摘要
目的:了解基因多态性内容在美国FDA、国内及国家食品药品监督管理局(SFDA)药品说明书中的标注情况及监测必要性。方法:对美国FDA网站提供的上市药品说明书与国内同成分中文药品说明书(包括SFDA药品说明书范本和部分厂家说明书)就基因多态性内容进行对比、分析。结果:与95种阐述了基因多态性在药物作用方面影响的美国FDA药品说明书比较,同类厂家中文说明书仅30%具有相关内容,且其中近一半为进口药品说明书,内容大多参考国外研究;在SFDA药品说明书范本中提到基因多态性以及代谢酶多态性的仅占14.7%。结论:SFDA应更加重视对药品说明书基因多态性内容的修改和补充,临床及药学部门应重视基因多态性监测。
OBJECTIVE： To investigate the mark and monitoring of genetic polymorphism in drug package inserts of FDA and SFDA and domestic ones. METHODS ：. The examples of drug package inserts in website of FDA were compared with the same kind ones in China （including examples of SFDA and some factories in term of genetic polymorphism）. RESULTS： Among 95 kinds of FDA drug package inserts which interpreted the effects of genetic polymorphism on drug, 30% of them had the same de- scription in Chinese vision of factories, and nearly half of them were imported drugs and the content of them mostly referred to for- eign study. The examples of SFDA drug package inserts which introduced genetic polymorphism and metabolic enzyme polymor- phism accounted from 14.7%. CONCLUSION： SFDA should pay more attention to revision and complement of genetic polymor- phism in drug package inserts. Clinical and pharmaceutical department should emphasize genetic polymorphism monitoring.
出处
《中国药房》
CAS
CSCD
2012年第41期3934-3936,共3页
China Pharmacy
关键词
药品说明书
内容差异
药物基因组学
基因多态性
监测
Package inserts
Difference of content
Pharmacogenomics
Genetic polymorphism
Monitoring
