Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité Universitätsmedizin Berlin, Berlin, Germany.
J Clin Psychopharmacol. 2013 Aug;33(4):453-62. doi: 10.1097/JCP.0b013e318295fe12.
Women of childbearing age are often affected with psychotic disorders, requiring the use of antipsychotic medication during pregnancy. In the present study, we prospectively followed the pregnancies of 561 women exposed to second-generation antipsychotic agents (SGAs; study cohort) and compared these to 284 pregnant women exposed to first-generation antipsychotic agents (FGAs; comparison cohort I) and to 1122 pregnant women using drugs known as not harmful to the unborn (comparison cohort II). Subjects were enrolled through the Institute's consultation service. Major malformation rates of SGA exposed were higher compared to comparison cohort II (adjusted odds ratio, 2.17; 95% confidence interval, 1.20-3.91), possibly reflecting a detection bias concerning atrial and ventricular septal defects. Postnatal disorders occurred significantly more often in infants prenatally exposed to SGAs (15.6%) and FGAs (21.6%) compared to 4.2% of comparison cohort II. Cumulative incidences of elective terminations of pregnancy were significantly higher in both the study cohort (17%) and comparison cohort I (21%) compared to comparison cohort II (3%), whereas the rates of spontaneous abortions did not differ. The numbers of stillbirths and neonatal deaths were within the reference range. Preterm birth and low birth weight were more common in infants exposed to FGAs. To conclude, our findings did not reveal a major teratogenic risk for SGAs, making the better studied drugs of this group a treatment option during pregnancy. Because neonates exposed to SGAs or FGAs in the last gestational week are at higher risk of postnatal disorders, delivery should be planned in clinics with neonatal intensive care units.
生育年龄的妇女常患有精神病，在怀孕期间需要使用抗精神病药物。在本研究中，我们前瞻性地随访了 561 名暴露于第二代抗精神病药物（SGAs；研究队列）的孕妇，并将这些孕妇与 284 名暴露于第一代抗精神病药物（FGAs；比较队列 I）和 1122 名使用已知对胎儿无害的药物的孕妇进行了比较（比较队列 II）。研究对象通过研究所的咨询服务招募。与比较队列 II 相比，SGA 暴露的主要畸形率更高（调整后的优势比，2.17；95%置信区间，1.20-3.91），这可能反映了房间隔和室间隔缺损的检测偏倚。与比较队列 II（4.2%）相比，产前暴露于 SGA（15.6%）和 FGA（21.6%）的婴儿出生后出现疾病的情况更为常见。与比较队列 II（3%）相比，研究队列（17%）和比较队列 I（21%）中选择性终止妊娠的累积发生率显著更高，而自然流产率没有差异。死胎和新生儿死亡的数量处于参考范围内。早产和低出生体重在暴露于 FGA 的婴儿中更为常见。总之，我们的研究结果并未显示 SGA 存在重大致畸风险，这使得该组研究更为充分的药物成为怀孕期间的一种治疗选择。由于在妊娠最后一周暴露于 SGA 或 FGA 的新生儿更有可能出现产后疾病，因此分娩应在设有新生儿重症监护病房的诊所进行计划。
