Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
CNS Drugs. 2018 Apr;32(4):351-366. doi: 10.1007/s40263-018-0517-5.
The issue of antipsychotic treatment during pregnancy is subject to substantial uncertainty and some controversy among healthcare providers, specifically pertaining to second-generation antipsychotics (SGAs) that are subject to a large gap in safety data during pregnancy compared with antidepressants. The amount of safety data for the use of SGAs during pregnancy is rapidly increasing, thus constantly changing the level of evidence. We performed a clinically focused review on the safety of SGA during pregnancy. Twenty-three studies provided various pregnancy outcomes for 14,382 pregnant women exposed to an SGA during pregnancy. In utero exposure to aripiprazole, olanzapine, and quetiapine is not associated with increased risks of major congenital malformations, whereas risperidone and paliperidone may be associated with a very minor increased risk of congenital malformations. Safety data on ziprasidone and clozapine remain scarce and insufficient for a quantitative safety evaluation. No or minimal safety data are available for amisulpride, asenapine, lurasidone, and sertindole. For other pregnancy outcomes of interest, e.g. miscarriage, stillbirth, and small for gestational age, the available data overall do not suggest a clinically important increased risk, and do not allow for a meaningful stratification on individual drug level. Furthermore, for neonatal adaption and childhood neurodevelopment, the data do not allow for a meaningful risk assessment. It is imperative that factors in addition to safety data, e.g. individual disease history, characteristics and treatment response, adverse reaction profile, and patient preferences, be considered for the individual patient when choosing specific SGA treatment during pregnancy.
抗精神病药物治疗在孕期的问题存在较大的不确定性，在医疗保健提供者中存在一定争议，特别是在第二代抗精神病药物（SGAs）方面，与抗抑郁药相比，其在孕期的安全性数据存在较大差距。SGAs 在孕期使用的安全性数据正在迅速增加，因此证据水平不断变化。我们对 SGA 在孕期的安全性进行了临床重点评估。23 项研究为 14382 名孕妇提供了各种妊娠结局，这些孕妇在孕期接触了 SGA。阿立哌唑、奥氮平、喹硫平的宫内暴露与重大先天性畸形风险增加无关，而利培酮和帕利哌酮可能与极小的先天性畸形风险增加相关。齐拉西酮和氯氮平的安全性数据仍然很少，不足以进行定量安全性评估。氨磺必利、阿塞那平、鲁拉西酮和舍吲哚的安全性数据几乎没有。对于其他感兴趣的妊娠结局，例如流产、死产和胎儿生长受限，现有数据总体上并未提示存在临床重要的风险增加，也无法在个体药物水平上进行有意义的分层。此外，对于新生儿适应和儿童神经发育，数据也无法进行有意义的风险评估。在选择孕期特定 SGA 治疗时，除了安全性数据外，还必须考虑其他因素，例如个体病史、特征和治疗反应、不良反应谱以及患者偏好。
