托皮拉用于偏头痛预防:一个随机对照试验
Jan Lewis Brandes1, Joel R Saper, Merle Diamond
1Nashville Neuroscience Group, Nashville, Tenn 37203, USA. jbrandes@nashvilleneuroscience.com
JAMA
|February 26, 2004
概括
托皮拉显著降低了每月偏头痛的频率和治疗的第一个月内的几天,在一项大型受控试验中证明了对偏头痛预防的持续有效性.
科学领域:
- 神经学 神经学
- 临床药理学 临床药理学
背景情况:
- 之前的试验表明,托皮拉马特在预防偏头痛方面具有潜力.
- 这项研究旨在证实它在更大的人群中的有效性和安全性.
研究的目的:
- 在一项大规模的,随机的,双盲的,安慰剂对照的试验中,评估托皮拉在预防偏头痛方面的疗效和安全性.
主要方法:
- 一项为期26周的试验随机选择了483名 (12-65岁) 患有偏头痛病史的患者接受安慰剂或托皮拉 (50,100或200毫克/天).
- 托皮拉酸盐在8周内进行了定位,随后进行了18周的维持治疗.
- 主要终点是平均每月偏头痛频率的变化;次要终点包括响应率和偏头痛日数的减少.
主要成果:
- 与安慰剂相比,托皮拉100和200毫克/天显著降低了每月偏头痛的频率 (P<.001).
- 在所有托皮拉剂量 (50,100,200毫克/天) 和安慰剂 (P<.001) 中,响应率显著更高.
- 随着100和200毫克/天托皮拉的使用,观察到偏头痛天数和救援药物使用的显著减少.
结论:
- 托皮拉在偏头痛预防方面表现出显著的疗效,在治疗的第一个月内观察到效果.
- 托皮拉的预防作用在整个26周的研究持续时间内保持不变.
- 导致停止治疗的常见不良事件包括麻醉,疲劳和恶心.
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