US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Pharmacoepidemiol Drug Saf. 2013 Sep;22(9):942-51. doi: 10.1002/pds.3462. Epub 2013 Jun 3.
Research on the association of maternal selective serotonin reuptake inhibitor (SSRI) use and cardiac malformations in the offspring has yielded conflicting findings. We therefore sought to further investigate the association using data from a large population-based cohort in the UK.
The study population consisted of 149 464 pregnancies ending in a live birth between January/1996 and November/2010 from the Clinical Practice Research Datalink's Mother Baby Link. We created propensity-score matched cohorts of first-trimester SSRI users who did not use other antidepressants in the same gestational period ('SSRI users', n=3046) and non-antidepressant users (no use from the 3 months before pregnancy through the second trimester of pregnancy, 'non-users'; n=8991). Weighted logistic regression was used to estimate the odds ratio (OR) and 95% confidence interval (CI) of cardiac malformations overall and septal defects diagnosed in the first year of life, or in the first 6 years of life.
Sixteen infants with cardiac malformations were identified among SSRI users; 10 of them were septal defects. Among non-users, there were 48 infants with cardiac malformations, 26 of whom had septal defects. The OR (95% CI) for cardiac malformations was 1.00 (0.50; 2.00), and for septal defects was 1.15 (0.46; 2.87). Results were similar for cardiac malformations diagnosed in the first 6 years of life, and in several sensitivity analyses that were also implemented.
The results of this study are most compatible with no association between maternal use of SSRIs in early pregnancy and cardiac malformations or septal defects in the offspring. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.
有关母体选择性 5-羟色胺再摄取抑制剂(SSRI)使用与后代心脏畸形之间关联的研究结果相互矛盾。因此,我们试图使用英国大型基于人群的队列数据进一步研究这种关联。
研究人群由 1996 年 1 月至 2010 年 11 月期间临床实践研究数据链接的母婴链接中以活产结束的 149464 例妊娠组成。我们创建了在同一孕早期未使用其他抗抑郁药的第一代 SSRI 用户(“SSRI 用户”,n=3046)和非抗抑郁药使用者(从怀孕前 3 个月到孕中期都未使用,“非使用者”,n=8991)的倾向评分匹配队列。使用加权逻辑回归估计心脏畸形的总体比值比(OR)和 95%置信区间(CI),以及出生后第一年或前 6 年诊断的间隔缺损。
在 SSRI 用户中发现 16 例心脏畸形婴儿,其中 10 例为间隔缺损。在非使用者中,有 48 例婴儿患有心脏畸形,其中 26 例患有间隔缺损。心脏畸形的 OR(95%CI)为 1.00(0.50;2.00),间隔缺损的 OR 为 1.15(0.46;2.87)。在前 6 年诊断的心脏畸形和实施的几项敏感性分析中,结果相似。
这项研究的结果最符合母亲在孕早期使用 SSRIs 与后代心脏畸形或间隔缺损之间无关联。发表于 2013 年。本文为美国政府的工作成果,在美国属于公有领域。