Perioperative immunonutrition in patients undergoing cancer surgery - Results of a randomized double-blind phase 3 trial
Perioperative immunonutrition in patients undergoing cancer surgery - Results of a randomized double-blind phase 3 trial
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DOI：
10.1001/archsurg.134.4.428
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发表时间：
1999-04-01
影响因子：
--
通讯作者：
Di Carlo, V
中科院分区：
文献类型：
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作者：
Braga, M;Gianotti, L;Di Carlo, V
假设：围手术期补充肠内配方可降低术后感染率。设计：前瞻性、随机、双盲临床试验。地点：某大学附属医院外科。患者：结、直肠、胃、胰腺肿瘤260例。干预：患者被随机分配为术前连续7天饮用1 L/d的对照肠内配方（n = 104）或富含精氨酸、RNA和ω - 3脂肪酸的相同配方（n = 102）。两种饲料均为等能、等氮饲料。术后6小时开始空肠输注相同配方，持续至术后第7天。主要观察指标：术后感染并发症发生率和住院时间。结果：两组患者在年龄、性别、体重减轻、Karnofsky评分、营养状况、血红蛋白水平、手术时间、出血量和同源输血率方面具有可比性。意向治疗分析显示，补充组感染并发症发生率为14%(14/102)，对照组为30% (31/104)（P = 0.009）。在符合条件的人群中，补充组术后感染率为11%(9/85)，对照组为24% (21/86)（P = 0.02）。补充组术后SD平均停留时间为11.1 +/- 4.4天，对照组为12.9 +/- 4.6天（P = 0.01）。结论：围手术期给予补充肠内配方可显著减少癌症手术患者的术后感染和住院时间。
Hypothesis: Perioperative administration of a supplemented enteral formula may reduce the rate of postoperative infections.Design: Prospective, randomized, double-blind clinical trial.Setting: Department of surgery at a university hospital.Patients: Two hundred six patients with neoplasm of colorectum, stomach, or pancreas.Intervention: Patients were randomized to drink 1 L/d of either a control enteral formula (n = 104) or the same formula enriched with arginine, RNA, and omega 3 fatty acids (n = 102) for 7 consecutive days before surgery. The 2 diets were isoenergetic and isonitrogenous. Jejunal infusion with the same formulas was started 6 hours after operation and continued until postoperative day 7.Main Outcome Measures: Rate of postoperative infectious complications and length of hospital stay.Results: Both groups were comparable for age, sex, weight loss, Karnofsky scale score, nutritional status, hemoglobin level, duration of surgery, blood loss, and rate of homologous transfusion. Intent-to-treat analysis showed a 14% (14/102) infectious complication rate in the supplemented group vs 30% (31/104) in the control group (P = .009). In the eligible population, the postoperative infection rate was 11% (9/85) in the supplemented group vs 24% (21/86) in the control group (P = .02). The mean SD length of postoperative stay was 11.1 +/- 4.4 days in the supplemented group and 12.9 +/- 4.6 in the control group (P = .01).Conclusion: Perioperative administration of a supplemented enteral formula significantly reduced postoperative infections and length of stay in patients undergoing surgery for cancer.