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一项评估异维甲酸对新生儿致畸作用的多中心队列研究。

A Multicenter Cohort Study Evaluating the Teratogenic Effects of Isotretinoin on Neonates.

作者信息

Brzezinski Piotr, Zonda Gabriela Ildiko, Hincu Maura Adelina, Vasilache Ingrid-Andrada, Chiriac Anca, Ciuhodaru Madalina Irina, Borowska Katarzyna, Paduraru Luminita

机构信息

Department of Physiotherapy and Medical Emergency, Faculty of Health Sciences, Pomeranian Academy Slupsk, 76-200 Slupsk, Poland.

Department of Dermatology, Provincial Specialist Hospital in Slupsk, 76-270 Ustka, Poland.

出版信息

Children (Basel). 2022 Oct 23;9(11):1612. doi: 10.3390/children9111612.

DOI:10.3390/children9111612
PMID:36360340
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9688499/
Abstract

(1) Background: Isotretinoin (ISO) is a systemic retinoid known for its teratogenic effects on embryos and fetuses. The aim of this study was to compare the pregnancy outcomes of women who were exposed to isotretinoin with those of women without such exposure from a teratogenic point of view. (2) Methods: A total of 1459 female patients from three clinical hospitals in Poland and Romania, segregated into two groups depending on their ISO exposure, were evaluated between January and December 2019. Medical records were screened to identify the pregnancy outcomes and congenital malformation rates. (3) Results: The congenital malformation rate for the exposed group was 1.2% (four cases), and no specific signs of Accutane embryopathy were identified. Women from the unexposed group were more likely to deliver preterm and through cesarean deliveries and had a higher rate of newborn congenital malformations as compared to women from the exposed group. (4) Conclusions: Even though we could not find a significant association between ISO exposure and teratogenic effects in newborns, effective contraceptive measures are key to preventing unfavorable pregnancy outcomes.

摘要

(1) 背景:异维A酸(ISO)是一种全身性类视黄醇,因其对胚胎和胎儿具有致畸作用而闻名。本研究的目的是从致畸角度比较接触异维A酸的女性与未接触异维A酸的女性的妊娠结局。(2) 方法:2019年1月至12月期间,对来自波兰和罗马尼亚三家临床医院的1459名女性患者进行了评估,根据她们接触异维A酸的情况分为两组。筛查医疗记录以确定妊娠结局和先天性畸形率。(3) 结果:暴露组的先天性畸形率为1.2%(4例),未发现异维A酸胚胎病的特定体征。与暴露组女性相比,未暴露组女性更有可能早产并通过剖宫产分娩,新生儿先天性畸形率更高。(4) 结论:尽管我们未发现接触异维A酸与新生儿致畸作用之间存在显著关联,但有效的避孕措施是预防不良妊娠结局的关键。

相似文献

1
A Multicenter Cohort Study Evaluating the Teratogenic Effects of Isotretinoin on Neonates.一项评估异维甲酸对新生儿致畸作用的多中心队列研究。
Children (Basel). 2022 Oct 23;9(11):1612. doi: 10.3390/children9111612.
2
Isotretinoin exposure during pregnancy: assessment of spontaneous reports in France.妊娠期间异维 A 酸暴露:法国自发报告评估。
Drug Saf. 2010 Aug 1;33(8):659-65. doi: 10.2165/11536250-000000000-00000.
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Identifying pregnancies in insurance claims data: Methods and application to retinoid teratogenic surveillance.在保险理赔数据中识别妊娠情况:方法及其在维甲酸致畸监测中的应用。
Pharmacoepidemiol Drug Saf. 2019 Sep;28(9):1211-1221. doi: 10.1002/pds.4794. Epub 2019 Jul 22.
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Congenital microtia in a neonate due to maternal isotretinoin exposure 1 month before pregnancy: Case Report.孕期前1个月母亲接触异维甲酸导致新生儿先天性小耳畸形:病例报告
J Obstet Gynaecol Res. 2015 Jun;41(6):975-8. doi: 10.1111/jog.12644. Epub 2015 Mar 15.
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Minor malformations characteristic of the retinoic acid embryopathy and other birth outcomes in children of women exposed to topical tretinoin during early pregnancy.在妊娠早期接触外用维甲酸的女性所生儿童中,出现的维甲酸胚胎病特征性轻微畸形及其他出生结局。
Am J Med Genet A. 2005 Jul 15;136(2):117-21. doi: 10.1002/ajmg.a.30744.
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Continued occurrence of Accutane-exposed pregnancies.暴露于异维甲酸的妊娠仍在持续发生。
Teratology. 2001 Sep;64(3):142-7. doi: 10.1002/tera.1057.
7
[Isotretinoin: compliance with recommendations in childbearing women].异维A酸:育龄期女性对相关建议的依从性
Ann Dermatol Venereol. 2005 May;132(5):415-23. doi: 10.1016/s0151-9638(05)79302-9.
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Prenatal exposure to teratogenic medications in the era of Risk Evaluation and Mitigation Strategies.产前暴露于致畸性药物时代的风险评估和缓解策略。
Am J Obstet Gynecol. 2022 Aug;227(2):263.e1-263.e38. doi: 10.1016/j.ajog.2022.01.004. Epub 2022 Jan 12.
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A new perspective on isotretinoin in pregnancy: Pregnancy outcomes, evaluation of complex phenotypes, and importance of teratological counselling.关于妊娠中异维 A 酸的新视角:妊娠结局、复杂表型的评估以及致畸咨询的重要性。
Eur J Obstet Gynecol Reprod Biol. 2023 Dec;291:148-155. doi: 10.1016/j.ejogrb.2023.10.024. Epub 2023 Oct 18.
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Face-to-face: isotretinoin use and pregnancy outcome.面对面:异维 A 酸的使用与妊娠结局。
Int J Dermatol. 2024 Feb;63(2):232-238. doi: 10.1111/ijd.16953. Epub 2023 Dec 14.

