Cutler N, Mushet G R, Davis R, Clements B, Whitcher L
California Clinical Trials Medical Group, Beverly Hills, CA 90211, USA.
Neurology. 1995 Aug;45(8 Suppl 7):S5-9.
This randomized, double-blind, parallel-group, placebo-controlled study evaluated the efficacy and tolerability of oral sumatriptan (Imitrex tablets) in 259 migraineurs. In the clinic, patients received oral sumatriptan 25 mg, 50 mg, or 100 mg, or placebo for the treatment of a migraine attack. The results indicate that by 2 hours post-dose, 50 to 56% of patients treated with any of the three doses, compared with 26% of patients treated with placebo, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). By 4 hours postdose, 68 to 71% of sumatriptan-treated patients, compared with 38% of placebo-treated patients, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). Oral sumatriptan was similarly effective at relieving nausea and photophobia and at reducing clinical disability. The pattern and incidence of adverse events did not differ between treatment groups. All doses--25 mg, 50 mg, and 100 mg--of sumatriptan were effective and generally well tolerated. Dosing should be individualized according to the needs of the patient.
这项随机、双盲、平行组、安慰剂对照研究评估了口服舒马曲坦(依米曲坦片)对259名偏头痛患者的疗效和耐受性。在诊所中,患者接受口服25毫克、50毫克或100毫克舒马曲坦或安慰剂来治疗偏头痛发作。结果表明,给药后2小时,接受三种剂量中任何一种治疗的患者中有50%至56%的人头痛得到缓解,而接受安慰剂治疗的患者中这一比例为26%(各舒马曲坦组与安慰剂组相比,p<0.05)。给药后4小时,接受舒马曲坦治疗的患者中有68%至71%的人头痛得到缓解,而接受安慰剂治疗的患者中这一比例为38%(各舒马曲坦组与安慰剂组相比,p<0.05)。口服舒马曲坦在缓解恶心和畏光以及减少临床残疾方面同样有效。各治疗组之间不良事件的模式和发生率没有差异。舒马曲坦的所有剂量——25毫克、50毫克和100毫克——均有效且一般耐受性良好。应根据患者的需求进行个体化给药。