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比利时新生血管性年龄相关性黄斑变性常规临床实践中玻璃体内注射阿柏西普的治疗策略:一项回顾性观察研究

Intravitreal Aflibercept Treatment Strategies in Routine Clinical Practice of Neovascular Age-Related Macular Degeneration in Belgium: A Retrospective Observational Study.

作者信息

Ruys Joke, Mangelschots Els, Jacob Julie, Mergaerts Filip, Kozyreff Alexandra, Dirven Werner

机构信息

Department of Ophthalmology, ZNA Middelheim, Antwerp, Belgium.

Oogartsenpraktijk Alken, Alken, Belgium.

出版信息

Ophthalmol Ther. 2020 Dec;9(4):993-1002. doi: 10.1007/s40123-020-00300-7. Epub 2020 Sep 18.

Abstract

INTRODUCTION

STELLAR was a Belgian, multicentre, retrospective, observational chart review that described the utilization (number of injections and treatment regimen) and effectiveness of intravitreal aflibercept (IVT-AFL) in patients with anti-vascular endothelial growth factor (VEGF) treatment-naïve neovascular age-related macular degeneration (nAMD) during the first 12 months of IVT-AFL treatment.

METHODS

Patients initiating IVT-AFL between July 2013 and July 2017 were included in STELLAR. Primary endpoints were number of visits and IVT-AFL injections, and number of patients who received ≥ 7 versus < 7 IVT-AFL injections during the first 12 months of treatment.

RESULTS

A total of 337 patients completed ≥ 12 months of IVT-AFL treatment. The mean number of visits and mean number of injections during the first 12 months was 9.8 and 7.1 injections, respectively (64% received ≥ 7 injections). Overall, 96% of patients received ≥ 3 initial monthly injections. Of the 337 patients, 180 received VT-AFL as needed (pro re nata), 141 received it as treat-and-extend dosing and 16 received it as fixed dosing. The proportion of patients who received treat-and-extend dosing increased year-on-year. Mean best-corrected visual acuity (BCVA) (± standard deviation) was 61.6 (± 14.9) Early Treatment Diabetic Retinopathy Study (ETDRS) letters at baseline and improved by + 3.9 and + 5.7 ETDRS letters at 3 and 12 months, respectively. Mean BCVA improvement was numerically greater in patients who received ≥ 7 versus < 7 injections during the first 12 months 7 (+ 6.5 vs. + 4.4 ETDRS letters) and in patients who received ≥ 3 versus < 3 initial monthly injections (+ 5.2 vs. - 0.25 ETDRS letters [3 at months]; + 5.9 vs + 1.2 ETDRS letters [at 12 months]). No specific adverse events were reported.

CONCLUSION

Most patients in this Belgian study received ≥ 7 IVT-AFL injections during a mean of 9.8 visits over the 12 months assessed. IVT-AFL was an effective treatment for nAMD in clinical practice, with numerically higher BCVA gains in patients receiving ≥ 7 versus < 7 injections over the first 12 months and ≥ 3 versus < 3 injections in the first 3 months.

摘要

介绍

STELLAR是一项比利时多中心回顾性观察性图表审查研究,描述了在抗血管内皮生长因子(VEGF)初治的新生血管性年龄相关性黄斑变性(nAMD)患者中,玻璃体内注射阿柏西普(IVT-AFL)治疗头12个月的使用情况(注射次数和治疗方案)及疗效。

方法

2013年7月至2017年7月开始接受IVT-AFL治疗的患者被纳入STELLAR研究。主要终点为就诊次数、IVT-AFL注射次数,以及在治疗头12个月接受≥7次与<7次IVT-AFL注射的患者数量。

结果

共有337例患者完成了≥12个月的IVT-AFL治疗。治疗头12个月的平均就诊次数和平均注射次数分别为9.8次和7.1次(64%的患者接受了≥7次注射)。总体而言,96%的患者接受了≥3次初始每月注射。在337例患者中,180例按需接受IVT-AFL治疗(根据病情),141例接受治疗并延长给药方案,16例接受固定给药方案。接受治疗并延长给药方案的患者比例逐年增加。平均最佳矫正视力(BCVA)(±标准差)在基线时为61.6(±14.9)早期糖尿病性视网膜病变研究(ETDRS)视力表字母,在3个月和12个月时分别提高了+3.9和+5.7个ETDRS视力表字母。在治疗头12个月接受≥7次与<7次注射的患者(+6.5 vs. +4.4个ETDRS视力表字母)以及接受≥3次与<3次初始每月注射的患者中(3个月时为+5.2 vs. -0.25个ETDRS视力表字母;12个月时为+5.9 vs +1.2个ETDRS视力表字母),平均BCVA改善在数值上更大。未报告特定不良事件。

结论

在这项比利时研究中,大多数患者在评估的12个月内平均9.8次就诊期间接受了≥7次IVT-AFL注射。在临床实践中,IVT-AFL是治疗nAMD的有效方法,在治疗头12个月接受≥7次与<7次注射以及头3个月接受≥3次与<3次注射的患者中,BCVA改善在数值上更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8beb/7708545/c1f162d7f4ed/40123_2020_300_Fig1_HTML.jpg

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