中医药临床研究评价指标体系中应引入核心指标集概念.doc

文档介绍：
中医药临床研究评价指标体系中应引入核
心指标集概念#
张莉1,张俊华1,陈静1,张伯礼1,王永炎2,商洪才1**
5
10
(1. 天津中医药大学循证医学中心,天津 300193;
2. 中国中医科学院中医临床基础医学研究所,北京 100700)
摘要:当前中医药临床研究的水平得到了一定程度的提高,然而,中医药临床研究方法学的
不足仍是制约中医药传承发展的瓶颈。结局指标是中医药临床研究中的关键环节之一,但是
由于中医药临床研究方案设计的科学内涵和关键要素研究不够深入,导致指标体系方面存在
诸多问题。作者对结局指标存在的问题进行了剖析,并引进核心指标集的概念,阐述了建立
中医药临床研究核心指标集的必要性和可行性,提出中医药临床研究评价指标体系应该与国
际接轨,尝试引入核心指标集概念。
关键词:中医药;临床研究;方法学;核心指标集
中图分类号:R2
15
e evaluation system in clinical research of
Traditional Chinese medicine should introduce Core
e Measurement Set
ZHANG Li1, ZHANG Junhua1, CHEN Jing1, ZHANG Boli1, WANG Yongyan2,
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25
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SHANG Hongcai1
(1. Evidence-Based Medicine Center, Tianjin University of Traditional Chinese, TianJin 300193;
2. 1Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,
Beijing 100700)
Abstract: At present, the quality of clinical research of Traditional Chinese medicine (TCM) has
been improved, to some extent. But the imperfection of methodology in clinical trials is the
bottleneck which limits the development of TCM. To our knowledge, the e is one of the
key points in clinical research of TCM. However, clinical research of TCM is not specific to
scientific connotation of design and key factors, which result in some issues on e system of
TCM. In view of this situation, the concept of Core e Measurement Set (COMS) was
introduced. Additionally, it