Lee Hyunji, Koh Jae-Whoan, Kim Young-Ah, Chun Kyoung-Chul, Han Jung Yeol, Hwang Jong Hee, Choi June-Seek, Joo Sung Hong, Kwon Hye-Young
Korean Mother-Safe Counselling Center, Pregnancy and Breastfeeding Medicines Information Center, Seoul, Korea.
Department of Obstetrics and Gynecology, Inje University Ilsan Paik Hospital, Goyang, Korea.
Front Pharmacol. 2022 Apr 25;13:854562. doi: 10.3389/fphar.2022.854562. eCollection 2022.
Alprazolam is a commonly prescribed benzodiazepine for anxiety or panic disorder, even in pregnant women. Information on the safety of alprazolam during pregnancy is insufficient. We aimed to evaluate pregnancy and neonatal outcomes after exposure to alprazolam during pregnancy. A prospective study was conducted on 725 pregnancies from January 2000 to December 2019. Participants were recruited through the Korean Mother-Safe Program, a service providing information on drug-induced teratogenic risk during pregnancy and breastfeeding. Exposed (N = 96) and non-exposed (N = 629) women to alprazolam during pregnancy were selected and followed-up until delivery. Pregnancy outcomes, including spontaneous abortion, still birth, low birth weight (LBW), preterm birth, Apgar score (at 1 and 5 min), and malformations were measured and compared. Multivariable logistic regression was performed to examine the association between alprazolam exposure and outcomes. The mean age was 32.9 (SD 4.0) years in the alprazolam-exposed group and 31.8 (SD 3.8) years in the unexposed group ( = 0.008). The alprazolam exposure group demonstrated a significantly higher likelihood of pregnancy and neonatal outcomes: spontaneous abortion (OR = 2.38; 95% CI 1.20-4.69), LBW (OR = 3.65; 95% CI 1.22-11.00), and Apgar score at 1 min ≤ 7 (OR = 2.19; 95% CI 1.02-4.67). There was no significant difference in congenital abnormalities between the exposure and non-exposure groups. Our findings confirmed that alprazolam exposure during pregnancy was significantly associated with adverse pregnancy and neonatal outcomes, including spontaneous abortion, low birth weight, and Apgar score at 1 min ≤ 7. Alprazolam during pregnancy should be appropriately regulated and monitored.
阿普唑仑是一种常用于治疗焦虑症或恐慌症的苯二氮䓬类药物,甚至在孕妇中也有使用。关于阿普唑仑在孕期安全性的信息不足。我们旨在评估孕期接触阿普唑仑后的妊娠及新生儿结局。对2000年1月至2019年12月期间的725例妊娠进行了一项前瞻性研究。参与者通过韩国母婴安全计划招募,该计划提供有关孕期和哺乳期药物致畸风险的信息。选择孕期接触阿普唑仑的女性(N = 96)和未接触阿普唑仑的女性(N = 629),并随访至分娩。测量并比较妊娠结局,包括自然流产、死产、低出生体重(LBW)、早产、阿氏评分(1分钟和5分钟时)以及畸形情况。进行多变量逻辑回归分析以检验阿普唑仑暴露与结局之间的关联。阿普唑仑暴露组的平均年龄为32.9(标准差4.0)岁,未暴露组为31.8(标准差3.8)岁(P = 0.008)。阿普唑仑暴露组出现妊娠及新生儿不良结局的可能性显著更高:自然流产(比值比[OR]=2.38;95%置信区间[CI]1.20 - 4.69)、低出生体重(OR = 3.65;95%CI 1.22 - 11.00)以及1分钟时阿氏评分≤7(OR = 2.19;95%CI 1.02 - 4.67)。暴露组与未暴露组之间先天性异常无显著差异。我们的研究结果证实,孕期接触阿普唑仑与不良妊娠及新生儿结局显著相关,包括自然流产、低出生体重以及1分钟时阿氏评分≤7。孕期使用阿普唑仑应进行适当管控和监测。