低剂量静脉注射大豆油乳剂预防早产儿胆汁淤积
Low-Dose Intravenous Soybean Oil Emulsion for Prevention of Cholestasis in Preterm Neonates.
作者信息
Levit Orly L, Calkins Kara L, Gibson L Caroline, Kelley-Quon Lorraine, Robinson Daniel T, Elashoff David A, Grogan Tristan R, Li Ning, Bizzarro Matthew J, Ehrenkranz Richard A
机构信息
Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut
Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, California.
出版信息
JPEN J Parenter Enteral Nutr. 2016 Mar;40(3):374-82. doi: 10.1177/0148607114540005. Epub 2014 Jun 24.
BACKGROUND
Premature infants depend on intravenous fat emulsions to supply essential fatty acids and calories. The dose of soybean-based intravenous fat emulsions (S-IFE) has been associated with parenteral nutrition (PN)-associated liver disease. This study's purpose was to determine if low-dose S-IFE is a safe and effective preventive strategy for cholestasis in preterm neonates.
MATERIALS AND METHODS
This is a multicenter randomized controlled trial in infants with a gestational age (GA) ≤29 weeks. Patients <48 hours of life were randomized to receive a low (1 g/kg/d) or control dose (approximately 3 g/kg/d) of S-IFE. The primary outcome was cholestasis, defined as a direct bilirubin ≥15% of the total bilirubin at 28 days of life (DOL) or full enteral feeds, whichever was later, after 14 days of PN. Secondary outcomes included growth, length of hospital stay, death, and major neonatal morbidities.
RESULTS
In total, 136 neonates (67 and 69 in the low and control groups, respectively) were enrolled. Baseline characteristics were similar for the 2 groups. When the low group was compared with the control group, there was no difference in the primary outcome (69% vs 63%; 95% confidence interval, -0.1 to 0.22; P = .45). While the low group received less S-IFE and total calories over time compared with the control group (P < .001 and P = .03, respectively), weight, length, and head circumference at 28 DOL, discharge, and over time were not different (P > .2 for all).
CONCLUSION
Compared with the control dose, low-dose S-IFE was not associated with a reduction in cholestasis or growth.
背景
早产儿依赖静脉脂肪乳剂来提供必需脂肪酸和热量。基于大豆的静脉脂肪乳剂（S-IFE）的剂量与肠外营养（PN）相关肝病有关。本研究的目的是确定低剂量S-IFE是否是预防早产新生儿胆汁淤积的安全有效策略。
材料和方法
这是一项针对胎龄（GA）≤29周婴儿的多中心随机对照试验。出生<48小时的患者被随机分配接受低剂量（1 g/kg/d）或对照剂量（约3 g/kg/d）的S-IFE。主要结局是胆汁淤积，定义为出生28天（DOL）或完全经口喂养时（以较晚者为准），在PN 14天后直接胆红素≥总胆红素的15%。次要结局包括生长、住院时间、死亡和主要新生儿疾病。
结果
总共纳入了136例新生儿（低剂量组和对照组分别为67例和69例）。两组的基线特征相似。将低剂量组与对照组比较，主要结局无差异（69%对63%；95%置信区间，-0.1至0.22；P = 0.45）。虽然随着时间推移，低剂量组比对照组接受的S-IFE和总热量更少（分别为P < 0.001和P = 0.03），但在28 DOL、出院时及随访期间的体重、身长和头围并无差异（均P > 0.2）。
结论
与对照剂量相比，低剂量S-IFE与胆汁淤积减少或生长无关。
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