本文引用的文献

1
Pregnancy and neonatal outcomes after periconceptional exposure to isotretinoin in Koreans.韩国人在受孕前后接触异维甲酸后的妊娠及新生儿结局。
Obstet Gynecol Sci. 2022 Mar;65(2):166-175. doi: 10.5468/ogs.21354. Epub 2022 Feb 23.
2
Vaginal birth after Cesarean experience in Romania: A retrospective case-series study and online survey.罗马尼亚剖宫产术后经阴道分娩的经验:一项回顾性病例系列研究及在线调查
Exp Ther Med. 2021 Aug;22(2):894. doi: 10.3892/etm.2021.10326. Epub 2021 Jun 18.
3
Awareness of isotretinoin use and Saudi FDA pregnancy prevention program in Riyadh, Saudi Arabia: A cross-sectional study among female patients.沙特阿拉伯利雅得地区女性患者对异维甲酸使用及沙特食品药品管理局妊娠预防计划的认知:一项横断面研究
Saudi Pharm J. 2021 Jun;29(6):527-532. doi: 10.1016/j.jsps.2021.04.013. Epub 2021 Apr 23.
4
A pilot study on the effect of isotretinoin on serum etonogestrel concentrations in contraceptive implant users.异维 A 酸对避孕埋植剂使用者血中依托孕烯浓度的影响的初步研究。
Contraception. 2020 Jul;102(1):58-60. doi: 10.1016/j.contraception.2020.04.011. Epub 2020 Apr 20.
5
Optimizing Isotretinoin Treatment of Acne: Update on Current Recommendations for Monitoring, Dosing, Safety, Adverse Effects, Compliance, and Outcomes.优化异维 A 酸治疗痤疮:当前监测、剂量、安全性、不良反应、依从性和结局建议的更新。
Am J Clin Dermatol. 2020 Jun;21(3):411-419. doi: 10.1007/s40257-020-00508-0.
6
[Isotretinoin embryopathy: An entity that can be avoided].异维甲酸胚胎病:一种可避免的病症
Arch Argent Pediatr. 2018 Apr 1;116(2):e303-e307. doi: 10.5546/aap.2018.e303.
7
Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy.异维 A 酸治疗期间的妊娠发生和妊娠结局。
CMAJ. 2016 Jul 12;188(10):723-730. doi: 10.1503/cmaj.151243. Epub 2016 Apr 25.
8
Isotretinoin updates.异维 A 酸更新。
Dermatol Ther. 2013 Sep-Oct;26(5):377-89. doi: 10.1111/dth.12084.
9
Important controversies associated with isotretinoin therapy for acne.与痤疮异维 A 酸治疗相关的重要争议。
Am J Clin Dermatol. 2013 Apr;14(2):71-6. doi: 10.1007/s40257-013-0014-z.
10
Pregnancy and isotretinoin therapy.妊娠与异维A酸治疗
CMAJ. 2013 Mar 19;185(5):411-3. doi: 10.1503/cmaj.120729. Epub 2013 Jan 7.