摘要
辨证论治是中医诊疗疾病的主体方法,个体化诊疗是其突出的特点,但辨证论治疗效评价问题长期以来制约着中医药的发展。将现代临床流行病学、循证医学与辨证论治特点相结合,根据辨证论治疗效的主导者是"医者"而非"方药",借鉴体育竞赛对运动员驾驭器械技能的评价思路,提出从评价人到评价方药的策略,以及评价"医者"辨证论治效果的思路和方法。评价过程同样要坚持对照的基本原则,采取随机对照以及队列研究等适宜的设计方法,将真实世界"全样本、混杂大数据"与"抽样、精确小数据"两法并举,根据临床目的来选择方法;评价结果首先推荐治疗某种疾病合适的"医者"而非某种"方药";用"代表队"综合疗效来体现一定范围内中医治疗某种疾病的辨证论治疗效。该研究的思路、策略和方法突破了传统临床评价的窠臼,为中医个体化诊疗临床评价开辟出一条全新的途径。
Syndrome differentiation and treatment(SDT) is the main method of traditiaonl Chinese medicine(TCM) diagnosis and treatment of disease, and individualized diagnosis and treatment is its outstanding feature. The issue of evaluation of therapeutic efficacy of SDT has long been a bottleneck restricting the development of TCM. By integrating the characteristics of modern clinical epidemiology, evidence-based medicine and SDT and adhering to the clinical principle that the key contribution factors for effectiveness of SDT are not prescriptions but physicians, with further referring to the evaluation idea in competitive sports for athletes to control the equipment skills, we proposed an idea and approach to evaluate the effectiveness of SDT by changing the evaluation objects from drugs to physicians who prescribe the drugs. The evaluation process should also adhere to the basic principle of "control". The appropriate clinical design should be adopted such as random control and cohort study, and the real world "full sample, mixed big data" and "sampling, accurate small data" were combined. Methods were selected accoding to clinical purpose. The evaluation results firstly recommend the appropriate "medical doctor" to treat a certain disease, rather than a certain "prescription". The comprehensive efficacy of "representative team" was used to reflect the therapeutic effect of TCM treatment of a certain disease within a certain range. The research ideas, strategies and methods break through the stereotype of traditional clinical evaluation and open up a new way for individualized clinical evaluation of TCM.
作者
刘保延
何丽云
周雪忠
张润顺
LIU Baoyan;HE Liyun;ZHOU Xuezhong;ZHANG Runshun(China Academy of Chinese Medical Sciences,Beijing,100700;Institute of Basic Research in Clinical Medicine,China Acade-my of Chinese Medical Sciences;School of Computer and Information Technology,Beijing Jiaotong University;Guang'anmen Hospital,China Academy of Chinese Medical Sciences)
出处
《中医杂志》
CSCD
北大核心
2020年第2期93-97,共5页
Journal of Traditional Chinese Medicine
基金
国家自然科学基金(81230086,81673964)
国家重点基础研究发展计划(“973”计划)(2006CB504600)
关键词
辨证论治
疗效评价
真实世界研究
个体化诊疗
syndrome differentiation and treatment
therapeutic effect evaluation
real-world study
individualized diagnosis and treatment
