替代指标和中间指标及其在中医药疗效评价研究中应用价值的思考

作者	单位
郭新峰	广州中医药大学DME中心临床流行病学应用研究室
朱泉	广州中医药大学DME中心临床流行病学应用研究室
赖世隆	广州中医药大学DME中心临床流行病学应用研究室

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中文摘要:

论述了替代指标、中间指标的概念,其与主要结局指标之间的关系以及替代指标在临床疗效评价研究中的应用条件,同时讨论了在中医药疗效评价研究中如何选择替代指标和中间指标的问题。基于中医药整体性特点,使用单一替代指标难以全面而客观地反应中医药的疗效,合理地选择重要临床症状、若干症状的组合、病人的主观感觉、对于治疗的总体满意度等中间指标和生存质量,将有助于客观评价中医药干预措施的效能。

英文摘要:

In this paper, the concepts of surrogate outcomes and intermediary outcomes, their correlation with the primary outcome, how to select surrogate outcomes and intermediary outcomes and the particular requirements for using surrogate outcomes in assessing TCM clinical efficacy were discussed and described. It is difficult to evaluate clinical efficacy objectively and thoroughly by means of a single surrogate outcome for reason of the global characteristics of TCM, therefore, to rationally select such intermediary outcomes as important clinical symptoms, combination of several syndromes, patients’ subject feeling, patients’ satisfaction for treatment and quality of life, should be beneficial for objectively evaluating the efficacy of TCM intervention approaches.

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