Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: a randomized clinical trial

Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: a randomized clinical trial
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DOI:
10.1016/s0378-3782(14)70020-9
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发表时间:
2014-03-01
影响因子:
2.5
通讯作者:
Stronati, Mauro
Stronati, Mauro
中科院分区:
医学4区
文献类型:
--
作者:
Manzoni, Paolo;Meyer, Michael;Stronati, Mauro

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重要性:NEC是一种常见的和严重的并发症,早产儿,特别是那些极低出生体重(VLBW,阶段2 NEC出院前。与对照组[14/258(5.4%)]相比,BLF和BLF+ LGG组[分别为5/247(2.0%)]和0/238(0%)]的NEC发生率显著降低(RR= 0.37; 95% CI:0.136-1.005; BLF与对照组相比p = 0.055; BLF+LGG与对照组相比RR= 0.00; p < 0.001)。两个治疗组的死亡和/或NEC发生率均显著较低(BLF和BLF+LGG组分别为4.0%和3.8%,对照组为10.1%; RR= 0.39; 95% CI:0.19-0.80; p = 0.008)。RR= 0.37; 95% CI:0.18-0.77; p = 0.006)。结论和相关性:与安慰剂相比,BLF单独补充或与LGG联合补充可降低VLBW新生儿> 2期NEC和死亡和/或>= 2期NEC的发生率。BLF可能是一个有前途的策略,以防止NEC在NICU设置。在BLF可以在临床环境中广泛使用之前,需要更多关于更大样本量的数据。(C)2014爱思唯尔爱尔兰有限公司版权所有。
Importance: NEC is a common and severe complication in premature neonates, particularly those with very-low-birth-weight (VLBW, stage 2 NEC prior to discharge.Results: Demographics, clinical and management characteristics of the 3 groups were similar, including type of feeding and maternal milk intakes. NEC incidence was significantly lower in groups BLF and BLF+ LGG [5/247(2.0%)] and 0/238(0%), respectively] than in controls [14/258 (5.4%)] (RR= 0.37; 95% CI: 0.136-1.005; p = 0.055 for BLF vs. control; RR= 0.00; p < 0.001 for BLF+LGG vs. control). The incidence of death-and/orNEC was significantly lower in both treatment groups (4.0% and 3.8% in BLF and BLF+LGG vs. 10.1% in control; RR= 0.39; 95% Cl: 0.19-0.80; p = 0.008. RR= 0.37; 95% Cl: 0.18-0.77; p = 0.006, respectively). No adverse effects or intolerances to treatment occurred.Conclusions and relevance: Compared with placebo, BLF supplementation alone or in combination with LGG reduced the incidence of > stage 2 NEC and of death-and/or >= stage 2 NEC in VLBW neonates. BLF might be a promising strategy to prevent NEC in NICU settings. Further data on larger sample sizes are warranted before BLF can be widespreadly used in clinical settings. (C) 2014 Elsevier Ireland Ltd. All rights reserved.