阐述式分级Briggs妊娠期及哺乳期药物风险分类方法分析

Analyzing Briggs Risk Categorization for Drugs During Pregnancy and Lactation

目的分析Briggs妊娠期及哺乳期药物风险分类方法,为我国进一步进行妊娠期及哺乳期药物暴露风险评估提供依据及参考。方法依据Briggs风险分类方法,对涉及药物的妊娠期及哺乳期药物暴露风险进行分析,同时对ABCDX字母风险分类、Hale哺乳期风险分类、FDA于2015年发布的新孕妇用药规则(PLLR)进行对比,对Briggs药物暴露风险分类方法特点进行分析。结果Briggs风险分类方法中,妊娠期风险分类共涉及6大类,18小类,哺乳期共涉及5大类9小类,共1412个药物进行分类,其中已撤市186种,妊娠期风险药物占50.22%,妊娠期适用及禁忌药物各占37.87%和10.11%。哺乳期适用药物占51.21%,哺乳期风险药物占24.18%。结论Briggs妊娠期哺乳期药物暴露风险评估方法阐述格式更为统一,对进一步建立我国妊娠期哺乳期药物暴露风险分类具有参考意义。

OBJECTIVE To analyze Briggs risk classification for drugs during pregnancy and lactation,providing reference for drug risk assessment for pregnancy and lactation in China.METHODS According to Briggs risk classification of drugs during pregnancy and lactation,the drugs were analyzed with“drugs in pregnancy and lactation”,10th edition.Comparation was made among Briggs risk categorization to ABCDX letter risk,Hale risk,PLLR classification to investigate the characteristics.RESULTS Briggs risk categorization classified the drugs during pregnancy into 6 categories and 18 subgroups including 1412 drugs.Drugs during lactation were divided into 5 classes and 9 subgroups.Except 186 drugs withdrawn from market,risk drugs during pregnancy made up to 50.22%,compared with 21%of compatible and 10.11%contraindicated.Drugs during lactation accounted for 51.21%compatible and 24.18%with risk.CONCLUSION As to the unified statement on risk of drugs during pregnancy and lactation,Briggs risk categorization can provide reference for establishing risk classification for drugs during pregnancy and lactation in China.