Martin Vincent, Cady Roger, Mauskop Alexander, Seidman Larry S, Rodgers Anthony, Hustad Carolyn M, Ramsey Karen E, Skobieranda Franck
University of Cincinnati, Cincinnati, OH 45267-0535, USA.
Headache. 2008 Feb;48(2):226-35. doi: 10.1111/j.1526-4610.2007.00947.x. Epub 2007 Nov 13.
A prospective subgroup analysis of the TAME (Treat A Migraine Early) studies examined the efficacy of rizatriptan in patients treating a menstrual migraine attack.
Both TAME studies were randomized, placebo-controlled, and double-blind. Adults with migraine were assigned (2:1) to either rizatriptan 10-mg tablet or placebo. Patients were instructed to treat within 1 hour of migraine onset and when the pain was mild. The primary endpoint was 2-hour pain freedom. The diagnosis of menstrual migraine was established according to the revised 2004 International Headache Society (IHS) diagnostic criteria. Data from both studies were pooled for logistic regression analyses. A test for interaction was performed to compare rates of 2-hour pain freedom between patients treating a menstrual and non-menstrual attack.
A total of 94 patients (63 in the rizatriptan group and 31 in the placebo group) met IHS criteria for menstrual migraine and treated a menstrual attack. The percentage of patients reporting 2-hour pain freedom was significantly greater for rizatriptan than for placebo (63.5% vs 29.0%; odds ratio = 4.5; 95% confidence interval: 1.7, 11.9; P = .002) in those treating a menstrual attack. In those treating with rizatriptan, the percentage of patients with 2-hour pain freedom did not statistically differ between those treating a menstrual or non-menstrual migraine attack (63.5% vs 57.5%; P = .454).
Rizatriptan 10 mg was effective for the treatment of menstrual migraine in an early intervention model, as measured by 2-hour pain freedom. Rates of 2-hour pain freedom were comparable for patients treating menstrual and non-menstrual migraine attacks with rizatriptan.
对TAME(早期治疗偏头痛)研究进行前瞻性亚组分析,以考察利扎曲普坦对月经性偏头痛发作患者的疗效。
两项TAME研究均为随机、安慰剂对照、双盲试验。偏头痛成人患者按2:1比例被分配服用10毫克利扎曲普坦片或安慰剂。患者被要求在偏头痛发作1小时内且疼痛轻微时进行治疗。主要终点为2小时无痛。月经性偏头痛的诊断依据2004年修订的国际头痛协会(IHS)诊断标准确定。两项研究的数据合并进行逻辑回归分析。进行交互作用检验以比较治疗月经性和非月经性发作患者的2小时无痛率。
共有94例患者(利扎曲普坦组63例,安慰剂组31例)符合IHS月经性偏头痛标准并治疗了月经性发作。在治疗月经性发作的患者中,报告2小时无痛的利扎曲普坦组患者百分比显著高于安慰剂组(63.5%对29.0%;优势比=4.5;95%置信区间:1.7, 11.9;P = 0.002)。在服用利扎曲普坦治疗的患者中,治疗月经性或非月经性偏头痛发作的患者2小时无痛百分比无统计学差异(63.5%对57.5%;P = .454)。
以2小时无痛为衡量标准,在早期干预模式下,10毫克利扎曲普坦对月经性偏头痛治疗有效。利扎曲普坦治疗月经性和非月经性偏头痛发作患者的2小时无痛率相当。