摘要
基于中医医案特点,挖掘中医医案数据特征,分析中医医案研究的困境,结合真实世界研究探索中医医案数据形成真实世界证据的方法。发现中医医案数据在内容上具有真实性、规律性、个体化、选择性差异等特点;在形式上呈动态性和复杂性的特点。认为目前中医医案研究的问题主要为其数据特点的局限性、现有研究方法的不足和医案质量较差3个方面。基于上述内容,结合真实世界研究方法提出建立医案质量评价制度、以个案作为中医药疗效和安全性评价证据、以诊次为单位作为疗效和安全性评价的数据、构建中医临床证据体系及分级制度等措施,以期为中医疗效及安全性评价提供新的思路与方法。
This article summarized the data characteristics of traditional Chinese medicine(TCM)case records,analyzed the related research dilemma,and discussed the method of forming TCM cases data into real-world evidence(RWE)based on real-world studies(RWS).It was found that the content of the TCM case records has the characte-ristics of authenticity,regularity,individualization,and selective differences;and the form was dynamic and complex.The problems of current researches on TCM case records were mainly from the limitation of its data characteristics,insufficient existing research methods,and poor quality of medical records.Considering the characteristics and problems mentioned about TCM case records and referring to the RWS methods,it was put forward to establish a TCM medical records quality evaluation system,to take individual cases as evidence for the evaluation of TCM,to take individual medical visit as a unit to evaluate TCM,and to construct a TCM clinical evidence grading system,thereby providing new ideas and methods for the evaluation of the effectiveness and safety of TCM.
作者
王琳琳
邵明义
刘奕兵
赵瑞霞
张果
吕兰青
崔鸿雁
WANG Linlin;SHAO Mingyi;LIU Yibing;ZHAO Ruixia;ZHANG Guo;LYU Lanqing;CUl Hongyan(The First Clinical Medical College of Henan University of Chinese Medicine,Zhengzhou,450000;The First Affiliated Hospitalof Henan University of Chinese Medicine;People's Hospital of Zhengzhou)
出处
《中医杂志》
CSCD
北大核心
2021年第10期850-855,共6页
Journal of Traditional Chinese Medicine
基金
国家自然科学基金(81574101)
河南省中医药科学研究专项课题(2017JDZX033)。
关键词
中医医案
真实世界研究
真实世界证据
真实世界数据
traditional Chinese medicine case records
real-world studies
real-world evidence
real-world data
