高剂量的simvastatin对二次进展性多发性硬化症 (MS-STAT) 中的大脑缩和残疾的影响:一个随机的,安慰剂控制的,第二阶段试验
Jeremy Chataway1, Nadine Schuerer2, Ali Alsanousi3
1National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust, London, UK; Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London, London, UK; UCL Institute of Neurology, University College London, London, UK; Imperial College Healthcare NHS Trust, London, UK; Imperial College, London, UK.
Lancet (London, England)
|March 25, 2014
概括
高剂量的simvastatin显著降低了二级渐进性多发性硬化症患者的脑缩. 这项研究发现simvastatin是这种疾病的安全和耐受性良好的治疗选择.
科学领域:
- 神经科学是一个神经科学.
- 临床试验 临床试验
- 药理学 药理学 是一个学科.
背景情况:
- 二次渐进性多发性硬化症 (SPMS) 是一种致残的神经疾病,目前没有有效的治疗方法.
- 西姆瓦斯塔丁是一种广泛使用的降胆固醇药,具有免疫调节和神经保护性质.
- 这些特性表明simvastatin作为一种潜在的治疗药物用于SPMS.
研究的目的:
- 评估高剂量simvastatin在减少SPMS患者大脑缩方面的疗效和安全性.
- 为了比较接受simvastatin和接受安慰剂的患者之间的全脑缩率.
主要方法:
- 这是一项双盲,安慰剂控制的试验,涉及140名年龄在18-65岁的SPMS患者.
- 参与者被随机分配,接受80毫克的simvastatin或安慰剂.
- 主要结局指标是通过连续体积核磁共振 (MRI) 评估的全脑缩年率.
主要成果:
- 与安慰剂相比,simvastatin治疗导致平均年化脑缩率显著降低 (-0.254%每年,p=0.003).
- 这意味着大脑缩的年率减少了43%.
- 西姆瓦斯塔丁耐受性良好,在西姆瓦斯塔丁和安慰剂组之间严重不良事件没有显著差异.
结论:
- 高剂量的simvastatin有效地减少了SPMS患者的大脑缩.
- 治疗表明了有利的安全性和耐受性.
- 这些发现支持在SPMS的第三阶段临床试验中对simvastatin的进一步调查.
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