基于文献的中医药临床研究结局指标现状分析及思考  

Analysis and Reflection on the Literature Status of TCM Clinical Research Outcome Indicators

作　　者：代欣玥 訾明杰[1] 杨巧宁[1] 张菀桐 钱真真 高蕊[1] DAI Xinyue;ZI Mingjie;YANG Qiaoning;ZHANG Wantong;QIAN Zhenzhen;GAO Rui(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing,100091)

机构地区：[1]中国中医科学院西苑医院,北京市100091

出　　处：《中医杂志》2022年第12期1122-1127,共6页Journal of Traditional Chinese Medicine

基　　金：国家重点研发计划“中医药现代化研究”重点专项(2019YFC1709300)。

摘　　要：中医药临床研究中结局指标的选择可在一定程度影响研究的科学性及实用性。通过搜集中医药临床研究结局指标现状分析相关文献,总结现存共性问题并提出可能解决的思路与方法。检索中国知网、万方数据知识服务平台、维普网中文数据库,检索时限为从各数据库建库至2021年4月23日。最终纳入22项研究,通过对结局指标现存问题进行提取,可概括为21个问题,其中提及频率最高的为测量方法/标准不统一及缺乏中医特色。将上述问题进行综合分析后可归为四大类:1)同类研究结局指标选择差异大,2)结局指标缺乏规范性,3)结局指标缺乏合理性,4)结局指标选择不全面。针对这四类问题,提出应规范和统一结局指标命名,构建中医药多维度核心指标集并规范结局指标测量方式、工具及时间点,探索能够体现中医药特色的指标及综合评价体系,以期为推动符合中医药特色的评价体系的形成提供思路。The selection of outcome indicators in clinical trials can affect the scientificity and practicability of the traditional Chinese medicine(TCM)researches.This study aims to understand the common problems of outcome indicators in TCM clinical researches by analyzing the current literature on outcome indicators in TCM clinical researches,and to explore the possible solutions and methods.Chinese databases such as CNKI,Wanfang and VIP were searched from the inception dates to April 23rd,2021 to collect the relevant literature.Totally,22 studies were included.The existing problems of outcome indicators were summarized into 21 problems,among which the inconsistency of measurement methods/standards and the lack of TCM features were most frequently mentioned.Moreover,the problems can be divided into four categories,including the difference of outcome indicators in similar studies,the lack of standardization of outcome indicators,the lack of rationality of outcome indicators,and the incomplete choice of outcome indicators.In order to solve these problems,some countermeasures have been proposed,such as standardizing and unifying the naming of outcome indicators,constructing multi-dimensional core outcome set of TCM,standardizing the measurement methods,tools and time points of outcome indicators,and exploring indicators and comprehensive evaluation system that can reflect the features of TCM,in order to provide ideas for promoting the better formation of TCM-specific evaluation system.

关 键 词：结局指标 中医药临床研究 评价体系 

分 类 号：R2-0[医药卫生—中医学]