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对抗视网膜失明——西班牙。报告3:血管内皮生长因子抑制剂治疗低视力新生血管性年龄相关性黄斑变性的临床结果。一项全国性数据库研究。

Fight Retinal Blindness SPAIN. Report 3: clinical outcomes of vascular endothelial growth factor inhibitors in low vision eyes with neovascular age-related macular degeneration. A national database study.

作者信息

Puzo Martín, Calvo-Perez Pilar, Bartol-Puyal Francisco, Sanchez-Monroy Jorge, Martin-Pinardel Ruben, Parrado-Carrillo Alba, Moll-Udina Aina, Bernal-Morales Carolina, Sanchez-Vela Laura, Sararols-Ramsay Laura, Garay-Aramburu Gonzaga, Arruabarrena Carolina, García-Arumí José, Abraldes Maximino, Ruiz-Moreno José María, Valldeperas Xavier, Velázquez-Villoria Daniel, Escobar-Barranco José Juan, Gallego-Pinazo Roberto, Figueroa Marta S, Figueras-Roca Marc, Barthelmes Daniel, Gillies Mark C, Casaroli-Marano Ricardo P, Zarranz-Ventura Javier

机构信息

Miguel Servet Ophthalmology Research Group (GIMSO), Miguel Servet University Hospital, Aragón Institute for Health Research (IIS-Aragón), Universidad de Zaragoza, Zaragoza, Spain.

Fundació de Recerca Clínic Barcelona-Institut de Investigacions Biomediques August Pi i Sunyer (FRCB-IDIBAPS), Barcelona, Spain.

出版信息

Eye (Lond). 2024 Dec;38(18):3450-3458. doi: 10.1038/s41433-024-03322-8. Epub 2024 Sep 21.

DOI:10.1038/s41433-024-03322-8
PMID:39306616
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11621359/
Abstract

OBJECTIVES

To compare visual outcomes for low vision eyes (LVE) (<35 letters LogMAR or <20/200 Snellen) versus non-low vision eyes (NLVE) (>35 letters LogMAR or >20/200 Snellen) at the time of the first injection in a clinical practice setting.

METHODS

Subgroup analysis of a multicenter national database of treatment- naïve eyes neovascular age related macular degeneration (nAMD) treated with anti-VEGF intravitreal injections divided into LVE and NLVE. Demographics, visual acuity (VA) at baseline and subsequent timepoints (12, 24, and 36 months), number of injections and visits data were collected using a validated web-based tool (Fight Retinal Blindness!).

RESULTS

3138 eyes were included, 705 LVE and 2433 NLVE. The LVE group had the greatest VA gain (p < 0.001), at 12, 24, and 36 months (+15, +15, and +13 letters respectively). The proportion of patients with VA loss (-5 letters) differed between groups at 12, 24, and 36 and was significantly greater (p < 0.001) in NLVE. The proportion of patients with VA gain (+5 letters) was significantly higher (p < 0.001) in LVE in all timeframes. The proportions of LVE that still had VA ≤ 35 letters at 12, 24, and 36 months were 54%, 54%, and 57%. Conversely, 8%, 9%, and 8% of LVE achieved VA ≥ 70 letters at 12, 24, and 36 months. LVE received fewer intravitreal injections than NLVE throughout follow-up (6, 9, 12 vs 7, 11, 15).

CONCLUSION

Findings of this study support the need for ongoing therapy in patients with initial visual acuity less than 35 letters since sustained visual improvements can be achieved and maintained for the first 3 years of treatment.

摘要

目的

在临床实践环境中,比较首次注射时低视力眼(LVE)(LogMAR视力表字母数<35或Snellen视力表<20/200)与非低视力眼(NLVE)(LogMAR视力表字母数>35或Snellen视力表>20/200)的视觉效果。

方法

对一个多中心全国性数据库进行亚组分析,该数据库包含未经治疗的新生血管性年龄相关性黄斑变性(nAMD)眼,这些眼接受了抗VEGF玻璃体内注射治疗,并分为LVE和NLVE组。使用经过验证的基于网络的工具(抗击视网膜失明!)收集人口统计学数据、基线及后续时间点(12、24和36个月)的视力(VA)、注射次数和就诊数据。

结果

共纳入3138只眼,其中705只为LVE,2433只为NLVE。LVE组在12、24和36个月时视力提高最多(p<0.001)(分别提高15、15和13个字母)。12、24和36个月时,视力下降(-5个字母)的患者比例在两组间存在差异,NLVE组显著更高(p<0.001)。在所有时间范围内,LVE组视力提高(+5个字母)的患者比例显著更高(p<0.001)。12、24和36个月时,仍有VA≤35个字母的LVE比例分别为54%、54%和57%。相反,12、24和36个月时,分别有8%、9%和8%的LVE达到VA≥70个字母。在整个随访期间,LVE接受的玻璃体内注射次数少于NLVE(分别为6、9、12次与7、11、15次)。

结论

本研究结果支持对初始视力低于35个字母的患者进行持续治疗的必要性,因为在治疗的前3年可以实现并维持视力的持续改善。

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本文引用的文献

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Ophthalmol Retina. 2024 Apr;8(4):350-359. doi: 10.1016/j.oret.2023.10.022. Epub 2023 Nov 2.
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Artificial intelligence-based fluid quantification and associated visual outcomes in a real-world, multicentre neovascular age-related macular degeneration national database.基于人工智能的真实世界多中心新生血管性年龄相关性黄斑变性国家数据库中的液体定量及其相关视觉结局。
Br J Ophthalmol. 2024 Jan 29;108(2):253-262. doi: 10.1136/bjo-2022-322297.
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Creation of a neovascular age-related macular degeneration national database using a web-based platform: Fight Retinal Blindness Spain. Report 1: Visual outcomes.利用基于网络的平台创建新生血管性年龄相关性黄斑变性国家数据库:西班牙抗击视网膜盲,报告 1: 视觉结果。
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Managing Neovascular Age-Related Macular Degeneration in Clinical Practice: Systematic Review, Meta-Analysis, and Meta-Regression.临床实践中新生血管性年龄相关性黄斑变性的管理:系统评价、Meta分析和Meta回归
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J Formos Med Assoc. 2021 Dec;120(12):2061-2071. doi: 10.1016/j.jfma.2021.06.012. Epub 2021 Jul 15.
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Ranibizumab and Bevacizumab for Treatment of Neovascular Age-related Macular Degeneration: Two-Year Results.雷珠单抗和贝伐单抗治疗新生血管性年龄相关性黄斑变性:两年结果。
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