Costa Bruno Braga Sisnando da, Windlin Isabela Costola, Koterba Edwin, Yamaki Vitor Nagai, Rabelo Nícollas Nunes, Solla Davi Jorge Fontoura, Samaia da Silva Coelho Antonio Carlos, Telles João Paulo Mota, Teixeira Manoel Jacobsen, Figueiredo Eberval Gadelha
J Neurosurg. 2021 Nov 19;137(1):121-128. doi: 10.3171/2021.7.JNS21846. Print 2022 Jul 1.
Glibenclamide has been shown to improve outcomes in cerebral ischemia, traumatic brain injury, and subarachnoid hemorrhage (SAH). The authors sought to evaluate glibenclamide's impact on mortality and functional outcomes of patients with aneurysmal SAH (aSAH).
Patients with radiologically confirmed aSAH, aged 18 to 70 years, who presented to the hospital within 96 hours of ictus were randomly allocated to receive 5 mg of oral glibenclamide for 21 days or placebo, in a modified intention-to-treat analysis. Outcomes were mortality and functional status at discharge and 6 months, evaluated using the modified Rankin Scale (mRS).
A total of 78 patients were randomized and allocated to glibenclamide (n = 38) or placebo (n = 40). Baseline characteristics were similar between groups. The mean patient age was 53.1 years, and the majority of patients were female (75.6%). The median Hunt and Hess, World Federation of Neurosurgical Societies (WFNS), and modified Fisher scale (mFS) scores were 3 (IQR 2-4), 3 (IQR 3-4), and 3 (IQR 1-4), respectively. Glibenclamide did not improve the functional outcome (mRS) after 6 months (ordinal analysis, unadjusted common OR 0.66 [95% CI 0.29-1.48], adjusted common OR 1.25 [95% CI 0.46-3.37]). Similar results were found for analyses considering the dichotomized 6-month mRS score (favorable score 0-2), as well as for the secondary outcomes of discharge mRS score (either ordinal or dichotomized), mortality, and delayed cerebral ischemia. Hypoglycemia was more frequently observed in the glibenclamide group (5.3%).
In this study, glibenclamide was not associated with better functional outcomes after aSAH. Mortality and delayed cerebral ischemia rates were also similar compared with placebo.
已证实格列本脲可改善脑缺血、创伤性脑损伤和蛛网膜下腔出血（SAH）的预后。作者旨在评估格列本脲对动脉瘤性SAH（aSAH）患者死亡率和功能预后的影响。
对年龄在18至70岁、发病后96小时内入院且经影像学确诊为aSAH的患者，采用改良意向性分析，随机分配接受21天每日5毫克口服格列本脲或安慰剂治疗。结局指标为出院时及6个月时的死亡率和功能状态，采用改良Rankin量表（mRS）进行评估。
共有78例患者被随机分组，分别接受格列本脲治疗（n = 38）或安慰剂治疗（n = 40）。两组的基线特征相似。患者平均年龄为53.1岁，大多数患者为女性（75.6%）。Hunt和Hess、世界神经外科协会联合会（WFNS）以及改良Fisher量表（mFS）评分的中位数分别为3（四分位间距2 - 4）、3（四分位间距3 - 4）和3（四分位间距1 - 4）。格列本脲未改善6个月后的功能预后（mRS）（序贯分析，未调整的共同比值比0.66 [95%可信区间0.29 - 1.48]，调整后的共同比值比1.25 [95%可信区间0.46 - 3.37]）。对于二分法的6个月mRS评分（良好评分为0 - 2）以及出院时mRS评分（序贯或二分法）、死亡率和迟发性脑缺血等次要结局指标的分析，也得出了类似结果。格列本脲组低血糖的发生率更高（5.3%）。
在本研究中，格列本脲与aSAH后更好的功能预后无关。与安慰剂相比，死亡率和迟发性脑缺血发生率也相似。
