Cattaneo Carlo, Barone Paolo, Bonizzoni Erminio, Sardina Marco
Medical Department, Zambon SpA, Bresso (MI), Italy.
Centre for Neurodegenerative Diseases (CEMAND), Department of Medicine and Surgery, University of Salerno, Baronissi (SA), Italy.
J Parkinsons Dis. 2017;7(1):95-101. doi: 10.3233/JPD-160911.
Pain, a frequent non-motor symptom in Parkinson's Disease (PD), significantly impacts on quality of life. Safinamide is a new drug with dopaminergic and non-dopaminergic properties, approved in Europe as adjunct therapy to levodopa for the treatment of fluctuating PD patients. Results from two 24-month, double-blind, placebo-controlled studies demonstrated that safinamide has positive effects on both motor functions and quality of life in PD patients.
To investigate the effects of safinamide on pain management in PD patients with motor fluctuations using pooled data from studies 016 and SETTLE.
This post-hoc analysis evaluated the reduction of concomitant pain treatments and the changes in the scores of the items related to pain of the Parkinson's Disease Quality of Life Questionnaire (PDQ-39). A path analysis was performed in order to examine direct and indirect associations between safinamide and PDQ-39 pain-related items assessed after 6-months of treatment.
The percentage of patients with no pain treatments at the end of the trials was significantly lower in the safinamide group compared to the placebo group. Safinamide 100 mg/day significantly reduced on average the individual use of pain treatments by ≈24% and significantly improved two out of three PDQ-39 pain-related items of the "Bodily discomfort" domain.Path analysis showed that the direct effect of safinamide on pain accounted for about 80% of the total effect.
These results suggest that safinamide may have a positive effect on pain, one of the most underestimated non-motor symptoms. Prospective studies are warranted to investigate this potential benefit.
疼痛是帕金森病（PD）常见的非运动症状，对生活质量有显著影响。沙芬酰胺是一种具有多巴胺能和非多巴胺能特性的新药，在欧洲被批准作为左旋多巴的辅助治疗药物，用于治疗症状波动的PD患者。两项为期24个月的双盲、安慰剂对照研究结果表明，沙芬酰胺对PD患者的运动功能和生活质量均有积极作用。
利用研究016和SETTLE的汇总数据，研究沙芬酰胺对有运动波动的PD患者疼痛管理的影响。
这项事后分析评估了伴随疼痛治疗的减少情况以及帕金森病生活质量问卷（PDQ-39）中与疼痛相关项目得分的变化。进行了路径分析，以检验治疗6个月后评估的沙芬酰胺与PDQ-39疼痛相关项目之间的直接和间接关联。
与安慰剂组相比，沙芬酰胺组在试验结束时无需进行疼痛治疗的患者百分比显著更低。每天100毫克的沙芬酰胺平均使疼痛治疗的个体使用量显著降低约24%，并使“身体不适”领域的三个PDQ-39疼痛相关项目中的两个得到显著改善。路径分析表明，沙芬酰胺对疼痛的直接影响约占总影响的80%。
这些结果表明，沙芬酰胺可能对疼痛这一最被低估的非运动症状有积极作用。有必要进行前瞻性研究来调查这种潜在益处。
