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法国在怀孕期间使用多发性硬化症的疾病修正疗法:2010 年至 2021 年的全国性研究。

Use of multiple sclerosis disease-modifying therapies during pregnancy in France: Nationwide study between 2010 and 2021.

机构信息

EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products-ANSM, French National Health Insurance-CNAM), Saint-Denis, France.

French National Institute of Health and Medical Research (INSERM), Department of Social Epidemiology (ERES), Pierre Louis Institute for Epidemiology and Public Health (IPLESP), Paris, France.

出版信息

Mult Scler. 2024 Feb;30(2):227-237. doi: 10.1177/13524585231223395. Epub 2024 Jan 27.

Abstract

BACKGROUND

Multiple sclerosis (MS) frequently affects women of childbearing age and pregnant women.

OBJECTIVE

To assess the use of MS disease-modifying therapies (DMTs) during pregnancy in France over the last decade, marked by an increasing DMTs availability.

METHODS

All pregnancies ended from April 2010 to December 2021 in women with MS were identified based on the nationwide Mother-Child Register EPI-MERES, built from the French National Health Data System ( (SNDS)).

RESULTS

Of a total of 20,567 pregnancies in women with MS, 7587 were exposed to DMT. The number of DMT-exposed pregnancies markedly increased from 1079 in 2010-2012 to 2413 in 2019-2021 (+124%), especially those exposed to glatiramer acetate, natalizumab, dimethyl fumarate, and anti-CD20. Among pregnancies of women on DMT 6 months before pregnancy, 78.0% underwent DMT discontinuation and 7.6% switched DMT, generally before (33.0% and 77.0%, respectively) or during the first trimester of pregnancy (58.3% and 17.8%, respectively). DMT discontinuation decreased from 84.0% in 2010-2012 to 72.4% in 2019-2021 and was less frequent among women aged ⩾35 years and those socioeconomically disadvantaged.

CONCLUSION

Despite MS therapeutic management adaptations to pregnancy, exposure during pregnancy to treatments whose safety profile has not yet been clearly established has increased sharply over the last decade.

摘要

背景

多发性硬化症(MS)常影响育龄期妇女和孕妇。

目的

评估过去十年中法国在 MS 疾病修饰疗法(DMT)在怀孕期间的使用情况,该时期 DMT 的可获得性有所增加。

方法

基于全国性母婴注册 EPI-MERES,从法国国家健康数据系统((SNDS))中确定了 2010 年 4 月至 2021 年 12 月期间所有结束妊娠的 MS 女性。

结果

在总计 20567 例 MS 女性妊娠中,7587 例暴露于 DMT。DMT 暴露妊娠的数量从 2010-2012 年的 1079 例显著增加到 2019-2021 年的 2413 例(增加 124%),尤其是接受聚乙二醇干扰素β、那他珠单抗、富马酸二甲酯和抗-CD20 治疗的患者。在妊娠前 6 个月接受 DMT 的妊娠中,78.0%停止 DMT,7.6%转换 DMT,通常是在妊娠前(分别为 33.0%和 77.0%)或妊娠早期(分别为 58.3%和 17.8%)。DMT 停药率从 2010-2012 年的 84.0%下降到 2019-2021 年的 72.4%,且在年龄≥35 岁和社会经济地位较低的女性中较少见。

结论

尽管 MS 治疗管理适应了妊娠需求,但在过去十年中,怀孕期间暴露于治疗药物的情况急剧增加,而这些药物的安全性尚未明确。

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