在急性脑性缺血中使用立即或延迟强度的他:INSPIRES随机临床试验
Ying Gao1, Lingling Jiang2, Yuesong Pan1,2
1Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
JAMA neurology
|May 28, 2024
概括
在患有轻度缺血性中风或动脉样硬化TIA的患者中,立即强化他类药物治疗没有降低复发性中风风险. 然而,它可能会改善功能结果,而不会增加出血风险,而与延迟使用他类药物相比.
科学领域:
- 神经学 神经学
- 心血管医学 心血管医学
- 临床试验 临床试验
背景情况:
- 在二次中风预防和神经保护中,立即与延迟密集型他类药物治疗之间存在有限的比较.
- 动脉样硬化是急性轻度缺血性中风和短暂缺血性发作 (TIA) 的重要原因.
- 优化他类药物治疗时间对于治疗急性脑血管事件的患者至关重要.
研究的目的:
- 评估立即密集型他类药物治疗与延迟密集型他类药物治疗的安全性和有效性.
- 为了确定急性轻度缺血性中风或由于动脉样硬化的高风险TIA患者的复发性中风风险的影响.
- 评估与不同类型他类药物启动时间相关的神经保护作用和功能结果.
主要方法:
- 针对高风险内或外动脉样硬化 (INSPIRES) 的强化他和抗血小板治疗试验是一项双盲,安慰剂控制,随机的临床试验.
- 在发病后72小时内注册了6100名35-80岁的轻度缺血性中风或高风险的动脉样硬化TIA患者.
- 患者接受了即时密集型阿托瓦斯塔丁 (80mg 1-21天) 或3天的延迟密集型阿托瓦斯塔丁治疗方案.
主要成果:
- 90天内发生的新中风发生在即时密集组的8.1%,延迟组的8.4% (HR,0.95;95%CI,0.80-1.13).
- 在即时密集型组的9.8%观察到功能性结局较差,而延迟型组的11.4% (OR,0.83;95% CI,0.71-0.98).
- 中度至重度出血发生在即时密集型组的0.8%,延迟型组的0.6%.
结论:
- 在72小时内立即强化使用他类药物并没有显著降低该患者群体中复发性中风的风险.
- 这些发现表明,在立即密集型他类药物治疗下,改善功能结果的潜在益处.
- 在立即和延迟开始使用他类药物组之间,中度至重度出血事件没有显著差异.
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