一种用于加纳第三级中心中风预防的心血管多药丸 (SMAART):一项2期随机临床试验
Fred Stephen Sarfo1, Jenifer Voeks2, Sheila Adamu3
1Kwame Nkrumah University of Science and Technology, Kumasi, Ghana; Komfo Anokye Teaching Hospital, Kumasi, Ghana.
The Lancet. Global health
|September 21, 2023
概括
一种心血管多药丸在降低中风幸存者的动脉内心介质厚度方面表现出与常规护理相似的有效性,但具有更多的不良事件. 为了获得长期的结果,需要进一步的研究.
科学领域:
- 心血管医学 心血管医学
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
背景情况:
- 心血管多药可能会改善治疗的坚持,特别是在资源有限的环境中.
- 在中风幸存者中减少动脉样硬化风险的多药药的有效性仍然被低估.
- 这项研究调查了多药剂治疗方案与常规护理对心动脉内膜介质厚度 (CIMT) 回归后缺血性中风的影响.
研究的目的:
- 为了比较多药剂治疗方案与常规护理在减少缺血性中风幸存者中CIMT的有效性.
- 在这个患者群体中评估多药药疗法的安全性.
主要方法:
- 在加纳进行了第二阶段,并行,开放标签,评估者掩盖,随机临床试验 (SMAART).
- 148名缺血性中风幸存者 (在2个月内) 被随机分配1:1接受多药丸 (拉米普利尔,阿提诺洛尔,甲,西姆瓦斯塔丁,阿司匹林) 或常规护理12个月.
- 主要结局是12个月后CIMT的变化,使用ANCOVA进行分析.
主要成果:
- 12个月后的CIMT平均变化在常规护理组为-0.092毫米,而在多药丸组为-0.017毫米 (调整后的平均差异:0.049;p=0.11),表明没有统计学上显著的差异.
- 与常规护理组相比,多药组 (11%) 的严重不良事件发生频率更高 (3%;p=0.049).
结论:
- 多药剂疗法在回归亚临床动脉样硬化和改善二次结果方面表现出与定制的常规护理相似的疗效.
- 然而,多药丸与严重不良事件的发生率更高有关.
- 在初级保健机构进行更大,更长期,基于事件的研究是有必要的,以进一步评估中风幸存者的多药丸使用情况.
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