多发性硬化症的怀孕和婴儿结果:来自全球MAPLE-MS药物监测计划的发现
Kerstin Hellwig1, Hugh H Tilson2, Sandra Thiel3
1Neurological Clinic, University of Bochum, Bochum, Germany.
Neurology(R) neuroimmunology & neuroinflammation
|June 30, 2025
概括
对于多发性硬化症 (MS) 暴露后的怀孕结果显示,大多数是活产,具有较低的重大先天性异常率. 这项研究评估了怀孕期间MS的女性和男性的克拉迪宾暴露.
科学领域:
- 神经学 神经学
- 药物监督 药物监督 药物监督
- 生殖健康 生殖健康
背景情况:
- 在患有多发性硬化症 (MS) 的妇女暴露于克拉迪宾片后,关于怀孕和婴儿后果的数据有限.
- 怀孕期间使用克拉德里宾是禁忌的,因此需要评估暴露风险.
- 这项研究解决了MS患者在怀孕前或怀孕期间暴露于cladribine的知识差距.
研究的目的:
- 评估患有多发性硬化症的妇女暴露于克拉迪片的怀孕和婴儿后果.
- 为了评估患有多发性硬化症的男性孕育的怀孕结果,这些男性暴露于克拉德里宾片.
- 为了确定重大先天性异常 (MCAs) 和其他妊娠结果的患病率.
主要方法:
- 利用了MAPLE-MS药物监测计划和全球患者安全数据库.
- 收集了孕妇在母亲或父亲期间暴露于克拉德里宾片的数据.
- 主要结局:MCA的流行;次要结局:活产,终止,堕胎,宫外妊娠,死产.
主要成果:
- 在7年对383例怀孕的临时分析中,336例涉及母亲和47例涉及父亲的克拉迪宾暴露.
- 孕产妇暴露:MCA患病率为1.1% (心房隔膜缺陷),活产率为57.3%.
- 父亲暴露:在活产中没有观察到MCAs; 81.3%的活产.
结论:
- 大多数已知结果的怀孕都导致活产,选择性终止和死产率较低.
- 报告了单个主要的先天性异常 (心房隔膜缺陷).
- 结果与一般人群和多发性硬化症患者队列估计相一致,尽管受到小样本规模的限制.
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