舒马曲坦鼻腔喷雾治疗青少年偏头痛的长时程耐受性

作     者：Natarajan S. Jabbour J.T. Webster C.J. Richardson M.S. 王英鹏 

作者机构：GlaxoSmithKline Research Triangle Park NC United States 

出 版 物：《世界核心医学期刊文摘（神经病学分册）》 (Digest of the World Core Medical Journals:Clinical Neurology)

年 卷 期：2005年第1卷第4期

页      面：25-26页

学科分类：1002[医学-临床医学] 100204[医学-神经病学] 10[医学] 

主　　题：头痛发作 味觉感知 舒马曲坦 头痛程度 功能评定 生命征象 数量限制 

摘      要：Objective. - 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. Methods. - 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. Results. - 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 spra