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缺血性卒中高血糖治疗(THIS):一项随机试点试验。

Treatment of hyperglycemia in ischemic stroke (THIS): a randomized pilot trial.

作者信息

Bruno Askiel, Kent Thomas A, Coull Bruce M, Shankar Ravi R, Saha Chandan, Becker Kyra J, Kissela Brett M, Williams Linda S

机构信息

Department of Neurology, Indiana University School of Medicine, Roudebush Veterans Affairs Medical Center, Indianapolis, IN 46202, USA.

出版信息

Stroke. 2008 Feb;39(2):384-9. doi: 10.1161/STROKEAHA.107.493544. Epub 2007 Dec 20.

DOI:10.1161/STROKEAHA.107.493544
PMID:18096840
Abstract

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 >or=8.3 mmol/L (>or=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.

摘要

背景与目的

高血糖可能会使急性脑梗死期间的脑损伤恶化。我们对急性脑梗死期间静脉注射胰岛素积极纠正高血糖与常规治疗的可行性和耐受性进行了测试。

方法

我们对发病12小时内、基线血糖值≥8.3 mmol/L(≥150 mg/dL)且美国国立卫生研究院卒中量表评分为3至22分的脑梗死患者进行了一项随机、多中心、盲法试点试验。患者按2:1随机分为积极治疗组,采用持续静脉注射胰岛素或根据需要皮下注射胰岛素每日4次(常规治疗)。积极治疗组的目标血糖水平<7.2 mmol/L(<130 mg/dL),常规治疗组的目标血糖水平<11.1 mmol/L(<200 mg/dL)。每1至2小时监测一次血糖,方案治疗持续长达72小时。在3个月时评估最终临床结局。

结果

我们将46例患者随机分组(31例接受积极治疗,15例接受常规治疗)。积极治疗组的所有患者和常规治疗组的11例(73%)患者患有糖尿病(P = 0.008)。在整个方案治疗期间,积极治疗组的血糖水平显著更低(7.4 vs 10.5 mmol/L [133 vs 190 mg/dL],P<0.001)。血糖<3.3 mmol/L(<60 mg/dL)的低血糖仅发生在积极治疗组(11例患者,35%),其中4例(13%)有短暂症状,仅1例(3%)有神经系统症状。积极治疗组的最终临床结局无显著更好。

结论

静脉注射胰岛素方案在急性脑梗死期间纠正高血糖明显优于常规治疗,且无重大不良事件,应在临床疗效试验中进行研究。

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