Background

Body weight loss (BWL) after gastrectomy is associated with not only a deteriorated quality of life but also a poor prognosis. Oral nutritional supplements (ONS) may be used to minimize BWL, which is observed in the first 3 months after gastrectomy and becomes stable thereafter, although the results of several randomized trials remain controversial.

Methods

We performed a multicenter, open-label randomized controlled trial including 1003 gastric cancer patients undergoing curative gastrectomy. Patients were assigned to the ONS group or the control group. In the former, 400 ml (400 kcal) per day for 12 weeks as enteral nutrition was planned, and the actual intake amount was recorded daily by patients themselves. The primary endpoint was BWL 1 year after gastrectomy.

Results

BWL data were available in 880 patients (ONS 437, control 443). BWL at 3 months was significantly lower in the ONS group than in the control group (7.1 ± 5.6% and 8.5 ± 5.8%, p = 0.0011). However, the difference gradually declined after 6 months and was not significant 1 year after surgery (9.3 ± 8.2% and 9.8 ± 8.7%, p = 0.37). In the ONS group, 50.4% of patients took more than 200 ml/day of ONS (average 301 ml) and showed significantly less BWL (8.2 ± 7.2%) at 1 year than the control (p = 0.0204).

Conclusion

The administration of ONS for 12 weeks after gastrectomy did not improve BWL at 1 year. However, the improvement in BWL remained until 1 year after surgery in patients who took more than 200 kcal/day of ONS.

中文翻译：

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胃切除术后口服营养补充剂与单纯常规饮食对减轻体重的比较：一项 3 期、多中心、开放标签的随机对照试验

背景

胃切除术后体重减轻（BWL）不仅与生活质量下降有关，而且与预后不良有关。口服营养补充剂 (ONS) 可用于将 BWL 降至最低，在胃切除术后的前 3 个月观察到 BWL，此后逐渐稳定，尽管几项随机试验的结果仍存在争议。

方法

我们进行了一项多中心、开放标签的随机对照试验，包括 1003 名接受根治性胃切除术的胃癌患者。患者被分配到ONS组或对照组。前者计划每天400毫升（400大卡）肠内营养，持续12周，实际摄入量由患者每天记录。主要终点是胃切除术后 1 年的 BWL。

结果

BWL 数据可用于 880 名患者（ONS 437，对照 443）。ONS 组 3 个月时的 BWL 显着低于对照组（7.1 ± 5.6% 和 8.5 ± 5.8%，p  = 0.0011）。然而，差异在 6 个月后逐渐下降，并且在术后 1 年不显着（9.3 ± 8.2% 和 9.8 ± 8.7%，p  = 0.37）。在 ONS 组中，50.4% 的患者每天服用超过 200 毫升的 ONS（平均 301 毫升），并且在 1 年时的 BWL（8.2 ± 7.2%）显着低于对照组（p  = 0.0204）。

结论

胃切除术后 12 周的 ONS 给药并没有改善 1 年的 BWL。然而，对于每天服用超过 200 kcal ONS 的患者，BWL 的改善一直持续到手术后 1 年。