The Efficacy and Safety of Glibenclamide in Improving Cerebral Edema and Neurological Outcomes in Stroke: a GRADE-Evaluated Systematic Review and Meta-analysis with Subgroup Analysis.
Hazem E Mohammed, Mohamed E Haseeb, Zeyad Bady, Mohamed Nasser, Mostafa Meshref
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引用次数: 0
Abstract
Background: Stroke is a significant cause of morbidity and mortality worldwide, with cerebral edema being a major complication. Glibenclamide, a SUR1-TRPM4 channel inhibitor, has been proposed to reduce cerebral edema, but its clinical efficacy remains uncertain. This meta-analysis aimed to evaluate the efficacy and safety of glibenclamide in patients with stroke, including acute ischemic stroke, acute subarachnoid hemorrhage, and intracerebral hemorrhage.
Methods: A comprehensive literature search was conducted in PubMed, Web of Science, and Scopus up to January 2025. The primary efficacy outcomes included excellent (modified Rankin Scale [mRS] score 0-1) and good (mRS score 0-2) functional outcomes at 90 days. Safety outcomes included the incidence of hypoglycemia and decompressive craniectomy. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach.
Results: Ten and eight randomized controlled trials (RCTs) were included in our qualitative and quantitative analysis, respectively, encompassing 1,691 participants aged 18 to 85. No significant difference was observed between the glibenclamide and control groups regarding excellent functional outcome (risk ratio [RR] 1.10, 95% confidence interval [CI] 0.92-1.32, P = 0.29) and good functional outcome (RR 1.07, 95% CI 0.96-1.18, P = 0.22). Safety analysis revealed no significant increase in serious adverse events (RR 1.11, 95% CI 1.00-1.23, P = 0.06). Notably, hypoglycemia incidence after sensitivity analysis was higher in the glibenclamide group (RR 4.56, 95% CI 2.07-10.03, P = 0.0002).
Conclusions: Glibenclamide did not significantly improve functional outcomes or reduce mortality in stroke patients but was associated with a higher incidence of hypoglycemia. Further well-designed RCTs are needed to clarify its therapeutic role and optimize safety protocols.
背景：脑卒中是世界范围内发病率和死亡率的重要原因，脑水肿是主要并发症。格列本脲是一种SUR1-TRPM4通道抑制剂，被认为可以减少脑水肿，但其临床疗效尚不确定。本荟萃分析旨在评价格列本脲治疗脑卒中患者的疗效和安全性，包括急性缺血性脑卒中、急性蛛网膜下腔出血和脑出血。方法：综合检索PubMed、Web of Science、Scopus等截至2025年1月的文献。主要疗效结果包括90天的良好（改良Rankin量表[mRS]评分0-1）和良好（mRS评分0-2）功能结果。安全性指标包括低血糖发生率和开颅减压术。证据质量采用建议分级评估、发展和评价方法进行评估。结果：我们的定性和定量分析分别纳入了10项和8项随机对照试验（rct），包括1691名年龄在18至85岁之间的参与者。格列本脲组和对照组在功能优等结局（风险比[RR] 1.10, 95%可信区间[CI] 0.92-1.32, P = 0.29）和功能优等结局（风险比[RR] 1.07, 95% CI 0.96-1.18, P = 0.22）方面无显著差异。安全性分析显示严重不良事件无显著增加（RR 1.11, 95% CI 1.00-1.23, P = 0.06）。值得注意的是，敏感性分析后，格列本脲组低血糖发生率较高（RR 4.56, 95% CI 2.07-10.03, P = 0.0002）。结论：格列本脲不能显著改善脑卒中患者的功能结局或降低死亡率，但与低血糖的高发生率相关。需要进一步精心设计的随机对照试验来阐明其治疗作用并优化安全方案。临床试验注册：PROSPERO注册号：CRD420251008350。
期刊介绍：
Neurocritical Care is a peer reviewed scientific publication whose major goal is to disseminate new knowledge on all aspects of acute neurological care. It is directed towards neurosurgeons, neuro-intensivists, neurologists, anesthesiologists, emergency physicians, and critical care nurses treating patients with urgent neurologic disorders. These are conditions that may potentially evolve rapidly and could need immediate medical or surgical intervention. Neurocritical Care provides a comprehensive overview of current developments in intensive care neurology, neurosurgery and neuroanesthesia and includes information about new therapeutic avenues and technological innovations. Neurocritical Care is the official journal of the Neurocritical Care Society.
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