全球妊娠期用药危险性分级系统的比较分析

发布时间：2018-01-21 23:09

本文关键词： 妊娠用药危险性分级系统　出处：《中国药学杂志》2016年03期 　论文类型：期刊论文

【摘要】：目的通过比较分析全球现有的3个妊娠期用药危险性分级,为妊娠期合理用药提供证据。方法检索美国食品药品监督局(US Food and Drug Administration,FDA)、澳大利亚药品评估委员会(Australian Drug Evaluation Committee,ADEC)和瑞典(Swedish Catalogue of Approved Drugs,FASS)3个妊娠期用药危险性分级,描述性分析3个分级在定义、药物各级分布、共有药物分级情况以及3目录差别大药物的异同。结果 1FDA采用药物使用的动物研究和人类观察研究说明在妊娠期使用的安全性,ADEC和FASS分级相似,使用人类使用经验和动物研究说明药物在妊娠期使用的安全性;23个目录共有3 167种药物,其中FDA分级有1 113种,ADEC分级有1 232种,FASS分级有983种,ADEC和FASS目录的A级药物多于FDA;3个目录共有367个药物重合,分别占FDA目录的33.0%,ADEC目录的29.8%,FASS目录的37.3%,ADEC和FASS分级目录的分布较为相似,但与FDA分级在A和X级药物的差别大;43个目录差别大的药物集中于FDA分级中X级和C级。结论全球现有的3个妊娠期用药危险性分级差别大,不能仅用分级评估妊娠期用药危险性。
[Abstract]:Objective to compare and analyze the risk classification of three drugs used in pregnancy in the world. Methods US Food and Drug Administration (FDAs) was searched for the rational use of drugs during pregnancy. Australian Drug Evaluation Committee. Adeca) and Swedish Catalogue of Approved drugs (FASS). Descriptive analysis of 3 levels in the definition of drug distribution. Results 1 Animal studies and human observation studies of FDA drug use demonstrated the safety of drug use during pregnancy. ADEC and FASS grades are similar, using human experience and animal studies to demonstrate the safety of drugs used during pregnancy; There were 3 167 kinds of drugs in 23 catalogues, of which 1 113 were classified by FDA and 1 232 by FASS. There were more A class drugs in ADEC and FASS catalogues than in FDAs. There were 367 drug superpositions in the three directories, accounting for 37.3% of the 29.8FASS in the FDA catalogue. The distribution of ADEC and FASS classification catalogues was similar, but there was a great difference between ADEC and FDA classification in A and X drugs. Conclusion there are significant differences in the risk of drug use during pregnancy in the world, so we can not only use the classification to evaluate the risk of drug use in pregnancy.
【作者单位】：四川大学华西第二医院药学部;四川大学华西第二医院循证药学中心;四川大学华西第二医院出生缺陷与相关妇儿疾病教育部重点实验室;四川大学华西第二医院妇产科;四川大学华西药学院;
【基金】：国家自然科学基金资助项目(81373381) 教育部长江学者创新团队基金资助项目(IRT0935)
【分类号】：R969.3
【正文快照】： 自50多年前反应停致畸事件后,妊娠期用药方案等[2]。但妊娠期用药不可避免,8%的妊娠成为世界关注的话题。由于伦理问题,药物上市期妇女因为癫痫、炎性肠病和哮喘等慢性疾病需前的临床试验排除了孕妇这一特殊人群[1],使得要长期药物治疗[3],美国1项调查显示妊娠期使妊娠期用药

【相似文献】