J Int Med Res. 1994 Jul-Aug;22(4):225-35. doi: 10.1177/030006059402200404.
The efficacy and safety of single doses of 6 mg sumatriptan, self-administered subcutaneously by patients using an auto-injector, for the acute treatment of up to three successive attacks of migraine was investigated in a multicentre, open, uncontrolled study in which 178 patients were enrolled. At attack 1, there was an improvement in headache (from severe or moderate to mild or no headache) in 74% of patients at 1 h, and in 82% at 2 h. The incidence of symptoms associated with migraine was decreased after sumatriptan injection. Nausea, vomiting and photo/phonophobia were reported by 72, 54, and 85% of patients, respectively, before the injection to treat attack 1, but by only 22, 12 and 27%, respectively, 2 h after the injection. Migraine recurred within 24 h in 27% of patients, but in 89% of patients was effectively treated with a further dose of 6 mg sumatriptan. Results for attacks 2 and 3 were similar. About 40% of patients experienced at least one adverse event; most of these were mild or moderate in intensity and were transient. It is concluded that 6 mg sumatriptan, self-administered using an auto-injector, is an effective and well tolerated treatment for migraine. Sumatriptan was as effective at attack 3 as at attack 1, and there was no evidence of a change in the incidence or the nature of adverse events with successive uses of the drug.
在一项多中心、开放、非对照研究中，纳入了178例患者，调查了患者使用自动注射器自行皮下注射单剂量6毫克舒马曲坦，用于急性治疗多达三次连续偏头痛发作的疗效和安全性。在第1次发作时，74%的患者在1小时时头痛有所改善（从重度或中度变为轻度或无头痛），82%的患者在2小时时有所改善。注射舒马曲坦后，与偏头痛相关的症状发生率降低。在治疗第1次发作前，分别有72%、54%和85%的患者报告有恶心、呕吐和畏光/畏声，但注射后2小时，分别仅为22%、12%和27%。27%的患者在24小时内偏头痛复发，但89%的患者用再一剂6毫克舒马曲坦有效治疗。第2次和第3次发作的结果相似。约40%的患者经历了至少一次不良事件；其中大多数强度为轻度或中度，且为短暂性。结论是，患者使用自动注射器自行注射6毫克舒马曲坦是一种有效且耐受性良好的偏头痛治疗方法。舒马曲坦在第3次发作时与第1次发作时一样有效，且没有证据表明连续使用该药物会使不良事件的发生率或性质发生变化。
