Lai K-L, Niddam D M, Fuh J-L, Chen S-P, Wang Y-F, Chen W-T, Wu J-C, Wang S-J
Department of Neurology, Taipei Municipal Gandau Hospital, Taipei, Taiwan.
Department of Neurology, Neurological Institute, Taipei Veterans General Hospital, Taipei, Taiwan.
Acta Neurol Scand. 2017 Apr;135(4):476-483. doi: 10.1111/ane.12626. Epub 2016 Jun 16.
Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic options. This study explored the efficacy of 10 mg/d flunarizine for CM prophylaxis as compared with 50 mg/d topiramate.
We conducted a prospective, randomized, open-label, blinded-endpoint trial. Patients with CM were randomized to flunarizine and topiramate treatment. The primary outcomes assessed were the reductions in the total numbers of headache days and migraine days after 8 weeks of treatment. Secondary outcomes were reductions in the numbers of days of acute abortive medication intake and acute abortive medication tablets taken, and the 50% responder rate.
Sixty-two subjects were randomized (n=31/group). Patients treated with flunarizine showed significant reductions in the numbers of total headache days (-4.9 vs -2.3, P=.012) and migraine days (-4.3 vs -1.4, P=.001) compared with those treated with topiramate. Patients treated with flunarizine also showed significant reductions in the numbers of days of acute abortive medication intake (-2.3 vs -0.2, P=.005) and acute abortive medication tablets taken (-4.6 vs -0.5, P=.005) and had a higher 50% responder rate in terms of total headache days (58.6% vs 25.9%, P=.013) and migraine days (75.9% vs 29.6%, P=.001), compared with topiramate-treated patients. Flunarizine was generally well tolerated and had a safety profile comparable to that of topiramate.
Our results suggest that, in an 8-week study, 10 mg/d flunarizine is more effective than 50 mg/d topiramate for CM prophylaxis.
慢性偏头痛(CM)是一种常见且严重的疾病,治疗选择有限。本研究探讨了每日10毫克氟桂利嗪与每日50毫克托吡酯相比在预防CM方面的疗效。
我们进行了一项前瞻性、随机、开放标签、盲终点试验。CM患者被随机分配接受氟桂利嗪和托吡酯治疗。评估的主要结局是治疗8周后头痛天数和偏头痛天数的减少。次要结局是急性缓解药物摄入天数和服用的急性缓解药物片数的减少,以及50%缓解率。
62名受试者被随机分组(每组n = 31)。与接受托吡酯治疗的患者相比,接受氟桂利嗪治疗的患者在总头痛天数(-4.9对-2.3,P = 0.012)和偏头痛天数(-4.3对-1.4,P = 0.001)方面有显著减少。接受氟桂利嗪治疗的患者在急性缓解药物摄入天数(-2.3对-0.2,P = 0.005)和服用的急性缓解药物片数(-4.6对-0.5,P = 0.005)方面也有显著减少,并且在总头痛天数(58.6%对25.9%,P = 0.013)和偏头痛天数(75.9%对29.6%,P = 0.001)方面的50%缓解率高于接受托吡酯治疗的患者。氟桂利嗪总体耐受性良好,安全性与托吡酯相当。
我们的结果表明,在一项为期8周的研究中,每日10毫克氟桂利嗪在预防CM方面比每日50毫克托吡酯更有效。