Intensive Care Med. 2015 Jun;41(6):1037-47. doi: 10.1007/s00134-015-3757-6. Epub 2015 Jun 19.
To compare the effect of intensive versus conventional blood glucose control in patients with traumatic brain injury.
In a large international randomized trial patients were randomly assigned to a target blood glucose (BG) range of either 4.5-6.0 mmol/L (intensive control) or <10 mmol/L (conventional control). Patients with traumatic brain injury (TBI) were identified at randomization and data were collected to examine the extended Glasgow outcome score (includes mortality) at 24 months.
Of the 6104 randomized patients, 391 satisfied diagnostic criteria for TBI; 203 (51.9%) were assigned to intensive and 188 (48.1%) to conventional control; the primary outcome was available for 166 (81.8%) and 149 (79.3%) patients, respectively. The two groups had similar baseline characteristics. At 2 years 98 (58.7%) patients in the intensive group and 79 (53.0%) in the conventional group had a favorable neurological outcome (odds ratio [OR] 1.26, 95% CI 0.81-1.97; P = 0.3); 35 patients (20.9%) in the intensive group and 34 (22.8%) in the conventional group had died (OR 0.90, 95% CI 0.53-1.53; P = 0.7); moderate hypoglycemia (BG 2.3-3.9 mmol/L; 41-70 mg/dL) occurred in 160/202 (79.2%) and 17/188 (9.0%), respectively (OR 38.3, 95% CI 21.0-70.1; P < 0.0001); severe hypoglycemia (BG ≤ 2.2 mmol/L; ≤40 mg/dL) in 10 (4.9%) and 0 (0.0%), respectively (OR 20.5 95% CI 1.2-351.6, P = 0.003).
Although patients with traumatic brain injury randomly assigned to intensive compared to conventional glucose control experienced moderate and severe hypoglycemia more frequently, we found no significant difference in clinically important outcomes.
比较强化血糖控制与常规血糖控制对创伤性脑损伤患者的影响。
在一项大型国际随机试验中,患者被随机分配到血糖目标范围为 4.5-6.0mmol/L(强化控制)或 <10mmol/L(常规控制)。在随机分组时确定了创伤性脑损伤(TBI)患者,并收集数据以检查 24 个月时的扩展格拉斯哥结局评分(包括死亡率)。
在 6104 名随机患者中,391 名符合 TBI 诊断标准;203 名(51.9%)被分配到强化组,188 名(48.1%)被分配到常规组;主要结局在 166 名(81.8%)和 149 名(79.3%)患者中可用。两组基线特征相似。在 2 年时,强化组 98 名(58.7%)患者和常规组 79 名(53.0%)患者有良好的神经功能结局(优势比[OR]1.26,95%置信区间[CI]0.81-1.97;P=0.3);强化组 35 名(20.9%)患者和常规组 34 名(22.8%)患者死亡(OR 0.90,95%CI0.53-1.53;P=0.7);中度低血糖(血糖 2.3-3.9mmol/L;41-70mg/dL)分别发生在 160/202(79.2%)和 17/188(9.0%)患者中(OR 38.3,95%CI21.0-70.1;P<0.0001);严重低血糖(血糖≤2.2mmol/L;≤40mg/dL)分别发生在 10 名(4.9%)和 0 名(0.0%)患者中(OR 20.5,95%CI1.2-351.6,P=0.003)。
尽管与常规血糖控制相比,随机分配到强化血糖控制的创伤性脑损伤患者经历中度和重度低血糖的频率更高,但我们没有发现临床重要结局的显著差异。