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[循证中医学:理论与实践]

[Evidence-based Chinese medicine:theory and practice].

作者信息

Zhang Jun-Hua, Li You-Ping, Zhang Bo-Li

机构信息

Institute of Chinese Medicine, Tianjin University of Traditional Chinses Medicine, Tianjin 300193, China.

Evidence-Based Medicine Center, Tianjin University of Traditional Chinses Medicine, Tianjin 300193, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2018 Jan;43(1):1-7. doi: 10.19540/j.cnki.cjcmm.20171127.001.

DOI:10.19540/j.cnki.cjcmm.20171127.001
PMID:29552804
Abstract

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine.

摘要

循证医学的引入与推广,开辟了中医临床疗效评价的新研究领域,产生了新的研究思路与方法,推动了中医临床研究的进步。经过约20年的潜心研究与认真实践,符合中医理论与实践特点的循证评价方法与技术不断发展。循证中医(EBCM)逐渐形成并成为循证医学的重要分支。循证中医的基本概念:循证中医是一门应用学科,遵循循证医学的理论与方法学,收集、评价、产生、转化中医有效性、安全性和经济性的证据,揭示中医起效的特点与规律,指导临床指南、临床路径及健康决策的制定。循证中医发展的成效与成果:以系统评价/Meta分析为主的二次研究广泛开展;以随机对照试验为主的临床疗效研究快速增长;基于真实世界研究的临床安全性评价得以进行;以研究质量控制为主的方法学研究逐步深入;以报告规范为主的国际化研究取得一些突破;基于治疗规范的标准化研究逐步加强;跨学科特色的研究团队与人才稳步增加。一批高质量研究成果在国际知名期刊发表;中医临床疗效与安全性证据增多;中医临床合理使用水平提高;培育了一大批市场销量大的中成药。循证中医未来的使命主要包括四类(科研、方法与标准、平台建设及人才培养)共九项任务。①开展系统评价,系统收集中医临床试验报告,建立中医临床证据数据库;②开展证据转化研究,为中医临床诊疗指南、临床路径的制定,为基本药物目录及医保目录筛选,为中医相关政策制定奠定基础;③开展评价中医优势与效应规律的研究,形成中医疗效证据链;④开展中医安全性评价研究,为中医临床合理安全使用提供证据支持;⑤开展循证中医方法学研究,为高质量证据产生提供方法;⑥开展制定中医标准规范的研究,形成方法、标准、规范及技术体系;⑦建立中医循证评价数据管理平台,促进数据共享;⑧搭建国际学术交流平台,促进循证中医研究国际合作与相互认可;⑨开展循证评价方法的教育与普及活动,培养本科、研究生、临床医护人员及中医从业者。循证中医的发展,不仅推动了中医临床研究及决策模式的转变,为中医现代化与国际化做出贡献,也丰富了循证医学的内涵。

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