临床疗效评价中效力与效果区别的思考临床疗效评价中效力与效果区别的思考.pdf

·临床试验方法学· 临床疗效评价中效力与效果区别的思考 青雪梅△ 刘保延王永炎 摘要 “效力”与“效果”是临床疗效评价中两个重要概念。本研究阐述了两者内涵的区别与联系，并进 一步探讨效力研究与效果研究分剐对应的解释性随机对照试验与实用性随机对照试验的区别，以及它们在 疗效评价中不同阶段的适用价值。本文评述对中医临床疗效评价过程中明确研究目的、定位好恰当的研究 阶段、选择合适的设计方案具有借鉴作用。 关键词 效力；效果；随机对照试验；中医；疗效评价 in DiscussiononDIfferencesbetween andEf怕ctivenessClinicalEvaluationQINGXue．mei．LIU E怖cacy andWANG InstituteBasicResearchinClinicalMedicine．ChinaChineseMedicalSci— of Bao-yan Yong—yan of Academy ences。Beijing(100070) ABSTRACT two inclinicalevaluation．Inthis Both“efficacy”and“effectiveness”areimportantconcepts differencesand betweenthetwoconnotationswere boththedifferences article，the relationship expounded，and randomizedcontrolled randomizedcontrolledtrial between“explanatory trial(ERCT)”and“pragmatic are their values (PRCT)”，which to“efficacy”and“effectiveness”，andapplicative respectivelycorresponding indifferent inclinical effectevaluationwerefurther bea refer- stages therapeutic explored．Thisstudymay helpful encefor research research suitable atits defining purposes，locatingappropriatestages，andchoosing designs different intheclinicalevaluationofC：hinesemedicineresearches． stages process controlled evaluation KEYWORDS medicine；clinicaI efficacy；effectiveness；randomizedtrials；Chinese 疗效是中医学赖以生存和发展的基石，也是中医 的确定、研究设计方案选择的重要依据，而且对