Ammon-Pinizzotto Center for Women's Mental Health, Massachusetts General Hospital, Boston, MA, USA.
Harvard Medical School, Boston, MA, USA.
Arch Womens Ment Health. 2021 Aug;24(4):659-667. doi: 10.1007/s00737-021-01115-6. Epub 2021 Mar 12.
Aripiprazole has become one of the most commonly prescribed psychotropics, making a more comprehensive understanding of its reproductive safety profile a priority. The goal of the current analysis was to determine the risk of major malformations in infants exposed during the first trimester of pregnancy to aripiprazole compared to infants whose mothers had psychiatric diagnoses but did not use an atypical antipsychotic during pregnancy. The National Pregnancy Registry for Atypical Antipsychotics is a prospective pharmacovigilance program in which pregnant women are enrolled and interviewed during pregnancy and the postpartum period. Medical records are assessed to confirm presence or absence of major malformations. Pregnant women ages 18-45 with psychiatric diagnoses are enrolled. As of April 2020, N = 848 women who had delivered infants were eligible for analyses. A total of 158 women with first trimester exposure to aripiprazole were compared to 690 controls. For 163 infants born to women in the exposed group, seven major malformations were confirmed (4.29%), compared to fourteen of the 690 unexposed infants (1.99%). The unadjusted odds ratio for major malformations between aripiprazole-exposed and unexposed infants was 2.21 (95% confidence interval [CI] = (0.88, 5.57) The adjusted odds ratio for major malformations was 1.35 (95% confidence interval [CI] = (0.43, 4.20). After adjustment for confounding variables, the risk of major malformations after first trimester exposure to aripiprazole was not significant compared to controls. While these results are reassuring, they are limited by relatively small numbers of participants. Future analyses with larger numbers are expected to provide more of a complete and precise reproductive safety profile regarding aripiprazole use during pregnancy. Trial registration: clinicaltrials.gov NCT01246765.
阿立哌唑已成为最常开的精神药物之一，因此更全面地了解其生殖安全性成为当务之急。本分析的目的是确定与母亲在怀孕期间患有精神疾病但未使用非典型抗精神病药物的婴儿相比，在怀孕第一 trimester 暴露于阿立哌唑的婴儿发生重大畸形的风险。国家非典型抗精神病药物妊娠登记处是一个前瞻性药物警戒计划，在此计划中，孕妇在怀孕期间和产后期间被招募并接受访谈。评估医疗记录以确认是否存在重大畸形。纳入年龄在 18-45 岁之间、患有精神疾病诊断的孕妇。截至 2020 年 4 月，共有 848 名分娩婴儿的孕妇符合分析条件。共有 158 名在怀孕第一 trimester 暴露于阿立哌唑的女性与 690 名对照进行了比较。在暴露组的 163 名婴儿中，有 7 名（4.29%）被证实患有重大畸形，而 690 名未暴露婴儿中有 14 名（1.99%）。阿立哌唑暴露组和未暴露组婴儿重大畸形的未调整比值比为 2.21（95%置信区间[CI]为（0.88，5.57）。重大畸形的调整比值比为 1.35（95%置信区间[CI]为（0.43，4.20）。在调整混杂变量后，与对照组相比，怀孕第一 trimester 暴露于阿立哌唑后发生重大畸形的风险并不显著。尽管这些结果令人放心，但由于参与者数量相对较少，它们存在局限性。预计未来的分析将有更多数量的参与者提供关于怀孕期间使用阿立哌唑的更完整和更准确的生殖安全性概况。试验注册：clinicaltrials.gov NCT01246765。
