Propre-save 研究：益生菌和益生元单独或联合应用对极低出生体重儿坏死性小肠结肠炎的影响。

The propre-save study: effects of probiotics and prebiotics alone or combined on necrotizing enterocolitis in very low birth weight infants.

机构信息

Department of Neonatology, Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara, Turkey.

出版信息

J Pediatr. 2015 Mar;166(3):545-51.e1. doi: 10.1016/j.jpeds.2014.12.004. Epub 2015 Jan 13.

DOI:10.1016/j.jpeds.2014.12.004

PMID:25596096

Abstract

OBJECTIVE

To test the efficacy of probiotic and prebiotic, alone or combined (synbiotic), on the prevention of necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.

STUDY DESIGN

A prospective, randomized, controlled trial was conducted at 5 neonatal intensive care units in Turkey. VLBW infants (n = 400) were assigned to a control group and 3 study groups that were given probiotic (Bifidobacterium lactis), prebiotic (inulin), or synbiotic (Bifidobacterium lactis plus inulin) added to breastmilk or formula for a maximum of 8 weeks before discharge or death. The primary outcome was NEC (Bell stage ≥2).

RESULTS

The rate of NEC was lower in probiotic (2.0%) and synbiotic (4.0%) groups compared with prebiotic (12.0%) and placebo (18.0%) groups (P < .001). The times to reach full enteral feeding were faster (P < .001), the rates of clinical nosocomial sepsis were lower (P = .004), stays in the neonatal intensive care unit were shorter, (P = .002), and mortality rates were lower (P = .003) for infants receiving probiotics, prebiotics, or synbiotic than controls. The use of antenatal steroid (OR 0.5, 95% CI 0.3-0.9) and postnatal probiotic (alone or in synbiotic) (OR 0.5, 95% CI 0.2-0.8) decreased the risk of NEC, and maternal antibiotic exposure increased this risk (OR 1.9, 95% CI 1.1-3.6).

CONCLUSIONS

In VLBW infants, probiotic (Bifidobacterium lactis) and synbiotic (Bifidobacterium lactis plus inulin) but not prebiotic (inulin) alone decrease NEC.

摘要

目的

检验益生菌和益生元（合称为合生元）单独或联合应用（合生元）对极低出生体重（VLBW）儿坏死性小肠结肠炎（NEC）的预防作用。

研究设计

在土耳其的 5 个新生儿重症监护病房进行了一项前瞻性、随机、对照试验。将 VLBW 婴儿（n=400）分为对照组和 3 个研究组，研究组分别在母乳喂养或配方奶中添加益生菌（长双歧杆菌）、益生元（菊粉）或合生元（长双歧杆菌加菊粉），最大剂量为 8 周，直至出院或死亡。主要结局是 NEC（Bell 分期≥2）。

结果

与益生元组（12.0%）和安慰剂组（18.0%）相比，益生菌组（2.0%）和合生元组（4.0%）的 NEC 发生率较低（P<.001）。达到完全肠内喂养的时间更快（P<.001），临床医院获得性败血症的发生率较低（P=0.004），新生儿重症监护病房的住院时间较短（P=0.002），接受益生菌、益生元或合生元的婴儿死亡率较低（P=0.003）。产前使用类固醇（OR 0.5，95%CI 0.3-0.9）和产后使用益生菌（单独或合生元）（OR 0.5，95%CI 0.2-0.8）降低了 NEC 的风险，而母亲使用抗生素则增加了这一风险（OR 1.9，95%CI 1.1-3.6）。