酸与托皮拉在偏头痛预防中的有效性和耐受性,这是一个随机控制的多中心试验
Mohamed G Zeinhom1, Mohamed Fouad Elsayed Khalil2, Tarek Youssif Omar Youssif3
1Neurology Dep., Faculty of Medicine, Kafr el-sheikh University, Kafr el-sheikh, Egypt.
概括
与酸相比,托皮拉显著降低了偏头痛的严重程度,改善了生活质量. 瓦尔酸盐引起了更多的不良反应,导致偏头痛患者中断率更高.
科学领域:
- 神经学 神经学
- 临床药理学 临床药理学
背景情况:
- 托皮拉和瓦尔酸盐用于偏头痛预防,特别是在低收入国家,尽管有潜在的副作用.
- 之前的试验比较了氨酸和托皮拉的偏头痛预防,但结果不确定.
研究的目的:
- 为了在中东和北非地区比较瓦尔酸盐与托皮拉酸盐在偏头痛预防方面的耐受性和有效性.
- 评估这些治疗对偏头痛发作严重程度和患者报告结果的影响.
主要方法:
- 一个单盲多中心随机对照试验,涉及600名成年偏头痛患者.
- 患者被随机分为两组:一组接受瓦尔酸盐 (500毫克两次) 和另一组接受托皮拉酸盐 (50毫克两次) 三个月.
- 通过减少偏头痛发作严重程度 (VAS) 和HIT-6得分来衡量有效性. 耐受性通过不良反应和治疗中止率来评估.
主要成果:
- 托皮拉与酸相比,在统计学上显著地减少了偏头痛发作严重程度 (VAS) 和HIT-6得分.
- 瓦尔酸盐治疗的43%的患者报告了不良反应,而托皮拉治疗的患者为22% (HR 3.11,P=0.05).
- 由于不良反应而提前停止治疗的情况在瓦尔酸盐组 (7.7%) 与托皮拉酸盐组 (4%) 相比显著更高 (HR 2.47,P=0.04).
结论:
- 在减少偏头痛发作严重程度和改善成年患者的生活质量方面,托皮拉酸 (50毫克两次) 比瓦尔酸 (500毫克两次) 更有效.
- 与托皮拉相比,瓦尔酸与显著更高的副作用发生率和过早停止治疗有关.
- 在这种人群中,托皮拉酸代表了对偏头痛预防治疗的更耐受和更有效的选择.
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