摘要
目的:探讨中药安全性重点监测品种遴选的基本原则和思路。方法:从药品不良反应信息、药品自身性质和药品使用特点三个方面,分析中药安全性重点监测品种的遴选原则。结果:应结合药品不良反应发生率,不良反应数量,不良反应严重程度,药品所含成分,药品销售量,药品风险效益比等多因素综合考虑遴选中药重点监测品种。结论:中药安全性重点监测品种遴选须全面考量药品各方面因素,综合分析,审慎抉择。
Objective： To investigate principles and ideas of variety selection for intensive safety monitoring of Chinese herbal medicine. Method： Selection principles and ideas were analyzed from three aspects as adverse drug reaction information, nature of drugs and drug using features. Result： The incidence and quantity of adverse drug reactions, drug ingredients, drug sales, ratio of drug risk - benefit and other aspects should be considered for variety selection of intensive safety monitoring. Conclusion： Variety selection for intensive safety monitoring of Chinese herbal medicine should be considered comprehensively and prudently.
出处
《药物流行病学杂志》
CAS
2008年第5期298-301,共4页
Chinese Journal of Pharmacoepidemiology
基金
国家食品药品监督管理局药品评价中心国家科技支撑计划课题(2006BAI21B11)。
关键词
中药
安全性
重点监测
Chinese herbal medicine
Safety
Intensive monitoring
