母亲暴露于皮和特定出生缺陷的风险
Meredith M Howley1, Martha M Werler2, Sarah C Fisher1
1New York State Department of Health, Birth Defects Registry, Albany, New York, USA.
Journal of sleep research
|June 3, 2023
概括
这项研究调查了在怀孕早期和出生缺陷期间使用佐洛皮的情况. 虽然结果表明风险没有很大增加,但不能排除特定出生缺陷的较小风险.
科学领域:
- 产科和妇科 产科和妇科
- 甲状腺学 甲状腺学
- 药学流行病学 药学流行病学
背景情况:
- 佐尔皮 (Zolpidem) 是一种常见的非二胺失眠治疗药物.
- 它在怀孕期间的安全性概况在很大程度上是未知的.
- 了解潜在风险对于母亲和婴儿健康至关重要.
研究的目的:
- 评估早期怀孕中使用佐洛皮德姆与特定出生缺陷之间的关联.
- 提供有关皮在怀孕第一季度的安全性数据.
主要方法:
- 利用来自两个大型多地点病例控制研究 (国家出生缺陷预防研究和斯隆流行病学中心出生缺陷研究) 的数据.
- 包括39,711例出生缺陷病例和23,035例对照病例.
- 采用后勤回归与Firth的惩罚概率调整的赔率比率,控制多个共变量.
主要成果:
- 总体而言,早期怀孕中使用佐洛皮很少 (0.2%的病例和对照).
- 针对七种缺陷的调整后赔率比率从0.76 (裂唇) 到2.18 (胃).
- 四个缺陷显示赔率比率>1.8,但所有置信区间包括零值,表明不准确的估计.
结论:
- 该研究没有发现证据支持与早期怀孕中使用佐洛皮相关的出生缺陷风险大幅增加.
- 然而,由于样本规模有限和估计不准确,不能排除某些特定出生缺陷的风险增加较小.
- 需要使用更大的样本大小进行进一步的研究来证实这些发现.
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