Newman L, Mannix L K, Landy S, Silberstein S, Lipton R B, Putnam D G, Watson C, Jöbsis M, Batenhorst A, O'Quinn S
St. Luke's-Roosevelt Hospital Center, Headache Institute, New York, NY 10019, USA.
Headache. 2001 Mar;41(3):248-56. doi: 10.1046/j.1526-4610.2001.111006248.x.
To determine the efficacy of naratriptan 1-mg and 2.5-mg tablets twice daily compared with placebo as short-term prophylaxis of menstrually associated migraine.
Approximately 60% of women with migraine report headaches associated with their menstrual cycles. Results from an open-label study suggest that short-term administration of sumatriptan is useful in the prophylaxis of menstrually associated migraine.
A randomized, double-blind, three-arm, parallel-group, placebo-controlled study was conducted in women aged 18 years or older with a history of migraine with or without aura, as defined by the International Headache Society, of at least 6 months. Two dose strengths of naratriptan (1 mg, 2.5 mg) or identical-appearing placebo tablets (1:1:1) were administered twice daily for 5 days starting 2 days prior to the expected onset of menses across four perimenstrual periods. End points included the number of menstrually associated migraines, total migraine days, peak headache severity, lost work/activity time, migraine-related quality of life, and incidence of adverse events.
Overall, the intent-to-treat population comprised 206 women (naratriptan 1 mg, n = 70; naratriptan 2.5 mg, n = 70, and placebo, n = 66); 171 women treated four perimenstrual periods. Significantly more perimenstrual periods per subject treated with naratriptan, 1 mg, were headache-free compared with placebo (50% versus 25%, P =.003). Naratriptan, 1 mg, significantly reduced the number of menstrually associated migraines (2.0 versus 4.0, P <.05) and menstrually associated migraine days (4.2 versus 7.0, P <.01) compared with placebo. More patients treated with naratriptan, 1 mg, were headache-free across all treated perimenstrual periods compared with placebo (23% versus 8%). No difference in headache severity was observed in breakthrough headaches. The incidence and severity of adverse events was similar across treatment groups. Naratriptan, 2.5 mg, was not statistically superior to placebo for any measure.
Naratriptan, 1 mg, with tolerability similar to placebo, is an effective, short-term, prophylactic treatment for menstrually associated migraine.
确定每日两次服用1毫克和2.5毫克那拉曲普坦片与安慰剂相比，作为月经相关性偏头痛短期预防用药的疗效。
约60%的偏头痛女性报告有与月经周期相关的头痛。一项开放标签研究的结果表明，短期服用舒马曲坦对预防月经相关性偏头痛有用。
对年龄在18岁及以上、有国际头痛协会定义的有或无先兆偏头痛病史至少6个月的女性进行了一项随机、双盲、三臂、平行组、安慰剂对照研究。在预期月经开始前2天开始，连续5天每天两次给予两种剂量强度的那拉曲普坦（1毫克、2.5毫克）或外观相同的安慰剂片（1:1:1），共四个月经周期。终点指标包括月经相关性偏头痛的发作次数、偏头痛总天数、头痛严重程度峰值、工作/活动时间损失、偏头痛相关生活质量以及不良事件的发生率。
总体而言，意向性治疗人群包括206名女性（1毫克那拉曲普坦组，n = 70；2.5毫克那拉曲普坦组，n = 70，安慰剂组，n = 66）；171名女性接受了四个月经周期的治疗。与安慰剂相比，接受1毫克那拉曲普坦治疗的受试者每个月经周期无头痛的比例显著更高（50%对25%，P =.003）。与安慰剂相比，1毫克那拉曲普坦显著减少了月经相关性偏头痛的发作次数（分别为2.0次和4.0次，P <.05）以及月经相关性偏头痛天数（分别为4.2天和7.0天，P <.01）。与安慰剂相比，接受1毫克那拉曲普坦治疗的更多患者在所有接受治疗的月经周期中均无头痛（23%对8%）。在突破性头痛中未观察到头痛严重程度的差异。各治疗组不良事件的发生率和严重程度相似。2.5毫克那拉曲普坦在任何测量指标上均未在统计学上优于安慰剂。
1毫克那拉曲普坦耐受性与安慰剂相似，是一种有效的月经相关性偏头痛短期预防性治疗药物。
