Mitchell Imogen, Knight Emma, Gissane Jelena, Tamhane Rohit, Kolli Rao, Leditschke I Anne, Bellomo Rinaldo, Finfer Simon
Department of Intensive Care, The Canberra Hospital, Canberra, ACT, Australia.
Crit Care Resusc. 2006 Dec;8(4):289-93.
To determine the safety and efficacy of an intensive insulin regimen compared with a conventional insulin regimen in general intensive care unit patients.
A phase II, randomised controlled trial was conducted in 70 critically ill patients in a closed multidisciplinary ICU of a university-affiliated tertiary hospital. We assessed patient characteristics at baseline. Trial process measures included number of blood glucose measurements per day and number in target range, type and quantity of caloric intake, patient outcome and insulin dosing. The primary outcome was the median blood glucose concentration. Secondary outcome measures were incidence of hypoglycaemia (blood glucose level < 2.2 mmol/L), clinical sequelae of hypoglycaemia and hospital mortality.
Thirty-five patients were randomised to each of the two groups. More blood glucose samples were taken per day in the intensive insulin group (16 versus 9), but the number of samples in the normoglycaemic range was 48.5%, compared with 79.8% within the target glucose range in the conventional insulin group. The median (interquartile range) blood glucose concentrations in the intensive and conventional insulin therapy groups were 5.4 (5.1-5.7) mmol/L and 7.9 (7.2-9.0) mmol/L, respectively (difference, 2.5 mmol/L; P < 0.0001). Five patients (14.3%) in the intensive insulin therapy group became hypoglycaemic versus none in the conventional insulin therapy group. There were no detected clinical sequelae of hypoglycaemia.
The intensive insulin regimen was effective in achieving the target blood glucose concentration, with clear separation from the conventional insulin regimen. Although the incidence of hypoglycaemia was increased, there was no detectable harm.
确定在综合重症监护病房患者中，强化胰岛素治疗方案与传统胰岛素治疗方案相比的安全性和有效性。
在一所大学附属医院三级甲等医院的封闭多学科重症监护病房对70例危重症患者进行了一项II期随机对照试验。我们评估了基线时的患者特征。试验过程指标包括每日血糖测量次数及处于目标范围内的次数、热量摄入的类型和数量、患者结局及胰岛素剂量。主要结局是血糖浓度中位数。次要结局指标是低血糖症（血糖水平<2.2 mmol/L）的发生率、低血糖症的临床后遗症及医院死亡率。
两组各随机分配35例患者。强化胰岛素治疗组每天采集的血糖样本更多（16次对9次），但血糖正常范围内的样本数量占48.5%，而传统胰岛素治疗组处于目标血糖范围内的样本数量占79.8%。强化胰岛素治疗组和传统胰岛素治疗组的血糖浓度中位数（四分位间距）分别为5.4（5.1 - 5.7）mmol/L和7.9（7.2 - 9.0）mmol/L（差值为2.5 mmol/L；P < 0.0001）。强化胰岛素治疗组有5例患者（14.3%）发生低血糖，而传统胰岛素治疗组无低血糖发生。未检测到低血糖的临床后遗症。
强化胰岛素治疗方案在实现目标血糖浓度方面有效，与传统胰岛素治疗方案有明显差异。虽然低血糖发生率增加，但未发现有害影响。
