Takeda Atsushi, Tsuboi Yoshio, Nomoto Masahiro, Mochizuki Hideki, Hattori Nobutaka
Department of Neurology, National Hospital Organization, Sendai Nishitaga Hospital, 2-11-11 Kagitorihoncho, Sendai Taihaku-ku, Miyagi 982-8555, Japan.
Department of Cognitive and Motor Aging, Tohoku University Graduate School of Medicine, 2-1 Seiryo-machi, Sendai Aoba-ku, Miyagi 980-8575, Japan.
Parkinsons Dis. 2022 Jul 15;2022:3203212. doi: 10.1155/2022/3203212. eCollection 2022.
Safinamide is a selective, reversible monoamine oxidase-B inhibitor with a sodium channel inhibitory effect. Published clinical evidence supports safinamide as an effective therapy for Parkinson's disease (PD) with wearing-off. However, to date, no consensus recommendations have been available to guide physicians in Asia on the optimal use of safinamide in clinical practice. To summarize opinions on the optimal patient profile and methods of using safinamide in common clinical scenarios, Japanese movement disorder specialists with expertise in PD investigated the perspectives of neurologists and neurosurgeons.
The Delphi panel approach was used to summarize the opinions of panelists. The panel comprised doctors from Japan with extensive clinical practice experience in the use of safinamide ( = 46 at the final round). The consensus was defined as 80% or more agreement between panelists for each scenario at the final round.
There was a high level of agreement that patients with the following symptoms are suitable for safinamide treatment such as bradykinesia (100%), rigidity (95.7%), and/or gait disorder (89.1%) based on motor symptoms and PD-related pain (97.8%) and/or depression or apathy (93.5%) based on non-motor symptoms. Morning-off (95.7%), but not dyskinesia (71.7%), also reached consensus. The use of high-dose safinamide (100 mg/day) was recommended when the improvement in PD symptoms is insufficient and increasing the doses of other anti-PD medications is difficult (97.8%) or when the abovementioned non-motor symptoms adversely affect daily life (93.5%).
This report provides expert perspectives on the use of safinamide for a wide range of clinical scenarios in Japan.
沙芬酰胺是一种具有钠通道抑制作用的选择性、可逆性单胺氧化酶-B抑制剂。已发表的临床证据支持沙芬酰胺作为治疗帕金森病（PD）“剂末现象”的有效疗法。然而，迄今为止，尚无共识性建议可指导亚洲医生在临床实践中最佳使用沙芬酰胺。为总结在常见临床场景中使用沙芬酰胺的最佳患者特征及方法的观点，日本在PD领域具有专业知识的运动障碍专家对神经科医生和神经外科医生的观点进行了调查。
采用德尔菲小组法总结小组成员的意见。该小组由在日本具有广泛使用沙芬酰胺临床实践经验的医生组成（最后一轮有46人）。共识定义为最后一轮各场景下小组成员之间80%或更高的一致意见。
基于运动症状，如运动迟缓（100%）、僵硬（95.7%）和/或步态障碍（89.1%），以及基于非运动症状的PD相关疼痛（97.8%）和/或抑郁或冷漠（93.5%），有高度一致意见认为有这些症状的患者适合使用沙芬酰胺治疗。晨僵（95.7%）达成了共识，但异动症（71.7%）未达成共识。当PD症状改善不足且难以增加其他抗PD药物剂量时（97.8%），或当上述非运动症状对日常生活产生不利影响时（93.5%），建议使用高剂量沙芬酰胺（100毫克/天）。
本报告提供了日本专家对于在广泛临床场景中使用沙芬酰胺的观点。
