Department of Pediatric Gastroenterology, Hepatology and Nutrition, Hôpital des Enfants Malades, University of Paris 5, René Descartes, France.
JPEN J Parenter Enteral Nutr. 2010 Sep-Oct;34(5):485-95. doi: 10.1177/0148607110363614.
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 ω-3 FAs as a mixed emulsion containing α-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).
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).
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 µmol/L vs SOE group 2.3 ± 3.5 µmol/L, P < .01; 95% confidence interval [CI], -6.2 to -1.4). In plasma and red blood cell (RBC) phospholipids, the ω-3 FAs C20:5ω-3 (eicosapentaenoic acid) and + C22:6ω-3 (docosahexaenoic acid) increased significantly in the SMOFlipid group on day 29. The ω-3:ω-6 FA ratio was significantly elevated with SMOFlipid 20% compared with SOE group (plasma, day 29: 0.15 ± 0.06 vs 0.07 ± 0.02, P < .01, 95% CI, 0.04-0.11; and RBC, day 29: 0.23 ± 0.07 vs 0.14 ± 0.04, P < .01, 95% CI, 0.04-0.13). Plasma α-tocopherol concentration increased significantly more with SMOFlipid 20% (15.7 ± 15.9 vs 5.4 ± 15.2 µmol/L, P < .05; 95% CI, -2.1 to 22.6). The low-density lipoprotein-TBARS concentrations were not significantly different between both groups, indicating that lipid peroxidation did not differ between groups.
SMOFlipid 20%, which contains 15% fish oil, was safe and well tolerated, decreased plasma bilirubin, and increased ω-3 FA and α-tocopherol status without changing lipid peroxidation.
SMOFlipid 20% 是一种含有大豆油、中链甘油三酯、橄榄油和鱼油的静脉内脂肪乳剂（ILE），旨在提供能量、必需脂肪酸（FA）和长链 ω-3 FA 作为含有 α-生育酚的混合乳剂。目的是评估与大豆油乳剂（SOE）相比，这种新的 ILE 在接受家庭肠外营养（HPN）的儿科患者中的疗效和安全性。
这项单中心、随机、双盲研究纳入了 28 名接受 HPN 的儿童，随机分为 SMOFlipid 20%（n=15）或标准 SOE（Intralipid 20%，n=13）组。ILE 每周 4-5 次给药（目标剂量为 2.0 g/kg/d），作为肠外营养方案的一部分。在第 0 天和最后一次研究输注后（第 29 天）进行评估，包括安全性和疗效参数。
第 29 天，两组的实验室安全性参数（包括肝功能酶）无显著差异。总胆红素浓度从初始值到终值（第 29 天到第 0 天）的平均±标准差变化在两组间有显著差异：SMOFlipid 组-1.5±2.4 µmol/L 比 SOE 组 2.3±3.5 µmol/L，P<0.01；95%置信区间[CI]，-6.2 至-1.4）。在血浆和红细胞（RBC）磷脂中，ω-3 FA C20:5ω-3（二十碳五烯酸）和+C22:6ω-3（二十二碳六烯酸）在 SMOFlipid 组中在第 29 天显著增加。与 SOE 组相比，SMOFlipid 20% 显著提高了 ω-3:ω-6 FA 比值（血浆，第 29 天：0.15±0.06 比 0.07±0.02，P<0.01，95%CI，0.04-0.11；和 RBC，第 29 天：0.23±0.07 比 0.14±0.04，P<0.01，95%CI，0.04-0.13）。SMOFlipid 20% 使血浆 α-生育酚浓度显著增加（15.7±15.9 比 5.4±15.2 µmol/L，P<0.05；95%CI，-2.1 至 22.6）。两组间低密度脂蛋白-TBARS 浓度无显著差异，表明两组间脂质过氧化无差异。
含有 15%鱼油的 SMOFlipid 20% 安全且耐受良好，降低了血浆胆红素，并增加了 ω-3 FA 和 α-生育酚状态，而不改变脂质过氧化。
