可纳预防对候群病和早产婴儿死亡率的影响:一项随机临床试验
Daniel K Benjamin1, Mark L Hudak2, Shahnaz Duara3
1Duke Clinical Research Institute, Durham, North Carolina.
JAMA
|May 6, 2014
概括
预防性甲醇 (一种抗真菌药物) 在极低出生体重的婴儿中没有显著减少死亡或侵入性角膜炎. 这项研究表明,在这个易受伤害的人群中,不支持普洛可纳的普遍使用.
科学领域:
- 新生儿医学 新生儿医学
- 传染性疾病 传染性疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 侵袭性候群病对早产婴儿构成严重威胁,导致死亡率和长期神经发育问题.
- 可纳预防药物用于预防候群病,但其对极低出生体重 (ELBW) 婴儿的死亡率和整体安全性的影响尚不清楚.
研究的目的:
- 评估可纳预防的疗效和安全性,以预防 ELBW 婴儿的死亡或侵袭性角膜炎.
- 为了评估与安慰剂相比,在接受可纳的婴儿中长期的神经发育结果.
主要方法:
- 一项随机,双盲,安慰剂对照试验,涉及32个美国NICU的361名ELBW婴儿 (出生体重<750g).
- 婴儿在42天内每周两次接受可纳 (6mg/kg) 或安慰剂.
- 主要终点是研究第49天死亡或侵袭性角膜炎的复合;神经发育结果在18-22个月的年龄修正后进行评估.
主要成果:
- 综合初级终点 (死亡或侵袭性候群病) 发生在16%的富可纳组和21%的安慰剂组 (P=.24),没有显示出统计学上显著的差异.
- 富可纳组的侵袭性候群病明显减少 (3%对9%,P=.02).
- 两组之间在其他次要结果或神经发育障碍率方面没有发现显著差异.
结论:
- 与安慰剂相比,在ELBW婴儿中进行42天的可纳预防并没有降低死亡或侵袭性角膜炎的发生率.
- 这些发现不支持在所有 ELBW 婴儿中常规使用预防性可纳.
- 虽然可纳减少了侵入性角膜病,但缺乏对死亡率和神经发育结果的影响限制了其普遍应用.
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