基于美国FAERS数据库抗抑郁药物与胎儿及新生儿的不良事件信号分析  

Safety signal analysis of antidepressants use in fetus and neonate based on US FAERS database

作　　者：时贯宏 王淇 孙昊[2] 陈雁杰 储紫雁 蒋傲 汤在祥[2] 刘静芳[1] SHI Guanhong;WANG Qi;SUN Hao;CHEN Yanjie;CHU Ziyan;JIANG Ao;TANG Zaixiang;LIU Jingfang(Gynaecology and Obstetrics Department,The First Affiliated Hospital of Soochow University,Suzhou Jiangsu 215006,China;School of Public Health,Suzhou Medical College of Soochow University,Suzhou Jiangsu 215123,China;Gynaecology and Obstetrics Department,The First Affiliated Hospital,Suzhou Medical College of Soochow University,Suzhou Jiangsu 215123,China;School of Public Health,Medical College of Ningbo University,Zhejiang Ningbo 315201,China)

机构地区：[1]苏州大学附属第一医院妇产科,江苏苏州215006 [2]苏州大学苏州医学院公共卫生学院,江苏苏州215123 [3]苏州大学苏州医学院第一临床医院妇产科,江苏苏州215123 [4]宁波大学医学部公共卫生学院,浙江宁波315201

出　　处：《中国药物警戒》2024年第6期687-692,共6页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(81773541、82373688)。

摘　　要：目的基于美国食品药品监督管理局不良事件报告系统(FAERS)挖掘抗抑郁药物的使用与胎儿及新生儿不良事件的风险信号,为临床安全合理用药提供参考。方法筛选FAERS数据库2004年1月1日至2022年12月31日中怀疑抗抑郁药的不良事件报告,并通过报告比值比(ROR)法和比例报告比值比(PRR)法挖掘抗抑郁药与胎儿及新生儿之间的不良事件信号。结果共有14492例儿胎儿及新生儿异常的病例纳入研究,其中胎儿组5546例,新生儿组病例8946例。药物方面,分别有68.97%、56.35%的胎儿不良事件信号和新生儿不良事件信号为选择性5-羟色胺再摄取抑制剂(SSRI)类抗抑郁药产生。不良事件方面,51.72%胎儿不良事件信号与羊水相关,20.99%的新生儿不良事件信号与呼吸系统异常相关。对产生的不良事件信号进行二次筛选后,西酞普兰和文拉法辛信号突出,且存在说明书未载明信号。结论抗抑郁药物的整体信号特征与现有的安全性资料基本一致,但通过分组分析仍然发现了如胎儿羊水异常、新生儿心脏方面等说明书未载明不良事件,临床使用时应重点关注。Objective To mine and evaluate the risk signals of antidepressants use in fetus and neonate adverse events based on the database of the US Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS),and provide reference for clinical rational drug use.Methods Filter primary suspect and second suspect antidepressants AE reports from 1th January 2004 to 31th December 2022 in FAERS database.Mine the signals of fetus or neonate adverse events with antidepressants via reporting odds ratio(ROR)and proportional reporting ratio(PRR).Results There are 14492 cases of fetal and neonatal anomalies in the study,including 5546 fetal abnormal cases and 8946 neonatal abnormal cases.From drug aspect,there 68.97%foetal adverse signals and 56.35%neonatal adverse signals are selective serotonin reuptake inhibitors(SSRIs).From adverse event aspect,there 51.72%foetal adverse signals is related to amniotic fluid and 20.99%neonatal adverse signals is respiratory system disorders.Signals of Citalopram and Venlafaxine are highlighted after the second screening,which have adverse signals not specified in the label.Conclusion The overall signal characteristics of antidepressants are basically consistent with the existing safety data.However,some adverse events such as fetal amniotic fluid disorders and neonatal heart disorders are not listed in label through group analysis,which should be paid attention to in clinical use.

关 键 词：抗抑郁药物 选择性5-羟色胺再摄取抑制剂 胎儿及新生儿 美国食品药品监督管理局不良事件报告系统 报告比值比法 比例报告比值比法 药物安全 不良事件 信号 

分 类 号：R994.11[医药卫生—毒理学]