Natarajan Shankar, Jabbour J T, Webster Christopher J, Richardson Mary S
Department of Pediatric Neurology, Le Bonheur Children's Hospital, Memphis, TN, USA.
Headache. 2004 Nov-Dec;44(10):969-77. doi: 10.1111/j.1526-4610.2004.04190.x.
This 1-year, open-label, multicenter study was designed to assess the long-term tolerability and efficacy of sumatriptan nasal spray 20 mg in adolescent patients with migraine.
A prospective, multicenter, open-label study was conducted in patients aged 12 to 17 years who were allowed to treat an unlimited number of migraines at severe, moderate, or mild pain intensity with sumatriptan nasal spray for up to 1 year. All patients started the study at the 20-mg dose of sumatriptan nasal spray. Dose could be adjusted downward to 5 mg at the discretion of the investigator to optimize therapy.
A total of 484 adolescent migraineurs treated 4676 migraines with sumatriptan nasal spray 20 mg (3593 during the first 6 months and 1083 during the second 6 months). A total of 3940 migraines and 699 migraines were treated with one and two 20-mg doses of sumatriptan nasal spray, respectively. Only 10 patients (treating 42 migraines) took the 5-mg dose of sumatriptan nasal spray. The overall percentage of migraines treated with either one 20-mg dose or one, two, or three 20-mg doses with at least 1 drug-related adverse event was 19%. The most common specific drug-related adverse event was unpleasant taste, reported in 17% of migraines. No other single drug-related adverse event was reported in more than 1% of migraines over the 1-year treatment period. When unpleasant taste was excluded from the adverse-event tabulations, the percentages of migraines with at least 1 drug-related adverse event after one or one, two, or three 20-mg doses declined to 4% and 3%, respectively. No patient experienced any drug-related changes in 12-lead ECGs, vital signs, or nasal assessments; and no clinically meaningful changes in clinical laboratory values were observed. Across all migraines with evaluable efficacy data (n=4334), headache relief was reported in 43% of migraines at 1 hour and in 59% at 2 hours after dosing with sumatriptan nasal spray 20 mg. Of the 2561 migraines with headache relief 2 hours postdose, headache recurrence was reported within 24 hours of initial dosing in 7% of migraines. None of the efficacy or tolerability results varied as a function of time in the study (ie, first 6 months vs. second 6 months).
Sumatriptan nasal spray 20 mg is generally well tolerated and may be beneficial during long-term use by adolescent migraineurs ages 12 to 17 years.
本项为期1年的开放标签多中心研究旨在评估20毫克舒马曲坦鼻喷雾剂对青少年偏头痛患者的长期耐受性和疗效。
对年龄在12至17岁的患者进行了一项前瞻性、多中心、开放标签研究，这些患者可以使用舒马曲坦鼻喷雾剂治疗严重、中度或轻度疼痛强度的不限数量的偏头痛，最长可达1年。所有患者均从20毫克剂量的舒马曲坦鼻喷雾剂开始研究。研究人员可自行决定将剂量下调至5毫克以优化治疗。
共有484名青少年偏头痛患者使用20毫克舒马曲坦鼻喷雾剂治疗了4676次偏头痛（前6个月治疗3593次，后6个月治疗1083次）。分别使用一剂量和两剂量20毫克舒马曲坦鼻喷雾剂治疗的偏头痛总数为3940次和699次。只有10名患者（治疗42次偏头痛）使用了5毫克剂量的舒马曲坦鼻喷雾剂。使用一剂量20毫克或一、二或三剂量20毫克且至少发生1次药物相关不良事件的偏头痛总体百分比为19%。最常见的特定药物相关不良事件是味觉不适，在17%的偏头痛中有所报告。在为期1年的治疗期间，没有其他单一药物相关不良事件在超过1%的偏头痛中被报告。当不良事件列表中排除味觉不适后，使用一剂量或一、二或三剂量20毫克后至少发生1次药物相关不良事件的偏头痛百分比分别降至4%和3%。没有患者在12导联心电图、生命体征或鼻腔评估方面出现任何与药物相关的变化；临床实验室值也未观察到有临床意义的变化。在所有具有可评估疗效数据的偏头痛（n = 4334）中，使用20毫克舒马曲坦鼻喷雾剂给药后1小时，43%的偏头痛报告头痛缓解，2小时时为59%。在给药后2小时头痛缓解的2561次偏头痛中，7%的偏头痛在初始给药后24小时内报告头痛复发。在研究中（即前6个月与后6个月），疗效或耐受性结果均未随时间变化。
20毫克舒马曲坦鼻喷雾剂总体耐受性良好，对于12至17岁的青少年偏头痛患者长期使用可能有益。
