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用于极度早产婴儿的内布德索尼德混合:PLUSS随机临床试验
Brett J Manley1,2,3, C Omar F Kamlin1,2, Susan M Donath3,4
1Newborn Research, The Royal Women's Hospital, Melbourne, Victoria, Australia.
JAMA
|November 11, 2024
概括
在极度早产的婴儿中,早期的内布埃索尼德并没有显著改善无支气管肺张症 (BPD) 的生存率. 这项研究表明这种干预措施在高风险新生儿中预防BPD的益处有限.
科学领域:
- 新生儿医学
- 儿童肺病学
- 临床试验
背景情况:
- 支气管肺功能障碍 (BPD) 是极度早产婴儿的常见并发症.
- 系统性皮质类固醇对BPD有效,但存在风险.
- 肺内皮质固醇是一种潜在的更安全的替代品.
研究的目的:
- 评估早期内内布德索尼德的疗效.
- 评估36周月经后对无BPD存活率的影响.
- 调查这项干预的安全结果.
主要方法:
- 这是一项双盲随机临床试验,涉及1059名极早产婴儿 (妊娠28周以下).
- 婴儿接受了布德索尼德与表面活性剂或表面活性剂单独的治疗.
- 主要结局是经月经36周后没有BPD的生存期.
主要成果:
- 没有BPD的生存率为25.6%与budesonide相比为22.6% (调整后的风险差异为2. 7%;95%CI为-2. 1%至7. 4%).
- 在月经后36周的整体存活率为budesonide的83. 2%和没有的80. 6%.
- 在幸存者中没有明显的BPD率差异.
结论:
- 在极度早产的婴儿中,早期的内治疗对没有BPD的存活率几乎没有影响.
- 这些发现表明这种干预可能对预防BSD没有好处.
- 可能需要进一步的研究来探索其他预防BPD的策略.
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