真实世界研究与中医临床疗效评价
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摘要
临床疗效是中医存在和发展的根本,构建遵循循证设计、适宜中医特点和科学规范的临床疗效评价方法是亟待解决的关键问题。随机对照试验(RCT)是传统临床研究方法的代表和循证证据的基石,但设计方法与中医诊疗特点难以较好融合。真实世界研究(RWS)契合了中医个体化诊疗、整体疗效评价的特点,有望为中医辨证论治的疗效评价开辟一条新的道路。中医真实世界研究的实施关键环节主要包括临床方案、中医术语规范化、病历模板设计、数据采集、数据仓库构建、数据分析、质量控制和伦理审查等。在不违背辨证论治的前提下,利用实际诊疗的中医临床数据,经严格规范的设计、测量和评价,获取高质量的真实世界证据,可为临床应用提供科学依据。同时,RWS是RCT重要的延续和补充,需应围绕具体的科学问题,选择适合的研究方法,并且不断优化和完善。
Clinical efficacy is the foundation of the existence and development of traditional Chinese medicine( TCM). Constructing clinical efficacy evaluation methods that follow evidence-based design,and suitable for TCM characteristics and scientific norms is a key issue to be solved urgently. Randomized controlled trials( RCTs) are the representative of traditional clinical research methods and the cornerstone of evidence-based evidence,but the design methods are difficult to integrate with TCM characteristics. Real world study( RWS) is in line with the characteristics of individualized diagnosis and treatment of TCM and overall efficacy evaluation,and it is expected to open a new path for the evaluation of TCM syndrome differentiation. The key aspects of the implementation of TCM RWS include clinical protocols,TCM terminology standardization,medical record template design,data collection,data warehouse construction,data analysis,quality control and ethical review. Under the premise of not relying on syndrome differentiation and treatment,the clinical data of TCM actual diagnosis and treatment is used,through strict normative design,measurement and evaluation,to obtain high-quality real-world evidence,which can provide scientific basis for clinical application. Meanwhile,RWS is an important continuation and supplement of RCT. It is necessary to select appropriate research methods around specific scientific issues,and continuously optimize and improve.
Clinical efficacy is the foundation of the existence and development of traditional Chinese medicine( TCM). Constructing clinical efficacy evaluation methods that follow evidence-based design,and suitable for TCM characteristics and scientific norms is a key issue to be solved urgently. Randomized controlled trials( RCTs) are the representative of traditional clinical research methods and the cornerstone of evidence-based evidence,but the design methods are difficult to integrate with TCM characteristics. Real world study( RWS) is in line with the characteristics of individualized diagnosis and treatment of TCM and overall efficacy evaluation,and it is expected to open a new path for the evaluation of TCM syndrome differentiation. The key aspects of the implementation of TCM RWS include clinical protocols,TCM terminology standardization,medical record template design,data collection,data warehouse construction,data analysis,quality control and ethical review. Under the premise of not relying on syndrome differentiation and treatment,the clinical data of TCM actual diagnosis and treatment is used,through strict normative design,measurement and evaluation,to obtain high-quality real-world evidence,which can provide scientific basis for clinical application. Meanwhile,RWS is an important continuation and supplement of RCT. It is necessary to select appropriate research methods around specific scientific issues,and continuously optimize and improve.
引文
[1]刘保延.真实世界的中医临床科研范式[J].中医杂志,2013,54(6):451-455.
[2]赖世隆.中医药临床疗效评价因果关联推断的探讨[J].中国中西医结合杂志,2005,25(4):293-296.
[3]李君,刘保延.古代中医临床疗效评价方法研究[J].中国中医基础医学杂志,2011,17(4):383-385.
[4]陈世波,刘保延,王永炎,等.“症”及其分类在中医临床评价中的作用分析[J].中医杂志,2009,50(1):5-7.
[5]刘凤斌,王维琼.中医脾胃系疾病PRO量表理论结构模型的构建思路[J].广州中医药大学学报,2008,25(1):12-14.
[6]陈可冀,宋军.病证结合的临床研究是中西医结合研究的重要模式[J].世界科学技术-中医药现代化,2006,8(2):1-5.
[7]王贤良,毛静远,侯雅竹.病证结合、系统分段、多维指标中医临床效应评价方法建立初探[J].中国中西医结合杂志,2013,33(2):270-273.
[8]符宇,范冠杰,黄皓月,等.中医原创思维之“动态思维”[J].中医杂志,2018,59(3):181-184.
[9]WANG Y,XU A. Zheng:A systems biology approach to diagnosis and treatments[J]. Science,2014,346(6216):S13-S15.
[10]黄悦勤.临床流行病学[M].北京:人民卫生出版社,2014:55-59.
