Department of Neurology, Charité Universitätsmedizin, Berlin, Germany.
Cephalalgia. 2010 May;30(5):543-51. doi: 10.1111/j.1468-2982.2009.01999.x. Epub 2010 Feb 11.
Data from the Prolonged Migraine Prevention (PROMPT) with Topiramate trial were evaluated post hoc to determine whether topiramate could prevent migraine auras, and whether its efficacy in preventing migraine headaches was similar in patients with (MA; n = 269) and without (MoA; n = 542) aura. Migraines and auras were recorded during prospective baseline, 6-month open-label (OL) topiramate and 6-month double-blind (DB), placebo-controlled phases. In the last 28 OL days, migraines without aura and migraine auras decreased by 43.1% and 54.1%, respectively, in MA patients. MoA patients experienced a 44.3% reduction in migraines. In the DB phase, increases in migraines with placebo vs. topiramate were similar to the full study, but were generally not statistically significant, probably due to lack of power in the subgroup analysis. Similarly, there were no statistically significant changes in number of auras between groups. Thus, topiramate appears to reduce migraine auras in parallel with headache reductions, which are similar in patients with and without aura.
事后分析托吡酯预防偏头痛延长试验(PROMPT)的数据,以确定托吡酯是否可以预防偏头痛先兆,以及其预防偏头痛发作的疗效在有先兆偏头痛(MA;n=269)和无先兆偏头痛(MoA;n=542)患者中是否相似。在前瞻性基线、6 个月开放标签(OL)托吡酯和 6 个月双盲(DB)、安慰剂对照阶段期间记录偏头痛和先兆。在最后 28 天 OL 期间,MA 患者偏头痛无先兆和偏头痛先兆分别减少了 43.1%和 54.1%。MoA 患者偏头痛减少了 44.3%。在 DB 阶段,安慰剂组与托吡酯组相比,偏头痛发作增加,但与整个研究相比,一般无统计学意义,可能是由于亚组分析的效力不足。同样,组间的先兆数量也没有统计学意义的变化。因此,托吡酯似乎与头痛减轻平行地减少偏头痛先兆,而在有先兆和无先兆的患者中,这种疗效相似。