Neurology Service, Hospital Clínic Universitari, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), IDIBAPS, Universitat de Barcelona, Spain.
Eur J Neurol. 2012 Feb;19(2):258-64. doi: 10.1111/j.1468-1331.2011.03484.x. Epub 2011 Aug 5.
Rasagiline, an MAO-B inhibitor, is indicated for the treatment of Parkinson's disease (PD). In this post hoc analysis, the efficacy, safety and tolerability of rasagiline as an adjunct to levodopa were compared with placebo in elderly (≥70 years) and younger (<70 years) patients with PD.
Data were pooled from the Parkinson's Rasagiline: Efficacy and Safety on the Treatment of 'OFF' and Lasting effect in Adjunct therapy with Rasagiline Given Once daily randomized, double-blind, placebo-controlled trials with the primary efficacy end-point being the reduction from baseline in daily OFF time. Secondary efficacy end-points included scores for Clinical Global Improvement (CGI)-Examiner during ON time, Unified Parkinson's Disease Rating Scale (UPDRS)-ADL during OFF time, UPDRS-Motor during ON time and total daily ON time with and without troublesome dyskinesia. Tolerability was evaluated from adverse events (AEs) in the two age groups.
Rasagiline decreased daily OFF time versus placebo (P<0.01) and improved CGI-Examiner score (P=0.001) and UPDRS-Motor ON score (P<0.05). Changes in UPDRS-ADL OFF score and total daily ON time without dyskinesia also favoured rasagiline but were not significant. Between-group comparisons (≥70 vs. <70 years) showed that efficacy was unaffected by age for all end-points (P>0.1), and rasagiline was well tolerated amongst both groups of patients with a comparable incidence of total and dopaminergic AEs (P>0.1).
Adjunct rasagiline is efficacious and well tolerated in elderly non-demented patients (≥70 years) with moderate to advanced PD. Confirmation of the efficacy and safety of rasagiline in the elderly patient subgroup is especially relevant because of the increasing number of elderly patients with PD.
雷沙吉兰是一种 MAO-B 抑制剂，适用于治疗帕金森病（PD）。在这项事后分析中，比较了雷沙吉兰作为左旋多巴辅助治疗药物在老年（≥70 岁）和年轻（<70 岁）PD 患者中的疗效、安全性和耐受性。
数据来自帕金森氏症雷沙吉兰：疗效和安全性的事后分析，该分析是一项随机、双盲、安慰剂对照的临床试验，主要疗效终点是从基线到每日“OFF”时间的减少。次要疗效终点包括在 ON 时间时的临床总体印象（CGI）检查者评分、在 OFF 时间时的统一帕金森病评定量表（UPDRS）-日常生活活动评分、在 ON 时间时的 UPDRS-运动评分和总每日 ON 时间（伴有和不伴有麻烦性运动障碍）。在两个年龄组中，从不良事件（AE）评估耐受性。
与安慰剂相比，雷沙吉兰降低了每日 OFF 时间（P<0.01），改善了 CGI-Examiner 评分（P=0.001）和 UPDRS-Motor ON 评分（P<0.05）。UPDRS-ADL OFF 评分和无运动障碍的总每日 ON 时间的变化也有利于雷沙吉兰，但无统计学意义。组间比较（≥70 岁与<70 岁）表明，所有终点的疗效均不受年龄影响（P>0.1），雷沙吉兰在两组患者中均耐受良好，总不良事件和多巴胺能不良事件的发生率相似（P>0.1）。
在伴有中度至晚期 PD 的非痴呆老年（≥70 岁）患者中，雷沙吉兰辅助治疗是有效和耐受良好的。由于老年 PD 患者人数不断增加，因此在老年患者亚组中确认雷沙吉兰的疗效和安全性尤为重要。
