在第一季度使用双激素后,没有先天性异常的额外风险:系统性审查和元分析
Alexander Katalinic1, Maria R Noftz1, Juan A Garcia-Velasco2,3
1Institute for Social Medicine and Epidemiology, University of Luebeck, Luebeck, Germany.
Human reproduction open
|February 12, 2024
概括
在怀孕早期使用二激素来治疗可能流产的威胁或辅助生殖技术 (ART) 并不会增加先天性异常的风险. 这一系统性审查在这些临床情景中提供了关于dydrogesterone安全性的保证.
科学领域:
- 生殖医学和内分泌学.
- 产科和妇科 产科和妇科
- 临床药理学 临床药理学
背景情况:
- 关于怀孕早期的二的安全性,存在相互矛盾的信息,一些撤回的研究表明产性.
- 二经常被认为比生物相同的孕激素不那么安全,造成临床不确定性.
- 之前的大规模试验和元分析没有确定二多激素与先天性异常之间的关联.
研究的目的:
- 系统地审查和元分析与第一季度迪多固暴露相关的先天性异常风险.
- 评估当用于复发性/威胁性妊娠损失或作为辅助生殖技术 (ART) 中的质支持时使用的二二的安全性.
主要方法:
- 对人类研究 (RCT和观察性研究) 进行了系统审查和元分析.
- 搜索包括Medline,Embase,CENTRAL和ClinicalTrials.gov,没有语言,地区或日期的限制.
- 纳入标准侧重于在怀孕第一季度为特定妊娠指示和报告先天性异常而接受二二的女性.
主要成果:
- 包括九项研究 (六项RCT,三项OS),共计5070名参与者和2680名活产婴儿.
- 对RCT的元分析显示,风险比率 (RR) 为0.92 (95%CI为0.55-1.55) 的确定性很低.
- 包括观察性研究在内,整体RR为1.11 (95%CI为0.73-1.68),确定性也很低.
结论:
- 先天性异常往往是次要的结果,并且在研究中没有一致报告.
- 这一系统性审查和元分析提供了保证,二二不是先天性异常的额外危险因素.
- 这些发现提供了当前最高水平的证据,解决了以往低质量或撤回研究引起的不确定性.
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