中药新药临床疗效评价的现状与发展  

Study on the current situation and development in clinical efficacy evaluation of new traditional Chinese medicine

作　　者：安宇[1,2] 王阶[1] 李赵陵 

机构地区：[1]中国中医科学院广安门医院,北京100053 [2]北京中医药大学,北京100029

出　　处：《中华中医药杂志》2015年第1期9-11,共3页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家中医药管理局国家公益性行业专项证候类中药新药疗效评价方法研究资助项目(No.201207009)~~

摘　　要：有效性是新药临床疗效评价的关键,目前的中医临床疗效评价体系主要包括以症状体征改善为内容的疗效评价、以理化指标为内容的疗效评价、以证候要素为内容的疗效评价、重要临床事件发生率疗效评价、基于患者报告的结局疗效评价、基于照顾者报告的结局疗效评价、安全性评价和卫生经济学评价等8个方面。目前证候类新药发展迅速,它是区别于其他新药以证候为基点纵向贯穿多种疾病的一类新药,是目前新药研发的重要部分,对于证候类新药的疗效评价需要更加完善的中医临床疗效评价体系。因此要在加强循证医学评价的基础上建立证候评定量表,采用综合多维疗效评价方法进行综合评价,这是科学的、全面的、综合的适用于证候类新药的中医临床疗效评价体系。Effectiveness is the key clinical curative effect evaluation of new drugs. There are 8 kinds of evaluations in current TCM curative effect evaluation system, including the improvement of symptoms and signs of traditional Chinese medicine, physical and chemical indicators, syndrome elements, the occurrence rate of important clinical event, the outcome based on patient report, the outcome based on caregivers report, the safety evaluation and health economics evaluation. The new drugs of syndrome type longitudinally run through a variety of diseases based on TCM syndrome, which is different from the other new drugs, are an important part of current new drugs research and development. With the rapid development, a more perfect clinical curative effect evaluation system need to be established. A scientific and comprehensive clinical curative effect evaluation system which is suitable for the new drugs of syndrome type will be established, on the basis of strengthening evidence-based medicine evaluation.

关 键 词：中药 新药 证候 疗效评价 思路 

分 类 号：R285.6[医药卫生—中药学]