Department of Obstetrics and Gynecology, Aarhus University Hospital, Aarhus, Denmark.
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
BJOG. 2021 Nov;128(12):1949-1957. doi: 10.1111/1471-0528.16772. Epub 2021 Jun 22.
Studies restricted to live births may underestimate severe teratogenic effects. We address the limitation by including data from both prenatal and postnatal diagnoses of cardiac malformations.
Register-based study.
Denmark.
364 012 singleton pregnancies from 2007 to 2014.
We used data from five nationwide registries. Exposure to antidepressants was measured using redeemed prescriptions.
Pregnancies with cardiac malformations that end in miscarriage, termination, stillbirth, postnatal death or cardiac surgery <1 year of birth were classified as severe cardiac malformations (SCM). Propensity scores with adjusted prevalence ratios (PRs) were calculated.
SCM were reported in 972 of 364 012 pregnancies overall and in 16 of 4105 exposed. For venlafaxine, the PR for SCM was 2.13 (95% confidence interval [CI] 0.89-5.13), 1.73 (95% CI 1.08-2.77) for other cardiac malformations, and there was a cluster of hypoplastic left heart syndromes (HLHS) (crude PR 17.4 [95% CI 6.41-47.2]), none of which ended in a live birth. For HLHS, the absolute risk increase was 4.4/1000 and the number needed to harm was 225. For selective serotonin reuptake inhibitors, the PRs were 1.09 (95% CI 0.52-2.30) and 1.38 (95% CI 1.00-1.92) for SCM and other cardiac malformations, respectively.
Pregnancy exposure to venlafaxine is associated with an increased risk of severe cardiac malformations but with a low absolute risk. Potential mechanisms include direct effects or confounding by indication. Venlafaxine exposure is a marker for risk pregnancies for which fetal echocardiography may be considered.
Exposure to venlafaxine is associated with an increased risk of cardiac malformations but with a low absolute risk.
仅关注活产儿的研究可能会低估严重的致畸影响。我们通过纳入产前和产后诊断的心脏畸形数据来解决这一局限性。
基于注册的研究。
丹麦。
2007 年至 2014 年的 364012 例单胎妊娠。
我们使用了来自五个全国性登记处的数据。使用 redeemed prescriptions 来衡量抗抑郁药的暴露情况。
以流产、终止妊娠、死产、新生儿死亡或出生后 1 年内行心脏手术为结局的妊娠被归类为严重心脏畸形（SCM）。采用调整后的患病率比（PR）计算倾向评分。
364012 例妊娠中，972 例（2.67%）和 4105 例暴露者中的 16 例报告了 SCM。文拉法辛的 SCM 患病率比（PR）为 2.13（95%可信区间[CI]：0.89-5.13），其他心脏畸形的 PR 为 1.73（95%CI：1.08-2.77），存在左心发育不良综合征（HLHS）的聚集（粗 PR 为 17.4[95%CI：6.41-47.2]），无一例活产。对于 HLHS，绝对风险增加了 4.4/1000，需要治疗的人数为 225。对于选择性 5-羟色胺再摄取抑制剂（SSRIs），SCM 和其他心脏畸形的 PR 分别为 1.09（95%CI：0.52-2.30）和 1.38（95%CI：1.00-1.92）。
妊娠期间暴露于文拉法辛与严重心脏畸形风险增加相关，但绝对风险较低。潜在机制包括直接作用或混杂因素。文拉法辛暴露是胎儿超声心动图可能被考虑的高危妊娠的标志物。
暴露于文拉法辛与心脏畸形风险增加相关，但绝对风险较低。
