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治疗脑损伤的glibenclamide:对一个有前途的临床试验设计进行上下文化,该设计利用基于成像的TBI内型
Ruchira M Jha1,2,3, J Marc Simard4,5,6
1Department of Neurology, Barrow Neurological Institute and St. Joseph's Hospital and Medical Center, Phoenix, AZ, USA. ruchirajha@gmail.com.
概括
创伤性脑损伤 (TBI) 的异质性使治疗复杂化. 在ASTRAL试验中,研究了草甘胺对抑制SUR1-TRPM4通道的作用,针对TBI患者的伤扩张,以改善结果.
科学领域:
- 神经科学是一个神经科学.
- 创伤学 创伤学 创伤学
- 药理学 药理学 是一个学科.
背景情况:
- 创伤性脑损伤 (TBI) 呈现出显著的异质性,阻碍了治疗转化.
- 脑膜内伤是关键的TBI亚型,具有扩张的高风险,是死亡和残疾的主要原因.
- 硫氨基素受体1-暂时受体潜在的梅拉斯4 (SUR1-TRPM4) 通道与二次TBI损伤有关,包括伤进展.
研究的目的:
- 评估静脉注射的glibenclamide (BIIB093) 在患有TBI相关脑损伤的患者的安全性和疗效.
- 通过专注于脑损伤的特定内型及其扩张来解决TBI异质性.
- 利用临床前和早期人类数据支持SUR1-TRPM4抑制伤扩张.
主要方法:
- ASTRAL试验是一项国际性的,多中心的,双盲的,安慰剂控制的II期临床试验.
- 注册仅限于患有脑病理解剖内型的患者.
- 伤扩张被用作主要的结果指标.
主要成果:
- 临床前模型显示,草甘胺抑制SUR1-TRPM4,减少大脑胀和伤进展,改善功能结果.
- 早期的人类研究表明,glibenclamide有益于伤扩张.
- 该ASTRAL试验正在积极招募160名参与者,以进一步评估glibenclamide的疗效.
结论:
- 通过有针对性的内型鉴定 (脑损伤) 来解决TBI异质性对于治疗开发至关重要.
- 抑制SUR1-TRPM4代表了一种有前途的治疗策略,用于管理TBI后伤扩张.
- ASTRAL试验的设计以强有力的科学理由为基础,旨在提供关于glibenclamide在TBI治疗中的作用的关键数据.
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