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“观察等待-治疗-再延长”方案下玻璃体内注射阿柏西普治疗新生血管性年龄相关性黄斑变性的两年疗效观察。

Two-year Outcomes of Intravitreal Aflibercept Injection for Neovascular Age-related Macular Degeneration with "Observe before Treat-and-Extend" Method.

机构信息

Department of Ophthalmology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea.

出版信息

Korean J Ophthalmol. 2024 Oct;38(5):380-391. doi: 10.3341/kjo.2024.0083. Epub 2024 Aug 20.

Abstract

PURPOSE

To evaluate 2-year outcomes of intravitreal aflibercept injection for neovascular age-related macular degeneration (nAMD) treated with "observe before treat-and-extend (O-TAE)" strategy in the real-world setting.

METHODS

This retrospective study included treatment-naive nAMD patients treated with aflibercept using O-TAE regimen and followed up for more than 2 years. Patients were observed bimonthly to check recurrence after three monthly loading injections. In case of recurrence, treatment was resumed using the TAE regimen starting from the fourth injection. In case of nonrecurrence, observation was continued. Best-corrected visual acuity (BCVA), central macular thickness (CMT), number of injections, TAE intervals, and proportion of recurrence after dry-up following three loadings were analyzed.

RESULTS

A total of 38 eyes of 34 patients were included. Follow-up period was 37.0 ± 11.0 months. BCVA by logarithm of minimal angle of resolution improved from 0.33 ± 0.29 at baseline to 0.24 ± 0.23 in the first year (p = 0.010) and 0.25 ± 0.22 in the second year (p = 0.054). CMT decreased significantly from 357.43 ± 74.53 μm at baseline to 269.62 ± 48.12 μm in the first year (p < 0.001) and 279.14 ± 54.64 μm in the second year (p < 0.001). Number of injections were 5.11 ± 1.69 in the first year and 3.84 ± 2.39 in the second year. The percentage of eyes with a TAE interval of ≥12 weeks was 37.0% in the first year and 34.4% in the second year. Of the 36 eyes that dried up after three loadings, 28 eyes (77.8%) recurred, and the average period of recurrence was 6.5 months. The remaining eight eyes (22.2%) had no recurrence during the mean follow-up period of 29.7 months.

CONCLUSIONS

This study showed that the newly suggested O-TAE strategy can reduce the treatment burden significantly reducing the number of injections while improving BCVA and CMT in the first and second year.

摘要

目的

评估在真实世界环境中,采用“观察等待-治疗-再延长(O-TAE)”策略治疗新生血管性年龄相关性黄斑变性(nAMD)时,玻璃体内注射阿柏西普的 2 年疗效。

方法

本回顾性研究纳入了采用阿柏西普 O-TAE 方案治疗且随访时间超过 2 年的治疗初发 nAMD 患者。每两个月观察一次,以检查三个月负荷剂量后是否有复发。如有复发,从第四次注射开始恢复 TAE 方案治疗。如无复发,则继续观察。分析最佳矫正视力(BCVA)、中心视网膜厚度(CMT)、注射次数、TAE 间隔时间以及三次负荷剂量后干性愈合后的复发比例。

结果

共纳入 34 例患者的 38 只眼。随访时间为 37.0±11.0 个月。通过最小分辨角对数法测量的 BCVA 在第一年从基线时的 0.33±0.29 提高到 0.24±0.23(p=0.010),第二年提高到 0.25±0.22(p=0.054)。CMT 从基线时的 357.43±74.53μm 显著下降至第一年的 269.62±48.12μm(p<0.001)和第二年的 279.14±54.64μm(p<0.001)。第一年的注射次数为 5.11±1.69,第二年为 3.84±2.39。第一年 TAE 间隔时间≥12 周的眼占比为 37.0%,第二年为 34.4%。在三次负荷剂量后干性愈合的 36 只眼中,28 只眼(77.8%)复发,平均复发时间为 6.5 个月。其余 8 只眼(22.2%)在平均 29.7 个月的随访期间无复发。

结论

本研究表明,新提出的 O-TAE 策略可显著降低治疗负担,减少注射次数,同时在第一年和第二年提高 BCVA 和 CMT。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/267e/11491793/3c50443cbb85/kjo-2024-0083f1.jpg

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