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欧盟预防怀孕计划修订后异维甲酸预防怀孕建议的依从性:爱沙尼亚的一项重复研究

Compliance with Pregnancy Prevention Recommendations for Isotretinoin Following the Amendment of the European Union Pregnancy Prevention Program: A Repeat Study in Estonia.

作者信息

Ivask Maaja, Kurvits Katrin, Uusküla Maia, Juppo Anne, Laius Ott, Siven Mia

机构信息

Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.

Roche International Pharmacovigilance, Roche Eesti OÜ, Tallinn, Estonia.

出版信息

Drugs Real World Outcomes. 2024 Mar;11(1):91-98. doi: 10.1007/s40801-023-00381-3. Epub 2023 Jul 18.

Abstract

BACKGROUND

Isotretinoin, indicated for severe acne, is a potent teratogen and therefore contraindicated in pregnancy. Thus, the pregnancy prevention program (PPP) for isotretinoin has been introduced.

OBJECTIVES

The aim of this study was to assess the concomitant use of isotretinoin and effective contraception and the rate of potential isotretinoin-exposed pregnancies in females of childbearing age in 2017-2020 in Estonia. In addition, we aimed to evaluate whether compliance with the PPP has improved compared with the previous study conducted in Estonia covering the period of 2012-2016.

METHODS

This retrospective, nationwide study using prescription and healthcare claims data included 2575 females aged 15-45 years who started using isotretinoin between 2017 and 2020.

RESULTS

For 64.7% of females of childbearing age, no concurrent use of an effective contraceptive was detected while using isotretinoin. A moderately higher contraceptive coverage (35.3%) was observed compared with the previous study (29.7%) (p < 0.001). Complete contraception coverage was highest in females aged 30-39 years with an adjusted OR of 12.8 (p < 0.001) compared with the age group 15-19 years and 2.47 (p < 0.001) compared with the age group 20-29 years. 17 pregnancies coincided with the isotretinoin treatment-related period. The risk for potential isotretinoin-exposed pregnancy was 6.6 (95% CI 3.9-10.5) per 1000 treated females of childbearing age over the 4-year observation period. The risk for potential isotretinoin-exposed pregnancies per 1000 treated females was 1.0 in females aged 15-19 years, 11.6 in females aged 20-29 years, 8.8 in females aged 30-39 years, and 7.4 in females aged 40-45 years (p = 0.009).

CONCLUSION

A slight improvement in complete contraceptive coverage during isotretinoin use has not resulted in a decrease in the risk of isotretinoin-exposed pregnancies. The contraceptive usage and risk for pregnancy vary greatly across age groups, suggesting the need for a more targeted approach to improve the effectiveness of the PPP.

摘要

背景

异维A酸用于治疗重度痤疮,是一种强效致畸剂,因此孕期禁用。因此,已推出异维A酸的妊娠预防计划(PPP)。

目的

本研究的目的是评估2017 - 2020年爱沙尼亚育龄女性中异维A酸与有效避孕措施的同时使用情况以及潜在的异维A酸暴露妊娠率。此外,我们旨在评估与爱沙尼亚此前在2012 - 2016年进行的研究相比,PPP的依从性是否有所提高。

方法

这项使用处方和医疗保健索赔数据的全国性回顾性研究纳入了2575名年龄在15 - 45岁之间、于2017年至2020年开始使用异维A酸的女性。

结果

在使用异维A酸的育龄女性中,64.7%未检测到同时使用有效避孕措施。与之前的研究(29.7%)相比,观察到避孕措施覆盖率适度提高(35.3%)(p < 0.001)。完全避孕覆盖率在30 - 39岁女性中最高,与15 - 19岁年龄组相比,调整后的比值比为12.8(p < 0.001),与20 - 29岁年龄组相比为2.47(p < 0.001)。17例妊娠与异维A酸治疗相关期重合。在4年观察期内,每1000名接受治疗的育龄女性中,潜在的异维A酸暴露妊娠风险为6.6(95%可信区间3.9 - 10.5)。每1000名接受治疗的女性中,15 - 19岁女性潜在的异维A酸暴露妊娠风险为1.0,20 - 29岁女性为11.6,30 - 39岁女性为8.8,40 - 45岁女性为7.4(p = 0.009)。

结论

在使用异维A酸期间,完全避孕覆盖率略有提高,但并未降低异维A酸暴露妊娠风险。不同年龄组的避孕措施使用情况和妊娠风险差异很大,这表明需要采取更有针对性的方法来提高PPP的有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b68f/10928043/73483e7dbc0a/40801_2023_381_Fig1_HTML.jpg

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