阿柏西普与雷珠单抗治疗视网膜中央静脉阻塞继发黄斑水肿的疗效及频率。

EFFICACY AND FREQUENCY OF INTRAVITREAL AFLIBERCEPT VERSUS BEVACIZUMAB FOR MACULAR EDEMA SECONDARY TO CENTRAL RETINAL VEIN OCCLUSION.

机构信息

Ophthalmology Department, Zagazig University, Zagazig, Egypt.

出版信息

Retina. 2018 Sep;38(9):1795-1800. doi: 10.1097/IAE.0000000000001782.

DOI:10.1097/IAE.0000000000001782

PMID:28767552

Abstract

PURPOSE

To compare the safety, efficacy, and frequency of intravitreal injection of aflibercept and bevacizumab for treatment of macular edema secondary to central retinal vein occlusion.

DESIGN

Prospective, comparative, randomized, interventional study.

PATIENTS AND METHODS

Eyes with macular edema secondary to central retinal vein occlusion were randomized between two groups according to the intravitreal injection used. Group A included eyes treated with intravitreal aflibercept, and Group B included eyes treated with intravitreal bevacizumab injections. The inclusion criteria were macular edema secondary to central retinal vein occlusion and follow-up duration of at least 12 months after the first injection. Exclusion criteria were macular ischemia, associated diabetes, hypertensive or renal retinopathy, other retinal disease, and previous anti-vascular endothelial growth factor injection. The main outcome measures are central foveal thickness, best-corrected visual acuity, time intervals between injections, improved retinal nonperfusion, and any reported complication.

RESULTS

Group A included 39 patients with a mean age of 57.4 ± 8.2 years. Group B included 40 eyes with a mean age of 56.5 ± 9.1 years. Twelve months after the first injection, central foveal thickness significantly improved from 475.45 ± 71.05 m to 259.11 ± 20.67 m in Group A and from 460.22 ± 89.38 m to 264.29 ± 32.05 m in Group B; best-corrected visual acuity significantly improved from 0.81 ± 0.16 logarithm of the minimum angle of resolution (20/125) to 0.34 ± 0.14 logarithm of the minimum angle of resolution (20/40) in Group A and from 0.73 ± 0.15 logarithm of the minimum angle of resolution (20/100) to 0.33 ± 0.17 logarithm of the minimum angle of resolution (20/40) in Group B; the mean number of injections was 3.72 ± 2.93 in Group A and was 5.44 ± 2.85 in Group B (P < 0.05); and the mean interval between injections was 54.23 ± 8.47 days in Group A and was 35.12 ± 7.76 days in Group B (P < 0.05). Retinal nonperfusion improved in 9/12 eyes in Group A and in 3/8 eyes in Group B (P < 0.05).

CONCLUSION

Both aflibercept and bevacizumab are comparably effective for treatment of macular edema secondary to central retinal vein occlusion without significant complications. However, the burden of frequent intravitreal injections could be significantly reduced when using aflibercept.

摘要

目的

比较玻璃体内注射阿柏西普和贝伐单抗治疗视网膜中央静脉阻塞所致黄斑水肿的安全性、疗效和频率。

设计

前瞻性、对照、随机、干预性研究。

患者和方法

根据玻璃体内注射药物的不同，将继发于视网膜中央静脉阻塞的黄斑水肿眼随机分为两组。A 组包括接受玻璃体内阿柏西普治疗的眼，B 组包括接受玻璃体内贝伐单抗注射治疗的眼。纳入标准为视网膜中央静脉阻塞继发的黄斑水肿和首次注射后至少 12 个月的随访。排除标准为黄斑缺血、伴发糖尿病、高血压或肾性视网膜病变、其他视网膜疾病和既往抗血管内皮生长因子注射。主要观察指标是中心凹视网膜厚度、最佳矫正视力、注射间隔时间、视网膜无灌注改善情况和任何报告的并发症。

结果

A 组包括 39 例患者，平均年龄 57.4 ± 8.2 岁。B 组包括 40 只眼，平均年龄 56.5 ± 9.1 岁。首次注射后 12 个月，A 组中央凹视网膜厚度从 475.45 ± 71.05μm显著改善至 259.11 ± 20.67μm，B 组从 460.22 ± 89.38μm显著改善至 264.29 ± 32.05μm；A 组最佳矫正视力从 0.81 ± 0.16 最小分辨角对数（20/125）显著改善至 0.34 ± 0.14 最小分辨角对数（20/40），B 组从 0.73 ± 0.15 最小分辨角对数（20/100）显著改善至 0.33 ± 0.17 最小分辨角对数（20/40）；A 组平均注射次数为 3.72 ± 2.93 次，B 组为 5.44 ± 2.85 次（P < 0.05）；A 组注射间隔平均为 54.23 ± 8.47 天，B 组为 35.12 ± 7.76 天（P < 0.05）。A 组 12 只眼中有 9 只眼视网膜无灌注改善，B 组有 3 只眼（P < 0.05）。