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急性缺血性脑卒中患者口服格列本脲的探索性分析。

Exploratory analysis of oral glibenclamide in acute ischemic stroke.

机构信息

Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou, China.

出版信息

Acta Neurol Scand. 2019 Sep;140(3):212-218. doi: 10.1111/ane.13134. Epub 2019 Jun 14.

Abstract

OBJECTIVES

Intravenous glibenclamide (GBC) exerts neuroprotection in both preclinical and preliminary clinical studies. This study explored the safety and potential efficacy of oral GBC in patients with acute hemispheric infarction.

MATERIALS & METHODS: During January 2017 and August 2017, adult volunteers were recruited to receive oral GBC treatment, if they presented with an acute anterior ischemic stroke and a National Institute of Health Stroke Score of ≥8. Controls were those who met the above inclusion criteria and had not been on GBC or other sulfonylureas prior to stroke or after hospitalization. Propensity score matching (PSM) was performed to balance baseline characteristics. The primary endpoint was the score on the modified Rankin Scale (mRS) at 6 months.

RESULTS

We included 213 patients in the unmatched cohort (20 in the GBC group and 193 in the control group) and 40 patients (20 in each group) in the matched cohort. In both cohorts, GBC treatment did not increase the risks of early death, hypoglycemia, and early neurological deterioration. Although GBC did not substantially improve 6-month functional outcome that measured in shift analysis of mRS, a slight trend toward less severe disability and death (mRS 5-6) was observed. In the matched cohort, GBC treatment was associated with lighter brain edema, when CED score was used for evaluation.

CONCLUSIONS

In this study, oral GBC is safe in treating acute hemispheric infarction and might have potential in preventing brain edema and consequential severe disability and death. An adequately powered and randomized trial is warranted.

摘要

目的

静脉滴注格列本脲(GBC)在临床前和初步临床研究中均具有神经保护作用。本研究探讨了口服 GBC 治疗急性大脑半球梗死患者的安全性和潜在疗效。

材料与方法

2017 年 1 月至 2017 年 8 月,招募成年志愿者接受口服 GBC 治疗,如果他们患有急性前缺血性脑卒中且国立卫生研究院卒中量表评分≥8 分。对照组为符合上述纳入标准且在卒中前或住院后未使用 GBC 或其他磺酰脲类药物的患者。采用倾向评分匹配(PSM)来平衡基线特征。主要终点为 6 个月时改良 Rankin 量表(mRS)评分。

结果

我们纳入了未匹配队列中的 213 例患者(GBC 组 20 例,对照组 193 例)和匹配队列中的 40 例患者(每组 20 例)。在两个队列中,GBC 治疗均未增加早期死亡、低血糖和早期神经恶化的风险。尽管 GBC 并未显著改善 6 个月的功能结局(mRS 移位分析),但观察到轻微的残疾和死亡(mRS 5-6)程度较轻的趋势。在匹配队列中,当使用 CED 评分进行评估时,GBC 治疗与较轻的脑水肿相关。

结论

在这项研究中,口服 GBC 治疗急性大脑半球梗死是安全的,并且可能具有预防脑水肿和继发严重残疾和死亡的潜力。需要进行一项充分的、随机的试验。

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