[11]FORD I,NORRIE J. Pragmatic trials[J]. N Engl J Med,2016,375(5):454-463.
[12]詹思延.临床实效研究的特点和挑战[J].中华肾病研究电子杂志,2014,3(1):7-9.
[13]BALAS EA,BOREN SA. Managing clinical knowledge for health care improvement[J]. Yearb Med Inform,2000,9(1):65-70.
[14]刘保延.有关辨证论治临床评价若干问题的思考[J].中医杂志,2007,48(1):12-14.
[15]郭蕾,王永炎,张志斌.关于证候概念的诠释[J].北京中医药大学学报,2003,26(2):5-8.
[16]符宇,范冠杰,黄皓月,等.基于大数据名老中医学术经验传承研究方法的思考[J].中华中医药杂志,2017,32(4):1644-1646.
[17]邵明义,魏明.临床实际与中医疗效评价的差异[J].时珍国医国药,2014,25(6):1442-1443.
[18]张惠敏,罗辉,刘兆兰,等.辨证论治临床疗效评价方法探讨[J].安徽中医学院学报,2011,30(6):1-4.
[19]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(23):2293-2297.
[20]MELDRUM M.“A calculated risk”:the Salk polio vaccine field trials of 1954[J]. BMJ,1998,317(7167):1233-1236.
[21]KAPLAN NM,SPROUL LE,MULCAHY WS. Large prospective study of ramipril in patients with hypertension. CARE Investigators[J]. Clin Ther,1993,15(5):810-818.
[22]Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices:draft guidance for industry and food and drug administration staff[EB/OL].(2017-08-31)[2018-02-05]. http://www. fda. gov/downloads/Medical Devices/DeviceRegulationandGuidance/GuidanceDocuments/UCM513027. pdf.
[23]杨松,马龙腾,张菁菁.中国临床医学真实世界研究施行规范[J].中华实验和临床感染病杂志(电子版),2017,11(6):521-525.
[24]孙鑫,谭婧,唐立,等.重新认识真实世界研究[J].中国循证医学杂志,2017,17(2):126-130.
[25]王思成,刘保延,熊宁宁,等.真实世界临床研究伦理问题及策略探讨[J].中国中西医结合杂志,2013,33(4):437-442.
[26]黄卓山,罗艳婷,刘金来.真实世界研究的方法与实践[J].循证医学,2014,14(6):364-368.
[27]REINKE T. Real-world evidence faces some real-world challenges[J]. Manag Care,2017,26(5):35-36.
[28]赵一鸣.中医疗效临床评价中的几个问题[J].中国中西医结合杂志,2010,30(10):1013-1015.
[29]邵明义,江锋,魏明,等.基于经方临证应用的实践探索中医疗效评价的新模式[J].中国中药杂志,2012,37(14):2171-2173.
[30]宋观礼,张润顺,刘保延,等.真实世界中医临床诊疗信息数据化实施与质量控制[J].中医杂志,2015,56(3):198-201.
[31]张润顺,王映辉,刘保延,等.基于共享系统的真实世界中医临床研究范式初步实施方案的设计[J].中医杂志,2014,55(18):1551-1554.
[32]刘保延,谢琪,史华新,等.构建真实世界临床研究技术平台的组织管理策略[J].中医杂志,2013,54(24):2071-2075.
[33]庄严,谢邦铁,翁盛鑫,等.中药上市后再评价HIS“真实世界”集成数据仓库的构建与实现[J].中国中药杂志,2011,36(20):2883-2887.
[34]WANG C,SHI Q,DING F,et al. Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations[J]. Drug Des Devel Ther,2018,12:757-767. doi:10. 2147/DDDT.S156000.
[35]班承钧,黎元元,谢雁鸣,等.真实世界26491例慢性阻塞性肺疾病住院患者的临床特征分析[J].中华中医药杂志,2014,29(11):3567-3570.
[36]余海滨,符宇,李卓,等.基于临床科研信息共享系统开展中医临床研究的探索[J].中医杂志,2013,54(24):2092-2094,2109.
[37]王家良.循证医学[M].北京:人民卫生出版社,2014:22-23.
[2]赖世隆.中医药临床疗效评价因果关联推断的探讨[J].中国中西医结合杂志,2005,25(4):293-296.
[3]李君,刘保延.古代中医临床疗效评价方法研究[J].中国中医基础医学杂志,2011,17(4):383-385.
[4]陈世波,刘保延,王永炎,等.“症”及其分类在中医临床评价中的作用分析[J].中医杂志,2009,50(1):5-7.
[5]刘凤斌,王维琼.中医脾胃系疾病PRO量表理论结构模型的构建思路[J].广州中医药大学学报,2008,25(1):12-14.
[6]陈可冀,宋军.病证结合的临床研究是中西医结合研究的重要模式[J].世界科学技术-中医药现代化,2006,8(2):1-5.
