非常早产婴儿的Bifidobacterium breve BBG- 001:一个随机对照的第三阶段试验
Kate Costeloe1, Pollyanna Hardy2, Edmund Juszczak2
1Centre for Paediatrics, Blizard Institute, Barts and the London School of Medicine and Dentistry, London, UK.
Lancet (London, England)
|December 3, 2015
概括
这项研究发现,益生菌Bifidobacterium breve BBG- 001并没有显著减少早产婴儿的死肠炎,晚发性败血症或死亡. 因此,对于非常早产的婴儿来说,不支持常规使用这种益生菌.
科学领域:
- 新生儿研究
- 微生物组和婴儿健康
- 临床试验方法
背景情况:
- 益生菌正在研究其降低早产婴儿死肠炎和晚发性败血症的潜力.
- 有关新生儿前期益生菌试验的严谨性和通用性存在担忧.
- 对于早产婴儿的常规使用益生菌没有确定的共识.
研究的目的:
- 评估益生菌Bifidobacterium breve BBG- 001在减少早产婴儿死性肠炎,晚发性败血症和死亡率方面的有效性.
- 提供关于新生儿重症监护中的益生菌补充剂的强有力的证据,以告知临床实践.
主要方法:
- 一个多中心,随机的,受控的3期试验 (PiPS试验) 涉及23至30周妊娠年龄之间的婴儿.
- 随机分配 (1: 1) 接受Bifidobacterium breve BBG- 001或安慰剂 (稀释婴儿配方奶粉).
- 主要结局包括死肠炎 (贝尔2或3期),败血症 (血培养阳性>72小时) 和离院前死亡. 进行了治疗意向分析.
主要成果:
- 在益生菌组和安慰剂组之间没有观察到死性肠球炎,败血症或死亡率的显著差异.
- 在益生菌组的9%,而在安慰剂组的10%发生了死肠炎 (aRR为0. 93).
- 在益生菌组的11%和安慰剂组的12%发生了败血症 (aRR为0. 97),死亡发生在8%和9% (aRR为0. 93). 没有报告任何不良反应.
结论:
- 这项研究没有发现Bifidobacterium breve BBG- 001对预防早产婴儿死肠炎和晚发性败血症有任何益处.
- 这些结果不支持对这种脆弱群体进行常规的B. breve BBG- 001注射.
- 可能需要进一步的研究来探索特定的益生菌菌株或不同的婴儿群体.
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