org.cn/zhzyyxh/bzhsj/202003/84ca423a5f9c46e29d78509907b0b846.shtml. [51] 王巍巍, 杨智荣, 孙凤, 等.网状Meta分析GRADE证据总结表的制订、解读与应用[J].中国循证医学杂志, 2020, 20:1471-1476. [52] 秦微.中医基础理论中信息思维文献检索探究[J].辽宁中医药大学学报, 2016, 18:163-165. [53] 杨其霖, 田思胜, 马梅青.中医药古籍文献数据库建设研究与思考[J].中国医药导报, 2018, 15:119-122. [54] 段逸山.中医典籍词语索引的编制及其作用[J].中国索引, 2020(02):3-14. [55] 王莹莹, 白宇, 丁长林, 等.面向语义检索的中医理论知识库构建方法的研究[J].中文信息学报, 2012, 26:72-78. [56] 杨忠奇, 高蕊, 胡思源, 等.中药人用经验研究专家共识[J].中国中药杂志, 2022, 47:4829- 4834. [57] Davis K, Minckas N, Bond V, et al.Beyond interviews and focus groups:a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions[J].Trials, 2019, 20:329. [58] Djulbegovic B, Guyatt GH.Progress in evidence-based medicine:a quarter century on[J].Lancet, 2017, 390:415-423. [59] Miles A, Bentley P, Polychronis A, et al.Advancing the evidence-based healthcare debate[J].J Eval Clin Pract, 1999, 5:97-101. [60] Miles A, Bentley P, Polychronis A, et al.Evidence-based medicine:why all the fuss? This is why[J].J Eval Clin Pract, 1997, 3:83-86. [61] Greenhalgh T, Howick J, Maskrey N. Evidence Based Medicine Renaissance Group.Evidence based medicine:a movement in crisis?[J].BMJ, 2014, 348:g3725. -

计量
- 文章访问数: 40
- HTML全文浏览量: 0
- PDF下载量: 7
- 被引次数: 0