*National Esophageal Center, St James Hospital, Dublin, Ireland †Clinical Nutrition, St James Hospital, Dublin, Ireland ‡School of Food & Nutritional Sciences, University College Cork, Cork, Ireland §School of Biological Sciences, Dublin Institute of Technology, Dublin, Ireland ¶Centre for Support and Training in Analysis and Research (CSTAR), University College Dublin, Dublin, Ireland ||Dept of Surgery, Mercy University Hospital, Cork, Ireland.
Ann Surg. 2017 Nov;266(5):720-728. doi: 10.1097/SLA.0000000000002390.
This randomized controlled trial (RCT) hypothesized that prolonged enteral nutrition (EN) with supplemental eicosapentanoic acid (EPA), an omega-3 fatty acid with immune and anabolic properties, may impact on clinical and nutritional outcomes.
Esophagectomy is associated with significant weight loss and catabolism, and negatively impacts quality of life (QL). Strategies to counter sustained catabolism have therapeutic rationale.
This multicenter, double-blind, placebo-controlled RCT was powered on a 5% difference in lean body mass (LBM) at 1 month. Patients were randomly assigned to receive either EN-EPA (2.2 g EPA/day) (n = 97) or isocaloric isonitrogenous standard EN (EN-S) (n = 94), preoperatively (5 days orally), and postoperatively via a jejunostomy until 1 month postdischarge. Assessments perioperatively, and at 1, 3, and 6 months included weight, body mass index (BMI), body composition, muscle strength, cytokines, complications, and QL.
The median (range) nutrition support was for 51 (36 to 78) days, and overall compliance was 96%. For the entire cohort, a significant (P < 0.005) decrease in weight (-7.4 ± 6.6 kg), BMI (-2.6 ± 2.2 kg/m), LBM (-2.5 ± 8.7 kg), and fat mass (-3.4 ± 5.8 kg) was evident from preoperatively to 6 months. The mean (±SD) loss of LBM (kg) at 1 month was -3.7 ± 8.7 in the EN-S group, compared with -5.6 ± 12.1 in the EN-EPA group (P = 0.355). Per-protocol analysis revealed no difference between the EN-EPA and EN-S in any clinical, nutritional, functional, QL or immune parameter at any time point.
The thesis that EPA impacts on anabolism, immune function, and clinical outcomes post-esophagectomy was not supported. Compliance with home EN was excellent, but weight, muscle, and fat loss was significant in 30% of patients, highlighting the complexity of postoperative weight loss.
本随机对照试验(RCT)假设,延长肠内营养(EN)并补充二十碳五烯酸(EPA),一种具有免疫和合成代谢特性的ω-3 脂肪酸,可能会影响临床和营养结局。
食管切除术会导致显著的体重减轻和分解代谢,并对生活质量(QL)产生负面影响。对抗持续分解代谢的策略具有治疗合理性。
这项多中心、双盲、安慰剂对照 RCT 的研究动力是 Lean Body Mass(LBM)在 1 个月时的差异为 5%。患者被随机分配接受肠内营养-EPA(2.2g EPA/天)(n=97)或等热量等氮标准肠内营养(EN-S)(n=94),术前(5 天口服),术后通过空肠造口管给予,直到出院后 1 个月。围手术期和 1、3 和 6 个月的评估包括体重、体重指数(BMI)、身体成分、肌肉力量、细胞因子、并发症和 QL。
中位(范围)营养支持时间为 51(36 至 78)天,总体依从性为 96%。对于整个队列,从术前到 6 个月体重(-7.4±6.6kg)、BMI(-2.6±2.2kg/m)、LBM(-2.5±8.7kg)和脂肪量(-3.4±5.8kg)明显下降(P<0.005)。EN-S 组 1 个月时 LBM(kg)的平均(±SD)损失为-3.7±8.7,而 EN-EPA 组为-5.6±12.1(P=0.355)。按方案分析显示,在任何时间点,EN-EPA 和 EN-S 在任何临床、营养、功能、QL 或免疫参数方面均无差异。
EPA 对食管切除术后合成代谢、免疫功能和临床结局的影响的假设没有得到支持。家庭肠内营养的依从性非常好,但 30%的患者体重、肌肉和脂肪仍有明显损失,这突出了术后体重减轻的复杂性。