Kieft Hans, Roos Arnout N, van Drunen Jenneke D E, Bindels Alexander J G H, Bindels Jacques G, Hofman Zandrie
Department of Intensive Care, Isala Clinics (Location Sophia), Dr. van Heesweg 2, 8025 AB Zwolle, The Netherlands.
Intensive Care Med. 2005 Apr;31(4):524-32. doi: 10.1007/s00134-005-2564-x. Epub 2005 Feb 10.
To study the effect of a high-protein enteral formula enriched with arginine, glutamine, and antioxidants and containing omega3 fatty acids and a mixture of fibers, on the clinical outcome of a heterogeneous intensive care (ICU) population.
A randomized, prospective, double blind, controlled, two-center clinical trial in two intensive care units in The Netherlands.
A total of 597 adult ICU patients expected to require enteral tube feeding for more than 2 days were randomized to receive immunonutrition or an isocaloric control formula.
Patients received either the immunonutrition or the control feed.
Intention-to-treat and per-protocol analyses showed no statistically significant difference in clinical outcome parameters between the two groups. Results of the intention-to-treat analysis in control vs. immunonutrition were: median ICU length of stay in days, 8.0 (IQR 5.0-16.0) vs. 7.0 (4.0-14.0); median hospital length of stay in days, 20.0 (IQR 10.0-34.0) vs. 20.0 (10.0-35.0); median days of ventilation, 6.0 (IQR 3.0-12.0) vs. 6.0 (IQR 3.0-12.0); ICU mortality, 26.8% vs. 28.2%; in-hospital mortality, 36.4% vs. 38.5%; infectious complications, 41.7% vs. 43.0%.
The results of this largest randomized, controlled trial found that in the general ICU population immunonutrition has no beneficial effect on clinical outcome parameters. These results are consistent with the literature that is currently available.
研究一种富含精氨酸、谷氨酰胺和抗氧化剂且含有ω-3脂肪酸及纤维混合物的高蛋白肠内营养配方,对异质性重症监护病房(ICU)患者临床结局的影响。
在荷兰的两个重症监护病房进行的一项随机、前瞻性、双盲、对照、双中心临床试验。
共有597名预计需要肠内管饲超过2天的成年ICU患者被随机分配接受免疫营养或等热量对照配方。
患者分别接受免疫营养或对照喂养。
意向性分析和符合方案分析显示,两组之间的临床结局参数无统计学显著差异。对照与免疫营养的意向性分析结果如下:ICU住院时间中位数(天),8.0(四分位间距5.0 - 16.0)对7.0(4.0 - 14.0);住院时间中位数(天),20.0(10.0 - 34.0)对20.0(10.0 - 35.0);机械通气天数中位数,6.0(3.0 - 12.0)对6.0(3.0 - 12.0);ICU死亡率,26.8%对28.2%;住院死亡率,36.4%对38.5%;感染并发症,41.7%对43.0%。
这项最大规模的随机对照试验结果发现,在普通ICU患者群体中,免疫营养对临床结局参数无有益影响。这些结果与目前可得的文献一致。