一项在马来西亚开展的富含谷氨酰胺的新生儿肠外营养的随机对照试验。

A randomised controlled trial of glutamine-enriched neonatal parenteral nutrition in Malaysia.

机构信息

Paediatric Department, Universiti Sains Malaysia, Kubang Kerian 16150, Malaysia.

出版信息

Singapore Med J. 2011 May;52(5):356-60.

Abstract

INTRODUCTION

The addition of glutamine to parenteral nutrition (PN) in neonates has not shown significant benefits as compared to adults thus far. This study aimed to determine the potential benefits of the addition of glutamine to neonatal PN in a tertiary hospital in a middle-income country.

METHODS

This was a double-blinded randomised controlled trial. Babies who were admitted to the neonatal intensive care unit (NICU) and who required PN were eligible for inclusion in the study. The subjects were randomised to receive either glutamine-added PN (intervention) or standard PN (control). The most important outcomes included time to full enteral nutrition, incidence of sepsis and necrotising enterocolitis (NEC), clinical or culture-proven sepsis.

RESULTS

Out of 270 subjects, 132 were randomised to the intervention group and 138, to the control group. Baseline data were comparable in both groups. The median time taken to reach full enteral nutrition was similar for both intervention and control groups (six days in each group, p-value is 0.52). The incidences of NEC, clinical sepsis and culture-proven sepsis did not differ significantly in the intervention and control groups (5.8 vs. 7.1 percent, p-value is 0.68; 15.7 percent vs. 10.2 percent, p-value is 0.21 and 16.5 percent vs. 15.7 percent, p-value is 0.38, respectively). Other outcomes such as duration of ventilation, duration of NICU stay and a subgroup analysis for preterm and term babies also showed no statistically significant differences.

CONCLUSION

Addition of glutamine to neonatal PN was not shown to improve outcome.

摘要

引言

与成人相比，目前在新生儿肠外营养（PN）中添加谷氨酰胺并未显示出显著益处。本研究旨在确定在中低收入国家的一家三级医院中，向新生儿 PN 中添加谷氨酰胺的潜在益处。

方法

这是一项双盲随机对照试验。需要 PN 的入住新生儿重症监护病房（NICU）的婴儿有资格入组本研究。受试者被随机分配接受添加谷氨酰胺的 PN（干预组）或标准 PN（对照组）。主要结局包括完全肠内营养的时间、败血症和坏死性小肠结肠炎（NEC）的发生率、临床或培养证实的败血症。

结果

在 270 名受试者中，132 名被随机分配到干预组，138 名被随机分配到对照组。两组的基线数据相似。达到完全肠内营养的中位时间在干预组和对照组相似（每组 6 天，p 值为 0.52）。NEC、临床败血症和培养证实败血症的发生率在干预组和对照组之间没有显著差异（5.8%对 7.1%，p 值为 0.68；15.7%对 10.2%，p 值为 0.21；16.5%对 15.7%，p 值为 0.38）。其他结局，如通气时间、NICU 住院时间以及早产儿和足月儿的亚组分析也没有显示出统计学上的显著差异。