不良反应监测对中药安全性评价的启示  

Enlightenment of adverse reaction monitoring on safety evaluation of traditional Chinese medicines

作　　者：宋海波[1] 杜晓曦[1] 任经天[1] 杨乐[1] 郭晓昕[1] 逄瑜[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国中药杂志》2015年第8期1620-1623,共4页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2015ZX09501004-001)

摘　　要：不良反应监测在早期预警中药风险、发现质量隐患、保障临床用药安全方面有重要作用。研究符合中药特点的风险信号挖掘技术,充分考虑中药成分、炮制、配伍、制备及临床用药的复杂性特点,早期发现中药风险信号,探索建立以不良反应风险信号为先导的中药安全性评价体系,提高中药安全性研究的靶向性,及时有效控制风险,有助于改变目前中药"安全性问题"频发的局面。The adverse reaction monitoring is important in warning the risks of traditional Chinese medicines at an early stage, finding potential quality problems and ensuring the safe clinical medication. In the study, efforts were made to investigate the risk signal mining techniques in line with the characteristics of traditional Chinese medicines, particularly the complexity in component, processing, compat- ibility, preparation and clinical medication, find early risk signals of traditional Chinese medicines and establish a traditional Chinese medicine safety evaluation system based on adverse reaction risk signals, in order to improve the target studies on traditional Chinese med- icine safety, effective and timely control risks and solve the existing frequent safety issue in traditional Chinese medicines.

关 键 词：中药 不良反应监测 安全性评价 

分 类 号：R288[医药卫生—中药学]