Falewee M N, Schilf A, Boufflers E, Cartier C, Bachmann P, Pressoir M, Banal A, Michel C, Ettaiche M
Centre Antoine Lacassagne, Cancer Research Centre, Nice, France.
Institut Gustave Roussy, Cancer Research Centre, Villejuif, France.
Clin Nutr. 2014 Oct;33(5):776-84. doi: 10.1016/j.clnu.2013.10.006. Epub 2013 Oct 17.
BACKGROUND & AIMS: Head and neck cancer surgery is affected by complications in 20-60% of cases, with risk factors being malnutrition, alcoholism and immunosuppression due to cancer. The aim of the study was to investigate whether preoperative or perioperative immunonutrition could reduce postoperative infectious complications (IC) and surgical-site infections (SSI) in this population.
This was a multicenter, prospective, randomized, double-blind study. Patients with oropharyngeal and pharyngolaryngeal tumour were randomly allocated to three groups: a) perioperative formula of Impact(®) without immune nutrients, named "reference diet" (group A, control); b) preoperative Impact(®) and "reference diet" postoperatively (group B); c) Impact(®) perioperatively (group C). Products were available in oral and enteral formula and were given 7 days before surgery and for 7-15 days postoperatively. The primary and secondary endpoints were the incidence of IC and SSI, respectively.
Of 312 randomized patients, 205 were evaluable for ITT analysis. There was no significant difference in IC and SSI. However out of this population, only 64 patients had taken at least 75% of the theoretical intake from surgery to day 10 (per-protocol population). In this condition, a significant difference in IC (OR = 0.24, p = 0.05), SSI (OR = 0.17, p = 0.04) and also in the median length of postoperative stay (18 vs. 25 days, p = 0.05) was demonstrated between groups A and C.
In the ITT population, no significant difference in IC, SSI and LOS was demonstrated. Positive exploratory results on the perioperative Impact(®) per-protocol population, encourage further study in head and neck cancer patients. Registered under ClinicalTrials.gov Identifier no. NCT00765440.
20%-60%的头颈癌手术会受到并发症影响，危险因素包括营养不良、酗酒以及癌症导致的免疫抑制。本研究旨在调查术前或围手术期免疫营养能否降低该人群术后感染性并发症（IC）和手术部位感染（SSI）的发生率。
这是一项多中心、前瞻性、随机、双盲研究。口咽及咽喉部肿瘤患者被随机分为三组：a）围手术期使用不含免疫营养素的Impact(®)配方，称为“参考饮食”（A组，对照组）；b）术前使用Impact(®)，术后使用“参考饮食”（B组）；c）围手术期全程使用Impact(®)（C组）。产品有口服和肠内配方，术前7天开始给予，术后给予7-15天。主要终点和次要终点分别为IC和SSI的发生率。
312例随机分组患者中，205例可进行意向性分析。IC和SSI方面无显著差异。然而，在该人群中，只有64例患者从手术至术后第10天摄入了至少75%的理论摄入量（符合方案人群）。在此情况下，A组和C组之间在IC（OR = 0.24，p = 0.05）、SSI（OR = 0.17，p = 0.04）以及术后住院时间中位数（18天对25天，p = 0.05）方面存在显著差异。
在意向性分析人群中，IC、SSI和住院时间无显著差异。符合方案人群中围手术期使用Impact(®)的探索性阳性结果，鼓励对头颈癌患者进行进一步研究。在ClinicalTrials.gov注册，标识符为NCT00765440。
