Treatment of hyperglycemia in ischemic stroke (THIS) a randomized pilot trial
Treatment of hyperglycemia in ischemic stroke (THIS) a randomized pilot trial
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DOI：
10.1161/strokeaha.107.493544
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发表时间：
2008-02-01
期刊：
影响因子：
8.3
通讯作者：
Williams, Linda S.
中科院分区：
文献类型：
--
作者：
Bruno, Askiel;Kent, Thomas A.;Williams, Linda S.
背景与目的——急性脑梗死时高血糖可加重脑损伤。我们测试了急性脑梗死期间静脉注射胰岛素积极纠正高血糖的可行性和耐受性，并与常规治疗进行了比较。方法：我们对发病后12小时内脑梗死患者进行了一项随机、多中心、盲法试验，基线血糖值>= 8.3 mmol/ L (>= 150 mg/dL)，美国国立卫生研究院卒中量表评分为3至22分。患者按2:1随机分组，根据需要给予持续静脉注射胰岛素或皮下注射胰岛素QID（常规护理）积极治疗。积极治疗组的目标血糖水平< 7.2 mmol/ L (< 130 mg/dL)，常规护理组的目标血糖水平< 11.1 mmol/ L （< 200 mg/dL）。每1 - 2小时监测一次血糖，方案治疗持续72小时。3个月时评估最终临床结果。结果：我们随机选择了46例患者（31例接受积极治疗，15例接受常规治疗）。积极治疗组所有患者均有糖尿病，常规治疗组11例（73%）有糖尿病（P=0.008）。在整个方案治疗过程中，积极治疗组的血糖水平显著降低（7.4 vs 10.5 mmol/ L [133 vs 190 mg/dL], P < 0.001）。低血糖< 3.3 mmol/ L （< 60 mg/dL）仅发生在积极治疗组（11例，35%），其中4例（13%）有短暂症状，包括1例（3%）神经系统症状。积极治疗组的最终临床结果无明显改善。结论：静脉注射胰岛素治疗方案对急性脑梗死期间高血糖的纠正明显优于常规治疗，且无重大不良事件，应在临床疗效试验中进行研究。
Background and Purpose - Hyperglycemia may worsen brain injury during acute cerebral infarction. We tested the feasibility and tolerability of aggressive hyperglycemia correction with intravenous insulin compared with usual care during acute cerebral infarction.Methods - We conducted a randomized, multicenter, blinded pilot trial for patients with cerebral infarction within 12 hours after onset, a baseline glucose value >= 8.3 mmol/ L (>= 150 mg/dL), and a National Institutes of Health Stroke Scale score of 3 to 22. Patients were randomized 2: 1 to aggressive treatment with continuous intravenous insulin or subcutaneous insulin QID as needed (usual care). Target glucose levels were < 7.2 mmol/ L (< 130 mg/dL) in the aggressive-treatment group and < 11.1 mmol/ L (< 200 mg/dL) in the usual-care group. Glucose was monitored every 1 to 2 hours, and the protocol treatments continued for up to 72 hours. Final clinical outcomes were assessed at 3 months.Results - We randomized 46 patients (31 to aggressive treatment and 15 to usual care). All patients in the aggressive-treatment group and 11 (73%) in the usual-care group had diabetes (P=0.008). Glucose levels were significantly lower in the aggressive-treatment group throughout protocol treatment (7.4 vs 10.5 mmol/ L [133 vs 190 mg/dL], P < 0.001). Hypoglycemia < 3.3 mmol/ L (< 60 mg/dL) occurred only in the aggressive-treatment group (11 patients, 35%), 4 (13%) of whom had brief symptoms, including only 1 (3%) neurologic. Final clinical outcomes were nonsignificantly better in the aggressive-treatment group.Conclusions - The intravenous insulin protocol corrected hyperglycemia during acute cerebral infarction significantly better than usual care without major adverse events and should be investigated in a clinical efficacy trial.