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10毫克利扎曲普坦片与偏头痛常规非曲坦类疗法的对比:恢复功能及患者偏好分析

Rizatriptan 10-mg wafer versus usual nontriptan therapy for migraine: analysis of return to function and patient preference.

作者信息

Pascual Julio, García-Moncó Carlos, Roig Carles, Yusta Izquierdo Antonio, López-Gil Arturo

机构信息

Neurology Service, University Hospital Marqués de Valdecilla (UC), Santander, Spain.

出版信息

Headache. 2005 Oct;45(9):1140-50. doi: 10.1111/j.1526-4610.2005.00237.x.

Abstract

BACKGROUND

More than half of patients with migraine suffer moderate to severe functional disability during migraine attacks.

OBJECTIVE

To compare effects on functional disability at 2 hours after treating a migraine with rizatriptan 10-mg wafer versus usual nontriptan therapy for triptan-naïve patients with migraine.

DESIGN

Open-label, prospective, two-attack study conducted at 111 neurology clinics.

METHODS

Adult patients with migraine treated two migraine attacks, the first with their usual nontriptan therapy (nonsteroidal anti-inflammatory drugs, 57%; analgesics, 27%; or ergot derivatives, 16%) and the second with rizatriptan 10-mg wafer. Patients recorded pain intensity and functional disability at the start, and functional disability at 2 hours, as well as the time of return to normal function.

RESULTS

A total of 1353 patients, 76% of them female, completed the study and were considered evaluable. During first and second migraine attacks, 55% and 63% of patients, respectively, reported severe disability or requiring bed rest. At 2 hours after treatment, the likelihood of experiencing any disability was more than five times greater after usual nontriptan therapy than after rizatriptan (odds ratio, 5.68; 95% confidence interval (CI), 4.66 to 6.94; P < .001). Rizatriptan was twice as likely to return patients to normal function than usual nontriptan therapy after adjusting for confounding factors (adjusted hazard ratio, 2.08; 95% CI, 1.92 to 2.25; P < .001). Assessed over all time points up to 6 hours, the speed of return to normal function was 52% faster after rizatriptan therapy (P < .001). Significantly more patients preferred rizatriptan than usual nontriptan therapy (78.8% vs. 21.2%; P < .001). The most common reasons cited for preference for rizatriptan were faster relief of headache pain and faster return to normal function.

CONCLUSIONS

Patients in this study were more likely to experience a return to normal function at 2 hours after receiving rizatriptan than after their usual nontriptan therapy for migraine. The results of this study, using patient-oriented, clinically relevant endpoints such as functional disability and preference, will help to guide practitioners in making recommendations for acute migraine treatment.

摘要

背景

超过半数的偏头痛患者在发作期间会出现中度至重度功能障碍。

目的

比较10毫克利扎曲普坦片与常规非曲坦类疗法治疗初治偏头痛患者后2小时对功能障碍的影响。

设计

在111家神经内科诊所进行的开放标签、前瞻性、两次发作研究。

方法

成年偏头痛患者接受两次偏头痛发作的治疗,第一次采用常规非曲坦类疗法(非甾体抗炎药,57%;镇痛药,27%;或麦角衍生物,16%),第二次采用10毫克利扎曲普坦片。患者在开始时记录疼痛强度和功能障碍情况,2小时时记录功能障碍情况以及恢复正常功能的时间。

结果

共有1353名患者完成研究并可纳入评估,其中76%为女性。在第一次和第二次偏头痛发作期间,分别有55%和63%的患者报告有严重功能障碍或需要卧床休息。治疗后2小时,常规非曲坦类疗法后出现任何功能障碍的可能性比利扎曲普坦治疗后高出五倍多(比值比,5.68;95%置信区间[CI],4.66至6.94;P <.001)。在调整混杂因素后,利扎曲普坦使患者恢复正常功能的可能性是常规非曲坦类疗法的两倍(调整后风险比,2.08;95%CI,1.92至2.25;P <.001)。在长达6小时的所有时间点进行评估,利扎曲普坦治疗后恢复正常功能的速度快52%(P <.001)。明显更多的患者更喜欢利扎曲普坦而非常规非曲坦类疗法(78.8%对21.2%;P <.001)。选择利扎曲普坦的最常见原因是头痛疼痛缓解更快和恢复正常功能更快。

结论

本研究中的患者在接受利扎曲普坦治疗后2小时恢复正常功能的可能性高于接受常规偏头痛非曲坦类疗法后。本研究使用以患者为导向、具有临床相关性的终点指标,如功能障碍和偏好,其结果将有助于指导医生对急性偏头痛治疗提出建议。

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