Landy S, Savani N, Shackelford S, Loftus J, Jones M
Wesley Headache and Neurology Clinic, 8000 Centerview Parkway, Suite 101, Memphis, TN 38018, USA.
Int J Clin Pract. 2004 Oct;58(10):913-9. doi: 10.1111/j.1368-5031.2004.00295.x.
Two randomised, double-blind, parallel-group, placebo-controlled clinical trials were conducted to assess the efficacy of sumatriptan tablets, 50mg and 100mg, for treatment during the mild-pain phase of a menstrually associated migraine among patients who typically experienced moderate to severe migraine preceded by an identifiable phase of mild pain. Subjects (n = 403 in Study 1 and n = 349 in Study 2) treated one menstrually associated migraine on an outpatient basis. The results demonstrate that sumatriptan tablets, 50 mg or 100 mg, were significantly more effective than placebo at conferring pain-free response 1 h and 2 h post-dose; migraine-free response (i.e. no pain and no associated symptoms) 2 h post-dose; returning patients to normal functioning 2 h post-dose; and conferring sustained freedom from pain from 2 through 24 h post-dose. Although the studies were not designed or statistically powered to show differences between the sumatriptan doses, a trend for slightly higher efficacy was observed for the 100-mg dose compared with the 50-mg dose on many measures. Both doses of sumatriptan were well-tolerated. The only adverse events reported in more than 2% of subjects in a treatment group were nausea, paresthesia, dizziness and malaise/fatigue, all of which were reported at incidences comparable to or slightly higher than those with placebo. Considered in the context of other findings, these data suggest that--with menstrually associated migraine as with non-menstrual migraine--optimal therapeutic benefit of sumatriptan tablets may be realised when they are administered during the mild-pain phase of an attack rather than delaying treatment until headache is moderate or severe.
开展了两项随机、双盲、平行组、安慰剂对照的临床试验，以评估50毫克和100毫克舒马曲坦片对通常经历中度至重度偏头痛且在轻度疼痛可识别阶段之前的月经相关性偏头痛患者在轻度疼痛阶段治疗的疗效。受试者（研究1中n = 403，研究2中n = 349）在门诊治疗一次月经相关性偏头痛。结果表明，50毫克或100毫克舒马曲坦片在给药后1小时和2小时产生无痛反应方面比安慰剂显著更有效；给药后2小时无偏头痛反应（即无疼痛和无相关症状）；给药后2小时使患者恢复正常功能；以及给药后2至24小时持续无疼痛。尽管这些研究并非设计用于显示舒马曲坦剂量之间的差异，也没有足够的统计学效力，但在许多指标上，观察到100毫克剂量比50毫克剂量的疗效略高的趋势。两种剂量的舒马曲坦耐受性均良好。在一个治疗组中超过2%的受试者报告的唯一不良事件是恶心、感觉异常、头晕和不适/疲劳，所有这些不良事件的发生率与安慰剂相当或略高于安慰剂。结合其他研究结果来看，这些数据表明——对于月经相关性偏头痛和非月经性偏头痛一样——舒马曲坦片在发作的轻度疼痛阶段给药而非延迟至头痛为中度或重度时给药，可能会实现最佳治疗效果。
