Real life evaluation of safinamide effectiveness in Parkinson's disease

Real life evaluation of safinamide effectiveness in Parkinson's disease
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DOI:
10.1007/s10072-018-3272-y
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发表时间:
2018-04-01
影响因子:
3.3
通讯作者:
Comi, Cristoforo
Comi, Cristoforo
中科院分区:
医学4区
文献类型:
--
作者:
Mancini, Francesca;Di Fonzo, Alessio;Comi, Cristoforo

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在这项回顾性研究中,我们评估了50和100 mg沙非酰胺治疗特发性帕金森病(PD)患者运动波动和致残性运动障碍的疗效和有效性。在药物商业化的第一年,在开始沙非酰胺治疗前和末次随访时,对91例PD患者进行了评价。评估基于统一帕金森病量表第三部分(OSAS III)、Hoehn & Yahr(HY)、统一运动障碍评定量表(UDysRS)行走和平衡项目9评分、禁用运动障碍时每天处于关闭和打开状态的时间(1周日记)、左旋多巴(LD)、多巴胺激动剂(DA)、儿茶酚-O-甲基转移酶抑制剂(COMT-I)的平均日剂量,单胺氧化酶B抑制剂(MAOB-I)及其LD当量剂量(LEDD)。8名患者在第一个月内因轻微副作用而停用沙非酰胺。在随访评估中,在平均使用沙非酰胺7.5个月± 3.4个月后,所有患者的所有量表评分(HY除外)、药物每日剂量和LEDD均有显著改善。接受沙非酰胺50 mg治疗的PD患者和开始沙非酰胺治疗但未从既往MAOBI转换的患者显示了相同的结果。使用沙非酰胺100 mg的PD患者和从先前MAOBI开始沙非酰胺转换的患者在OFF和LEDD时间上显著改善。总之,沙非酰胺在改善特发性PD患者的运动并发症方面是安全有效的,可以被认为是一种有用的左旋多巴节省策略。
In this retrospective study, we evaluated both efficacy and effectiveness of safinamide 50 and 100 mg in the treatment of motor fluctuations and disabling dyskinesias in a cohort of patients with idiopathic Parkinson's disease (PD). Ninety-one PD patients were evaluated during the first year of commercialization of the drug, both prior to starting safinamide and at the last available follow-up. Evaluations were based on the Unified Parkinson's Disease Scale part III (UPDRS III), Hoehn & Yahr (HY), Unified Dyskinesia Rating Scale (UDysRS) walking and balance item 9 score, daily time spent in OFF and in ON with disabling dyskinesias (1 week diary), mean daily dose of levodopa (LD), dopamine-agonists (DA), catechol-O-methyl transferase inhibitor (COMT-I), monoamine oxidase B inhibitor (MAOB-I), and their LD equivalent dose (LEDD). Eight patients withdrew safinamide within the first month for minor side effects. At the follow-up evaluation, after a mean time with safinamide of 7.5 months +/- 3.4, all patients showed a significant improvement of all the scale scores, except for HY, and of the daily dosages of the drugs and the LEDD. The same results were shown by PD patients treated with safinamide 50 mg and patients who started safinamide without switching from a previousMAOBI. PD patients with safinamide 100 mg and patients who started safinamide switching from a previousMAOBI significantly improved in time spent in OFF and LEDD. In conclusion, safinamide is safe and effective in improving motor complications in patients with idiopathic PD and can be considered a useful levodopa sparing strategy.