Bussone Gennaro, D'Amico Domenico, McCarroll Kathleen A, Gerth William, Lines Christopher R
National Neurological Institute C. Besta, Milan, Italy.
Eur Neurol. 2002;48(3):172-7. doi: 10.1159/000065513.
Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms, rather than looking at functional impact. This study compared the efficacy of different oral triptans for restoring normal function in migraine sufferers.
Retrospective subgroup analysis of data from five randomized, placebo-controlled, double-blind clinical trials in which oral rizatriptan was directly compared with oral sumatriptan 100 mg (772 attacks), 50 mg (2,227 attacks), and 25 mg (1,182 attacks), naratriptan 2.5 mg (413 attacks), and zolmitriptan 2.5 mg (578 attacks) for the acute treatment of a moderate or severe migraine attack. Functional disability was evaluated by patients on a 4-grade scale ('normal', 'mild impairment', 'severe impairment', 'requires bedrest') at baseline and at 0.5, 1, 1.5, 2, 3 and 4 h after dosing. This analysis looked at the percentage of patients who had normal functional ability at 2 h, the last time point before escape medications were allowed, in the subgroup of patients who had some level of disability at baseline.
Most patients in each trial and treatment group had some level of disability at baseline (range = 94-100%). At 2 h, more patients on rizatriptan 10 mg were able to function normally compared with sumatriptan 100 mg (39 vs. 32%, odds ratio = 1.4, p = 0.021), sumatriptan 50 mg (47 vs. 42%, odds ratio = 1.2, p = 0.033), sumatriptan 25 mg (48 vs. 36%, odds ratio = 1.7, p < 0.001), naratriptan 2.5 mg (39 vs. 22%, odds ratio = 2.5, p < 0.001), and zolmitriptan 2.5 mg (45 vs. 36%, odds ratio = 1.6, p = 0.008).
In direct head-to-head comparative clinical trials, oral rizatriptan 10 mg enabled more migraine sufferers to function normally at 2 h after dosing than oral sumatriptan, naratriptan, and zolmitriptan.
许多偏头痛患者在偏头痛发作期间无法正常工作。治疗效果评估往往侧重于偏头痛症状,而非功能影响。本研究比较了不同口服曲坦类药物恢复偏头痛患者正常功能的疗效。
对五项随机、安慰剂对照、双盲临床试验的数据进行回顾性亚组分析,其中口服利扎曲普坦与口服100 mg舒马曲坦(772次发作)、50 mg舒马曲坦(2227次发作)、25 mg舒马曲坦(1182次发作)、2.5 mg那拉曲坦(413次发作)和2.5 mg佐米曲坦(578次发作)直接比较,用于中重度偏头痛发作的急性治疗。患者在基线以及给药后0.5、1、1.5、2、3和4小时,通过4级量表(“正常”、“轻度损害”、“重度损害”、“需要卧床休息”)评估功能残疾情况。该分析观察了基线时有一定程度残疾的患者亚组中,在2小时(允许使用解救药物前的最后一个时间点)功能能力恢复正常的患者百分比。
各试验和治疗组中的大多数患者在基线时都有一定程度的残疾(范围为94 - 100%)。在2小时时,与100 mg舒马曲坦相比,10 mg利扎曲普坦组有更多患者能够恢复正常功能(39%对32%,优势比 = 1.4,p = 0.021);与50 mg舒马曲坦相比(47%对42%,优势比 = 1.2,p = 0.033);与25 mg舒马曲坦相比(48%对36%,优势比 = 1.7,p < 0.001);与2.5 mg那拉曲坦相比(39%对22%,优势比 = 2.5,p < 0.001);与2.5 mg佐米曲坦相比(45%对36%,优势比 = 1.6,p = 0.008)。
在直接的头对头比较临床试验中,口服10 mg利扎曲普坦比口服舒马曲坦、那拉曲坦和佐米曲坦能使更多偏头痛患者在给药后2小时恢复正常功能。