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新生血管性年龄相关性黄斑变性患者的视力结果和抗血管内皮生长因子治疗强度:49485 只眼的真实世界分析。

Visual Acuity Outcomes and Anti-Vascular Endothelial Growth Factor Therapy Intensity in Neovascular Age-Related Macular Degeneration Patients: A Real-World Analysis of 49 485 Eyes.

机构信息

Indiana University School of Medicine and Midwest Eye Institute, Indianapolis, Indiana.

Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.

出版信息

Ophthalmol Retina. 2020 Jan;4(1):19-30. doi: 10.1016/j.oret.2019.05.017. Epub 2019 May 25.

DOI:10.1016/j.oret.2019.05.017
PMID:31324588
Abstract

PURPOSE

This study assessed anti-vascular endothelial growth factor (VEGF) therapy intensity and its relationship with visual acuity (VA) change in real-world neovascular age-related macular degeneration (nAMD) patients.

DESIGN

This retrospective analysis was performed on a large database of aggregated, longitudinal, de-identified electronic medical records from a geographically and demographically diverse sample of patients of United States retina specialists (Vestrum Health Retina Database).

PARTICIPANTS

Treatment-naïve nAMD patients who underwent anti-VEGF injections between January 1, 2012, and October 31, 2016, were eligible if follow-up data were available before October 31, 2017.

METHODS

Age, gender, anti-VEGF treatment type, number of treatments, and VA were extracted from the database.

MAIN OUTCOME MEASURE

Mean VA change assessed at 1 year and stratified based on number of anti-VEGF injections received over 1 year.

RESULTS

In this analysis, 49 485 eyes were included. The mean age was 80.9 years, and 64% were female. Mean baseline VA was 53.8 letters (Snellen equivalent, 20/80). At 1 year, after a mean of 7.3 anti-VEGF injections, there was a mean gain of 1 letter (0.95 letter; 95% confidence interval [CI] for change in VA, +0.77 to +1.13 letter; P < 0.001). When stratified by anti-VEGF agent, the mean VA changes were nearly identical at 1 year. There was a linear relationship between mean letters gained and mean number of injections, between 4 and 10 injections over 1 year, with 4 or fewer or 10 or more injections associated with loss of vision or a plateau, respectively. Greater mean 1-year change in VA also trended with worse baseline VA; those patients with better VA at presentation tended to be particularly vulnerable to vision loss. Those who received the fewest injections tended to be older and have worse baseline VA.

CONCLUSIONS

Real-world nAMD patients receive fewer anti-VEGF injections and experience worse visual outcomes compared with patients receiving fixed, frequent therapy in randomized controlled trials. Mean change in VA correlates with treatment intensity at 1 year, but with ceiling effects related to treatment intensity and baseline VA. Older patients and those with poor baseline VA may be particularly prone to undertreatment.

摘要

目的

本研究评估了真实世界中新生血管性年龄相关性黄斑变性(nAMD)患者抗血管内皮生长因子(VEGF)治疗的强度及其与视力(VA)变化的关系。

设计

这是一项回顾性分析,基于美国视网膜专家的地理和人口统计学多样化患者的聚合、纵向、去识别电子病历的大型数据库进行(Vestrum Health Retina Database)。

参与者

2012 年 1 月 1 日至 2016 年 10 月 31 日期间接受抗 VEGF 注射治疗且在 2017 年 10 月 31 日之前有随访数据的治疗初治 nAMD 患者有资格入组。

方法

从数据库中提取年龄、性别、抗 VEGF 治疗类型、治疗次数和 VA。

主要观察指标

1 年时的平均 VA 变化,并根据 1 年内接受的抗 VEGF 注射次数进行分层。

结果

在这项分析中,共纳入 49485 只眼。平均年龄为 80.9 岁,64%为女性。基线时 VA 平均为 53.8 个字母(Snellen 等价物,20/80)。在 1 年时,平均接受 7.3 次抗 VEGF 注射后,VA 平均增加 1 个字母(0.95 个字母;VA 变化的 95%置信区间[CI],+0.77 至+1.13 个字母;P < 0.001)。按抗 VEGF 药物分类,1 年后 VA 平均变化几乎相同。在 1 年的时间里,平均获得的字母数与平均注射次数之间存在线性关系,4 至 10 次注射之间,注射次数分别为 4 次或更少或 10 次或更多与视力丧失或平台期有关,分别。VA 1 年平均变化较大也与基线 VA 较差呈正相关;在出现时 VA 较好的患者更容易出现视力丧失。接受最少注射的患者年龄较大,且基线 VA 较差。

结论

与接受随机对照试验中固定、频繁治疗的患者相比,真实世界中 nAMD 患者接受的抗 VEGF 注射次数较少,视力预后较差。VA 的平均变化与 1 年时的治疗强度相关,但与治疗强度和基线 VA 有关。老年患者和基线 VA 较差的患者可能特别容易治疗不足。

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