能量密集口服营养补充剂对胃癌手术后营养支持依从性的影响：一项多中心II期研究

IF 2.6 Q3 NUTRITION & DIETETICS

Clinical nutrition ESPEN Pub Date : 2025-05-28 DOI:10.1016/j.clnesp.2025.05.041

Hiroshi Ichikawa , Masaki Aizawa , Yosuke Kano , Yusuke Muneoka , Takeo Bamba , Sou Hiroi , Hiroto Ueki , Kazuki Moro , Yuki Hirose , Yoshifumi Shimada , Jun Sakata , Hiroshi Yabusaki , Satoru Nakagawa , Yu Koyama , Toshifumi Wakai

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引用次数: 0

摘要

背景与目的：维持口服营养补充剂（ONS）的依从性是胃癌手术后接受营养支持的患者的主要问题。这项多中心、单臂II期研究的目的是测试能量密集ONS （1.6 kcal/mL）的营养支持是否比以前的研究报告中更大比例的患者提供200 kcal/天或更多的平均热量摄入。方法：纳入接受根治性胃癌切除术的患者，采用能量密集的ONS进行营养支持。ONS在术后口服饮食开始后3天内开始，并持续到术后3个月。主要终点是实现率（AR），定义为能够在营养支持中实现平均热量摄入200千卡/天或更多的患者比例。结果：在45例接受营养支持的符合条件的患者中，有30例能够达到200 kcal/d及以上的平均热量摄入，AR为66.7%(95%可信区间为53%-100%)，与50%的阈值有显著差异（P = 0.018）。3级高甘油三酯血症和2级腹泻各1例。在手术后3个月和12个月，每天摄入200千卡或更多的患者和每天摄入少于200千卡的患者在体重百分比（BW）或骨骼肌指数（SMI）方面没有显著差异。结论：在高比例的胃癌手术后患者中，能量密集的营养支持提供了200 kcal/天或更多的平均热量摄入，而没有引起严重的不良事件。然而，能量密集的ONS对BW和SMI损失的显著抑制作用尚未得到证实。（UMIN-CTR, https://www.umin.ac.jp/ctr/index.htm，研究唯一标识符：UMIN000045645）。

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Impact of energy-dense oral nutritional supplements on compliance with nutritional support after surgical treatment for gastric cancer: A multicenter phase II study

Background & aims

Maintaining compliance with oral nutritional supplements (ONS) is a major problem in patients receiving nutritional support after surgical treatment for gastric cancer. The objective of this multicenter, single-arm phase II study was to test whether nutritional support with energy-dense ONS (1.6 kcal/mL) provides an average caloric intake of 200 kcal/day or more for a greater proportion of patients than that reported in previous studies.

Methods

Patients who underwent curative gastrectomy for gastric cancer were enrolled and received nutritional support with energy-dense ONS. ONS was initiated within three days after the start of the postoperative oral diet and continued until three months after surgery. The primary endpoint was the achievement rate (AR), which was defined as the proportion of patients who were able to achieve an average caloric intake of 200 kcal/day or more in nutritional support.

Results

Among 45 eligible patients who received nutritional support, 30 were able to achieve an average caloric intake of 200 kcal/day or more, and the AR was 66.7% (95% confidence interval, 53%–100%), which significantly differed from the threshold of 50% (P = 0.018). Grade 3 hypertriglyceridemia and grade 2 diarrhea were observed in one patient each. There were no significant differences in the percentage of body weight (BW) or the skeletal muscle index (SMI) between patients who consumed 200 kcal/day or more and those who consumed less than 200 kcal/day at three and 12 months after surgery.

Conclusions

Nutritional support with energy-dense ONS provides an average caloric intake of 200 kcal/day or more in a high proportion of patients after surgical treatment for gastric cancer without causing severe adverse events. However, the significant suppressive effect of energy-dense ONS on BW and SMI loss is not demonstrated (UMIN-CTR, https://www.umin.ac.jp/ctr/index.htm, study unique identifier: UMIN000045645).

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来源期刊

Clinical nutrition ESPEN NUTRITION & DIETETICS-

CiteScore

4.90

自引率

3.30%

发文量

512

期刊介绍： Clinical Nutrition ESPEN is an electronic-only journal and is an official publication of the European Society for Clinical Nutrition and Metabolism (ESPEN). Nutrition and nutritional care have gained wide clinical and scientific interest during the past decades. The increasing knowledge of metabolic disturbances and nutritional assessment in chronic and acute diseases has stimulated rapid advances in design, development and clinical application of nutritional support. The aims of ESPEN are to encourage the rapid diffusion of knowledge and its application in the field of clinical nutrition and metabolism. Published bimonthly, Clinical Nutrition ESPEN focuses on publishing articles on the relationship between nutrition and disease in the setting of basic science and clinical practice. Clinical Nutrition ESPEN is available to all members of ESPEN and to all subscribers of Clinical Nutrition.