Ekbom K, Monstad I, Prusinski A, Cole J A, Pilgrim A J, Noronha D
Department of Neurology, Söder Hospital, Stockholm, Sweden.
Acta Neurol Scand. 1993 Jul;88(1):63-9. doi: 10.1111/j.1600-0404.1993.tb04189.x.
This multicentre, double-blind, randomised, crossover study compared the efficacy, safety and tolerability of subcutaneous sumatriptan (6 mg and 12 mg) with placebo in 134 in-patients with cluster headache. Headache improvement to mild or no pain at 5, 10 and 15 min after treatment was recorded. At 10 min, headache relief was reported by 25% (placebo), 49% (6 mg) and 63% (12 mg) of patients and at 15 min the results were 35% (placebo), 75% (6 mg) and 80% (12 mg) (p < 0.001 for all comparisons with placebo). The 12 mg dose was not significantly better than the 6 mg dose and was associated with more adverse events. The 6 mg dose is therefore recommended for the acute treatment of cluster headache.
这项多中心、双盲、随机、交叉研究比较了皮下注射舒马曲坦(6毫克和12毫克)与安慰剂对134例丛集性头痛住院患者的疗效、安全性和耐受性。记录治疗后5分钟、10分钟和15分钟时头痛改善至轻度或无痛的情况。10分钟时,分别有25%(安慰剂组)、49%(6毫克组)和63%(12毫克组)的患者报告头痛缓解;15分钟时,结果分别为35%(安慰剂组)、75%(6毫克组)和80%(12毫克组)(与安慰剂组的所有比较p<0.001)。12毫克剂量并不比6毫克剂量显著更好,且不良事件更多。因此,推荐6毫克剂量用于丛集性头痛的急性治疗。