Li Xiao-Kun, Cong Zhuang-Zhuang, Wu Wen-Jie, Xu Yang, Zhou Hai, Wang Gao-Ming, Qiang Yong, Luo Li-Guo, Shen Yi
Department of Cardiothoracic Surgery, Jingling Hospital, Medicine School of Southeast University, Nanjing, China.
Department of Cardiothoracic Surgery, Jingling Hospital, Medical School of Nanjing University, Nanjing, China.
Ann Palliat Med. 2021 Feb;10(2):1351-1361. doi: 10.21037/apm-20-1399. Epub 2020 Nov 19.
In recent years, immunonutrition has been introduced and proposed to have a positive modulatory effect on inflammatory and immune responses and gut function for surgical patients, especially for patients undergoing gastrointestinal cancer resection. We conducted this parallel-group, randomized and double-blind clinical controlled trial to investigate the efficacy of perioperative enteral immunonutrition (EIN) on clinical and immunological outcomes of patients undergoing esophageal resection.
A randomized, parallel-group, double-blind, clinical trial was conducted between December 1, 2017 and March 1, 2018. This study enrolled 120 patients with esophageal cancer. And 112 patients were divided into two groups randomly: EIN group and enteral nutrition (EN) group. The EIN contained extra immunonutritional substrates, including a consistent combination of arginine, RNA and the omega-3 fatty acids compared with EN. Immune indicators were measured at preoperative day 7, postoperative day (POD) 1, 3, 7 and post-discharge day (PDD) 30.
There were 56 participants randomized to each group. Finally, 53 patients in EIN and 50 patients in EN were analyzed. Immune indicator was the primary outcome in this study. EIN yielded a significantly lower rate of CD8/CD3 (%) at POD 3 compared with EN group (P=0.005). The rate of CD4/CD8 (%) in EIN group was higher than that in EN group at POD3 (P=0.004). The serum levels of IgM at POD 3 and 7 were significantly higher in EN group compared with EIN group (P=0.025 and P=0.009, respectively). The rate of NK (%) and the serum level of IgA were significantly higher in EIN group compared with EN group at PDD 30 (P=0.022 and P=0.041, respectively). No significant differences were found in 2-year progressionfree survival and overall survival.
Immunonutrition is a safe and feasible nutritional treatment, which has a positive modulatory impact on immune responses after esophagectomy. Although no significant difference was found in clinical and survival outcomes between EIN and EN groups, immunonutrition could still have a positive effect on immunological function of patients undergoing esophagectomy.
近年来，免疫营养已被引入并被认为对外科手术患者，尤其是接受胃肠道癌切除术的患者的炎症和免疫反应以及肠道功能具有积极的调节作用。我们开展了这项平行组、随机双盲临床对照试验，以研究围手术期肠内免疫营养（EIN）对接受食管切除术患者的临床和免疫结局的疗效。
2017年12月1日至2018年3月1日进行了一项随机、平行组、双盲临床试验。本研究纳入了120例食管癌患者。112例患者被随机分为两组：EIN组和肠内营养（EN）组。与EN组相比，EIN含有额外的免疫营养底物，包括精氨酸、RNA和ω-3脂肪酸的固定组合。在术前第7天、术后第1、3、7天以及出院后第30天测量免疫指标。
每组随机分配56名参与者。最后，分析了EIN组的53例患者和EN组的50例患者。免疫指标是本研究的主要结局。与EN组相比，EIN组术后第3天CD8/CD3（%）率显著降低（P = 0.005）。EIN组术后第3天CD4/CD8（%）率高于EN组（P = 0.004）。与EIN组相比，EN组术后第3天和第7天血清IgM水平显著更高（分别为P = 0.025和P = 0.009）。出院后第30天，EIN组NK（%）率和血清IgA水平显著高于EN组（分别为P = 0.022和P = 0.041）。在2年无进展生存期和总生存期方面未发现显著差异。
免疫营养是一种安全可行的营养治疗方法，对食管切除术后的免疫反应具有积极的调节作用。虽然EIN组和EN组在临床和生存结局方面未发现显著差异，但免疫营养仍可对接受食管切除术患者的免疫功能产生积极影响。
