循证中医药学:理论与实践
|
摘要
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.
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.
引文
[1]赖世隆,胡镜清,郭新峰.循征医学与中医药临床研究[J].广州中医药大学学报,2000,17(1):1.
[2]Guyatt G H.Evidence-based medicine[J].ACP J Club,1991,114:A16.
[3]Evidence-Based Medicine Working Group.Evidence-based medicine:a new approach to teaching the practice of medicine[J].JAMA,1992,268(17):2420.
[4]李幼平,李静,孙鑫,等.循证医学在中国的起源与发展:献给中国循证医学20周年[J].中国循证医学杂志,2016,16(1):2.
[5]李幼平,刘鸣.循证医学与中医药现代化[J].中国中医药信息杂志,1999,6(12):14.
[6]王永炎,刘保延,谢雁鸣.应用循证医学方法构建中医临床评价体系[J].中国中医基础医学杂志,2003,9(3):17.
[7]陈可冀,宋军.循证医学的提出对中西医结合的启发[J].中国中西医结合杂志,1999,19(11):643.
[8]赖世隆,胡镜清,郭新峰.循证医学与中医药临床研究[J].广州中医药大学学报,2000,17(1):1.
[9]张伯礼.中药新药临床再评价---采用循证医学方法进行Ⅳ期临床研究[J].中国中医药信息杂志,2000,7(1):72.
[10]张伯礼.辨证论治与循证医学[J].中国循证医学杂志,2002,2(1):1.
[11]刘保延.循证医学与中医药现代化[J].中国循证医学杂志,2001,1(1):3.
[12]常静,李廷谦,万美华.中国4种中医药大学学报随机对照临床试验文献的质量评价[J].中国循证医学杂志,2006,6(3):171.
[13]毛兵,王刚,陈小东,等.《中国中西医结合杂志》发表随机对照试验报告的质量评价[J].中国循证医学杂志,2006,6(4):297.
[14]张明妍,杨丰文,李越,等.《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究[J].中国循证医学杂志,2017,17(3):357.
[15]Shang H,Zhang J,Yao C,et al.Qi-shen-yi-qi dripping pills for the secondary prevention of myocardial infarction:a randomised clinical trial[J].Evid Based Complement Altern Med,2013,2013:738391.
[16]李幼平,吴泰相,刘关键,等.中国循证医学中心促进中医药现代化的策略[J].中国循证医学杂志,2007,7(3):159.
[17]第一届循证中医药学国际论坛在津召开[J].中医杂志,2016,57(13):1165.
[18]Zhang J H,Shang H C,Gao X M,et al.Methodology and reporting quality of systematic review/Meta-analysis of traditional Chinese medicine[J].J Altern Complement Med,2007,13(8):797.
[19]Taichman D B,Sahni P,Pinborg A,et al.Data sharing statements for clinical trials-a requirement of the international committee of medical journal editors[J].N Engl J Med,2017,376(23):2277.
[20]张冬,张俊华,郑文科,等.中药临床安全性研究注册平台(CSRP)的构建[J].世界科学技术---中医药现代化,2016,18(12):2097.
[21]陈可冀,钱振淮,张问渠,等.精制冠心片对冠心病心绞痛双盲法治疗112例疗效分析[J].中华心血管病杂志,1982,10(2):85.
[22]Li X,Zhang J,Huang J,et al.A multicenter,randomized,double-blind,parallel-group,placebo-controlled study of the effects of Qili Qiangxin capsules in patients with chronic heart failure[J].J Am Coll Cardiol,2013,62(12):1065.
[23]Wang C,Cao B,Liu Q,et al.Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza:a randomized trial[J].Ann Intern Med,2011,155(4):217.
[24]Liu Z,Yan S,Wu J,et al.Acupuncture for chronic severe functional constipation:a randomized trial[J].Ann Intern Med,2016,165(11):761.
[25]Liu Z,Liu Y,Xu H,et al.Effect of electroacupuncture on urinary leakage among women with stress urinary incontinence:a randomized clinical trial[J].JAMA,2017,317(24):2493.
[26]天津中医药大学循证医学中心.中医药临床证据数据库[DB/OL].[2017-11-13].http://tcmevd.com/evidence/index.
[27]邢冬梅,张俊华,张伯礼.中医临床研究核心结局指标集形成路径[J].中华中医药杂志,2014,29(5):1352.
[28]刘保延.真实世界的中医临床科研范式[J].中医杂志,2013,54(6):451.
[29]Zhang J H,Zhang B L.Clinical research of traditional Chinese medicine in big data era[J].Front Med,2014,8(3):321.
[30]Mac Pherson H,Altman D G,Hammerschlag R,et al.Revised standards for reporting interventions in clinical trials of acupuncture(STRICTA):extending the CONSORT statement[J].PLo SMed,2010,7(6):e1000261.
[31]Cheng C W,Wu T X,Shang H C,et al.CONSORT extension for Chinese herbal medicine formulas 2017:recommendations,explanation,and elaboration[J].Ann Int Med,2017,doi:10.7326/M16-2977.
