中成药价值评估指标体系研究  

The research on the value framework of Chinese patent medicine

作　　者：党海霞[1] 刘骏[1] 李兵[1] 游蓉丽[1] 陈炳为 陈启光[2] 申春悌[3] 王忠[1] DANG Hai-xia;LIU Jun;LI Bing;YOU Rong-li;CHEN Bing-wei;CHEN Qi-guang;SHEN Chun-di;WANG Zhong(Institute of Basic Clinical Medicine,China Academy of Chinese Medical Science,Beijing 100700,China;Dongnan University,Nanjing 210096 China;Nanjing University of Chinese Medicine,Nanjing 210023,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]东南大学,南京210096 [3]南京中医药大学,南京210023

出　　处：《中国新药杂志》2021年第11期961-970,共10页Chinese Journal of New Drugs

基　　金：原国家食品药品监督管理局政策研究课题资助项目(G20150I)。

摘　　要：中成药是我国药品市场的重要组成部分,探索建立体现中医药特点的中成药价值评估体系,将是推进以"临床价值"为导向的中药新药研发与应用及相关药品政策制定中的重要环节。本研究在全面检索Pubmed,CNKI等国内外文献数据库、国际上主要国家网站,收集国内外与药品价值评估相关的文献、政策、规范、指南和专家意见,并综合运用了文献分析、内容分析、专家咨询等方法,对相关的法规、文献进行了解读、梳理、对比和分析,结合中医药的特点,在广泛的专家共识基础上,构建了一套涵盖从研发立项、临床前、上市前及上市后全生命周期的中成药价值评估指标体系,为中药新药的研发、上市后再评价、临床用药指南制定、药品定价、医保补偿以及患者的选择用药提供有效支撑。Chinese patent medicine is one of important parts in Chinese drug market.It is imperative for new drug development and drug policy-making to establish a drug value assessment framework of Chinese patent medicine embodying the characteristics of traditional Chinese medicine.In this study,PubMed,CNKI and other domestic and foreign literature databases as well as the major international government and academic websites were searched to collect literature,policies,standards,guidelines and expert opinions related to drug value assessment at home and abroad.The methods of literature analysis,content analysis and expert consultation were comprehensively adopted to interpret,compare and analyze the relevant laws and regulations.We obtained the core elements and index system of drug value assessment in the world.According to the characteristics of Chinese medicine and the extensive expert consensus,a set of value assessment framework of Chinese patent medicine covering the whole life cycle from the establishment of the R&D project,pre-clinical application,new drug certificate application and post-marketing use is established,providing strong support for the research and development of new Chinese medicine,post marketing re-evaluation,establishment of clinical medication guidelines,drugs pricing,medical insurance compensation and medication choice of patients.

关 键 词：中成药 价值评估 指标体系 

分 类 号：R95[医药卫生—药学]