孕期使用舍曲林与重大畸形风险

Sertraline use during pregnancy and the risk of major malformations.

作者信息

Bérard Anick, Zhao Jin-Ping, Sheehy Odile

机构信息

Research Center, Sainte-Justine Hospital, and Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada.

出版信息

Am J Obstet Gynecol. 2015 Jun;212(6):795.e1-795.e12. doi: 10.1016/j.ajog.2015.01.034. Epub 2015 Jan 28.

DOI:10.1016/j.ajog.2015.01.034

PMID:25637841

Abstract

OBJECTIVE

Given the current debate and growing public concerns on selective serotonin reuptake inhibitors (SSRIs) and birth defects generated by Food and Drug Administration warnings, we aim to quantify the association between first-trimester exposure to sertraline, a first-line treatment, and the risk of congenital malformations in a cohort of depressed women.

STUDY DESIGN

This was a population-based cohort study in Quebec, Canada, 1998 through 2010. From a cohort of 18,493 depressed/anxious pregnancies, sertraline-exposed, nonsertraline SSRI-exposed, non-SSRI exposed, and unexposed (reference category) women were studied. Major malformations overall and organ-specific malformations in the first year of life were identified. Generalized estimating equation models were used to obtain risk estimates and 95% confidence intervals (CIs). Analyses were adjusted for potential confounders.

RESULTS

Among the 18,493 eligible pregnancies, 366 were exposed to sertraline, 1963 to other SSRIs, and 1296 to non-SSRI antidepressants during the first trimester of pregnancy. Sertraline use was not statistically significantly associated with the risk of overall major malformations when compared to nonuse of antidepressants. However, sertraline exposure was associated with an increased risk of atrial/ventricular defects specifically (risk ratio [RR], 1.34; 95% CI, 1.02-1.76; 9 exposed cases), and craniosynostosis (RR, 2.03; 95% CI, 1.09-3.75; 3 exposed cases). Exposure to SSRIs other than sertraline during the first trimester of pregnancy was associated with craniosynostosis (RR, 2.43; 95% CI, 1.44-4.11; 19 exposed cases), and musculoskeletal defects (RR, 1.28; 95% CI, 1.03-1.58; 104 exposed cases).

CONCLUSION

Sertraline use during the first trimester of pregnancy was associated with an increased risk of atrial/ventricular defects and craniosynostosis above and beyond the effect of maternal depression. Nonsertraline SSRIs were associated with an increased risk of craniosynostosis and musculoskeletal defects.

摘要

目的

鉴于当前关于选择性5-羟色胺再摄取抑制剂（SSRIs）的争论以及食品药品监督管理局发出的警告引发公众对其与出生缺陷关系的日益关注，我们旨在量化在一组抑郁症女性中，孕早期使用一线治疗药物舍曲林与先天性畸形风险之间的关联。

研究设计

这是一项基于人群的队列研究，于1998年至2010年在加拿大魁北克进行。从18493例患有抑郁症/焦虑症的孕妇队列中，对暴露于舍曲林、暴露于非舍曲林的SSRIs、未暴露于SSRIs以及未暴露（参照组）的女性进行研究。确定了总体主要畸形以及出生后第一年特定器官的畸形情况。使用广义估计方程模型来获得风险估计值和95%置信区间（CIs）。分析针对潜在混杂因素进行了调整。

结果

在18493例符合条件的妊娠中，366例在孕早期暴露于舍曲林，1963例暴露于其他SSRIs，1296例暴露于非SSRIs抗抑郁药。与未使用抗抑郁药相比，使用舍曲林与总体主要畸形风险之间无统计学显著关联。然而，暴露于舍曲林与心房/心室缺损风险增加显著相关（风险比[RR]，1.34；95% CI，1.02 - 1.76；9例暴露病例），以及与颅缝早闭相关（RR，2.03；95% CI，1.09 - 3.75；3例暴露病例）。孕早期暴露于舍曲林以外的SSRIs与颅缝早闭相关（RR，2.43；95% CI，1.44 - 4.11；19例暴露病例），以及与肌肉骨骼缺陷相关（RR，1.28；95% CI，1.03 - 1.58；104例暴露病例）。