利扎曲普坦5mg用于青少年偏头痛的急性治疗:一项双盲单次给药的研究与两项开放性多次给药研究

作     者：Visser W.H. Winner P. Strohmaier K. 李锐 

作者机构：BL 1-12 Merck Research Laboratories West Point PA 19486 United States Dr. 

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3期

页      面：40-41页

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

主　　题：单次给药 性治疗 安慰剂对照 随机研究 缓解程度 药物不良反应 

摘      要：Objective. To examine the short and long term efficacy and tolerabilty of rizatriptan 5 mg in adolescents with migraine. Methods. Two studies were condu cted in patients aged 12 to 17 years. The first study was a randomized, double blind, placebo controlled, single attack study followed by a randomized, 1 ye ar, open label extension. The second study was a randomized, 1 year, open lab el study. In the single attack study, patients treated a moderate or severe mig raine headache and up to two recurrences with rizatriptan 5-mg tablets (n = 234 ) or placebo (n = 242). Patients were instructed to use the study medication onl y on nonschool days. Headache severity, associated symptoms, and functional disa bility were assessed by the patient at 0.5,1, 1.5, 2, 3, and 4 hours after the i nitial dose. In the 1 year studies, patients treated up to 6 migraine attacks p er month with rizatriptan 5-mg tablets (n = 273), rizatriptan 5-mg wafers (n = 281), or standard care therapy (n = 132). Headache severity was assessed by the patient at 2 hours after the initial dose. In all studies, the primary efficacy measure was pain relief at 2 hours post dose. Results. In the single attack study, the proportion of patients with pain relief at 2 hours was not significan tly different between rizatriptan 5 mg (68.2%) and placebo (68.8%). Fewer pat ients than expected (about 30%) treated their migraine attacks on the weekend. Among these patients, the proportion with pain relief at 2 hours was significant ly higher in the rizatriptan group than in the placebo group (74%vs. 58%, P = 0.022). In the multiple attack studies, pain relief at 2 hours was achieved in significantly more attacks treated with rizatriptan 5-mg tablet (77%) or with rizatriptan 5-mg wafer (77%) than with standard care (64%). Rizatriptan 5 mg was well tolerated in both the studies, with an adverse event profile not signif icantly different from that of placebo or standard care. Conclusions. Rizatrip tan 5 mg was not more e