CAJ | 학술논문

临床疗效评价是证候类中药新药研发的重要环节和难点所在。本文在回顾现有临床疗效评价方法的基础上，针对中药新药临床评价中遇到的问题，探讨在证病结合的模式下证候类中药新药临床疗效的评价方法。主要围绕证候评价与疾病评价的关系，疗效评价指标的设定，证候评价方法如四级标准法、量表法的使用，以及自评、他评模式的结合运用，疗程的设置、安全性指标的选择等问题进行探讨。
림상료효평개시증후류중약신약연발적중요배절화난점소재。본문재회고현유림상료효평개방법적기출상，침대중약신약림상평개중우도적문제，탐토재증병결합적모식하증후류중약신약림상료효적평개방법。주요위요증후평개여질병평개적관계，료효평개지표적설정，증후평개방법여사급표준법、량표법적사용，이급자평、타평모식적결합운용，료정적설치、안전성지표적선택등문제진행탐토。
Clinical curative effect evaluation is an important and difficult part for the research of new medicine of syndrome TCM.Based on the review of existing clinical curative effect evaluation methods,we explore the new method in the mode of disease combined with syndrome.We mainly include the relationship between syndrome evaluation and disease evaluation,the setting of the curative effect e-valuation index,the use of syndrome evaluation methods such as 4 level standard method and scale,the combination of self-evaluation and other-evaluation,the setting of treatment period,the choice of safety indicators and so on.