孕产妇在第一季度暴露于莫萨酸水合物:评估先天性异常的风险
Yumiko Hirasawa1, Hisashi Tagashira2, Anna Ueno3
1Department of Pharmacy, NHO Shikoku Medical Center for Children and Adults, Zentuuji-shi, Kagawa, Japan.
Digestive diseases and sciences
|July 9, 2025
概括
孕妇在怀孕早期使用莫萨普里德酸 (莫萨普里德) 似乎不会显著增加婴儿出现重大先天性异常的风险. 这项研究表明,莫萨普里德可能对孕妇是安全的.
科学领域:
- 生殖毒理学 生殖毒理学
- 产周医学 产周医学
- 临床药理学 临床药理学
背景情况:
- 关于在怀孕期间使用莫萨普里德酸盐水合物 (莫萨普里德) 的安全性存在有限的数据.
- 在怀孕期间评估药物的安全性对于母亲和婴儿的健康至关重要.
研究的目的:
- 评估孕妇在怀孕期间暴露于莫萨普里德的安全性.
- 为了确定第一季度莫萨普里德使用与怀孕/婴儿结局之间的关联.
主要方法:
- 一项前性队列研究,利用来自日本病学信息中心的数据 (1988-2017年).
- 摩萨普里德暴露和对照孕妇之间重大先天性异常发生率的比较.
- 多变量物流回归分析用于评估风险.
主要成果:
- 莫萨普里德暴露 (1.92%) 和对照 (1.89%) 组之间主要先天性异常没有统计学上显著的差异.
- 重大先天性异常的相对风险为1.02 (95% CI 0.24-4.26).
- 在死产,自发流产,早产或低出生体重方面没有观察到显著差异.
结论:
- 怀孕早期的莫萨普里德暴露与重大先天性异常风险的大幅增加无关.
- 这些发现可能有助于减少怀孕期间对莫萨普里德使用的担忧.
- 可能需要进一步的研究来排除因样本大小而导致的轻微风险增加.
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