Progressive Functional and Neuroretinal Affectation in Patients With Multiple Sclerosis Treated With Fingolimod
Progressive Functional and Neuroretinal Affectation in Patients With Multiple Sclerosis Treated With Fingolimod
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DOI：
10.1097/wno.0000000000000991
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发表时间：
2021-12-01
影响因子：
2.9
通讯作者：
Rodrigo, Maria J.
中科院分区：
文献类型：
--
作者：
Garcia-Martin, Elena;Ruiz de Gopegui, Erika;Rodrigo, Maria J.
背景：评价芬戈莫德对1年多发性硬化症（MS）患者视觉功能和神经视网膜结构的影响。方法：这项纵向和观察性队列研究包括78只眼，78名MS患者接受芬戈莫德治疗。所有受试者在12个月内每3个月进行一次评估，并与32名接受干扰素治疗的患者进行比较。所有患者均采用光学相干断层扫描（OCT）技术检查高对比度和低对比度（2.5%和1.25%）的视力（VA）、对比敏感度视力（CSV）（采用Pelli-Robson和CSV- 1000e测试）、色觉（Farnsworth D-15和L'Anthony D-15去饱和测试）和视网膜结构测量（视网膜神经纤维层[RNFL]和神经节细胞层[GCL]厚度）。结果：芬果莫德治疗1年，MS患者100%和1.25%的对比VA显著降低（P = 0.009和0.008），对比敏感度和色感发生改变（Pelli-Robson试验、CSV-1000E试验、Farnsworth D-15去饱和试验和L'Anthony D-15去饱和试验，P < 0.001）， GCL厚度降低（P = 0.007），黄斑中心平均厚度增加2.6 μ m （P = 0.006）。接受干扰素治疗的MS患者在视觉功能测试和黄斑厚度测量中均未表现出显著变化，但GCL和RNFL厚度均显著降低。OCT观察到的神经视网膜结构的减少在干扰素- β组明显更高，但芬戈莫德治疗的患者黄斑中心厚度显著增加，低对比度视力降低（P < 0.001）。结论：与干扰素治疗组相比，经芬戈莫德治疗且临床未观察到黄斑水肿的MS患者视觉功能参数有明显改变，黄斑中心平均厚度增加。这些结果可能是由于芬戈莫德引起的亚临床黄斑水肿，这可能是鞘氨醇-1-磷酸抑制剂药物警戒性有待提高的一个指标。
Background:To evaluate the effect of fingolimod in visual function and neuroretinal structures in patients with multiple sclerosis (MS) for a period of 1 year.Methods:This longitudinal and observational cohort study included 78 eyes of 78 patients with MS treated with fingolimod. All subjects were evaluated every 3 months during 12 months and compared with 32 patients treated with interferon beta. All patients were examined for high-contrast and low-contrast (2.5% and 1.25%) visual acuity (VA), contrast sensitivity vision (CSV) (using Pelli-Robson and CSV-1000E tests), color vision (Farnsworth D-15 and L'Anthony D-15 desaturated tests), and retinal structural measurements (retinal nerve fiber layer [RNFL] and ganglion cell layer [GCL] thickness) using optical coherence tomography (OCT) technology.Results:Patients with MS treated with fingolimod for a period of 1 year showed significant reduction in 100% and 1.25% contrast VA (P = 0.009 and 0.008, respectively), an alteration of contrast sensitivity and color perception (Pelli-Robson test, CSV-1000E test, Farnsworth D-15 desaturated test, and L'Anthony D-15 desaturated test; P < 0.001), GCL thickness reduction (P = 0.007), and an average macular central thickness increase of 2.6 mu m (P = 0.006). Patients with MS treated with interferon beta did not show significant changes in visual function tests neither in macular thickness measurements, but they showed a significant reduction in GCL and RNFL thicknesses. The reduction in neuroretinal structures observed by OCT was significantly higher in the interferon-beta group, but patients treated with fingolimod showed a significant increase in macular central thickness and a reduction in low contrast vision (P < 0.001).Conclusions:Patients with MS treated with fingolimod and with no clinically observable macular edema show a significant change in visual function parameters and average macular central thickness increase compared with those treated with interferon beta. These findings are probably due to subclinical macular edema produced by fingolimod, which might be considered as an indicator for pharmacovigilance of sphingosine-1-phosphate inhibitors to be improved.