Department of Obstetrics, The Second Hospital, Cheeloo College of Medicine, Shandong University, No. 247 Beiyuan Road, Tianqiao District, Jinan, Shandong Province, China.
Department of Obstetrics, Jining First People's Hospital, No. 6 Jiankang Road, Rencheng District, Jining, Shandong Province, China.
Biomed Res Int. 2022 Jul 13;2022:9914931. doi: 10.1155/2022/9914931. eCollection 2022.
Sertraline is one of the most commonly used antidepressants worldwide and is one of the first-choice treatments for depression during pregnancy. This study is aimed at testing the possible association between sertraline intrauterine exposure and congenital cardiac and vascular disorder occurrences by assessing the publicly available US Food and Drug Administration Adverse Event Reporting System (FAERS).
Disproportionality analysis and Bayesian analysis were used to mine FAERS for suspected congenital cardiac and vascular disorder data for sertraline intrauterine exposure from the first quarter of 2004 to the second quarter of 2021.
Among the 914 cases of sertraline used with congenital cardiovascular disease in the FAERS database, the reporting areas were mainly in the United States and Europe. The number of adverse events reported every year since 2004 has no many differences. Congenital anomalies are the most frequently reported serious clinical outcome. Among the 69 positive signals detected from 914 cases, 31 were invalid signals, and 38 were valid signals according to criteria. The most common ones are heart disease congenital, atrial septal defect, ventricular septal defect, patent ductus arteriosus, and persistent fetal circulation.
Mining FAERS data can analyze and study the adverse reactions of sertraline in a more comprehensive and in-depth manner, thereby effectively reducing the risk of clinical medication.
舍曲林是世界上使用最广泛的抗抑郁药之一，也是治疗妊娠期抑郁症的首选药物之一。本研究旨在通过评估美国食品和药物管理局不良事件报告系统（FAERS）中公开可用的数据，检测舍曲林宫内暴露与先天性心脏和血管疾病发生之间的可能关联。
采用比例失调分析和贝叶斯分析，从 2004 年第一季度到 2021 年第二季度，从 FAERS 数据库中挖掘舍曲林宫内暴露与疑似先天性心脏和血管疾病数据。
在 FAERS 数据库中，与先天性心血管疾病相关的 914 例舍曲林使用病例中，报告地区主要集中在美国和欧洲。自 2004 年以来，每年报告的不良事件数量没有太大差异。先天性异常是最常报告的严重临床结局。在 914 例病例中检测到的 69 个阳性信号中，根据标准，31 个是无效信号，38 个是有效信号。最常见的是先天性心脏病、房间隔缺损、室间隔缺损、动脉导管未闭和持续性胎儿循环。
挖掘 FAERS 数据可以更全面、更深入地分析和研究舍曲林的不良反应，从而有效降低临床用药风险。
