Cady Roger, Martin Vincent, Mauskop Alexander, Rodgers Anthony, Hustad Carolyn M, Ramsey Karen E, Skobieranda Franck
Primary Care Network, 3805 S. Kansas Expressway, Springfield, MO 65807, USA.
Headache. 2006 Jun;46(6):914-24. doi: 10.1111/j.1526-4610.2006.00466.x.
To determine if administration of rizatriptan 10 mg is superior to placebo for the early treatment of acute migraine, while the pain is mild.
Past studies have suggested that treatment outcomes can be improved if a triptan is administered early in the time course of a migraine attack.
Two randomized, parallel, placebo-controlled, double-blind studies. TAME (Treat A Migraine Early)1 was conducted at 46 centers in the United States; TAME2, at 48 centers in the United States. Totally, 1030 adult patients with at least a 6-month history of migraine were studied. Patients were instructed to treat within 1 hour of migraine onset, while pain was mild. Patients maintained a headache diary in which they rated their levels of pain and disability, and recorded other symptoms of migraine. Primary endpoints were pain freedom at 2 hours and sustained pain freedom at 24 hours post-dose.
In TAME1, 57.3% versus 31.1% of patients reported pain freedom at 2 hours post-dose and 42.6% versus 23.2% reported 24-hour sustained pain freedom with rizatriptan versus placebo, respectively (P < .001 for both). In TAME2, 58.9% versus 31.1% of patients reported pain freedom at 2 hours post-dose and 48.0% versus 24.6% reported 24-hour sustained pain freedom with rizatriptan versus placebo, respectively (P < .001 for both). All other efficacy endpoints favored rizatriptan. Repeat doses of the medicine were not allowed; patients may have delayed treatment; non-migraine headaches may have been treated.
Rizatriptan 10 mg was superior to placebo when treating migraine early, while pain is mild, as measured by pain freedom at 2 hours and 24-hour sustained pain freedom.
确定在偏头痛疼痛轻微时，服用10毫克利扎曲普坦是否比安慰剂更能有效早期治疗急性偏头痛。
既往研究表明，如果在偏头痛发作的早期阶段使用曲坦类药物，治疗效果可能会更好。
两项随机、平行、安慰剂对照、双盲研究。TAME（早期治疗偏头痛）1研究在美国46个中心开展；TAME2研究在美国48个中心开展。共有1030名有至少6个月偏头痛病史的成年患者参与研究。患者被要求在偏头痛发作且疼痛轻微的1小时内进行治疗。患者需记录头痛日记，对疼痛和功能障碍程度进行评分，并记录偏头痛的其他症状。主要终点为给药后2小时无痛以及给药后24小时持续无痛。
在TAME1研究中，服用利扎曲普坦和安慰剂的患者在给药后2小时无痛的比例分别为57.3%和31.1%，在给药后24小时持续无痛的比例分别为42.6%和23.2%（两者P值均<0.00）。在TAME2研究中，服用利扎曲普坦和安慰剂的患者在给药后2小时无痛的比例分别为58.9%和31.1%，在给药后24小时持续无痛的比例分别为48.0%和24.6%（两者P值均<0.00）。所有其他疗效终点均有利于利扎曲普坦。不允许重复给药；患者可能延迟治疗；可能对非偏头痛性头痛进行了治疗。
以给药后2小时无痛和给药后24小时持续无痛为衡量标准，在偏头痛疼痛轻微时早期治疗，10毫克利扎曲普坦优于安慰剂。
