Imamura Hiroshi, Nishikawa Kazuhiro, Kishi Kentaro, Inoue Kentaro, Matsuyama Jin, Akamaru Yusuke, Kimura Yutaka, Tamura Shigeyuki, Kawabata Ryohei, Kawada Junji, Fujiwara Yoshiyuki, Kawase Tomono, Fukui Junichi, Takagi Mari, Takeno Atsushi, Shimokawa Toshio
Department of Surgery, Toyonaka Municipal Hospital, 4-14-1 Shibahara-cho, Toyonaka, Japan.
Department of Surgery, Osaka National Hospital, Osaka, Japan.
Ann Surg Oncol. 2016 Sep;23(9):2928-35. doi: 10.1245/s10434-016-5221-4. Epub 2016 Apr 15.
Post-gastrectomy weight loss is associated with deterioration in quality of life, and influences the long-term prognosis of gastric cancer patients. We conducted a prospective, randomized controlled, open-label study to examine whether an oral elemental diet (Elental(®), Ajinomoto Pharmaceuticals, Tokyo, Japan; hereafter referred to as ED) prevents postoperative weight loss in post-gastrectomy patients.
Patients were randomly divided to receive the ED or control diet. The ED group received 300 kcal of ED plus their regular diet for 6-8 weeks after surgery, starting from the day the patient started a soft rice or equivalent diet after surgery, while the control group received the regular diet alone. The primary endpoint was the percentage of body weight loss (%BWL) from the presurgical body weight to that at 6-8 weeks after surgery. Secondary endpoints were dietary adherence, nutrition-related blood parameters, and adverse events.
This study included 112 patients in eight hospitals. The mean treatment compliance rate in the ED group was 68.7 ± 30.4 % (median 81.2 %). The %BWL was significantly different between the ED and control groups (4.86 ± 3.72 vs. 6.60 ± 4.90 %, respectively; p = 0.047). In patients who underwent total gastrectomy, the %BWL was significantly different between the two groups (5.03 ± 3.65 vs. 9.13 ± 5.43 %, respectively; p = 0.012). In multivariate analysis, ED treatment, surgery type, and preoperative performance status were independently associated with %BWL. No significant differences were observed in the other clinical variables.
ED supplementation reduced postoperative weight loss in gastric cancer patients undergoing gastrectomy.
胃切除术后体重减轻与生活质量下降相关，并影响胃癌患者的长期预后。我们进行了一项前瞻性、随机对照、开放标签研究，以检验口服要素饮食（Elemental（®），日本东京味之素制药公司；以下简称ED）是否能预防胃切除术后患者的体重减轻。
患者被随机分为接受ED或对照饮食组。ED组在术后从患者开始食用软米饭或等效饮食之日起，接受300千卡的ED并加上其常规饮食，持续6 - 8周，而对照组仅接受常规饮食。主要终点是从术前体重到术后6 - 8周体重减轻的百分比（%BWL）。次要终点是饮食依从性、营养相关血液参数和不良事件。
本研究纳入了8家医院的112例患者。ED组的平均治疗依从率为68.7±30.4%（中位数81.2%）。ED组和对照组之间的%BWL有显著差异（分别为4.86±3.72%和6.60±4.90%；p = 0.047）。在接受全胃切除术的患者中，两组之间的%BWL有显著差异（分别为5.03±3.65%和9.13±5.43%；p = 0.012）。在多变量分析中，ED治疗、手术类型和术前表现状态与%BWL独立相关。在其他临床变量中未观察到显著差异。
补充ED可减少接受胃切除术的胃癌患者的术后体重减轻。
