Pini L A, Sternieri E, Fabbri L, Zerbini O, Bamfi F
Clinical Pharmacology Department, University of Modena, Italy.
J Int Med Res. 1995 Mar-Apr;23(2):96-105. doi: 10.1177/030006059502300202.
This multicentre, double-blind study compared (100 mg) sumatriptan administered orally with placebo in treating an acute attack of migraine; 238 patients were studied over a 48-h period. Four hours after treatment, 92 of the 142 evaluable sumatriptan patients (65%) showed significant reductions (P < 0.001) in headache severity, clinical disability and accompanying symptoms compared with 32 of the 80 evaluable placebo-treated patients (40%). The duration of attack prior to taking medication and the history of persistent migraine do not influence the observed difference between the two treatment regimens (sumatriptan and placebo), which remained statistically significant (P < 0.001) in both cases. The incidence of headache recurrence in patients who experienced relief 4 h after initial treatment was low, occurring in 16 (17%) and 4 (13%) of the sumatriptan- and placebo-treated patients, respectively. Only patients with a history of migraine attacks lasting longer than 24 h suffered headache recurrences, and these recurrences were not consistent with the International Headache Society definition of migraine. Treatment with sumatriptan was well tolerated.
这项多中心、双盲研究比较了口服舒马曲坦（100毫克）与安慰剂治疗偏头痛急性发作的效果；在48小时内对238名患者进行了研究。治疗4小时后，142名可评估的舒马曲坦治疗患者中有92名（65%）头痛严重程度、临床残疾及伴随症状显著减轻（P<0.001），而80名可评估的安慰剂治疗患者中有32名（40%）。服药前发作持续时间及持续性偏头痛病史并不影响两种治疗方案（舒马曲坦和安慰剂）间观察到的差异，两种情况下差异均有统计学意义（P<0.001）。初始治疗4小时后症状缓解的患者中，头痛复发率较低，舒马曲坦治疗组和安慰剂治疗组分别为16名（17%）和4名（13%）。仅偏头痛发作持续时间超过24小时病史的患者出现头痛复发，且这些复发不符合国际头痛协会对偏头痛的定义。舒马曲坦治疗耐受性良好。
