Havanka H, Dahlöf C, Pop P H, Diener H C, Winter P, Whitehouse H, Hassani H
Lansi-Pohjan Keskussairaala, Neurologian Poliklinikka, Kemi, Finland.
Clin Ther. 2000 Aug;22(8):970-80. doi: 10.1016/s0149-2918(00)80068-5.
This study sought to compare the efficacy of several doses of naratriptan tablets with that of sumatriptan tablets and placebo in the acute treatment of a single migraine attack.
This was a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study. Patients received either naratriptan tablets (1, 2.5, 5, 7.5, or 10 mg), sumatriptan tablets (100 mg), or placebo.
A total of 643 patients took part in the study. Two hours after dosing, headache relief was reported by significantly more patients treated with any dose of naratriptan (52%-69%) or sumatriptan (60%) than with placebo (31%) (P < 0.05). Four hours after dosing, headache relief was reported by significantly more patients treated with any dose of naratriptan (63%-80%) or sumatriptan (80%) than with placebo (39%) and by significantly more patients treated with sumatriptan 100 mg (80%) than with naratriptan 1 mg (64%), 2.5 mg (63%), or 5 mg (65%) (P < 0.05). Twenty-four-hour overall efficacy (headache relief maintained through 24 hours postdose with no worsening, no use of rescue medication, and no recurrence) was reported by more patients treated with any dose of naratriptan (39%-58%) or sumatriptan (44%) than with placebo (22%). Headache recurrence was reported in 17% to 32% of naratriptan-treated patients, 44% of sumatriptan-treated patients, and 36% of placebo recipients. The overall incidence of adverse events was similar in patients treated with naratriptan 1 mg (20%), naratriptan 2.5 mg (21%), and placebo (23%). For naratriptan 5, 7.5, and 10 mg, the incidence of adverse events was 32%, 37%, and 35%, respectively, and for sumatriptan 100 mg it was 26%.
Our results suggest that the 2.5-mg dose of naratriptan tablets offers the optimal efficacy-to-tolerability ratio at the dose range between 1 and 10 mg. Although naratriptan 2.5 mg was less effective than sumatriptan 100 mg at 4 hours after dosing, the 2 medications showed similar efficacy at 24 hours.
本研究旨在比较几种剂量的那拉曲普坦片与舒马曲普坦片及安慰剂在急性治疗单次偏头痛发作中的疗效。
这是一项随机、双盲、安慰剂对照、平行组、剂量范围研究。患者接受那拉曲普坦片（1、2.5、5、7.5或10毫克）、舒马曲普坦片（100毫克）或安慰剂治疗。
共有643名患者参与了该研究。给药两小时后，与安慰剂组（31%）相比，接受任何剂量那拉曲普坦（52%-69%）或舒马曲普坦（60%）治疗的患者中，报告头痛缓解的患者明显更多（P<0.05）。给药四小时后，与安慰剂组（39%）相比，接受任何剂量那拉曲普坦（63%-80%）或舒马曲普坦（80%）治疗的患者中，报告头痛缓解的患者明显更多；与1毫克那拉曲普坦（64%）、2.5毫克那拉曲普坦（63%）或5毫克那拉曲普坦（65%）相比，接受100毫克舒马曲普坦治疗的患者中，报告头痛缓解的患者明显更多（P<0.05）。更多接受任何剂量那拉曲普坦（39%-58%）或舒马曲普坦（44%）治疗的患者报告了24小时总体疗效（给药后24小时内头痛缓解持续存在，无病情恶化，未使用急救药物，无复发），而接受安慰剂治疗的患者为22%。那拉曲普坦治疗的患者中，17%至32%报告有头痛复发，舒马曲普坦治疗的患者中有44%，安慰剂组中有36%。接受1毫克那拉曲普坦（20%）、2.5毫克那拉曲普坦（21%）和安慰剂（23%）治疗的患者中，不良事件的总体发生率相似。对于5毫克、7.5毫克和10毫克那拉曲普坦，不良事件的发生率分别为32%、37%和35%，对于100毫克舒马曲普坦，不良事件的发生率为26%。
我们的结果表明，在1至10毫克的剂量范围内，2.5毫克剂量的那拉曲普坦片提供了最佳的疗效与耐受性之比。尽管给药4小时后，2.5毫克那拉曲普坦的疗效不如100毫克舒马曲普坦，但这两种药物在24小时时显示出相似的疗效。
