Li Yuanyuan, Xie Yanming, Fu Yingkun
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2828-30.
Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.
目前，针对上市后中药专利药（CPM）中成药的安全性、有效性和经济性已展开大量研究，但缺乏全面解读。建立CPM的风险评估指标体系和风险评估模型是解决药品安全问题、保障人民健康的关键。CPM的临床风险因素与西药存在相似之处，既可以借鉴国外经验，又有自身多因素、多变量、多层次的复杂特征。针对药品安全风险评估的不确定性和复杂性，运用层次分析法（AHP）赋予指标权重，基于AHP的模糊神经网络构建上市后CPM风险评估指标体系和风险评估模型，并不断完善应用，是符合中医药特色的可行有益探索之路。