[32]郑文科.发挥中医药优势,应对感染性疾病挑战---第二届循证中医药学国际论坛成功举行[J].天津中医药,2017,34(5):289.
[2]Guyatt G H.Evidence-based medicine[J].ACP J Club,1991,114:A16.
[3]Evidence-Based Medicine Working Group.Evidence-based medicine:a new approach to teaching the practice of medicine[J].JAMA,1992,268(17):2420.
[4]李幼平,李静,孙鑫,等.循证医学在中国的起源与发展:献给中国循证医学20周年[J].中国循证医学杂志,2016,16(1):2.
[5]李幼平,刘鸣.循证医学与中医药现代化[J].中国中医药信息杂志,1999,6(12):14.
[6]王永炎,刘保延,谢雁鸣.应用循证医学方法构建中医临床评价体系[J].中国中医基础医学杂志,2003,9(3):17.
[7]陈可冀,宋军.循证医学的提出对中西医结合的启发[J].中国中西医结合杂志,1999,19(11):643.
[8]赖世隆,胡镜清,郭新峰.循证医学与中医药临床研究[J].广州中医药大学学报,2000,17(1):1.
[9]张伯礼.中药新药临床再评价---采用循证医学方法进行Ⅳ期临床研究[J].中国中医药信息杂志,2000,7(1):72.
[10]张伯礼.辨证论治与循证医学[J].中国循证医学杂志,2002,2(1):1.
[11]刘保延.循证医学与中医药现代化[J].中国循证医学杂志,2001,1(1):3.
[12]常静,李廷谦,万美华.中国4种中医药大学学报随机对照临床试验文献的质量评价[J].中国循证医学杂志,2006,6(3):171.
[13]毛兵,王刚,陈小东,等.《中国中西医结合杂志》发表随机对照试验报告的质量评价[J].中国循证医学杂志,2006,6(4):297.
[14]张明妍,杨丰文,李越,等.《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究[J].中国循证医学杂志,2017,17(3):357.
[15]Shang H,Zhang J,Yao C,et al.Qi-shen-yi-qi dripping pills for the secondary prevention of myocardial infarction:a randomised clinical trial[J].Evid Based Complement Altern Med,2013,2013:738391.
[16]李幼平,吴泰相,刘关键,等.中国循证医学中心促进中医药现代化的策略[J].中国循证医学杂志,2007,7(3):159.
[17]第一届循证中医药学国际论坛在津召开[J].中医杂志,2016,57(13):1165.
[18]Zhang J H,Shang H C,Gao X M,et al.Methodology and reporting quality of systematic review/Meta-analysis of traditional Chinese medicine[J].J Altern Complement Med,2007,13(8):797.
[19]Taichman D B,Sahni P,Pinborg A,et al.Data sharing statements for clinical trials-a requirement of the international committee of medical journal editors[J].N Engl J Med,2017,376(23):2277.
[20]张冬,张俊华,郑文科,等.中药临床安全性研究注册平台(CSRP)的构建[J].世界科学技术---中医药现代化,2016,18(12):2097.
[21]陈可冀,钱振淮,张问渠,等.精制冠心片对冠心病心绞痛双盲法治疗112例疗效分析[J].中华心血管病杂志,1982,10(2):85.
[22]Li X,Zhang J,Huang J,et al.A multicenter,randomized,double-blind,parallel-group,placebo-controlled study of the effects of Qili Qiangxin capsules in patients with chronic heart failure[J].J Am Coll Cardiol,2013,62(12):1065.
[23]Wang C,Cao B,Liu Q,et al.Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza:a randomized trial[J].Ann Intern Med,2011,155(4):217.
[24]Liu Z,Yan S,Wu J,et al.Acupuncture for chronic severe functional constipation:a randomized trial[J].Ann Intern Med,2016,165(11):761.
[25]Liu Z,Liu Y,Xu H,et al.Effect of electroacupuncture on urinary leakage among women with stress urinary incontinence:a randomized clinical trial[J].JAMA,2017,317(24):2493.
[26]天津中医药大学循证医学中心.中医药临床证据数据库[DB/OL].[2017-11-13].http://tcmevd.com/evidence/index.
[27]邢冬梅,张俊华,张伯礼.中医临床研究核心结局指标集形成路径[J].中华中医药杂志,2014,29(5):1352.
[28]刘保延.真实世界的中医临床科研范式[J].中医杂志,2013,54(6):451.
[29]Zhang J H,Zhang B L.Clinical research of traditional Chinese medicine in big data era[J].Front Med,2014,8(3):321.
[30]Mac Pherson H,Altman D G,Hammerschlag R,et al.Revised standards for reporting interventions in clinical trials of acupuncture(STRICTA):extending the CONSORT statement[J].PLo SMed,2010,7(6):e1000261.
[31]Cheng C W,Wu T X,Shang H C,et al.CONSORT extension for Chinese herbal medicine formulas 2017:recommendations,explanation,and elaboration[J].Ann Int Med,2017,doi:10.7326/M16-2977.
[32]郑文科.发挥中医药优势,应对感染性疾病挑战---第二届循证中医药学国际论坛成功举行[J].天津中医药,2017,34(5):289.