Shilash Ola Bin, Alhathlol Hussam, Alduhaysh Rana, Almufarriji Razan, Bafaquh Mohammed
College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Front Neurol. 2025 Jun 27;16:1609101. doi: 10.3389/fneur.2025.1609101. eCollection 2025.
Secondary brain injuries, including delayed cerebral ischemia, neuroinflammation, and stroke induced cerebral edema can occur following both ischemic and hemorrhagic strokes, contributing to a negative impact on clinical outcomes. Glibenclamide, a sulfonylurea antidiabetic medication, has shown potential in minimizing these consequences by targeting the SUR1-TRPM4 channel. However, glibenclamide's therapeutic effectiveness and safety in stroke patients remain unknown. Therefore, this systematic review aims to assess the safety and efficacy of glibenclamide in improving outcomes following both ischemic and hemorrhagic strokes.
Four databases were searched for RCTs published up to November 2024. Studies were included if they involved adult patients with ischemic stroke, hemorrhagic stroke, or subarachnoid hemorrhage, and reported relevant safety and efficacy outcomes. Efficacy outcomes were measured using the Modified Rankin Scale at 3 and 6 months. Safety outcomes included adverse events such as hypoglycemia, hydrocephalus, and mortality.
Data from six RCTs, involving 555 patients (280 intervention, 275 control), were included: 4 trials in subarachnoid hemorrhage, one trial in ischemic stroke, and one in hemorrhagic stroke. At 3 months, the pooled odds ratio (OR) for poor functional outcomes was 0.98 (95% CI: 0.65-1.48), and at 6 months, 0.52 (95% CI: 0.24-1.12; = 0.094), with no significant differences between glibenclamide and placebo. Safety analysis showed a significant increase in symptomatic hypoglycemia (OR 4.69, 95% CI: 1.45-15.23; = 0.010) but no significant differences for hydrocephalus (OR 1.60, 95% CI: 0.76-3.37; = 0.220) or mortality (OR 0.57, 95% CI: 0.32-1.05; = 0.071). Delayed cerebral ischemia (DCI) showed a borderline reduction in risk (OR 0.43, 95% CI: 0.18-1.00; = 0.051) in the treatment group.
In patients with ischemic or hemorrhagic stroke, glibenclamide demonstrates a favorable safety profile but shows limited efficacy in improving functional outcomes. The elevated risk of hypoglycemia emphasizes the necessity of using this medication with caution.
继发性脑损伤，包括迟发性脑缺血、神经炎症和中风诱发的脑水肿，可发生于缺血性和出血性中风之后，对临床结局产生负面影响。格列本脲是一种磺酰脲类抗糖尿病药物，已显示出通过靶向SUR1-TRPM4通道将这些后果降至最低的潜力。然而，格列本脲在中风患者中的治疗效果和安全性尚不清楚。因此，本系统评价旨在评估格列本脲在改善缺血性和出血性中风后结局方面的安全性和有效性。
检索四个数据库中截至2024年11月发表的随机对照试验。纳入的研究需涉及患有缺血性中风、出血性中风或蛛网膜下腔出血的成年患者，并报告相关的安全性和有效性结局。使用改良Rankin量表在3个月和6个月时测量有效性结局。安全性结局包括低血糖、脑积水和死亡率等不良事件。
纳入了六项随机对照试验的数据，涉及555名患者（280名干预组，275名对照组）：四项蛛网膜下腔出血试验，一项缺血性中风试验，一项出血性中风试验。在3个月时，功能结局不良的合并比值比（OR）为0.98（95%置信区间：0.65-1.48），在6个月时为0.52（95%置信区间：0.24-1.12；P=0.094），格列本脲与安慰剂之间无显著差异。安全性分析显示，症状性低血糖显著增加（OR 4.69，95%置信区间：1.45-15.23；P=0.010），但脑积水（OR 1.60，95%置信区间：0.76-3.37；P=0.220）或死亡率（OR 0.57，95%置信区间：0.32-1.05；P=0.071）无显著差异。治疗组迟发性脑缺血（DCI）的风险有临界降低（OR 0.43，95%置信区间：0.18-1.00；P=0.051）。
在缺血性或出血性中风患者中，格列本脲显示出良好的安全性，但在改善功能结局方面疗效有限。低血糖风险升高强调了谨慎使用该药物的必要性。
