Banerjee M, Findley L J
Department of Neurology, Oldchurch Hospital, Romford, Essex, UK.
Cephalalgia. 1992 Feb;12(1):39-44. doi: 10.1046/j.1468-2982.1992.1201039.x.
The efficacy of the selective 5HT1-like agonist sumatriptan in acute treatment of classical migraine (i.e. migraine with aura) was assessed in a double-blind, placebo-controlled, parallel group randomized trial. An oral dose of 200 mg was chosen on the basis of the efficacy rates achieved (70-85%) with 70-280 mg in open studies (1, 2). The dose of 200 mg was also chosen for the study because preliminary data from an oral pilot study indicated that efficacy increased with increasing dose up to 200 mg. Each patient was treated for a maximum of three separate attacks of migraine with aura within a three months' period. Three attacks were treated so that we could examine consistency of response across more than one attack. For attack 1, 200 mg sumatriptan was significantly more effective, safe and well tolerated than placebo at relieving headache 2 h after treatment was given (p = 0.023). In subsequent attacks, i.e. in attacks 2 and 3, there was no such significant effect of sumatriptan compared with placebo in relieving headache. This reduced efficacy of sumatriptan in the second and third attacks may be due to a high incidence of vomiting induced by the high dose of dispersible formulation and also by the bitter taste of the tablets. In addition, there was an increase in placebo response in attacks 2 and 3 compared to the first attack.
在一项双盲、安慰剂对照、平行组随机试验中，评估了选择性5HT1样激动剂舒马曲坦在经典偏头痛（即伴有先兆的偏头痛）急性治疗中的疗效。根据开放研究中70 - 280毫克剂量所达到的有效率（70 - 85%），选择了200毫克的口服剂量（1, 2）。选择200毫克剂量进行该研究，还因为一项口服预试验的初步数据表明，在剂量增加至200毫克之前，疗效随剂量增加而提高。每位患者在三个月内最多接受三次伴有先兆的偏头痛单独发作的治疗。进行三次发作的治疗，以便我们能够检查不止一次发作时反应的一致性。对于第1次发作，在给药后2小时缓解头痛方面，200毫克舒马曲坦比安慰剂显著更有效、更安全且耐受性更好（p = 0.023）。在随后的发作中，即第2次和第3次发作，与安慰剂相比，舒马曲坦在缓解头痛方面没有这种显著效果。舒马曲坦在第2次和第3次发作中疗效降低，可能是由于高剂量分散片剂引起的呕吐发生率高，以及片剂的苦味所致。此外，与第1次发作相比，第2次和第3次发作中安慰剂反应有所增加。
