上市后中成药再评价临床定位的原则和方法——基于循证医学的理念  

Clinical orientation of post-marketing Chinese patent drugs:an evidence-based practice

作　　者：商洪才[1] 张伯礼[2] 李幼平[1] 

机构地区：[1]四川大学华西医院临床医学博士后流动站 [2]天津中医药大学中医药研究院,天津300193

出　　处：《中西医结合学报》2008年第9期887-890,共4页Journal of Chinese Integrative Medicine

基　　金：国家自然科学基金资助项目(No30600834);中国博士后科学基金资助项目(No20070411156)

摘　　要：针对当前名优中药二次开发过程中普遍存在的临床定位不清的弊端,剖析了导致中药品种临床定位不清的主要原因,阐明了临床定位在名优中药品种二次开发中的必要性。基于循证医学的理念,提出了中成药上市后再评价临床定位的确定原则、方法和步骤,为名优中成药二次开发的顺利实施奠定了理论基础和方法保证。Unclear clinical orientation in practice has become one of the common problems with the effective application of famous and excellent Chinese herbal drugs, consequently restricting their development. The authors suggest that there are three aspects to be considered in dealing with this problem. Clinical evaluation and orientation of the famous and excellent Chinese herbal drugs is an important task, and it is also a requirement for the internationalization of traditional Chinese medicine. Literature evaluation-pharmacology research-clinical expertise analysis method will establish a theoretical basis and method for post-marketing development of famous and excellent Chinese patent drugs.

关 键 词：中成药 药物评价 临床定位 循证医学 

分 类 号：R-03[医药卫生] R28