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阿柏西普治疗并延长与按需给药方案治疗贝伐单抗耐药性糖尿病性黄斑水肿的一年结局:一项真实世界研究

One-Year Outcomes of Aflibercept in Treat-and-Extend Versus Pro Re Nata Regimens for Bevacizumab-Resistant Diabetic Macular Edema: A Real-World Study.

作者信息

Yozgat Zubeyir, Isik Mehmed Ugur, Sabaner Mehmet Cem

机构信息

Retina Division, Department of Ophthalmology, Kastamonu Training and Research Hospital, Kastamonu University, 37150, Kastamonu, Turkey.

出版信息

Ophthalmol Ther. 2025 Jan;14(1):169-181. doi: 10.1007/s40123-024-01067-x. Epub 2024 Nov 22.

DOI:10.1007/s40123-024-01067-x
PMID:39576487
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11724814/
Abstract

INTRODUCTION

The aim of this study was to compare the efficacy of the treat-and-extend (TAE) regimen versus the pro re nata (PRN) regimen in patients with bevacizumab-resistant diabetic macular edema (DME) treated with aflibercept, with or without adjunctive laser therapy.

METHODS

Ninety-one eyes from 91 patients who were switched to aflibercept after three consecutive intravitreal bevacizumab injections for the treatment of DME were included in this retrospective real-world study. The patients were categorized into three groups: TAE (n = 30), TAE + laser (n = 31), and PRN (n = 30). Changes in best-corrected visual acuity and central macular subfield thickness (CMST) at 12, 24, and 52 weeks were defined as the primary functional and anatomical outcomes.

RESULTS

A total of 91 eyes from 91 patients (49.5% female) with a mean age of 63.9 ± 7.1 years were included in the analysis. At 52 weeks, the mean letter gains were 8.03, 8.90, and 10.23 in the TAE, TAE + laser, and PRN groups, respectively. Anatomical improvements, as measured by CMST reduction, were 55.33 µm, 33.35 µm, and 48.96 µm in the TAE, TAE + laser, and PRN groups, respectively. The average number of injections administered was 7.7, 8.1, and 8.1, respectively. The final extension interval for the TAE group was 8.7 weeks, compared to 9.5 weeks in the TAE + laser group.

CONCLUSIONS

The PRN group demonstrated the highest functional improvement while the TAE group showed the greatest anatomical improvement. Overall, both anatomical and functional outcomes in the TAE regimen were comparable to the PRN regimen in patients with bevacizumab-resistant diabetic macular edema.

摘要

引言

本研究旨在比较在接受阿柏西普治疗的贝伐单抗耐药性糖尿病性黄斑水肿(DME)患者中,治疗并延长(TAE)方案与按需治疗(PRN)方案的疗效,无论是否联合激光治疗。

方法

本回顾性真实世界研究纳入了91例患者的91只眼,这些患者在连续3次玻璃体内注射贝伐单抗治疗DME后改用阿柏西普。患者分为三组:TAE组(n = 30)、TAE + 激光组(n = 31)和PRN组(n = 30)。将12周、24周和52周时最佳矫正视力和中心黄斑子区域厚度(CMST)的变化定义为主要功能和解剖学结局。

结果

分析纳入了91例患者的91只眼(49.5%为女性),平均年龄为63.9±7.1岁。在52周时,TAE组、TAE + 激光组和PRN组的平均字母增益分别为8.03、8.90和10.23。以CMST降低衡量的解剖学改善,TAE组、TAE + 激光组和PRN组分别为55.33μm、33.35μm和48.96μm。平均注射次数分别为7.7次、8.1次和8.1次。TAE组的最终延长间隔为8.7周,TAE + 激光组为9.5周。

结论

PRN组显示出最高的功能改善,而TAE组显示出最大的解剖学改善。总体而言,在贝伐单抗耐药性糖尿病性黄斑水肿患者中,TAE方案的解剖学和功能结局与PRN方案相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b900/11724814/8b1e53a42a44/40123_2024_1067_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b900/11724814/8b1e53a42a44/40123_2024_1067_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b900/11724814/8b1e53a42a44/40123_2024_1067_Fig1_HTML.jpg

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