随机对照临床试验比较胃癌全胃切除术后标准饮食与围手术期口服免疫营养。

Randomized clinical trial comparing standard diet with perioperative oral immunonutrition in total gastrectomy for gastric cancer.

机构信息

Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Department of Gastrointestinal Surgery, Kanagawa Cancer Centre, Yokohama, Japan.

出版信息

Br J Surg. 2017 Mar;104(4):377-383. doi: 10.1002/bjs.10417. Epub 2017 Jan 10.

DOI:10.1002/bjs.10417

PMID:28072447

Abstract

BACKGROUND

Total gastrectomy for gastric cancer is associated with excessive weight loss and decreased calorie intake. Nutritional support using eicosapentaenoic acid modulates immune function and limits catabolism in patients with advanced cancer, but its impact in the perioperative period is unclear.

METHODS

This was a randomized phase III clinical trial of addition of eicosapentaenoic acid-rich nutrition to a standard diet in patients having total gastrectomy for gastric cancer. Patients were randomized to either a standard diet or standard diet with oral supplementation of an eicosapentaenoic acid (ProSure®), comprising 600 kcal with 2·2 g eicosapentaenoic acid, for 7 days before and 21 days after surgery. The primary endpoint was percentage bodyweight loss at 1 and 3 months after surgery.

RESULTS

Of 127 eligible patients, 126 were randomized; 124 patients (61 standard diet, 63 supplemented diet) were analysed for safety and 123 (60 standard diet, 63 supplemented diet) for efficacy. Across both groups, all but three patients underwent total gastrectomy with Roux-en-Y reconstruction. Background factors were well balanced between the groups. Median compliance with the supplement in the immunonutrition group was 100 per cent before and 54 per cent after surgery. The surgical morbidity rate was 13 per cent in patients who received a standard diet and 14 per cent among those with a supplemented diet. Median bodyweight loss at 1 month after gastrectomy was 8·7 per cent without dietary supplementation and 8·5 per cent with eicosapentaenoic acid enrichment (P = 0·818, adjusted P = 1·000). Similarly, there was no difference between groups in percentage bodyweight loss at 3 months (P = 0·529, adjusted P = 1·000).

CONCLUSION

Immunonutrition based on an eicosapentaenoic acid-enriched oral diet did not reduce bodyweight loss after total gastrectomy for gastric cancer compared with a standard diet. Registration number: UMIN000006380 ( http://www.umin.ac.jp/).

摘要

背景

胃癌全胃切除术会导致体重过度下降和热量摄入减少。使用二十碳五烯酸进行营养支持可以调节免疫功能并限制晚期癌症患者的分解代谢，但在围手术期的影响尚不清楚。

方法

这是一项随机 III 期临床试验，旨在评估在胃癌全胃切除术后，添加富含二十碳五烯酸的营养支持对标准饮食的影响。患者被随机分为标准饮食组或标准饮食加口服二十碳五烯酸（ProSure®）补充组，术前 7 天和术后 21 天每天补充 600 千卡热量和 2.2 克二十碳五烯酸。主要终点是术后 1 个月和 3 个月的体重百分比下降。

结果

在 127 名符合条件的患者中，126 名患者被随机分组；124 名患者（标准饮食组 61 例，补充饮食组 63 例）进行了安全性分析，123 名患者（标准饮食组 60 例，补充饮食组 63 例）进行了疗效分析。两组患者均接受了全胃切除术和 Roux-en-Y 重建。两组患者的背景因素基本平衡。免疫营养组在术前的补充剂依从率为 100%，术后为 54%。标准饮食组的手术并发症发生率为 13%，补充饮食组为 14%。全胃切除术后 1 个月，未进行饮食补充的患者体重下降 8.7%，补充二十碳五烯酸的患者体重下降 8.5%（P=0.818，调整后 P=1.000）。同样，3 个月时两组间体重下降百分比也无差异（P=0.529，调整后 P=1.000）。