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艾塞那肽静脉输注在冠状动脉旁路移植术后围手术期血糖控制中的临床疗效:一项II/III期随机试验

Clinical Effectiveness of Intravenous Exenatide Infusion in Perioperative Glycemic Control after Coronary Artery Bypass Graft Surgery: A Phase II/III Randomized Trial.

作者信息

Besch Guillaume, Perrotti Andrea, Mauny Frederic, Puyraveau Marc, Baltres Maude, Flicoteaux Guillaume, Salomon du Mont Lucie, Barrucand Benoit, Samain Emmanuel, Chocron Sidney, Pili-Floury Sebastien

机构信息

From the Department of Anesthesiology and Intensive Care Medicine (G.B., M.B., G.F., B.B., E.S., S.P.-F.), EA 3920 (G.B., A.P., L.S., E.S., S.C., S.P.-F.), Department of Cardiothoracic Surgery (A.P., S.C.), Clinical Methodology Center (F.M., M.P.), and Department of Vascular Surgery (L.S.), University Hospital of Besancon, Chrono-environement Laboratory, UMR6249 CNRS (F.M.), and SFR-FED 4234 INSERM (E.S., S.P.-F.), University of Franche-Comte, Besancon, France.

出版信息

Anesthesiology. 2017 Nov;127(5):775-787. doi: 10.1097/ALN.0000000000001838.

DOI:10.1097/ALN.0000000000001838
PMID:28820780
Abstract

BACKGROUND

We aimed to assess the clinical effectiveness of intravenous exenatide compared to insulin in perioperative blood glucose control in coronary artery bypass grafting surgery patients.

METHODS

Patients more than 18 yr old admitted for elective coronary artery bypass grafting were included in a phase II/III nonblinded randomized superiority trial. Current insulin use and creatinine clearance of less than 60 ml/min were exclusion criteria. Two groups were compared: the exenatide group, receiving exenatide (1-h bolus of 0.05 µg/min followed by a constant infusion of 0.025 µg/min), and the control group, receiving insulin therapy. The blood glucose target range was 100 to 139 mg/dl. The primary outcome was the proportion of patients who spent at least 50% of the study period within the target range. The consumption of insulin (Cinsulin) and the time to start insulin (Tinsulin) were compared between the two groups.

RESULTS

In total, 53 and 51 patients were included and analyzed in the exenatide and control groups, respectively (age: 70 ± 9 vs. 68 ± 11 yr; diabetes mellitus: 12 [23%] vs. 10 [20%]). The primary outcome was observed in 38 (72%) patients in the exenatide group and in 41 (80%) patients in the control group (odds ratio [95% CI] = 0.85 [0.34 to 2.11]; P = 0.30). Cinsulin was significantly lower (60 [40 to 80] vs. 92 [63 to 121] U, P < 0.001), and Tinsulin was significantly longer (12 [7 to 16] vs. 7 [5 to 10] h, P = 0.02) in the exenatide group.

CONCLUSIONS

Exenatide alone at the dose used was not enough to achieve adequate blood glucose control in coronary artery bypass grafting patients, but it reduces overall consumption of insulin and increases the time to initiation of insulin.

摘要

背景

我们旨在评估与胰岛素相比,静脉注射艾塞那肽在冠状动脉搭桥手术患者围手术期血糖控制中的临床效果。

方法

纳入年龄超过18岁的择期冠状动脉搭桥手术患者,进行一项II/III期非盲随机优效性试验。当前正在使用胰岛素以及肌酐清除率低于60 ml/min为排除标准。比较两组:艾塞那肽组,接受艾塞那肽治疗(先以0.05μg/min的速度静脉推注1小时,随后以0.025μg/min的速度持续输注),以及对照组,接受胰岛素治疗。血糖目标范围为100至139mg/dl。主要结局是在目标范围内度过至少50%研究期的患者比例。比较两组之间的胰岛素消耗量(Cinsulin)和开始使用胰岛素的时间(Tinsulin)。

结果

艾塞那肽组和对照组分别纳入并分析了53例和51例患者(年龄:70±9岁 vs. 68±11岁;糖尿病:12例[23%] vs. 10例[20%])。艾塞那肽组38例(72%)患者和对照组41例(80%)患者观察到主要结局(优势比[95%CI]=0.85[0.34至2.11];P=0.30)。艾塞那肽组的Cinsulin显著更低(60[40至80]U vs. 92[63至121]U,P<0.001),且Tinsulin显著更长(12[7至16]小时 vs. 7[5至10]小时,P=0.02)。

结论

单独使用该剂量的艾塞那肽不足以在冠状动脉搭桥手术患者中实现充分的血糖控制,但它可降低胰岛素的总体消耗量并延长开始使用胰岛素的时间。

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