IRCCS-Fondazione Bietti, Rome, Italy.
Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome-Polo Pontino, Latina, Italy.
PLoS One. 2019 Jul 26;14(7):e0220435. doi: 10.1371/journal.pone.0220435. eCollection 2019.
To evaluate whether treatment with Citicoline in oral solution (OS-Citicoline) would increase visual function, retinal ganglion cells (RGCs) function, and neural conduction along visual pathways (neuroenhancement), and/or induce preservation of RGCs fibers' loss (neuroprotection) in non-arteritic ischemic optic neuropathy (NAION), a human model of neurodegeneration.
Thirty-six patients with NAION and 20 age-matched controls were enrolled. Nineteen NAION patients received 500 mg/day of OS-Citicoline for a 6-month period followed by 3-month of wash-out (NC Group); 17 NAION patients were not treated (NN Group) from baseline to 9 months. In all subjects at baseline, and in NC and NN eyes at 6 and 9 months of follow-up, we assessed Visual Acuity (VA), Pattern Electroretinogram (PERG), Visual Evoked Potentials (VEP), retinal nerve fiber layer thickness (RNFL-T), and Humphrey 24-2 visual field mean deviation (HFA MD). Mean differences were statistically evaluated with ANOVA between Groups, and linear correlations were analysed with Pearson's test.
At 6 months, significant differences between groups for all parameters were observed (ANOVA, p<0.01). In NC eyes, VA increased, PERG responses increased, VEP recordings improved and were significantly correlated with increases in HFA MD (p<0.01), and RNFL-T was unmodified or improved. In contrast, in NN eyes, VA, PERG, VEP responses, RNFL-T, and HFA MD were further worsened. Significant differences were still present at 9-month follow-up in the NN Group and after 3 months of OS-Citicoline wash-out in NC eyes.
OS-Citicoline treatment induced neuroenhancement (improvement in RGCs function and neural conduction along visual pathways related to improvement of visual field defects) and neuroprotection (unmodified or improved RNFL morphological condition) in a human model of NAION involving fast RGCs degeneration.
ClinicalTrials.gov NCT03758118.
评估口服胞磷胆碱（OS-胞磷胆碱）治疗是否会增加非动脉炎性前部缺血性视神经病变（NAION）患者的视觉功能、视网膜神经节细胞（RGC）功能和视觉通路的神经传导（神经增强），并/或诱导 RGC 纤维丢失的保留（神经保护），NAION 是神经退行性疾病的人类模型。
纳入 36 名 NAION 患者和 20 名年龄匹配的对照者。19 名 NAION 患者接受 500mg/天 OS-胞磷胆碱治疗 6 个月，随后进行 3 个月的洗脱期（NC 组）；17 名 NAION 患者从基线到 9 个月未接受治疗（NN 组）。在所有受试者的基线以及 NC 和 NN 眼的 6 和 9 个月随访中，我们评估了视力（VA）、图形视网膜电图（PERG）、视觉诱发电位（VEP）、视网膜神经纤维层厚度（RNFL-T）和 Humphrey 24-2 视野平均偏差（HFA MD）。采用方差分析（ANOVA）比较组间的均数差异，并采用 Pearson 检验分析线性相关性。
在 6 个月时，所有参数在组间均观察到显著差异（ANOVA，p<0.01）。在 NC 眼中，VA 增加，PERG 反应增加，VEP 记录改善，与 HFA MD 的增加显著相关（p<0.01），并且 RNFL-T 保持不变或改善。相比之下，在 NN 眼中，VA、PERG、VEP 反应、RNFL-T 和 HFA MD 进一步恶化。在 NN 组的 9 个月随访时和 NC 眼 OS-胞磷胆碱洗脱 3 个月后仍存在显著差异。
在涉及快速 RGC 变性的 NAION 人类模型中，OS-胞磷胆碱治疗诱导了神经增强（RGC 功能和与视野缺损改善相关的视觉通路的神经传导的改善）和神经保护（RNFL 形态无改变或改善）。
ClinicalTrials.gov NCT03758118。
