肠内和补充性肠外营养富集ω-3 多不饱和脂肪酸在重症监护患者中的应用-一项随机、对照、双盲临床试验。

Enteral and supplemental parenteral nutrition enriched with omega-3 polyunsaturated fatty acids in intensive care patients - A randomized, controlled, double-blind clinical trial.

机构信息

Department of General Intensive Care and Institute for Nutrition Research, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel; Laboratory of Nutrition and Metabolism Research, Felsenstein Medical Research Center, Sackler Faculty of Medicine, Tel-Aviv University, Israel.

Department of General Intensive Care and Institute for Nutrition Research, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.

出版信息

Clin Nutr. 2021 May;40(5):2544-2554. doi: 10.1016/j.clnu.2021.03.034. Epub 2021 Apr 1.

DOI:10.1016/j.clnu.2021.03.034

PMID:33932802

Abstract

BACKGROUND & AIMS: Enteral nutrition (EN) and parenteral nutrition (PN) enriched with omega-3 polyunsaturated fatty acids (PUFA) have beneficial effects in critical illness. This study aimed to assess the combined effect of EN and supplemental PN enriched with omega-3 PUFA on blood oxygenation in intensive care unit (ICU) patients.

METHODS

Single-center, prospective, randomized, controlled, double-blind, phase III trial conducted from 10/2013 to 11/2017. A total of 100 ICU patients (18-85 years, APACHE II score > 15) requiring mechanical ventilation were randomly assigned to received combined EN and PN either with omega-3 PUFA (omega-3 group) or without (control group) for up to 28 days. Primary endpoint: 'change of PaO/FiO from day (D) 1 to D4'. Secondary endpoints: lung function parameters, ICU complications, length of hospital stay, days free of ICU care/ventilation/sedation/catecholamine treatment, mortality, erythrocyte fatty acid composition, inflammatory parameters. Safety parameters: standard laboratory assessment, vital signs, physical examination, SOFA score, adverse events.

RESULTS

Combined EN and PN covered energy requirements to more than 80%. Blood oxygenation (ΔPaO/FiO from D1 to D4: -1.3 ± 83.7, n = 42, and 13.3 ± 86.1, n = 39, in omega-3 and control group, respectively, p = 0.7795) and other lung function parameters did not differ between groups but days free of catecholamine treatment were significantly higher in the omega-3 group (~4 days, p = 0.0481). On D6, significantly more patients in the omega-3 group tolerated EN alone (51.0% vs. 29.8%, p = 0.0342). Eicosapentaenoic acid (EPA) content in erythrocytes was significantly increased in the omega-3 group at last observation compared with the control group (ΔEPA: 0.928 ± 0.808% vs. -0.024 ± 0.190%, p < 0.0001). No further significant group differences were detected.

CONCLUSIONS

Enteral and supplemental PN both enriched with omega-3 PUFA did not improve lung function but allowed earlier weaning from catecholamine treatment and PN. Supplemental PN succeeded to adequately cover energy requirements in critically ill patients.

TRIAL REGISTRATION

www.clinicaltrials.gov, registration number: NCT01162928.

摘要

背景与目的

肠内营养（EN）和富含ω-3 多不饱和脂肪酸（PUFA）的肠外营养（PN）在危重病中有有益作用。本研究旨在评估富含ω-3 PUFA 的 EN 和补充性 PN 联合应用对重症监护病房（ICU）患者的血液氧合的影响。

方法

单中心、前瞻性、随机、对照、双盲、III 期临床试验，于 2013 年 10 月至 2017 年 11 月进行。共纳入 100 名需要机械通气的 ICU 患者（18-85 岁，APACHE II 评分>15），随机分为接受富含 ω-3 PUFA 的联合 EN 和 PN（ω-3 组）或不接受（对照组）治疗，持续 28 天。主要终点：“从第 1 天（D1）到第 4 天（D4）的 PaO/FiO 变化”。次要终点：肺功能参数、ICU 并发症、住院时间、无 ICU 护理/通气/镇静/儿茶酚胺治疗天数、死亡率、红细胞脂肪酸组成、炎症参数。安全性参数：标准实验室评估、生命体征、体格检查、SOFA 评分、不良事件。

结果

联合 EN 和 PN 可满足超过 80%的能量需求。两组间的血液氧合（从 D1 到 D4 的 PaO/FiO 变化：-1.3±83.7，n=42 和 13.3±86.1，n=39，分别在 ω-3 和对照组，p=0.7795）和其他肺功能参数无差异，但 ω-3 组儿茶酚胺治疗天数明显更长（~4 天，p=0.0481）。在 D6，ω-3 组有更多患者能耐受单独的 EN（51.0%比 29.8%，p=0.0342）。与对照组相比，ω-3 组红细胞中二十碳五烯酸（EPA）的含量在最后一次观察时明显增加（ΔEPA：0.928±0.808%比-0.024±0.190%，p<0.0001）。未发现其他有意义的组间差异。