Klassen A, Elkind A, Asgharnejad M, Webster C, Laurenza A
Department of Neurology, UMHC, Minneapolis 55455, USA.
Headache. 1997 Nov-Dec;37(10):640-5. doi: 10.1046/j.1526-4610.1997.3710640.x.
To evaluate the efficacy and tolerability of naratriptan, a novel 5-HT1 agonist, in the acute treatment of migraine.
DESIGN/METHODS: Six hundred thirteen migraineurs, diagnosed according to International Headache Society criteria, treated a single migraine attack with naratriptan tablets (2.5 mg, 1 mg, 0.25 mg, or 0.1 mg) or placebo in a randomized, double-blind, placebo-controlled, parallel-group study conducted at 54 United States centers. At dosing and at predetermined intervals beginning 30 minutes postdose, patients recorded migraine pain severity, clinical disability, and presence of associated migraine symptoms. Safety measures included adverse events, physical examinations, vital signs, ECGs, and clinical laboratory tests.
Headache relief (moderate or severe pain at dosing reduced to mild or no pain) 4 hours postdose was reported in 60% of patients receiving naratriptan 2.5 mg compared with 50%, 35%, 32%, and 34% of patients receiving naratriptan 1 mg, 0.25 mg, 0.1 mg, and placebo, respectively (P < 0.05 naratriptan 2.5 mg and 1 mg versus placebo, 1 mg versus 0.1 mg, and 2.5 mg versus 0.1 mg and 0.25 mg). Clinical disability 4 hours postdose was reported as mild or none for 70% of patients receiving naratriptan 2.5 mg compared with 63%, 47%, 48%, and 48% of patients receiving naratriptan 1 mg, 0.25 mg, 0.1 mg, or placebo, respectively (P < 0.05 naratriptan 2.5 mg and 1 mg versus placebo, 1 mg versus 0.1 mg, and 2.5 mg versus 0.1 mg and 0.25 mg). Four-hour efficacy for absence of nausea, photophobia, and phonophobia was similar to efficacy for headache relief at each dose. The adverse event profile of each dose of naratriptan was similar to that of placebo. No clinically relevant change in any safety measure was reported.
Naratriptan is effective and well tolerated for the acute treatment of migraine. The 2.5-mg dose appears to offer the optimum ratio of efficacy to tolerability.
评估新型5-羟色胺1（5-HT1）激动剂那拉曲普坦在偏头痛急性治疗中的疗效和耐受性。
设计/方法：根据国际头痛协会标准诊断的613名偏头痛患者，在美国54个中心进行的一项随机、双盲、安慰剂对照、平行组研究中，用那拉曲普坦片（2.5毫克、1毫克、0.25毫克或0.1毫克）或安慰剂治疗单次偏头痛发作。在给药时以及给药后30分钟开始的预定时间间隔，患者记录偏头痛疼痛严重程度、临床残疾情况以及相关偏头痛症状的存在情况。安全措施包括不良事件、体格检查、生命体征、心电图和临床实验室检查。
给药后4小时，接受2.5毫克那拉曲普坦的患者中有60%报告头痛缓解（给药时的中度或重度疼痛减轻至轻度或无疼痛），而接受1毫克、0.25毫克、0.1毫克那拉曲普坦和安慰剂的患者分别为50%、35%、32%和34%（2.5毫克和1毫克那拉曲普坦与安慰剂相比，P<0.05；1毫克与0.1毫克相比，P<0.05；2.5毫克与0.1毫克和0.25毫克相比，P<0.05）。给药后4小时，接受2.5毫克那拉曲普坦的患者中有70%报告临床残疾为轻度或无，而接受1毫克、0.25毫克、0.1毫克那拉曲普坦或安慰剂的患者分别为63%、47%、48%和48%（2.5毫克和1毫克那拉曲普坦与安慰剂相比，P<0.05；1毫克与0.1毫克相比，P<0.05；2.5毫克与0.1毫克和0.25毫克相比，P<0.05）。各剂量下无恶心、畏光和畏声的4小时疗效与头痛缓解疗效相似。各剂量那拉曲普坦的不良事件情况与安慰剂相似。未报告任何安全措施有临床相关变化。
那拉曲普坦在偏头痛急性治疗中有效且耐受性良好。2.5毫克剂量似乎提供了最佳的疗效与耐受性比例。
