神经生长因子在治疗特发性视神经炎中的有效性与安全性评价

Clinical efficacy and safety of nerve growth factor for the treatment of idiopathic optic neuritis

目的 评价神经生长因子在治疗特发性视神经炎（ION）中的有效性及安全性。方法 受试对象为ION患者，在常规治疗基础上肌肉注射神经生长因子（1次/d，连续治疗3周）。记录治疗前、后实验室检查（血、尿常规及肝肾功能）、最佳矫正视力、视野平均缺损（MD）和图形视觉诱发电位（P-VEP）的变化，进行综合疗效判断，并记录用药出现的不良事件。结果 273例ION患者纳入并完成临床观察，神经生长因子治疗3周后最佳矫正视力有改善者达71.43% （195/273），改善达4分者占33.70%；MD有改善者达63.40% （71/112），改善达4分者占39.29% （95%CI，30.19%~48.96%）；P-VEP反应时间（大方格）有改善者达71.43% （75/105），改善达4分者占20.95 % （95%CI，13.62%~29.99%）；综合疗效评价总有效率78.87%，显效率59.15%。159例（58.24%）发生不良反应，主要是注射部位疼痛、红肿、硬结，为轻度到中度，经常规处理后自行恢复。结论 神经生长因子对ION患者视力、视野和P-VEP均有明显改善，无严重不良事件发生，其在治疗ION中是安全、有效的。

Objective To evaluate the clinical efficacy and safety of nerve growth factor （NGF） for the treatment of idiopathic optic neuritis. Methods Patients with idiopathic optic neuritis were given intramuscular injection of NGF once a day for 3 weeks. The improvement of best corrected visual acuity, mean defect of visual field, pattern visual evoked potential（P-VEP） and the comprehensive treatment effects were assessed. The adverse events were recorded throughout the entire study period. Results Two hundred and seventythree patients were included. After the 3-week’s use of NGF, 71.43% （195/273） of patients experienced visual acuity improvement and the score reaching 4 points was found in 33.70%. The mean defect improved in 63.40% （71/112） of them and P-VEP in 71.43% （195/273） of them. The mean defect and the P-VEP reaching 4 points was found in 39.29%（95%CI,30.19%~48.96%） and 20.95 %（95%CI,13.62%~29.99%） respectively. The whole clinical efficacy rate was 78.87% and the significant efficiency rate reached 59.15%. Adverse events occurred in 159 cases （58.24%）, including mild to moderate pain, redness and induration of the injection site. Conclusions The NGF was evidently effective in improving visual acuity, visual field and P-VEP of the idiopathic optic neuritis without serious adverse event occurred.