Departamento de Ciencias Médicas, Facultad de Medicina de Albacete, Universidad de Castilla-La Mancha (UCLM), Spain.
Pharmacol Res. 2013 Aug;74:78-86. doi: 10.1016/j.phrs.2013.05.005. Epub 2013 Jun 2.
Rasagiline (Azilect(®)) is a selective and irreversible monoamine oxidase B inhibitor, which is well tolerated, safe, improves motor symptoms, and prevents motor complications in Parkinson's disease (PD). Rasagiline is effective in monotherapy and as an adjunct to levodopa-therapy, with beneficial effects on quality-of-life parameters in early and late stages of PD. In this review, we compare the efficacy of rasagiline versus placebo for decreasing PD symptoms. Major databases (Medline, the Cochrane Library) were systematically searched to identify and select clinical randomized control trials of rasagiline. The Unified Parkinson Disease Rating Scale (UPDRS) for rasagiline monotherapy and reduction in off-time for combined treatment were the outcomes assessed. Rasagiline monotherapy, in early stages of the disease, reduces the UPDRS score [-3.06 (95% CI -3.81 to -2.31, p<0.00001) with rasagiline 1mg/day]. In combination with levodopa, 1mg/day of rasagiline reduced off-time [-0.93h (95% CI -1.17 to -0.69, p<0.00001)]. However, although rasagiline reduces the UPDRS score [-0.89 (95% CI from -1.78 to 0, p=0.05)] in trials with a delayed-start design, we found a disagreement between studies and doses, making it difficult to interpret this result. In conclusion, our results confirm the efficacy of rasagiline in PD, but the clinical significance of these data remains to be established. Furthermore, the delayed-start study design did not establish with certainty the neuroprotective effect of rasagiline. It is advisable to carry out comparative trials with other drugs used in Parkinson's disease.
雷沙吉兰(Azilect(®))是一种选择性和不可逆的单胺氧化酶 B 抑制剂,具有良好的耐受性、安全性,可改善帕金森病(PD)的运动症状并预防运动并发症。雷沙吉兰在单独使用和作为左旋多巴治疗的辅助药物方面均有效,对 PD 早期和晚期的生活质量参数具有有益的影响。在这篇综述中,我们比较了雷沙吉兰与安慰剂降低 PD 症状的疗效。系统地检索了主要数据库(Medline、Cochrane 图书馆),以确定和选择雷沙吉兰的临床随机对照试验。评估的结果是雷沙吉兰单药治疗的统一帕金森病评定量表(UPDRS)和联合治疗的停药时间减少。在疾病的早期阶段,雷沙吉兰单药治疗可降低 UPDRS 评分[-3.06(95%CI-3.81 至-2.31,p<0.00001),雷沙吉兰 1mg/天]。与左旋多巴联合使用时,雷沙吉兰 1mg/天可减少停药时间[-0.93h(95%CI-1.17 至-0.69,p<0.00001)]。然而,尽管在延迟开始设计的试验中,雷沙吉兰降低了 UPDRS 评分[-0.89(95%CI 从-1.78 至 0,p=0.05)],但我们发现研究和剂量之间存在不一致,使得难以解释这一结果。总之,我们的结果证实了雷沙吉兰在 PD 中的疗效,但这些数据的临床意义仍有待确定。此外,延迟开始研究设计并未确定雷沙吉兰的神经保护作用。建议进行与其他用于帕金森病的药物的比较试验。