低剂量静脉大豆油脂肪乳预防早产儿胆汁淤积
虽然早产儿依赖静脉脂肪乳提供必需脂肪酸和热量,但是既往研究发现大豆来源静脉脂肪乳(S-IFE)剂量与肠外营养(PN)相关肝病发生有关。
为了明确低剂量S-IFE可否成为安全有效的早产儿胆汁淤积预防策略,耶鲁大学医学院、加利福尼亚大学洛杉矶分校、西北大学医学院在胎龄(GA)<29周婴儿中开展了一项多中心随机对照试验。
在该研究中,出生<48小时的患儿随机接受低剂量(1g/kg/d)或对照剂量(约3g/kg/d)的S-IFE。主要结局指标为出生28天或完全肠内喂养时的胆汁淤积(定义为14天PN后直接胆红素≥总胆红素的15%),以较迟者为准。次要结局指标包括生长发育、住院天数、死亡情况和主要新生儿发病率。
结果共入组136例新生儿,低剂量组和对照组分别为67例和69例,两组基线资料特点相似。低剂量组与对照组相比,主要结局指标无显著差异(69%比63%;95%置信区间:-0.1~0.22;P=0.45)。低剂量组与对照组相比,虽然在研究期间接受较少的S-IFE和总热量(P<0.001和P=0.03),但是出生28天、出院时、住院期间的体重、身长、头围无显著差异(所有P>0.2)。
因此,低剂量S-IFE与对照剂量相比,与生长发育或胆汁淤积减少无相关性。
JPEN J Parenter Enteral Nutr. 2016;40(3):374-82.
Low-Dose Intravenous Soybean Oil Emulsion for Prevention of Cholestasis in Preterm Neonates.
Yale University School of Medicine, New Haven, Connecticut; University of California, Los Angeles, California; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
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.
KEYWORDS: growth; parenteral nutrition–associated liver disease; prematurity
PMID: 24963025
PMCID: PMC4537394
DOI: 10.1177/0148607114540005
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