Department of General Surgery, Jinling Hospital, Medical School of Nanjing University, 305 Zhongshan East Road, Nanjing, China.
Department of Medical Statistics, Jinling Hospital of the First School of Clinical Medicine, Southern Medical University, 305 Zhongshan East Road, Nanjing, China; Department of Biostatistics, School of Public Health, Nanjing Medical University, 101 Longmian Avenue, Jiangning District, Nanjing, China.
Clin Nutr. 2021 Dec;40(12):5802-5811. doi: 10.1016/j.clnu.2021.10.014. Epub 2021 Oct 30.
BACKGROUND & AIMS: The strategy of increasing the postoperative enteral nutrition dose to the target goal has not yet been clarified. This study aimed to determine whether an immediate goal-dose enteral nutrition (IGEN) strategy is non-inferior to a gradual goal-dose enteral nutrition (GGEN) strategy in reducing infections in patients undergoing abdominal surgery involving the organs of the digestive system.
This randomized controlled trial enrolled postoperative patients with nutritional risk screening 2002 scores ≥3 from 11 Chinese hospitals. Energy targets were calculated as 25 kcal/kg and 30 kcal/kg of ideal body weight for women and men, respectively. Patients were randomly assigned 1:1 to IGEN or GGEN group after enteral tolerance was confirmed (30% of the target on day 2). The IGEN group immediately started receiving 100% of the caloric requirements on day 3, while the GGEN group received 40% progressing to 80% of target on day 7. The primary endpoint was the infection rate until discharge, based on the intention-to-treat population.
A total of 411 patients were enrolled and randomized to the IGEN and GGEN groups, and five patients did not receive the allocated intervention. A total of 406 patients were included in the primary analysis, with 199 and 207 in the IGEN and GGEN groups, respectively. Infection was observed in 17/199 (8.5%) in the IGEN group and 19/207 (9.2%) in the GGEN group, respectively (difference, -0.6%; [95% confidence interval (CI), -6.2%-4.9%]; P = 0.009 for non-inferiority test). There were significantly more gastrointestinal intolerance events with IGEN than with GGEN (58/199 [29.1%] vs. 32/207 [15.5%], P < 0.001). All other secondary endpoints were non-significant.
Among postoperative patients at nutritional risk, IGEN was non-inferior to GGEN in regards to infectious complications. IGEN was associated with more gastrointestinal intolerance events. It showed that IGEN cannot be considered to be clinically directive. ClinicalTrials.gov (#NCT03117348).
增加术后肠内营养剂量至目标值的策略尚未明确。本研究旨在确定即刻目标剂量肠内营养（IGEN）策略是否不劣于逐渐目标剂量肠内营养（GGEN）策略，以减少接受涉及消化系统器官的腹部手术的患者的感染。
这项随机对照试验纳入了来自 11 家中国医院的营养风险筛查 2002 评分≥3 的术后患者。能量目标分别计算为女性和男性理想体重的 25 kcal/kg 和 30 kcal/kg。在确认肠内耐受后（第 2 天达到目标的 30%），患者按 1:1 随机分配到 IGEN 或 GGEN 组。IGEN 组在第 3 天立即开始接受 100%的热量需求，而 GGEN 组在第 7 天从 40%进展到 80%的目标。主要终点是基于意向治疗人群的出院前感染率。
共纳入 411 名患者并随机分为 IGEN 和 GGEN 组，5 名患者未接受分配的干预。共有 406 名患者纳入主要分析，其中 IGEN 组和 GGEN 组分别为 199 名和 207 名。IGEN 组 17/199（8.5%）和 GGEN 组 19/207（9.2%）发生感染，差异为-0.6%（[95%置信区间（CI），-6.2%至 4.9%]；非劣效性检验 P=0.009）。IGEN 组胃肠道不耐受事件明显多于 GGEN 组（58/199 [29.1%] vs. 32/207 [15.5%]，P<0.001）。所有其他次要终点均无显著性差异。
在有营养风险的术后患者中，IGEN 在感染并发症方面不劣于 GGEN。IGEN 与更多的胃肠道不耐受事件相关。这表明 IGEN 不能被认为具有临床指导意义。ClinicalTrials.gov（#NCT03117348）。
