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。

OBJECTIVE To compare and analyze three risk classification systems for drug use during pregnancy, so as to provide evidence for drug safety used in pregnancy.METHODS The drugs included in the risk classification systems from the US Food and Drug Administration (FDA), the Australian Drug Evaluation Committee (ADEC) and the Swedish Catalogue of Approved Drugs (FASS) were searched, and descriptive analysis was performed in terms of definition of category, allocation of drugs and difference of categories. RESULTS FDA uses animal studies and human observations studies in pregnancy to define the risk of drugs in pregnancy. The classification systems of ADEC and FASS are similar, which use experience in human and animal research for defining the drug safety during pregnancy. The category assignments for 1 113 drugs in FDA system, 1 232 in ADEC system and 983 in FASS system were compared. Only 367 (11.6%) drugs among the total of 3 167 in the three systems were placed in the same risk level category, which accounted for 33.0%, 29.8% and 37.3% of FDA, ADEC and FASS systems, respectively. The main differences existed in drugs in X and C categories between FDA and ADEC/FASS systems. CONCLUSION Differences in category allocation for the same drug can be a source of great confusion among users of the classification systems, and may limit the usefulness and reliability of risk classification systems.