摘要
现代临床流行病学的设计、测量与评价方法在中医药临床评价研究中得到了广泛的应用,但并没有完全解决中医在"真实世界"研究的方法学问题。在中医临床诊疗实际条件下开展临床研究,给临床流行病学提出了挑战,也给中医临床疗效评价方法的创新带来了机遇。本文在对中医临床疗效评价现状回顾的基础上,提出了充分利用临床流行病学和循证医学研究成果,以人为核心,以建立临床"实际条件下"疗效评价的方法和评价指标,构建临床科研信息一体化技术体系,形成"阶梯递进"的"证据链",并与高质量的"理想条件下"验证研究相结合,两条腿走路,解决中医临床疗效评价的瓶颈问题,提出国内外"公认"与"认可"的高质量的临床证据的建议。
The design, measurement and evaluation of modern clinical epidemiology have been extensively used for the treatment effect assessment in TCM, but it has not completely solved the methodology research problem in the ＂real world＂. How to play the research in conformity with clinical practice, which gives challenges to the clinical epidemiology and brings many opportunities to the methods innovation of treatment effect assessment in TCM. From the retrospective view on the study of clinical effectiveness evaluation, we analyze the evaluation content and evaluation indexes in the ＂real world＂, then set up a unified clinical and research information platform, based on the achievements of clinical epidemiology and evidencebased medicine （EBM）, and at last gives out a set of evidence chain with hierarchical structure. Combined with the observational study in the ＂real world＂ and the confirmatory study in the ＂ideal condition＂, the bottleneck problem of clinical effectiveness evaluation of TCM would be solved, and the recommendations for the clinical evidence with acknowledgement, acceptance and high quality at home and abroad would be reported.
出处
《中国科学基金》
CSCD
北大核心
2010年第5期268-274,共7页
Bulletin of National Natural Science Foundation of China
基金
国家重点基础研究发展计划("973"计划)项目(No.2006CB504601)
关键词
临床流行病学
循证医学
真实世界
临床研究
clinical epidemiology, evidence-based medicine, real world, clinical research
