摘要
真实世界研究是指基于医疗实践的场景开展的贴近于现实情况的临床研究,其目的是力求使临床研究的结果更具有实用性。近年来真实世界研究已经成为临床研究的热点领域。目前,由于随机对照临床试验自身的局限性,如实施难度大、外部真实性低、运行成本高等,已难以适应中医药证据需求的日益增长,而真实世界研究则为中医疗效评价和证据积累提供了新的方法。目前,针对真实世界研究的证据分级尚无一个成熟、公认的体系,且目前常用的证据分级方法均是建立在现代西医学体系之上,照搬用于中医学领域仍然存在一定的局限性。为此,有必要针对中医药真实世界研究的证据进行分级建议,以便为中医药真实世界研究的结果转化为临床证据提供参考。
Real world study(RWS)refers to the clinical research which is close to real world situation based on medical practice scene.Its purpose is to make the results of clinical research more practical,influence clinical practice and change medical decision.RWS has obtained increasing attention in clinical research during the past years.Currently,due to its limitations,such as difficulty in the implementation,low external validity and high cost,randomized trials cannot meet the growing demand for Chinese medicine evidence.However,RWS emerged as a new method for therapeutic effect evaluation and evidence diversity.At present,there is no recognized grading system for real world evidence of observational studies.The commonly used grading system are all based on western medicine system,and may not be suitable for Chinese medicine.Therefore,a grading system for RWS in Chinese medicine is necessary in order to provide guidance for the transformation of real world evidence into clinical practice.
作者
陈薇
陈可冀
刘建平
CHEN Wei;CHEN Ke-ji;LIU Jian-ping(Center for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing,100029;Institute for Excellence in Evidence-Based Chinese Medicine,Beijing,100029;Cardiovascular Disease Center of Xiyuan Hospital,China Academy of Chinese Medical Sciences,National Clinical Center for Chinese Medicine Cardiology,Bejjing,100091)
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2021年第5期608-611,共4页
Chinese Journal of Integrated Traditional and Western Medicine
基金
国家自然科学基金资助项目(No.81830115)。
关键词
中医药
真实世界研究
真实世界证据
证据分级
Chinese medicine
real world study
real world evidence
grading of evidence
