静脉艾塞那肽对冠脉搭桥术后患者围手术期血糖控制的疗效:Ⅱ期/Ⅲ期随机试验

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

背景与目的

本研究旨在评估冠脉搭桥术患者静脉输注艾塞那肽与胰岛素相比对围术期血糖控制的疗效。

方  法

18岁以上的择期冠状动脉搭桥术患者纳入本II期/ III期非盲随机优化试验。当前胰岛素应用或肌酐清除率小于60ml / min予以排除。两组比较:艾塞那肽组接受艾塞那肽治疗(0.05μg/ min1h剂量的推注,然后恒定输注0.025μg/ min),对照组接受胰岛素治疗。血糖目标控制范围为100〜139mg / dl。主要结局指标是至少50%的研究时间血糖控制在目标范围内的患者比例。比较两组患者胰岛素消耗量和胰岛素输注开始时间。

结  果

纳入患者艾塞那肽组53例,对照组51例(年龄70±9 vs 68±11岁,糖尿病患者12[23%]vs10[20%])。主要结局指标结果:艾塞那肽组38例(72%)和对照组41例(80%)(优势比[95%CI] = 0.85 [0.34〜2.11]; P = 0.30)。艾塞那肽组胰岛素消耗量较少(60 [40〜80] vs 92 [63〜121] U,P <0.001),胰岛素输注开始时间更长(12 [7〜16] vs. 7 [5〜10] h,P = 0.02)。

结  论

冠脉搭桥手术患者单独使用该剂量的艾塞那肽不足以获得满意的血糖控制,但降低了胰岛素的总体消耗,并延迟了胰岛素的输注开始时间。

原始文献摘要

Besch GPerrotti AMauny F, et al. Clinical Effectiveness of Intravenous Exenatide  Infusion in Perioperative Glycemic Control after Coronary Artery Bypass Graft Surgery: A Phase II/III Randomized Trial[J]. Anesthesiology, 2017. doi: 10.1097/ALN.0000000000001838. [Epub ahead of print]

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.

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