A New Intravenous Fat Emulsion Containing Soybean Oil, Medium-Chain Triglycerides, Olive Oil, and Fish Oil: A Single-Center, Double-Blind Randomized Study on Efficacy and Safety in Pediatric Patients Receiving Home Parenteral Nutrition
A New Intravenous Fat Emulsion Containing Soybean Oil, Medium-Chain Triglycerides, Olive Oil, and Fish Oil: A Single-Center, Double-Blind Randomized Study on Efficacy and Safety in Pediatric Patients Receiving Home Parenteral Nutrition
复制标题
DOI：
10.1177/0148607110363614
复制
发表时间：
2010-09-01
影响因子：
3.4
通讯作者：
Colomb-Jung, Virginie
中科院分区：
文献类型：
--
作者：
Goulet, Olivier;Antebi, Helena;Colomb-Jung, Virginie
背景：smof脂质20%是一种静脉注射脂质乳剂（ILE），含有大豆油、中链甘油三酯、橄榄油和鱼油，开发用于提供能量、必需脂肪酸（FAs）和长链omega-3脂肪酸，作为含有a-生育酚的混合乳剂。目的是评估这种新型ILE在接受家庭肠外营养（HPN）和豆油乳剂（SOE）的儿科患者中的疗效和安全性。方法：这项单中心、随机、双盲研究包括28名接受HPN治疗的儿童，他们分别接受20%的smof脂质（n = 15）和20%的标准SOE （n = 13）。在肠外营养方案中，每周给药4 - 5次（目标剂量，2.0 g/kg/d）。在第0天和最后一次研究输注后（第29天）进行评估，包括安全性和有效性参数。脂质过氧化用硫代巴比妥酸活性物质（TBARS）测定。结果：第29天各组间肝酶等实验室安全参数无显著差异。总胆红素浓度在初始值和终值（第29天至第0天）之间的平均+/-标准差变化在组间有显著差异：smof脂组-1.5 +/- 2.4 mu mol/L vs SOE组2.3 +/- 3.5 mu mol/L， P
Background: SMOFlipid 20% is an intravenous lipid emulsion (ILE) containing soybean oil, medium-chain triglycerides, olive oil, and fish oil developed to provide energy, essential fatty acids (FAs), and long-chain omega-3 FAs as a mixed emulsion containing a-tocopherol. The aim was to assess the efficacy and safety of this new ILE in pediatric patients receiving home parenteral nutrition (HPN) compared with soybean oil emulsion (SOE). Methods: This single-center, randomized, double-blind study included 28 children on HPN allocated to receive either SMOFlipid 20% (n = 15) or a standard SOE (Intralipid 20%, n = 13). ILE was administered 4 to 5 times per week (goal dose, 2.0 g/kg/d) within a parenteral nutrition regimen. Assessments, including safety and efficacy parameters, were performed on day 0 and after the last study infusion (day 29). Lipid peroxidation was determined by measurement of thiobarbituric acid reactive substances (TBARS). Results: There were no significant differences in laboratory safety parameters, including liver enzymes, between the groups on day 29. The mean +/- standard deviation changes in the total bilirubin concentration between the initial and final values (day 29 to day 0) were significantly different between groups: SMOFlipid group -1.5 +/- 2.4 mu mol/L vs SOE group 2.3 +/- 3.5 mu mol/L, P