Abstract：
BACKGROUND: This study aims to investigate the efficacy and safety of glibenclamide treatment in patients with acute aneurysmal subarachnoid hemorrhage (aSAH).
METHODS: 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).
RESULTS: 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).
CONCLUSIONS: 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.
METHODS: 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).
RESULTS: 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).
CONCLUSIONS: 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.
摘要：
背景：本研究旨在探讨格列本脲治疗急性动脉瘤性蛛网膜下腔出血（aSAH）患者的疗效和安全性。
方法：随机对照试验于2021年10月至2023年5月在北京的两家大学附属医院进行，中国。该研究包括发病48小时内的aSAH患者，按随机数字表法分为干预组和对照组。干预组患者接受格列本脲片剂3.75mg/天，共7天。主要终点是两组之间的血清神经元特异性烯醇化酶（NSE）和可溶性蛋白100B（S100B）水平。次要终点包括评估中线偏移和灰质-白质比率的变化，以及在随访期间评估改良的Rankin量表评分。该试验在ClinicalTrials.gov注册（标识符NCT05137678）。
结果：共有111名研究参与者完成了这项研究。中位年龄为55岁,52%是女性。平均入学格拉斯哥昏迷量表为10，而Hunt-Hess等级的58％不低于III级。两组的基线特征相似。第3天和第7天，两组血清NSE和S100B水平差异无统计学意义（P>0.05）。入院时，基底神经节灰质和白质的计算机断层扫描（CT）值较低，提示早期脑水肿.然而,两组中线移位、灰质白质比值比较差异无统计学意义(P>0.05)。超过一半的患者有一个有益的结果（改良Rankin量表评分0-2），两组间差异无统计学意义。两组低血糖发生率分别为4%和9%,分别为(P=0.439)。
结论：口服格列本脲治疗早期aSAH患者并没有降低血清NSE和S100B水平，也没有改善90天不良的神经系统预后。在干预组中，迟发性脑缺血病例呈明显下降趋势,但没有观察到统计学上的显著差异。两组之间的低血糖发生率没有显着差异。
方法：随机对照试验于2021年10月至2023年5月在北京的两家大学附属医院进行，中国。该研究包括发病48小时内的aSAH患者，按随机数字表法分为干预组和对照组。干预组患者接受格列本脲片剂3.75mg/天，共7天。主要终点是两组之间的血清神经元特异性烯醇化酶（NSE）和可溶性蛋白100B（S100B）水平。次要终点包括评估中线偏移和灰质-白质比率的变化，以及在随访期间评估改良的Rankin量表评分。该试验在ClinicalTrials.gov注册（标识符NCT05137678）。
结果：共有111名研究参与者完成了这项研究。中位年龄为55岁,52%是女性。平均入学格拉斯哥昏迷量表为10，而Hunt-Hess等级的58％不低于III级。两组的基线特征相似。第3天和第7天，两组血清NSE和S100B水平差异无统计学意义（P>0.05）。入院时，基底神经节灰质和白质的计算机断层扫描（CT）值较低，提示早期脑水肿.然而,两组中线移位、灰质白质比值比较差异无统计学意义(P>0.05)。超过一半的患者有一个有益的结果（改良Rankin量表评分0-2），两组间差异无统计学意义。两组低血糖发生率分别为4%和9%,分别为(P=0.439)。
结论：口服格列本脲治疗早期aSAH患者并没有降低血清NSE和S100B水平，也没有改善90天不良的神经系统预后。在干预组中，迟发性脑缺血病例呈明显下降趋势,但没有观察到统计学上的显著差异。两组之间的低血糖发生率没有显着差异。
