Early enteral immunonutrition in patients with severe sepsis - Results of an interim analysis of a randomized multicentre clinical trial
Early enteral immunonutrition in patients with severe sepsis - Results of an interim analysis of a randomized multicentre clinical trial
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DOI：
10.1007/s00134-003-1711-5
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发表时间：
2003-05-01
影响因子：
38.9
通讯作者：
Tognoni, G
中科院分区：
文献类型：
--
作者：
Bertolini, G;Iapichino, G;Tognoni, G
目的：比较采用免疫增强配方奶粉肠内喂养或肠外营养（PN）的危重患者的死亡率。我们报告了对严重脓毒症患者进行的计划中期分析的结果，该分析比计划提前进行，荟萃分析表明：给予肠内免疫营养的严重脓毒症患者死亡率过高。设计：随机多中心非盲对照临床试验。在意大利设立三十三个普通重症监护病房。患者和参与者：在237名招募的患者中，39名患有严重脓毒症或感染性休克；其中 21 人收到 PN。干预措施：符合条件的患者接受全 PN 或肠内营养，后者含有额外的 L-精氨酸、omega-3 脂肪酸、维生素 E、β 胡萝卜素、锌和硒。测量和结果：严重脓毒症患者亚组分析的主要终点是重症监护病房 (ICU) 的死亡率。接受肠内营养 (EN) 的严重脓毒症患者的 ICU 死亡率高于接受 PN 的患者（44.4% vs 14.3%；p=0.039）。与接受 PN 的患者相比，更多接受 EN 治疗的患者在死亡时仍患有严重脓毒症（38.9% vs 9.5%，p=0.055）。随后停止招募严重败血症患者。结论：我们的结果表明，与 PN 相比，肠内免疫营养可能与严重脓毒症患者死亡率过高有关。
Objective: To compare the mortality of critically ill patients given either enteral feeding with an immune-enhancing formula or parenteral nutrition (PN). We report the results of a planned interim analysis on patients with severe sepsis which was undertaken earlier than planned once a meta-analysis suggested:excess mortality in patients with severe sepsis given enteral immunonutrition. Design: Randomised multicentre unblinded controlled clinical trial. Setting Thirty-three General Intensive Care Units in Italy. Patients and participants: Among the 237 recruited patients, 39 had severe sepsis or septic shock; 21 of them received PN. Interventions: Eligible patients received either total PN or enteral nutrition, the latter containing extra L-arginine, omega-3 fatty acids, vitamin E, beta carotene, zinc, and selenium. Measurements and results: The primary endpoint for the subgroup analysis on patients with severe sepsis was mortality on Intensive Care Unit (ICU). The ICU mortality of patients with severe sepsis given enteral nutrition (EN) was higher than for those given PN (44.4% vs 14.3%; p=0.039). More patients given EN than patients given PN still had severe sepsis when they died (38.9% vs 9.5%, p=0.055). Recruitment of patients with severe sepsis was subsequently stopped. Conclusions: Our results show that enteral immunonutrition, compared to PN, may be associated with excess mortality in patients with severe sepsis.