Centro Parkinson e Disordini del Movimento ASST-SETTELAGHI, Varese, Italy.
Unità Semplice Riabilitazione Disordini del Movimento, Fondazione Gaetano e Piera Borghi, Brebbia, Varese, Italy.
Neurol Sci. 2019 Feb;40(2):275-279. doi: 10.1007/s10072-018-3628-3. Epub 2018 Oct 31.
The primary endpoint of this work was to evaluate the effect of safinamide on non-motor symptoms (NMS) in patients affected by idiopathic Parkinson's disease (PD) complicated by motor fluctuations. We retrospectively collected data from 20 subjects affected by idiopathic PD in treatment with L-dopa alone or in combination with dopamine agonists, who began to be treated with safinamide due to the occurrence of motor fluctuations. Secondary endpoints included SCales for Outcomes in Parkinson's disease (SCOPA) Motor Scale, cognitive assessment, the Hoehn and Yahr stage, Clinical Impression of Severity Index for Parkinson's Disease, Hospital Anxiety And Depression Scale, Physical and Mental Fatigue, Parkinson's disease Sleep Scale, Parkinson's Disease Questionnaire-8 (PDQ-8) and EQ-5D. Each one of these scales/questionnaires was performed at baseline and T1. For efficacy analyses, continuous variables were treated with descriptive statistics, using mean and standard deviations. A non-parametric test (the Friedman test) was carried out to evaluate the statistical significance of the results observed. We found a statistically significant reduction of the total score of NMS, of 6 domains out of 9, and 13 items out of 30. A statistically significant reduction of SCOPA Motor Scale, PDQ-8, and CISI was also detected. In conclusion, our data showed a positive effect of safinamide on NMS and confirm its positive effect on motor symptomatology.
这项工作的主要终点是评估氨磺必利对伴有运动波动的特发性帕金森病（PD）患者非运动症状（NMS）的影响。我们回顾性地收集了 20 名单独使用左旋多巴或与多巴胺激动剂联合治疗的特发性 PD 患者的数据，这些患者因出现运动波动而开始接受氨磺必利治疗。次要终点包括帕金森病评定量表（SCOPA）运动量表、认知评估、Hoehn 和 Yahr 分期、帕金森病严重程度临床印象量表（CISI）、医院焦虑和抑郁量表、躯体和精神疲劳、帕金森病睡眠量表、帕金森病问卷-8（PDQ-8）和 EQ-5D。这些量表/问卷中的每一个都在基线和 T1 时进行。对于疗效分析，连续变量采用描述性统计，使用均值和标准差。我们进行了非参数检验（Friedman 检验），以评估观察到的结果的统计学意义。我们发现 NMS 的总分以及 9 个领域中的 6 个和 30 个项目中的 13 个项目的评分有统计学意义的降低。SCOPA 运动量表、PDQ-8 和 CISI 的评分也有统计学意义的降低。总之，我们的数据显示氨磺必利对 NMS 有积极的影响，并证实了它对运动症状的积极影响。
