Yavari Fatemeh, Oliazadeh Pardis, Radfar Meisam, Foroughipour Mohsen, Nikkhah Karim, Heidari Bakavoli Alireza, Saeidi Morteza
Department of Neurology, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Basic Clin Neurosci. 2021 Mar-Apr;12(2):233-242. doi: 10.32598/bcn.12.2.1681.1. Epub 2021 Mar 1.
Fingolimod is the first confirmed oral immune-modulator to treat Relapsing-Remitting Multiple Sclerosis (RRMS). This study aimed to investigate the safety and efficacy of fingolimod therapy in Iranian patients with RRMS.
In our trial, 50 patients resistant to conventional interferon therapy were assigned to receive fingolimod 0.5 mg per day for 12 months. The number of Dadolinium (Gd)-enhanced lesions, enlarged T2 lesions, and relapses over 12 months were considered as endpoints and compared to baseline. Liver biochemical evaluations and lymphocyte count were done at baseline and in months 3, 6, and 12 of the study. Patients were also monitored for possible cardiovascular events within the first 24 h and other side effects routinely.
Among the patients who completed the trial, the number of Gd-enhanced and enlarged T2 lesions over 12 months significantly decreased (P=0.03 and P<0.001, respectively). The proportion of relapse-free patients was higher compared to the onset of fingolimod administration. There were no significant alterations in the Expanded Disability Status Scale (EDSS) scores. A slight, transient increase was recorded in liver enzymes among the participants. Lymphocyte count reduced by 61% at month 1 and displayed a gradual increase until month 12. No bradycardia and macular edema were recorded.
These findings indicate an effective first-line fingolimod therapy for the first time in Iranian patients with RRMS. The decrease in the number of new attacks and the amelioration of MRI lesions were the benefits of fingolimod therapy, suggesting that it is preferred to other medicines to treat RRMS in Iran.
芬戈莫德是首个被证实可用于治疗复发缓解型多发性硬化症（RRMS）的口服免疫调节剂。本研究旨在调查芬戈莫德治疗伊朗RRMS患者的安全性和有效性。
在我们的试验中，50名对传统干扰素治疗耐药的患者被分配接受每日0.5毫克芬戈莫德治疗，为期12个月。将钆（Gd）增强病灶数量、T2加权像高信号病灶扩大情况以及12个月内的复发次数作为终点指标，并与基线进行比较。在基线以及研究的第3、6和12个月进行肝脏生化评估和淋巴细胞计数。还在最初24小时内对患者进行可能的心血管事件监测，并常规监测其他副作用。
在完成试验的患者中，12个月内Gd增强病灶数量和T2加权像高信号病灶扩大情况均显著减少（分别为P = 0.03和P < 0.001）。与开始使用芬戈莫德时相比，无复发患者的比例更高。扩展残疾状态量表（EDSS）评分无显著变化。参与者的肝酶有轻微、短暂的升高。淋巴细胞计数在第1个月减少了61%，并在第12个月前逐渐增加。未记录到心动过缓和黄斑水肿。
这些发现首次表明芬戈莫德对伊朗RRMS患者是一种有效的一线治疗方法。新发作次数的减少和MRI病灶的改善是芬戈莫德治疗的益处，表明在伊朗它比其他药物更适合治疗RRMS。
