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抗VEGF治疗视网膜血管疾病的视觉和解剖学失败:真实世界数据的生存分析

Visual and anatomical failure of anti-VEGF therapy for retinal vascular diseases: a survival analysis of real-world data.

作者信息

Fu Dun Jack, Mishra Amit V, Quek Chrystie, Balaskas Konstantinos, Pontikos Nikolas, Sim Dawn, Sivaprasad Sobha, Faes Livia

机构信息

NIHR Biomedical Research Centre At Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, London, UK.

Kings College London, London, UK.

出版信息

Eye (Lond). 2025 Apr;39(5):977-985. doi: 10.1038/s41433-024-03529-9. Epub 2024 Dec 10.

Abstract

IMPORTANCE

Predicting undesirable outcomes following anti-VEGF initiation in macular oedema is critical for effective clinical decision-making and optimised care.

OBJECTIVE

To estimate the time to undesirable events in diabetic macular oedema (DMO), central and branch vein occlusions (CRVO and BRVO) after appropriate loading doses with either ranibizumab or aflibercept and identified baseline predictors of negative outcome.

DESIGN, SETTING, PARTICIPANTS: A retrospective cohort study of 3277 patients (N = 2107 in DMO, N = 413 in CRVO and N = 757 in BRVO) collected over a 10-year period, in a large UK tertiary centre. Only one eye was included per patient. Inclusion criteria pre-specified a minimum of two clinic visits with one being at least 6 months post treatment.

MAIN OUTCOME AND MEASURES

The main outcome measure was absence of visual acuity (VA) improvement due to macular oedema failure of anti-VEGF therapy (defined as VA gain <5 ETDRS letters and CST increase of 50 µm or CST > 325 µm) modelled using time-event analyzes of appropriately loaded patients. Secondary outcomes included survival curves by individual condition (DMO, CRVO, BRVO) and factors associated with negative outcomes.

RESULTS

After starting anti-VEGF, there was a 50% chance of undesirable outcomes at 2.3, 5.24 and 6.16 years for DMO, CRVO and BRVO, respectively. Cox proportional hazards modelling identified presenting age, intraretinal (IRF) volume, presence of DMO and VA as predictors of negative outcomes, whilst South East Asian ethnicity conferred an independent protective effect.

CONCLUSION

Real-world data suggest that undesirable events following anti-VEGF injections is likely to in 50% of patients by the third year of treatment in spite of appropriate loading. The definition of undesirable treatment events captured nearly all patients who were escalated to another therapy, but this proportion represented a small percentage of our definition of failed response.

摘要

重要性

预测黄斑水肿抗VEGF治疗起始后的不良结局对于有效的临床决策和优化治疗至关重要。

目的

评估在给予雷珠单抗或阿柏西普适当负荷剂量后,糖尿病性黄斑水肿(DMO)、中央静脉阻塞(CRVO)和分支静脉阻塞(BRVO)出现不良事件的时间,并确定不良结局的基线预测因素。

设计、地点、参与者:一项回顾性队列研究,对英国一家大型三级中心在10年期间收集的3277例患者(DMO患者2107例,CRVO患者413例,BRVO患者757例)进行研究。每位患者仅纳入一只眼。纳入标准预先规定至少进行两次门诊就诊,其中一次至少在治疗后6个月。

主要结局和测量指标

主要结局指标是由于抗VEGF治疗黄斑水肿失败导致视力(VA)无改善(定义为VA增加<5个ETDRS字母且中央视网膜厚度(CST)增加50μm或CST>325μm),使用对适当负荷患者的时间-事件分析进行建模。次要结局包括按个体病情(DMO、CRVO、BRVO)的生存曲线以及与不良结局相关的因素。

结果

开始抗VEGF治疗后,DMO、CRVO和BRVO分别在2.3年、5.24年和6.16年出现不良结局的概率为50%。Cox比例风险模型确定就诊年龄、视网膜内(IRF)体积、DMO的存在和VA是不良结局的预测因素,而东南亚种族具有独立的保护作用。

结论

真实世界数据表明,尽管给予了适当负荷剂量,但抗VEGF注射后的不良事件在治疗第三年时可能发生在50%的患者中。不良治疗事件的定义涵盖了几乎所有升级至另一种治疗的患者,但这一比例在我们定义的治疗反应失败中占比很小。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f6e/11933433/b5a29de206d0/41433_2024_3529_Fig1_HTML.jpg

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