Department of Critical Care Medicine, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, 119 South Fourth Ring Road West, Fengtai District, Beijing, China.
Neurocrit Care. 2024 Dec;41(3):828-839. doi: 10.1007/s12028-024-01999-z. Epub 2024 Aug 8.
This study aims to investigate the efficacy and safety of glibenclamide treatment in patients with acute aneurysmal subarachnoid hemorrhage (aSAH).
The randomized controlled trial was conducted from October 2021 to May 2023 at two university-affiliated hospitals in Beijing, China. The study included patients with aSAH within 48 h of onset, of whom were divided into the intervention group and the control group according to the random number table method. Patients in the intervention group received glibenclamide tablet 3.75 mg/day for 7 days. The primary end points were the levels of serum neuron-specific enolase (NSE) and soluble protein 100B (S100B) between the two groups. Secondary end points included evaluating changes in the midline shift and the gray matter-white matter ratio, as well as assessing the modified Rankin Scale scores during follow-up. The trial was registered at ClinicalTrials.gov (identifier NCT05137678).
A total of 111 study participants completed the study. The median age was 55 years, and 52% were women. The mean admission Glasgow Coma Scale was 10, and 58% of the Hunt-Hess grades were no less than grade III. The baseline characteristics of the two groups were similar. On days 3 and 7, there were no statistically significant differences observed in serum NSE and S100B levels between the two groups (P > 0.05). The computer tomography (CT) values of gray matter and white matter in the basal ganglia were low on admission, indicating early brain edema. However, there were no significant differences found in midline shift and gray matter-white matter ratio (P > 0.05) between the two groups. More than half of the patients had a beneficial outcome (modified Rankin Scale scores 0-2), and there were no statistically significant differences between the two groups. The incidence of hypoglycemia in the two groups were 4% and 9%, respectively (P = 0.439).
Treating patients with early aSAH with oral glibenclamide did not decrease levels of serum NSE and S100B and did not improve the poor 90-day neurological outcome. In the intervention group, there was a visible decreasing trend in cases of delayed cerebral ischemia, but no statistically significant difference was observed. The incidence of hypoglycemia did not differ significantly between the two groups.
本研究旨在探讨格列本脲治疗急性蛛网膜下腔出血（aSAH）患者的疗效和安全性。
这是一项在北京两家大学附属医院进行的随机对照试验，研究时间为 2021 年 10 月至 2023 年 5 月。纳入发病 48 小时内的 aSAH 患者，按随机数字表法将患者分为干预组和对照组。干预组患者给予格列本脲片 3.75mg/天，共 7 天。主要终点为两组患者血清神经元特异性烯醇化酶（NSE）和可溶性蛋白 100B（S100B）水平。次要终点包括评估随访期间中线移位和灰质-白质比值的变化，以及评估改良 Rankin 量表评分。该试验在 ClinicalTrials.gov 注册（标识符 NCT05137678）。
共有 111 名研究参与者完成了研究。中位年龄为 55 岁，52%为女性。入院时格拉斯哥昏迷量表平均评分为 10 分，Hunt-Hess 分级中 58%不低于 3 级。两组的基线特征相似。第 3 天和第 7 天，两组血清 NSE 和 S100B 水平无统计学差异（P>0.05）。基底节灰质和白质的 CT 值在入院时较低，表明早期脑水肿。然而，两组中线移位和灰质-白质比值无显著差异（P>0.05）。超过一半的患者预后良好（改良 Rankin 量表评分 0-2），两组间无统计学差异。两组低血糖发生率分别为 4%和 9%（P=0.439）。
口服格列本脲治疗早期 aSAH 患者不能降低血清 NSE 和 S100B 水平，也不能改善 90 天不良神经结局。干预组迟发性脑缺血病例有减少的趋势，但无统计学差异。两组低血糖发生率无显著差异。
