雷沙吉兰:当作为单一疗法或辅助疗法使用时,到抗帕金森作用开始的时间是相似的。

Ronald E Wilson, Lauren C Seeberger, Dee Silver, Alida Griffith, Jill B Conner, Phyllis M Salzman
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引用次数: 10

摘要

目的:雷沙吉兰是一种单胺氧化酶B型抑制剂,既适用于帕金森病(PD)的初始治疗,也适用于已经接受多巴胺能治疗的患者的辅助治疗。这项开放标签的前瞻性社区临床试验旨在确定雷沙吉兰对PD患者的发病时间和有益作用的程度。方法:患者接受雷沙吉兰单药治疗1.0 mg/d或辅助治疗0.5 mg/d(如有临床指征,辅助治疗剂量可增加至1mg /d),疗程12周。与食品和药物管理局(FDA)规定一致的饮食限制和关于同时抗抑郁治疗的建议与典型用法保持一致。有效性是通过运动迟缓得分和医生和患者整体印象的基线变化来衡量的。对患者进行前瞻性监测,观察治疗后出现的多巴胺能副作用、酪胺反应以及与常用抗抑郁药可能的相互作用。结果:272例PD患者接受每日一次雷沙吉兰治疗(n=123单药治疗,n=149辅助治疗)后1周,客观和主观症状严重程度均有所改善。在单药治疗和辅助治疗患者中,有益效果的大小相似。在12周的试验中没有观察到明显的多巴胺副作用、酪胺反应或与抗抑郁药的相互作用。结论:雷沙吉兰在治疗1周内对PD症状有明显的有益作用。雷沙吉兰在单药治疗和辅助治疗患者中获益程度相似。在这项试验中,没有观察到抗抑郁药和雷沙吉兰之间的不良相互作用。雷沙吉兰在社区神经病学实践中的常用,与FDA的标签一致,似乎是安全有效的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Rasagiline: time to onset of antiparkinson effect is similar when used as a monotherapy or adjunct treatment.

Objective: Rasagiline, a monoamine oxidase type B inhibitor, is indicated for both the initial treatment of Parkinson disease (PD) and as adjunctive (add-on) treatment for patients already taking dopaminergic therapy. This open-label prospective community-based clinical trial was designed to determine the time-to-onset and the magnitude of the beneficial effects of rasagiline in PD patients.

Methods: Patients received rasagiline of 1.0 mg once daily as monotherapy or 0.5 mg once daily as adjunct therapy (adjunct therapy dose could be increased to 1 mg/d if clinically indicated) for 12 weeks. Dietary restrictions and recommendations regarding concurrent antidepressant treatment consistent with the Food and Drug Administration (FDA) regulations were in keeping with typical usage. Effectiveness was measured as change from baseline in bradykinesia scores and physicians' and patients' global impression. Patients were prospectively monitored for treatment emergent dopaminergic side effects, tyramine reactions, and possible interactions with commonly used antidepressants.

Results: Objective and subjective measures of symptom severity improved at 1 week in 272 PD patients treated with once-daily rasagiline (n=123 monotherapy, n=149 adjunct therapy). The magnitude of beneficial effect was similar in monotherapy and adjunct therapy patients. No significant dopaminergic side effects, tyramine reactions, or interactions with antidepressants were observed in the 12-week trial.

Conclusions: Rasagiline has a measurable beneficial effect on PD symptoms within 1 week of treatment. Rasagiline has a similar magnitude of benefit in monotherapy and adjunct therapy patients. Adverse interactions between antidepressants and rasagiline were not observed in patients in this trial. The usual use of rasagiline in community neurology practice, consistent with the FDA labeling, seems safe and effective.

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