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在有风险患上支气管肺失生症的早产婴儿中,罗塞米德的安全性:一项随机临床试验
Rachel G Greenberg1, Jason Lang1, P Brian Smith1
1Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA.
The Journal of pediatrics
|April 30, 2025
概括
富罗塞米德并没有增加风险为支气管肺张力症 (BPD) 的早产婴儿的不良事件,听力损失或骨. 然而,它确实增加了电解质异常,但没有影响BPD或死亡率.
科学领域:
- 新生儿医学 新生儿医学
- 儿科药理学 儿科药理学
- 呼吸系统医学 呼吸系统医学
背景情况:
- 支气管肺功能障碍症 (BPD) 是早产婴儿的常见并发症.
- 罗塞米德经常用于新生儿,但其在这个人群中的安全性需要进一步调查.
研究的目的:
- 评估罗塞米德在患有BPD风险的早产婴儿的安全性和有效性.
- 评估不良事件 (AE) 的发生率,BPD,死亡,听力损失和骨瘤.
主要方法:
- 一个多中心的,随机的,剂量升级的,安慰剂受控的试验.
- 婴儿出生时<29周的妊娠年龄被随机分配,接受28天的罗塞米德或安慰剂剂的升级剂量.
- 结果包括AEs总数,BPD,死亡,听力损失,电解质异常和骨.
主要成果:
- 罗塞米德和安慰剂组之间的AEs,BPD,死亡,听力损失或神经结症总体没有显著差异.
- 发胺的使用与血清电解质异常的显著增加有关 (P = .048和P = .023在队列中).
结论:
- 罗塞米德对于总体的副作用,听力损失和患有BPD风险的早产婴儿的骨瘤是安全的.
- 罗西米德增加了电解质异常的风险,但没有影响中度至重度BPD或死亡率.
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