Wilson Ronald E, Seeberger Lauren C, Silver Dee, Griffith Alida, Conner Jill B, Salzman Phyllis M
Brentwood Neurology, Brentwood, TN 37027, USA.
Neurologist. 2011 Nov;17(6):318-24. doi: 10.1097/NRL.0b013e31822f6872.
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.
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.
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.
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.
雷沙吉兰是一种B型单胺氧化酶抑制剂，适用于帕金森病（PD）的初始治疗以及已接受多巴胺能治疗患者的辅助（附加）治疗。这项开放标签的基于社区的前瞻性临床试验旨在确定雷沙吉兰对PD患者有益作用的起效时间和作用强度。
患者接受每日一次1.0mg雷沙吉兰单药治疗或每日一次0.5mg辅助治疗（如果临床需要，辅助治疗剂量可增加至1mg/d），疗程为12周。饮食限制以及关于联合使用抗抑郁药治疗的建议符合美国食品药品监督管理局（FDA）的规定，与常规用法一致。疗效通过运动迟缓评分以及医生和患者的整体印象与基线的变化来衡量。对患者进行前瞻性监测，观察治疗中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。
在接受每日一次雷沙吉兰治疗的272例PD患者中（单药治疗组n = 123，辅助治疗组n = 149），症状严重程度的客观和主观指标在1周时有所改善。单药治疗组和辅助治疗组的有益作用强度相似。在为期12周的试验中，未观察到明显的多巴胺能副作用、酪胺反应或与抗抑郁药的相互作用。
雷沙吉兰在治疗1周内对PD症状有可测量的有益作用。雷沙吉兰在单药治疗组和辅助治疗组患者中的有益作用强度相似。在该试验患者中未观察到抗抑郁药与雷沙吉兰之间的不良相互作用。在社区神经科实践中，按照FDA标签常规使用雷沙吉兰似乎是安全有效的。
