Silberstein Stephen D, Loder Elizabeth, Forde Grace, Papadopoulos George, Fairclough Diane, Greenberg Steven
Jefferson Headache Center, Philadelphia, PA 19107, USA.
Curr Med Res Opin. 2006 Jun;22(6):1021-9. doi: 10.1185/030079906X104731.
Assess the impact of migraine preventive therapy on patient-reported routine daily activities using the Migraine Specific Questionnaire (MSQ) and the Medical Outcomes Study Short Form-36 (SF-36) in patients with migraine who participated in a 26-week, randomized, double-blind, placebo-controlled trial of topiramate for migraine prevention.
Patients were required to have 3-12 migraines and < or = 15 headache days/month during the baseline phase. Patients who failed > 2 adequate regimens of migraine preventive therapy were excluded. MSQ and SF-36 data were collected at baseline, weeks 8, 16, and 26 from 469 patients receiving either topiramate 50, 100, or 200 mg/day or placebo. Patients entered a double-blind, 8-week titration period followed by an 18-week maintenance period. Two activity-related MSQ domains (Role Restrictive [RR] and Role Prevention [RP]) and two activity-related SF-36 domains (Role Physical [SF-36-RP] and Vitality [SF-36-VT]) were prospectively designated as the outcome measures. Changes in MSQ and SF-36 scores during the double-blind phase relative to prospective baseline scores were compared between topiramate- and placebo-treated groups. Specifically, a mixed-effect piecewise linear regression model was used to estimate average domain score over time, and areas under the domain-over-time curve (AUC) were compared using a 2-sided t-test, with multiplicity adjustment.
In the intent-to-treat population (N = 469), topiramate (all doses) significantly improved mean MSQ-RR domain scores versus placebo (topiramate 50 mg/day, p = 0.035; topiramate 100 mg/day; p < 0.001; topiramate 200 mg/day, p = 0.001). Topiramate-associated improvements in mean MSQ-RP domain scores were significant versus placebo only for topiramate 100 mg/day (p = 0.045). SF-36-RP and SF-36-VT domain scores improved (not significant versus placebo) for topiramate 100 and 200 mg/day. Changes in these MSQ and SF-36 domain scores significantly correlated with changes in mean monthly migraine frequency.
Improvements in patient-reported outcomes specific for migraine (measured by the MSQ) were significantly better for patients receiving topiramate than for those receiving placebo. Improvements in the prospectively selected MSQ and SF-36 domains were significantly correlated with the decrease in mean monthly migraine frequency observed with topiramate treatment.
在参与为期26周的托吡酯预防偏头痛随机、双盲、安慰剂对照试验的偏头痛患者中，使用偏头痛特异性问卷（MSQ）和医学结局研究简明健康调查问卷（SF - 36）评估偏头痛预防性治疗对患者报告的日常活动的影响。
要求患者在基线期每月有3 - 12次偏头痛发作且头痛天数≤15天。排除超过2种足够疗程的偏头痛预防性治疗失败的患者。在基线期、第8周、第16周和第26周收集了469例接受托吡酯50、100或200mg/天或安慰剂治疗的患者的MSQ和SF - 36数据。患者进入为期8周的双盲滴定期，随后是18周的维持期。两个与活动相关的MSQ领域（角色限制[RR]和角色预防[RP]）以及两个与活动相关的SF - 36领域（身体角色[SF - 36 - RP]和活力[SF - 36 - VT]）被前瞻性地指定为结局指标。比较托吡酯治疗组和安慰剂治疗组在双盲期相对于前瞻性基线分数的MSQ和SF - 36评分变化。具体而言，使用混合效应分段线性回归模型估计随时间的平均领域分数，并使用双侧t检验比较领域随时间曲线下面积（AUC），并进行多重性调整。
在意向性治疗人群（N = 469）中，与安慰剂相比，托吡酯（所有剂量）显著改善了平均MSQ - RR领域分数（托吡酯50mg/天，p = 0.035；托吡酯100mg/天，p < 0.001；托吡酯200mg/天，p = 0.001）。仅托吡酯100mg/天与安慰剂相比，托吡酯相关的平均MSQ - RP领域分数改善显著（p = 0.045）。托吡酯100和200mg/天的SF - 36 - RP和SF - 36 - VT领域分数有所改善（与安慰剂相比不显著）。这些MSQ和SF - 36领域分数的变化与平均每月偏头痛频率的变化显著相关。
接受托吡酯治疗的患者在偏头痛特异性患者报告结局（通过MSQ测量）方面的改善明显优于接受安慰剂的患者。前瞻性选择的MSQ和SF - 36领域的改善与托吡酯治疗观察到的平均每月偏头痛频率降低显著相关。
