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Lancet:双歧杆菌BBG-001对于极度早产儿的坏死性小肠结肠炎没有益处

2015-11-26 崔倩 译 MedSci原创

益生菌可以减少坏死性肠炎和晚发型败血症后早产。然而,已经有一些试验的严谨性和普适性的关注并没有约定是否应常规使用。我们的目的是测试的益生菌双歧杆菌bbg-001效能,减少坏死性肠炎,晚发型败血症,和早产儿死亡。

益生菌可能减少早产后坏死性小肠结肠炎和晚发性败血症的发生。但是,出现了对于一些试验严谨性和普适性的关注,并没有关于他们是否按照常规协议的证据。该研究的目的是测试益生菌双歧杆菌BBG-001,对于减少早产儿坏死性小肠结肠炎,晚发性败血症,甚至死亡的有效性。

在这个多中心、随机对照的3期研究(PiPS试验)中,研究人员招募了来自英格兰东南部24家医院的出生48小时内的23到30周胎龄的婴儿。这些婴儿经由最小化算法随机化程序被随机分配(1:1)接受益生菌或安慰剂。益生菌干预是乙杆菌BBG-001悬浮,用含有微量元素的婴儿配方奶粉稀释,肠内给予每日剂量为8.2-9.2 log10 CFU;安慰剂只用婴幼儿配方奶粉稀释。临床医生和家庭成员均不知道治疗分配。主要成果是在出生后超过72小时坏死性小肠结肠炎(钟状期2或3)、败血症血培养阳性;以及出院前死亡。所有主要分析采用意向治疗分析。

在2010年7月1日和2013年7月31日期间,1315名婴儿参与此研究;其中654名被分配接受益生菌,661名接受安慰剂。五名婴儿在随机分组后被同意退出研究,所以安慰剂组有650名婴儿,益生菌组有660名婴儿进行分析。主要成果率在益生菌组和安慰剂组之间没有显著差异。益生菌组61(9%)名婴儿和安慰剂组的66(10%)名婴儿发生坏死性小肠结肠炎(调整后的危险比0.93(95%Cl 0.68-1.27);益生菌组73(11%)名婴儿和安慰剂组77(12%)名婴儿发生脓毒症(0.97(0.73-1.29);益生菌组54(8%)名婴儿出院回家之前死亡,安慰剂组56(9%)名婴儿发生死亡(0.93[0.67-1.30])。未发生益生菌相关的不良事件。

没有任何证据表明这一干预措施对于这一人群有益;这个结果并不支持常规采用B杆菌BBG-001来预防极度早产儿坏死性小肠结肠炎和迟发性脓毒症。

原始出处:

Kate Costeloe,Pollyanna Hardy,Edmund Juszczak,et al.Bifidobacterium breve BBG-001 in very preterm infants,Lancet,2015.11.25

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    2016-02-22 howi
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    2015-11-27 millore
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