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早产儿中中性和酸性寡糖:一项随机、双盲、安慰剂对照试验。

Neutral and acidic oligosaccharides in preterm infants: a randomized, double-blind, placebo-controlled trial.

机构信息

Department of Pediatrics, VU University Medical Center, Amsterdam, Netherlands.

出版信息

Am J Clin Nutr. 2010 Mar;91(3):679-86. doi: 10.3945/ajcn.2009.28625. Epub 2009 Dec 23.

DOI:10.3945/ajcn.2009.28625
PMID:20032496
Abstract

BACKGROUND

Serious infectious morbidity is high in preterm infants. Enteral supplementation of prebiotics may reduce the incidence of serious infections, especially infections related to the gastrointestinal tract.

OBJECTIVE

The objective was to determine the effect of enteral supplementation of a prebiotic mixture consisting of neutral oligosaccharides ((SC)GOS/(LC)FOS) and acidic oligosaccharides (AOS) on serious infectious morbidity in preterm infants.

DESIGN

In a randomized controlled trial, preterm infants (gestational age <32 wk and/or birth weight <1500 g) received enteral supplementation of 80% (SC)GOS/(LC)FOS and 20% AOS (1.5 g . kg(-1) . d(-1)) or placebo (maltodextrin) between days 3 and 30 of life. Serious infectious morbidity was defined as a culture positive for sepsis, meningitis, pyelonephritis, or pneumonia. The analysis was performed by intention-to-treat and per-protocol, defined as > or =50% supplementation dose during the study period.

RESULTS

In total, 113 preterm infants were included. Baseline and nutritional characteristics were not different between groups. In the intention-to-treat analysis, the incidence of > or =1 serious infection, > or =1 serious endogenous infection, or > or =2 serious infectious episodes was not significantly different in the (SC)GOS/(LC)FOS/AOS-supplemented and placebo groups. In the per-protocol analysis, there was a trend toward a lower incidence of > or =1 serious endogenous infection and > or =2 serious infectious episodes in the (SC)GOS/(LC)FOS/AOS-supplemented group than in the placebo group (P = 0.09 and P = 0.07, respectively).

CONCLUSIONS

Enteral supplementation of (SC)GOS/(LC)FOS/AOS does not significantly reduce the risk of serious infectious morbidity in preterm infants. However, there was a trend toward a lower incidence of serious infectious morbidity, especially for infections with endogenous bacteria. This finding suggests a possible beneficial effect that should be evaluated in a larger study. This trial was registered at isrctn.org as ISRCTN16211826.

摘要

背景

早产儿的严重感染发病率很高。肠内补充益生元可能会降低严重感染的发生率,尤其是与胃肠道相关的感染。

目的

本研究旨在确定肠内补充由中性低聚糖((SC)GOS/(LC)FOS)和酸性低聚糖(AOS)组成的益生元混合物对早产儿严重感染发病率的影响。

设计

在一项随机对照试验中,早产儿(胎龄<32 周和/或出生体重<1500 g)在出生后第 3 天至 30 天内接受肠内补充 80%(SC)GOS/(LC)FOS 和 20% AOS(1.5 g/kg/d)或安慰剂(麦芽糊精)。严重感染发病率定义为培养阳性的败血症、脑膜炎、肾盂肾炎或肺炎。分析采用意向治疗和方案分析,定义为研究期间补充剂量>或=50%。

结果

共有 113 名早产儿入组。两组的基线和营养特征无差异。意向治疗分析显示,(SC)GOS/(LC)FOS/AOS 补充组和安慰剂组的严重感染发生率、严重内源性感染发生率或严重感染发作次数均无显著差异。方案分析显示,(SC)GOS/(LC)FOS/AOS 补充组的严重内源性感染和严重感染发作次数>或=2 次的发生率有降低趋势(P=0.09 和 P=0.07)。

结论

肠内补充(SC)GOS/(LC)FOS/AOS 不能显著降低早产儿严重感染发病率。然而,严重感染发病率有降低趋势,尤其是内源性细菌感染。这一发现提示可能有有益效果,值得在更大的研究中进一步评估。本试验在国际临床试验注册平台(ISRCTN)注册,注册号为 ISRCTN81063147。

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