■格列本脲减轻脑水肿并改善中风实验模型的神经系统预后。我们旨在评估格列本脲是否能改善重组组织型纤溶酶原激活剂(rtPA)治疗的急性缺血性卒中患者的功能预后。
■在这个随机的,双盲,安慰剂对照试验,急性缺血性卒中患者被纳入中国8家学术医院.如果患者年龄在18-74岁,则符合资格。出现有症状的前循环闭塞,NIHSS缺陷为4-25,并且在症状发作后4.5小时内接受了rtPA治疗。我们使用基于网络的随机化(1:1)将符合条件的参与者分配到格列本脲或安慰剂组,根据血管内治疗和基线卒中严重程度进行分层。格列本脲或安慰剂在症状发作后10小时内口服或通过管饲,负荷剂量为1.25mg,然后每8小时0.625毫克,持续5天。主要结果是90天预后良好(改良Rankin量表0-2)的患者比例,在所有被正确诊断并开始研究药物治疗的随机分配患者中进行评估.这项研究在ClinicalTrials.gov注册,NCT03284463,并对新参与者关闭。
■在2018年1月1日至2022年5月28日之间,随机分配了305名患者,其中272人(142人接受格列本脲治疗,130人接受安慰剂治疗)被纳入主要疗效分析.格列本脲组103例(73%)患者和安慰剂组94例(72%)患者均有良好的预后(调整后的风险差异0.002,95%CI-0.098至0.103;p=0.96)。分配给格列本脲的12名(8%)患者和分配给安慰剂的7名(5%)患者在90天因任何原因死亡(p=0.35)。两组之间的不良事件的数量和类型相似。没有与药物相关的不良事件,也没有与药物相关的死亡。
■与安慰剂相比,在溶栓治疗中加入格列本脲并没有增加卒中后取得良好预后的患者比例,但这并没有导致任何安全问题。
■南方医科大学和南方医院.
UNASSIGNED: Glibenclamide alleviates brain edema and improves neurological outcomes in experimental models of stroke. We aimed to assess whether glibenclamide improves functional outcomes in patients with acute ischemic stroke treated with recombinant tissue plasminogen activator (rtPA).
UNASSIGNED: In this randomized, double-blind, placebo-controlled
trial, patients with acute ischemic stroke were recruited to eight academic hospitals in China. Patients were eligible if they were aged 18-74 years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4-25, and had been treated with rtPA within 4.5 h of symptom onset. We used web-based randomization (1:1) to allocate eligible participants to the glibenclamide or placebo group, stratified according to endovascular treatment and baseline stroke severity. Glibenclamide or placebo was taken orally or via tube feeding at a loading dose of 1.25 mg within 10 h after symptom onset, followed by 0.625 mg every 8 h for 5 days. The primary outcome was the proportion of patients with good outcomes (modified Rankin Scale of 0-2) at 90 days, assessed in all randomly assigned patients who had been correctly diagnosed and had begun
study medication. The
study is registered with ClinicalTrials.gov, NCT03284463, and is closed to new participants.
UNASSIGNED: Between January 1, 2018, and May 28, 2022, 305 patients were randomly assigned, of whom 272 (142 received glibenclamide and 130 received placebo) were included in the primary efficacy analysis. 103 (73%) patients in the glibenclamide group and 94 (72%) in the placebo group had a good outcome (adjusted risk difference 0.002, 95% CI -0.098 to 0.103; p = 0.96). 12 (8%) patients allocated to glibenclamide and seven (5%) patients allocated to placebo died from any cause at 90 days (p = 0.35). The number and type of adverse events were similar between the two groups. There were no drug-related adverse events and no drug-related deaths.
UNASSIGNED: The addition of glibenclamide to thrombolytic therapy did not increase the proportion of patients who achieved good outcomes after stroke compared with placebo, but it did not lead to any safety concerns.
UNASSIGNED: Southern Medical University and Nanfang Hospital.