Oghazian Mohammad Bagher, Javadi Mohammad Reza, Radfar Mania, Torkamandi Hassan, Sadeghi Mostafa, Hayatshahi Alireza, Gholami Kheirollah
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Pharmacotherapy. 2015 Feb;35(2):148-57. doi: 10.1002/phar.1546.
To compare the effectiveness and safety of two glycemic control regimens in stable critical care patients receiving parenteral nutrition (PN).
Prospective, randomized open-label clinical trial.
Eligible postoperative critical care patients in the ICU began PN on the first to the seventh day of ICU admission. The PN admixture included regular insulin, in doses sufficient to maintain 3 or more goal blood glucose (BG) levels between 110 and 180 mg/dl. After 3 to 5 days of PN containing regular insulin, patients were randomized to 3 more days of regular insulin at the same dose or 80% of their total daily regular insulin dose provided in PN solution as glargine insulin. Capillary BG monitoring was performed every 6 hours.
Twenty one patients were randomized to each treatment group. Median APACHE II scores were not significantly different between the two groups within the first 24-hour of ICU admission. There were no significant differences between the two groups at day 3 for mean daily dextrose (306.9 ± 46.2 vs. 305.2 ± 52.2 g; p=0.913) or insulin (18.3 ± 8.8 vs. 19.5 ± 10.0 units; p=0.696) doses. The percentage of BG values in the goal (110-180 mg/dl), hyperglycemic (> 180 mg/dl), and hypoglycemic (< 70 mg/dl) BG levels were similar between the two groups (69.0% vs. 66.7%, p=0.567; 11.9% vs. 11.1%, p=0.780; 0% vs. 1.6%, p=0.124, respectively). Mean daily BG levels were not significantly different between the two groups on each of the 3 study days (day 1: 140 ± 20 vs. 131 ± 25 mg/dl, p=0.194; day 2: 136 ± 20 vs. 140 ± 18 mg/dl, p=0.498; day 3: 142 ± 15 vs. 140 ± 19 mg/dl; p=0.741).
These data suggest that, compared with regular insulin added to PN, glargine insulin results in similar glycemic control and rates of hyperglycemia and hypoglycemia in stable critical care patients.
比较两种血糖控制方案在接受肠外营养(PN)的稳定重症监护患者中的有效性和安全性。
前瞻性、随机开放标签临床试验。
符合条件的ICU术后重症监护患者在入住ICU的第1天至第7天开始接受PN。PN混合液中包含常规胰岛素,剂量足以使3个或更多目标血糖(BG)水平维持在110至180mg/dl之间。在含有常规胰岛素的PN治疗3至5天后,患者被随机分为两组,一组继续接受3天相同剂量的常规胰岛素治疗,另一组接受PN溶液中提供的每日总常规胰岛素剂量80%的甘精胰岛素治疗。每6小时进行一次毛细血管BG监测。
每个治疗组随机分配21例患者。两组在入住ICU的前24小时内APACHE II评分中位数无显著差异。两组在第3天的平均每日葡萄糖剂量(306.9±46.2 vs. 305.2±52.2g;p=0.913)或胰岛素剂量(18.3±8.8 vs. 19.5±10.0单位;p=0.696)无显著差异。两组目标BG水平(110 - 180mg/dl)、高血糖(>180mg/dl)和低血糖(<70mg/dl)的BG值百分比相似(分别为69.0% vs. 66.7%,p=0.567;11.9% vs. 11.1%,p=0.780;0% vs. 1.6%,p=0.124)。在3个研究日中的每一天,两组的平均每日BG水平均无显著差异(第1天:140±20 vs. 131±25mg/dl,p=0.194;第2天:136±20 vs. 140±18mg/dl,p=0.498;第3天:142±15 vs. 140±19mg/dl;p=0.741)。
这些数据表明,与添加到PN中的常规胰岛素相比,甘精胰岛素在稳定的重症监护患者中能实现相似的血糖控制以及高血糖和低血糖发生率。