对中医药临床研究结局评价问题的研讨

随着中医药临床研究的不断深化,逐渐暴露出一些深层次的问题。本文针对目前中医药临床研究中结局评价极不规范的现状和国外对于临床评价中结局评价的研究近况,指出中医药临床研究需要转变理念,与时俱进。同时阐述了中医药临床研究结局评价中的有关概念化的知识和深层次的整体理念,指出了今后中医药临床研究在疗效性研究和探索性研究中结局指标选择的六大基本原则与四个相应的选取技巧,以便更好的解决中医临床研究中的许多关键问题。

Discussion about clinical research outcome evaluation of TCMGAI

With the continuous deepening of clinical research of TCM,it’s also gradually exposed some deep-seated problems.In this paper,we pointed out that the clinical research of TCM need to change the philosophy and advance with the times,based on the status quo of the outcome evaluation of clinical research of TCM which is highly irregular and the recent foreign research for clinical evaluation of outcome evaluation.This paper also described the outcome evaluation of clinical research of TCM on the conceptualization of knowledge and the overall deep-seated concept.And pointed out the six basic principles of clinical research in the future choice of outcome measures in efficacy studies and exploratory research and the four selection techniques,to solve bitterly many key issues in TCM clinical research.