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背景危重患者血糖控制的最佳目标范围仍不清楚。方法入住重症监护病房(ICU)24h内、预期需要在ICU连续治疗3d或3d以上的成年人随机分配入进行强化血糖控制组,目标血糖范围为81～108mg/dL(4.5～6.0mmol/L),或者进入常规血糖控制组,目标血糖范围为180mg/dL或以下(10.0mmol/L或以下)。将随机分组后90d内任何原因引起的死亡作为试验主要终点。结果6104例患者入选随机分组,3054例进行强化血糖控制,3050例实施常规血糖控制,两组分别有3010例和3012例患者有90d时主要预后资料。两组的基线特征相似,强化血糖控制组中共有829(27.5%)例患者死亡,而常规血糖控制组中有751(24.9%)例患者死亡(强化血糖控制组的比值比为1.14,95%置信区间为1.02～1.28,P=0.02)。手术(外科手术)患者和非手术(医疗)患者间的治疗效果差别无统计学意义(强化血糖控制组的死亡比值比分别是1.31和1.07,P=0.10)。强化血糖控制组的3016例患者中有206(6.8%)例报告有严重低血糖,血糖水平=40mg/dL(2.2mmol/L),而常规血糖控制组的3014例患者中有15(0.5%)例报告有严重低血糖(P<0.001)。两组间平均住ICU天数(P=0.84)、平均住院天数(P=0.86)、平均机械通气天数(P=0.56)以及平均肾脏替代治疗天数(P=0.39)差别无统计学意义。结论在这项大样本国际性的随机临床试验中发现,强化血糖控制增加ICU病房成年人的病死率:180mg/dL或以下的血糖控制目标比81～108mg/dL的目标病死率低。
Background The optimal target range for glycemic control in critically ill patients remains unclear. Methods Intensive glycemic control was enrolled in adults admitted to intensive care unit (ICU) within 24 hours after ICU continuous treatment for 3d or 3d, and the target blood glucose ranged from 81 to 108 mg / dL (4.5 to 6.0 mmol / L) , Or into the regular glycemic control group with a target glycemic range of 180 mg / dL or less (10.0 mmol / L or less). Death from any cause within 90 days of randomisation was used as the primary endpoint of the trial. Results A total of 6104 patients were enrolled in the randomized control group. 3054 patients underwent intensive glycemic control and 3050 patients underwent routine blood glucose control. The main prognostic data of 3010 and 3012 patients in both groups were 90 days. Baseline characteristics were similar between the two groups, with a total of 829 (27.5%) deaths in the intensive glycemic control group compared with 751 (24.9%) in the regular glycemic control group (odds ratio 1.14, 95% Confidence interval was 1.02 ~ 1.28, P = 0.02). There was no statistically significant difference in the efficacy of treatment between surgery (surgical) patients and non-surgical (medical) patients (mortality ratio of intensive glycemic control was 1.31 and 1.07, respectively, P = 0.10). 206 (6.8%) of 3016 patients with intensive glycemic control reported severe hypoglycemia with a blood glucose level of 40 mg / dL (2.2 mmol / L) compared with 15 (0.5% ) Cases reported severe hypoglycemia (P <0.001). Mean ICU days (P = 0.84), average length of hospital stay (P = 0.86), mean number of days of mechanical ventilation (P = 0.56), and mean number of days of renal replacement therapy (P = .39) were not statistically different between the two groups. Conclusions In this large international randomized trial, it was found that intensive glycemic control increases mortality in adults in ICU wards: the target for glycemic control of 180 mg / dL or less is lower than the target mortality of 81-108 mg / dL.