大半球性中风 (CHARM) 后静脉注射 Glibenclamide 治疗大脑 oedema:一个第三阶段,双盲,安慰剂控制,随机化试验
Kevin N Sheth1, Gregory W Albers2, Jeffrey L Saver3
1Center for Brain & Mind Health, Departments of Neurology & Neurosurgery, Yale School of Medicine, Yale University, New Haven, CT, USA.
The Lancet. Neurology
|November 22, 2024
概括
静脉注射的glibenclamide并没有改善70岁以下中风患者的功能结果. 该试验被提前停止,限制了对glibenclamide的最终结论.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 脑卒中医学 脑卒中医学
背景情况:
- 大型半球心脏病发作可能导致大脑,目前没有预防性治疗方法.
- 之前的研究表明,草甘胺可能会改善年轻的中风患者的结果,这些患者有脑风险.
- 在CHARM试验中,研究了静脉注射的glibenclamide能否改善大半球心脏病发作中的功能结果.
研究的目的:
- 评估静脉注射glibenclamide在90天后改善大半球心脏病发作患者的功能结果的疗效.
- 评估静脉注射glibenclamide在这个患者群体中的安全性.
主要方法:
- 第三阶段,双盲,安慰剂控制,随机试验 (CHARM) 在21个国家的143个中心.
- 包括18-85岁的大型中风患者 (ASPECT 1-5或病变体积80-300毫升).
- 随机分配 (1:1) 给静脉注射 Glibenclamide (8.6 mg/72h) 或安慰剂,在中风发作后10小时内开始.
- 主要结局:在18至70岁的患者中,90天后修改了兰金度表的转移 (修改了治疗意图人口).
主要成果:
- 纳入了535名患者,431名 (年龄在18-70岁之间) 在修改后的治疗意向人口中.
- 静脉注射的glibenclamide在90天后没有显著改善功能结果 (OR 1.17;p=0.42).
- 90天死亡率在各组之间是相似的 (32%的草甘胺与29%的安慰剂;HR 1.20;p=0.30).
- 低血糖在glibenclamide组中更频繁 (6%与2%相比).
结论:
- 静脉注射的glibenclamide在大半球心脏病发作后的18-70岁患者中没有改善功能结果.
- 由于招生速度缓慢,试验被提前停止,导致最终结论不足.
- 进一步的研究可能是有必要的,以探索特定患者子组的潜在益处.
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