Mertes Norbert, Grimm Helmut, Fürst Peter, Stehle Peter
Department of Anaesthesiology and Intensive Care, Raphaelsklinik Münster, Münster, Germany.
Ann Nutr Metab. 2006;50(3):253-9. doi: 10.1159/000091683. Epub 2006 Feb 23.
BACKGROUND/AIMS: A new lipid emulsion based on soybean oil, medium chain triglycerides, olive oil and fish oil (SMOFlipid) was tested for safety, tolerance, metabolic and clinical efficacy in surgical patients.
In a prospective, double-blind European multicenter study, postoperative patients (elective abdominal or thoracic surgery) were randomized to receive isonitrogenous, isoenergetic (30-35 kcal/kg) total parenteral nutrition over 5 postoperative days including either SMOFlipid 20% or standard soybean oil emulsion (Lipovenoes 20%) as lipid source (1.5 g kg(-1) day(-1)). Metabolic efficacy measurements included serum levels of triglycerides (AUC), phospholipids, and total cholesterol. Safety/tolerance parameters were: hematology; clinical chemistry; coagulation profile; clinical course (arterial blood pressure, heart rate, body temperature), and documentation of adverse events. Clinical efficacy was monitored by length of hospital stay and mortality.
The 2 groups (per-protocol population: SMOFlipid n = 99, and Lipovenoes n = 100) were similar with respect to demographic characteristics and types of surgical intervention. Concentrations of serum triglycerides, phospholipids, and total cholesterol were comparable in both groups and within the expected ranges. Laboratory and clinical parameters were not different. A trend towards a reduced length of hospital stay was observed with SMOFlipid (15.7 +/- 6.3 vs. 17.8 +/- 13.2 days).
SMOFlipid is clinically safe and well tolerated in postoperative patients. There are indications that SMOFlipid may be associated with a better liver tolerance and a shorter length of hospitalization.
背景/目的：对一种基于大豆油、中链甘油三酯、橄榄油和鱼油的新型脂质乳剂（SMOFlipid）在外科手术患者中的安全性、耐受性、代谢及临床疗效进行测试。
在一项前瞻性、双盲的欧洲多中心研究中，术后患者（择期腹部或胸部手术）被随机分组，在术后5天接受等氮、等能量（30 - 35千卡/千克）的全胃肠外营养，其中脂质来源为SMOFlipid 20%或标准大豆油乳剂（Lipovenoes 20%）（1.5克/千克/天）。代谢疗效测量指标包括血清甘油三酯水平（曲线下面积）、磷脂和总胆固醇。安全性/耐受性参数为：血液学；临床化学；凝血指标；临床过程（动脉血压、心率、体温）以及不良事件记录。通过住院时间和死亡率监测临床疗效。
两组（符合方案人群：SMOFlipid组n = 99，Lipovenoes组n = 100）在人口统计学特征和手术干预类型方面相似。两组血清甘油三酯、磷脂和总胆固醇浓度相当，且在预期范围内。实验室和临床参数无差异。观察到使用SMOFlipid有住院时间缩短的趋势（15.7±6.3天对17.8±13.2天）。
SMOFlipid在术后患者中临床安全且耐受性良好。有迹象表明SMOFlipid可能与更好的肝脏耐受性和更短的住院时间相关。
