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危重患者低碳水化合物肠内配方与标准组成肠内配方的血糖效应比较:一项开放标签随机对照临床试验。

Glycemic Effects of a Low-Carbohydrate Enteral Formula Compared With an Enteral Formula of Standard Composition in Critically Ill Patients: An Open-Label Randomized Controlled Clinical Trial.

机构信息

Department of Endocrinology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.

Department of Intensive Care, OLVG, Amsterdam, the Netherlands.

出版信息

JPEN J Parenter Enteral Nutr. 2018 Aug;42(6):1035-1045. doi: 10.1002/jpen.1045. Epub 2017 Dec 27.

DOI:10.1002/jpen.1045
PMID:30133840
Abstract

BACKGROUND

Enteral low-carbohydrate formulas (LCFs) could serve as a noninsulin alternative for the treatment of stress hyperglycemia in critically ill patients. We compared the glycemic effects of an LCF with a standard formula.

METHODS

We conducted an open-label randomized trial in patients admitted to our intensive care unit between September 2015 and June 2016. Adult patients with an indication for enteral nutrition were randomized to an LCF (Glucerna 1.5 kcal) or a standard enteral formula (Fresubin Energy Fibre, with additional protein supplement). Primary outcome was glucose variability defined as mean absolute glucose (MAG) change (mmol/L/h). Secondary outcomes were mean glucose, time in target, hypoglycemic and hyperglycemic events, and insulin requirements. We assessed glycemic outcomes per blinded continuous glucose monitoring (CGM) system and compared outcomes with glucose measurements per blood gas analysis and point-of-care device.

RESULTS

We randomized 107 patients (LCF: n = 53; standard: n = 54). Six patients had no CGM data, leaving 101 patients (n = 52; n = 49) for the intention-to-treat analysis. MAG change and time in target range were not different between groups. LCF gave a lower mean glucose measured per point-of-care device (7.8 ± 1.0 vs 8.4 ± 1.1 mmol/L, P = .007). LCF patients required significantly less insulin on the second study day (46.8 vs 68.0 IU, P = .036).

CONCLUSION

LCF showed a trend toward a modestly reduced mean glucose and significantly lower insulin requirements as compared with standard feeding but had no effect on glucose variability or time in target range.

摘要

背景

肠内低碳水化合物配方(LCF)可作为治疗危重症患者应激性高血糖的非胰岛素替代疗法。我们比较了 LCF 与标准配方的血糖效应。

方法

我们在 2015 年 9 月至 2016 年 6 月期间进行了一项 ICU 住院患者的开放性随机试验。有肠内营养适应证的成年患者被随机分配到 LCF(佳膳 1.5kcal)或标准肠内配方(Fresubin Energy Fibre,添加蛋白质补充剂)。主要结局为血糖变异性定义为平均绝对血糖(MAG)变化(mmol/L/h)。次要结局为平均血糖、目标时间、低血糖和高血糖事件以及胰岛素需求。我们根据盲法连续血糖监测(CGM)系统评估血糖结局,并将结果与血气分析和即时血糖监测仪的血糖测量值进行比较。

结果

我们随机分配了 107 例患者(LCF:n = 53;标准:n = 54)。6 例患者无 CGM 数据,101 例患者(n = 52;n = 49)纳入意向治疗分析。两组间 MAG 变化和目标范围内时间无差异。LCF 通过即时血糖仪测量的平均血糖较低(7.8 ± 1.0 与 8.4 ± 1.1 mmol/L,P =.007)。LCF 患者在第 2 天的胰岛素需求量显著减少(46.8 与 68.0 IU,P =.036)。

结论

与标准喂养相比,LCF 显示出适度降低平均血糖和显著降低胰岛素需求的趋势,但对血糖变异性或目标范围内时间无影响。

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