超急性原发性脑内出血 (TICH-2):国际随机对照的3期优势试验
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在PubMed上查看摘要
概括
此摘要是机器生成的。在脑内出血的患者中,胺酸没有改善功能状态. 然而,在中风患者中,胺酸减少了早期死亡和严重的不良事件.
科学领域
- 神经学
- 临床试验
- 药理学
背景情况
- 已知特兰克萨姆酸可以预防创伤和产后出血导致的死亡.
- 研究了降低血瘤扩张和改善脑内出血 (ICH) 中风患者的疗效.
研究的目的
- 评估特兰克萨姆酸对大脑内出血导致中风的成年人血液扩张和功能结果的影响.
主要方法
- 在12个国家的124个地点进行的国际随机,安慰剂对照试验,涉及2325名患有ICH的成年人.
- 参与者在症状出现后8小时内接受了静脉注射的松酸或安慰剂.
- 主要结局是90天后的功能状态,用修改的兰金尺度进行测量.
主要成果
- 在90天的功能状态中没有显著的差异 (aOR为0.88, p=0.11).
- 在特兰克萨姆酸组中,死亡率在第7天显著降低 (9%对11%,p=0. 0406).
- 在二,七和九十天的治疗中,报告的严重不良事件较少.
结论
- 在患有脑内出血的患者中,90天的功能状态没有显著改善.
- 这种药物可以减少早期死亡率和严重的不良反应,这表明该药物可能在更大规模的试验中发挥作用,需要进一步调查.
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