A double-blind, randomized clinical trial comparing soybean oil-based versus olive oil-based lipid emulsions in adult medical-surgical intensive care unit patients requiring parenteral nutrition
A double-blind, randomized clinical trial comparing soybean oil-based versus olive oil-based lipid emulsions in adult medical-surgical intensive care unit patients requiring parenteral nutrition
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DOI：
10.1097/ccm.0b013e3182474bf9
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发表时间：
2012-06-01
影响因子：
8.8
通讯作者：
Ziegler, Thomas R.
中科院分区：
文献类型：
--
作者：
Umpierrez, Guillermo E.;Spiegelman, Ronnie;Ziegler, Thomas R.
目的：肠外营养与重症监护病房患者的代谢和感染并发症有关。并发症高风险的潜在机制尚不清楚，但可能与大豆油基脂肪乳剂的促炎作用有关，大豆油基脂肪乳剂是唯一经食品和药物管理局批准用于临床的脂肪制剂。设计：前瞻性、双盲、随机、对照试验。设置：来自一家大型城市教学医院和一所三级转诊大学医院的内外科重症监护病房。患者：成人内外科重症监护病房患者。干预：含有大豆油基(Intralipid)或橄榄油基(Clinolic)脂肪乳剂的肠外营养。测量：医院临床结果(医院感染和非感染性并发症)、住院时间、血糖控制、并发症的差异结果：100例患者被随机分为豆油肠外营养组和橄榄油肠外营养组，疗程长达28天。49例患者接受大豆油为主的肠外营养(年龄51+/-15岁，体重指数27+/-6 kg/m(2)，急性生理学和慢性健康评估II评分15.5+/-7[+/-SD])，51例患者接受橄榄油脂肪乳肠外营养(年龄46+/-19岁，体重指数27+/-8 kg/m(2))，和急性生理学和慢性健康评估II评分15.1+/-6[+/-SD])，平均持续12.9+/-8天。肠外营养期间住院期间平均血糖浓度为129+/-14 mg/dL，组间无差异。接受大豆油和橄榄油肠外营养治疗的患者有相似的住院时间(47+/-47天和41+/-36天，p=.49)、死亡率(16.3%和9.8%，p=.38)、医院感染(43%对57%，p=.16)和急性肾功能衰竭(26%对18%，p=.34)。此外，炎症和氧化应激标志物以及粒细胞和单核细胞功能在两组之间也没有差异。结论：在危重成人中，给予含有大豆油和橄榄油脂肪乳剂的肠外营养导致感染和非感染性并发症的发生率相似，而在血糖控制、炎症和氧化应激标志物以及免疫功能方面没有差异。(CRET CARE Med 2012；40：1792-1798)
Objective: Parenteral nutrition has been associated with metabolic and infectious complications in intensive care unit patients. The underlying mechanism for the high risk of complications is not known but may relate to the proinflammatory effects of soybean oil-based lipid emulsions, the only Food and Drug Administration-approved lipid formulation for clinical use.Design: Prospective, double-blind, randomized, controlled trial.Setting: Medical-surgical intensive care units from a major urban teaching hospital and a tertiary referral university hospital.Patients: Adult medical-surgical intensive care unit patients.Intervention: Parenteral nutrition containing soybean oil-based (Intralipid) or olive oil-based (ClinOleic) lipid emulsions.Measurements: Differences in hospital clinical outcomes (nosocomial infections and noninfectious complications), hospital length of stay, glycemic control, inflammatory and oxidative stress markers, and granulocyte and monocyte functions between study groups.Results: A total of 100 patients were randomized to either soybean oil-based parenteral nutrition or olive oil-based parenteral nutrition for up to 28 days. A total of 49 patients received soybean oil-based parenteral nutrition (age 51 +/- 15 yrs, body mass index 27 +/- 6 kg/m(2), and Acute Physiology and Chronic Health Evaluation II score 15.5 +/- 7 [+/- SD]), and a total of 51 patients received olive oil based lipid emulsion in parenteral nutrition (age 46 +/- 19 yrs, body mass index 27 +/- 8 kg/m(2), and Acute Physiology and Chronic Health Evaluation II score 15.1 +/- 6 [+/- SD]) for a mean duration of 12.9 +/- 8 days. The mean hospital blood glucose concentration during parenteral nutrition was 129 +/- 14 mg/dL, without differences between groups. Patients treated with soybean oil-based and olive oil-based parenteral nutrition had a similar length of stay (47 +/- 47 days and 41 +/- 36 days, p = .49), mortality (16.3% and 9.8%, p = .38), nosocomial infections (43% vs. 57%, p = .16), and acute renal failure (26% vs. 18%, p = .34). In addition, there were no differences in inflammatory and oxidative stress markers or in granulocyte and monocyte functions between groups.Conclusion: The administration of parenteral nutrition containing soybean oil-based and olive oil-based lipid emulsion resulted in similar rates of infectious and noninfectious complications and no differences in glycemic control, inflammatory and oxidative stress markers, and immune function in critically ill adults. (Crit Care Med 2012; 40:1792-1798)