Department of Anesthesiology and Cardiothoracic Surgery, Mount Sinai School of Medicine, New York, NY 10029, USA.
Curr Opin Clin Nutr Metab Care. 2010 Mar;13(2):211-4. doi: 10.1097/MCO.0b013e32833571f4.
The publication of the long awaited results of the Normoglycaemia in Intensive Care Evaluation - Survival Using Glucose Algorithm Regulation (NICE-SUGAR) trial generated intense controversy in the area of glycemic control in the critically ill. NICE-SUGAR reported results in direct contrast to the original Leuven study and challenged the legitimacy of a mortality benefit of tight glycemic control in the intensive care unit (ICU). This review of the recent literature critically examines the salient differences between NICE-SUGAR and the original Leuven study.
Differences in glycemic targets within the control and intervention groups, variability with patients reaching these set targets, and the disparity in study execution and nutritional strategies are some of the methodological differences explaining the observed differences in mortality and morbidity between the two studies. The Leuven study should be viewed as a 'proof-of-concept' study with future studies aimed at confirming its finding and optimizing clinical algorithms to safely implement it in various 'real world' settings. Discrepancies in implementation and nutrition make direct comparison of NICE-SUGAR and the original Leuven study impracticable.
Accurate replication of the original Leuven methodology may be the limiting factor for achieving the benefits gained by intensive insulin therapy (IIT). Determination of ICU capability (physicians, nurses, standardization of equipment, etc.) is crucial to implementing tight glycemic targets. If IIT is not achievable due to adverse outcomes such as hypoglycemia, more lax and reachable glucose control should be sought.
备受期待的强化血糖控制对重症监护患者预后影响的临床试验(NICE-SUGAR)结果公布后,在重症患者血糖控制领域引发了激烈的争议。NICE-SUGAR 研究的结果与最初的鲁汶研究截然相反,对 ICU 中严格血糖控制是否具有生存获益提出了质疑。本文对近期文献进行了批判性回顾,重点分析了 NICE-SUGAR 研究与最初的鲁汶研究之间的显著差异。
在对照组和干预组中,血糖目标的差异、患者达到这些设定目标的变异性,以及研究执行和营养策略的差异,都是导致这两项研究死亡率和发病率差异的部分原因。鲁汶研究应被视为一项“概念验证”研究,未来的研究旨在证实其研究结果,并优化临床算法,以安全地将其应用于各种“真实世界”环境中。由于实施和营养方面的差异,使得 NICE-SUGAR 研究与最初的鲁汶研究直接比较变得不切实际。
准确复制最初的鲁汶研究方法可能是实现强化胰岛素治疗(IIT)获益的限制因素。确定 ICU 的能力(医生、护士、设备标准化等)对于实现严格的血糖目标至关重要。如果由于低血糖等不良后果导致无法实施 IIT,则应寻求更宽松且可实现的血糖控制。