2nd Department of Paediatrics, Semmelweis University, Budapest, Hungary.
J Pediatr Gastroenterol Nutr. 2010 Oct;51(4):514-21. doi: 10.1097/MPG.0b013e3181de210c.
Safety, tolerability, and efficacy of a novel lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil (SMOFlipid 20%) with reduced n-6 fatty acids (FA), increased monounsaturated and n-3 FA, and enriched in vitamin E were evaluated in premature infants compared with a soybean oil-based emulsion.
Sixty (30/30) premature neonates (age 3-7 days, gestational age ≤ 34 weeks, birth weights 1000-2500 g) received parenteral nutrition (PN) with either SMOFlipid 20% (study group) or a conventional lipid emulsion (Intralipid 20%, control group) for a minimum of 7 up to 14 days. Lipid supply started at 0.5 g · kg body weight(-1) · day(-1) on day 1 and increased stepwise (by 0.5 g) up to 2 g · kg body weight(-1) · day(-1) on days 4 to 14. Safety and efficacy parameters were assessed on days 0, 8, and 15 if PN was continued.
Adverse events, serum triglycerides, vital signs, local tolerance, and clinical laboratory did not show noticeable group differences, confirming the safety of study treatment. At study end, γ-glutamyl transferase was lower in the study versus the control group (107.8 ± 81.7 vs 188.8 ± 176.7 IU/L, P < 0.05). The relative increase in body weight (day 8 vs baseline) was 5.0% ± 6.5% versus 5.1% ± 6.6% (study vs control, not significant). In the study group, an increase in n-3 FA in red blood cell phospholipids and n-3:n-6 FA ratio was observed. Plasma α-tocopherol (study vs control) was increased versus baseline on day 8 (26.35 ± 10.03 vs 3.67 ± 8.06 μmol/L, P < 0.05) and at study termination (26.97 ± 18.32 vs 8.73 ± 11.41 μmol/L, P < 0.05).
Parenteral infusion of SMOFlipid was safe and well tolerated and showed a potential beneficial influence on cholestasis, n-3 FA, and vitamin E status in premature infants requiring PN.
与大豆油为基础的乳剂相比，评估含有混合大豆油、中链甘油三酯、橄榄油和鱼油（SMOFlipid 20%）的新型含低 n-6 脂肪酸（FA）、增加单不饱和和 n-3 FA、富含维生素 E 的脂肪乳剂在早产儿中的安全性、耐受性和疗效。
60 名（30/30）早产儿（3-7 天龄，胎龄≤34 周，出生体重 1000-2500g）接受肠外营养（PN），分别给予 SMOFlipid 20%（研究组）或常规脂肪乳剂（Intralipid 20%，对照组），持续至少 7 天，最多 14 天。脂肪供给从第 1 天开始，起始剂量为 0.5 g·kg 体重（-1）·天（-1），第 4 天至第 14 天逐步增加（每次增加 0.5 g）至 2 g·kg 体重（-1）·天（-1）。如果 PN 继续进行，则在第 0、8 和 15 天评估安全性和疗效参数。
不良事件、血清甘油三酯、生命体征、局部耐受性和临床实验室检查均未显示出明显的组间差异，证实了研究治疗的安全性。研究结束时，与对照组相比，γ-谷氨酰转移酶在研究组中较低（107.8±81.7 比 188.8±176.7IU/L，P<0.05）。与基线相比，第 8 天体重的相对增加（研究组 vs 对照组）为 5.0%±6.5%比 5.1%±6.6%（无显著差异）。在研究组中，红细胞磷脂中的 n-3 FA 和 n-3:n-6 FA 比值增加。与基线相比，第 8 天（26.35±10.03 比 3.67±8.06μmol/L，P<0.05）和研究结束时（26.97±18.32 比 8.73±11.41μmol/L，P<0.05）血浆α-生育酚（研究组 vs 对照组）增加。
早产儿需要 PN 时，静脉输注 SMOFlipid 是安全且耐受良好的，并显示对胆汁淤积、n-3 FA 和维生素 E 状态有潜在有益影响。