[7]王贤良,毛静远,侯雅竹.病证结合、系统分段、多维指标中医临床效应评价方法建立初探[J].中国中西医结合杂志,2013,33(2):270-273.
[8]符宇,范冠杰,黄皓月,等.中医原创思维之“动态思维”[J].中医杂志,2018,59(3):181-184.
[9]WANG Y,XU A. Zheng:A systems biology approach to diagnosis and treatments[J]. Science,2014,346(6216):S13-S15.
[10]黄悦勤.临床流行病学[M].北京:人民卫生出版社,2014:55-59.
[11]FORD I,NORRIE J. Pragmatic trials[J]. N Engl J Med,2016,375(5):454-463.
[12]詹思延.临床实效研究的特点和挑战[J].中华肾病研究电子杂志,2014,3(1):7-9.
[13]BALAS EA,BOREN SA. Managing clinical knowledge for health care improvement[J]. Yearb Med Inform,2000,9(1):65-70.
[14]刘保延.有关辨证论治临床评价若干问题的思考[J].中医杂志,2007,48(1):12-14.
[15]郭蕾,王永炎,张志斌.关于证候概念的诠释[J].北京中医药大学学报,2003,26(2):5-8.
[16]符宇,范冠杰,黄皓月,等.基于大数据名老中医学术经验传承研究方法的思考[J].中华中医药杂志,2017,32(4):1644-1646.
[17]邵明义,魏明.临床实际与中医疗效评价的差异[J].时珍国医国药,2014,25(6):1442-1443.
[18]张惠敏,罗辉,刘兆兰,等.辨证论治临床疗效评价方法探讨[J].安徽中医学院学报,2011,30(6):1-4.
[19]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(23):2293-2297.
[20]MELDRUM M.“A calculated risk”:the Salk polio vaccine field trials of 1954[J]. BMJ,1998,317(7167):1233-1236.
[21]KAPLAN NM,SPROUL LE,MULCAHY WS. Large prospective study of ramipril in patients with hypertension. CARE Investigators[J]. Clin Ther,1993,15(5):810-818.
[22]Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices:draft guidance for industry and food and drug administration staff[EB/OL].(2017-08-31)[2018-02-05]. http://www. fda. gov/downloads/Medical Devices/DeviceRegulationandGuidance/GuidanceDocuments/UCM513027. pdf.
[23]杨松,马龙腾,张菁菁.中国临床医学真实世界研究施行规范[J].中华实验和临床感染病杂志(电子版),2017,11(6):521-525.
[24]孙鑫,谭婧,唐立,等.重新认识真实世界研究[J].中国循证医学杂志,2017,17(2):126-130.
[25]王思成,刘保延,熊宁宁,等.真实世界临床研究伦理问题及策略探讨[J].中国中西医结合杂志,2013,33(4):437-442.
[26]黄卓山,罗艳婷,刘金来.真实世界研究的方法与实践[J].循证医学,2014,14(6):364-368.
[27]REINKE T. Real-world evidence faces some real-world challenges[J]. Manag Care,2017,26(5):35-36.
[28]赵一鸣.中医疗效临床评价中的几个问题[J].中国中西医结合杂志,2010,30(10):1013-1015.
[29]邵明义,江锋,魏明,等.基于经方临证应用的实践探索中医疗效评价的新模式[J].中国中药杂志,2012,37(14):2171-2173.
[30]宋观礼,张润顺,刘保延,等.真实世界中医临床诊疗信息数据化实施与质量控制[J].中医杂志,2015,56(3):198-201.
[31]张润顺,王映辉,刘保延,等.基于共享系统的真实世界中医临床研究范式初步实施方案的设计[J].中医杂志,2014,55(18):1551-1554.
[32]刘保延,谢琪,史华新,等.构建真实世界临床研究技术平台的组织管理策略[J].中医杂志,2013,54(24):2071-2075.
[33]庄严,谢邦铁,翁盛鑫,等.中药上市后再评价HIS“真实世界”集成数据仓库的构建与实现[J].中国中药杂志,2011,36(20):2883-2887.
[34]WANG C,SHI Q,DING F,et al. Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations[J]. Drug Des Devel Ther,2018,12:757-767. doi:10. 2147/DDDT.S156000.
[35]班承钧,黎元元,谢雁鸣,等.真实世界26491例慢性阻塞性肺疾病住院患者的临床特征分析[J].中华中医药杂志,2014,29(11):3567-3570.
[36]余海滨,符宇,李卓,等.基于临床科研信息共享系统开展中医临床研究的探索[J].中医杂志,2013,54(24):2092-2094,2109.
[37]王家良.循证医学[M].北京:人民卫生出版社,2014:22-23.
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