中国中药杂志

2018, v.43(01) 1-7

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循证中医药学:理论与实践
Evidence-based Chinese medicine:theory and practice

张俊华;李幼平;张伯礼;
ZHANG Jun-hua;LI You-ping;ZHANG Bo-li;Institute of Chinese Medicine,Tianjin University of Traditional Chinses Medicine;Evidence-Based Medicine Center,Tianjin University of Traditional Chinses Medicine;Chinese Evidence-Based Medicine Center,West China Hospital of Sichuan University;

摘要(Abstract):

循证医学的引进和普及应用,开拓了中医药临床疗效评价新的研究领域,产生了新的研究思路方法,推动了中医药临床研究的进步。通过近20年的努力学习和认真实践,符合中医药理论和实践特点的循证评价技术方法不断发展,循证中医药学逐步形成,已成为循证医学的重要分支。循证中医药学的基本概念:借鉴循证医学的理论和方法,收集、评价、生产、转化中医药有效性、安全性和经济性证据,揭示中医药临床作用特点和规律,并指导临床指南、路径和卫生决策制定的一门应用学科。循证中医药学发展的成效: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有效性研究快速增长;以真实世界研究为主的安全性评价得到发展;以质量控制为主的方法学研究不断深入;以报告规范为主的国际化研究取得突破;以诊疗规范为主的标准化研究不断加强;以复合型和跨学科合作为特征的人才队伍不断壮大。一批高质量研究成果在国际知名期刊发表;中医药临床有效性和安全性证据不断增加;临床合理用药水平得到提升;一批中成药大品种成长涌现。循证中医药学未来的主要任务包括科学研究、方法学与标准、平台建设和人才培养4个方面共9项任务:(1)开展系统评价研究,系统收集评价中医药临床研究报告,建成中医药临床研究证据库;(2)开展证据转化研究,为制定中医药临床诊疗指南和临床路径,为基本药物目录和医保目录遴选及中医药相关政策制定奠定基础;(3)开展中医药优势和作用规律评价研究,形成中医药疗效证据链;(4)开展中医药安全性评价研究,为临床合理安全用药提供证据支撑;(5)开展循证中医药学方法研究,为高质量证据生产提供方法学保障;(6)开展中医药行业标准和规范制定研究,形成方法、标准、规范和技术体系;(7)搭建中医药循证评价数据管理平台,推动实现数据共享;(8)搭建国际学术交流平台,促进循证中医药研究的国际合作和国际认可;(9)开展循证评价方法普及教育活动,培训本科生、研究生、临床医护人员及中医药相关从业者。可以说,循证中医药学的发展不仅推动中医药临床研究和决策模式的转变,有利于中医药现代化和国际化发展,也丰富了循证医学的内涵。
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.(1) Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM;(2) Carry 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;(3) Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy;(4) Carry out researches for the safety evaluation of TCM,and provide evidence supporting the rational and safe use of TCM in clinical practice;(5) Conduct researches on methodology of EBCM and provide method for developing high quality evidence;(6) Carry out researches to develop standards and norms of TCM,and to form methods,standards,specifications and technical systems;(7) Establish data management platform for evidence-based evaluation of TCM,and promote data sharing;(8) Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research;(9) Carry 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.

关键词(KeyWords): 循证医学;循证中医药学;临床评价;循证评价
evidence-based medicine;evidence-based Chinese medicine;evidence-based traditional Chinese medicine;evidence-based evaluation

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金项目(81473544);; 天津市人才发展特殊支持计划-青年拔尖人才项目(201504)

作者(Author): 张俊华;李幼平;张伯礼;
ZHANG Jun-hua;LI You-ping;ZHANG Bo-li;Institute of Chinese Medicine,Tianjin University of Traditional Chinses Medicine;Evidence-Based Medicine Center,Tianjin University of Traditional Chinses Medicine;Chinese Evidence-Based Medicine Center,West China Hospital of Sichuan University;

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