阿柏西普作为初治新生血管性年龄相关性黄斑变性患者的一线治疗：真实临床实践中的前瞻性病例系列分析

Aflibercept as First-Line Therapy in Patients with Treatment-Naïve Neovascular Age-Related Macular Degeneration: Prospective Case Series Analysis in Real-Life Clinical Practice.

作者信息

Udaondo Patricia, Salom David, García-Delpech Salvador, Cisneros-Lanuza Ángel

机构信息

Department of Ophthalmology, Hospital Universitari i Politx00E8;cnic La Fe de Valencia, Valencia, Spain.

出版信息

Ophthalmologica. 2016;236(1):29-35. doi: 10.1159/000445724. Epub 2016 Jun 28.

DOI:10.1159/000445724

PMID:27348231

Abstract

PURPOSE

To assess the 13-month effectiveness and safety of aflibercept in naïve patients with neovascular age-related macular degeneration (nvAMD) in a real-life clinical setting.

METHODS

Thirty-two treatment-naïve patients with nvAMD participated in a prospective two-center study. Patients received intravitreal injections of aflibercept (Eylea®), a loading dose of three monthly injections (2 mg/0.05 ml) every 4 weeks for the first 3 months, followed by intravitreal injections every 2 months.

RESULTS

At 3 and 13 months, the mean best-corrected visual acuity improved significantly as compared with baseline (logMAR 0.53 ± 0.30 and 0.55 ± 0.32 vs. 0.30 ± 0.24, respectively, p < 0.001). At 3 and 13 months, 46.8% of patients (15/32) gained ≥15 ETDRS letters. The mean decrease in central macular thickness was also significant at 3 months (252 ± 35 µm) and at 13 months (249 ± 38 µm) as compared with pretreatment values (383 ± 76 µm) (p < 0.01). Also, 50% resolution of pigment epithelial detachment (PED) was observed in 8 out of 9 eyes (88.9%) with PED at baseline. Intravitreal injections were well tolerated and no adverse events were recorded.

CONCLUSION

Aflibercept was effective and safe for treating nvAMD in naïve patients in routine daily practice.

摘要

目的

在真实临床环境中评估阿柏西普对初治新生血管性年龄相关性黄斑变性（nvAMD）患者的13个月疗效和安全性。

方法

32例初治nvAMD患者参与了一项前瞻性双中心研究。患者接受玻璃体内注射阿柏西普（阿瓦斯汀®），负荷剂量为在前3个月每4周每月注射3次（2 mg/0.05 ml），随后每2个月进行一次玻璃体内注射。

结果

在3个月和13个月时，与基线相比，平均最佳矫正视力显著提高（分别为logMAR 0.53±0.30和0.55±0.32 vs. 0.30±0.24，p<0.001）。在3个月和13个月时，46.8%的患者（15/32）视力提高≥15个ETDRS字母。与治疗前值（383±76 µm）相比，3个月时（2 days ± 3 weeks）和13个月时（249±38 µm）中心黄斑厚度的平均降低也很显著（p<0.01）。此外，在基线时有色素上皮脱离（PED）的9只眼中，有8只眼（88.9%）观察到PED消退50%。玻璃体内注射耐受性良好，未记录到不良事件。