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抗血管内皮生长因子注射剂循环治疗 3 次治疗糖尿病性黄斑水肿。

Treatment of Diabetic Macular Edema with Cycles of Three Injections of Anti-vascular Endothelial Growth Factor Injections.

机构信息

University of Texas Medical Branch College of Medicine, Galveston, TX, USA.

Department of Ophthalmology, University of Texas Medical Branch, Galveston, TX, USA.

出版信息

Middle East Afr J Ophthalmol. 2024 Sep 13;30(3):141-148. doi: 10.4103/meajo.meajo_17_22. eCollection 2023 Jul-Sep.

Abstract

PURPOSE

The purpose of this study was to report the visual and anatomic results at 12 and 24 months using the protocol of 3 monthly (PRN) injections for diabetic macular edema (DME).

METHODS

This was a retrospective chart review of 97 eyes with DME treated with a protocol of cycles consisting of 3 monthly injections of anti-vascular endothelial growth factor drugs on a PRN basis. Change in visual acuity was the main outcome measure. Macular thickness, number of injections, cycles, and visits in years 1 and 2 of follow-up were secondary outcomes.

RESULTS

Ninety-six patients with a mean age of 60.9 ± 9.96 years were followed for a mean of 22.17 ± 12.30 months. Ninety-two (95.9%), 3 (3%), and 1 (1%) patients were started on bevacizumab, ranibizumab, and aflibercept, respectively. Of bevacizumab patients, 17 (18.2%) were eventually switched to aflibercept. The mean 12-month improvement (standard deviation [SD]) was + 3.3 (17.4) letters (95% confidence interval [CI] = +0.36-+7.05, < 0.001) after an average (SD) of 5.97 (2.98) injections over a mean (SD) of 1.7 (1.0) three-injection cycles. The mean 24-month improvement (SD) was + 5.6 (13.0) letters (95% CI: -0.28-11.05, = 0.0186) after an average (SD) of 8.72 (6.31) injections over a mean (SD) of 2.9 (2.1) three-injection cycles. The mean central macular thickness (SD) at baseline, 12 months, and 24 months was 374 ± 120, 322 ± 88, and 305 ± 70 µm. Optical coherence tomography was fluid free at 12 and 24 months in 27.6% and 46% of eyes, respectively.

CONCLUSION

Comparable to real-world studies, this protocol can stabilize or improve vision in more than 85% of DME patients over 24 months. The most important factor in improvement of vision is increasing number of injections and visits.

摘要

目的

本研究旨在报告采用每 3 个月(PRN)注射方案治疗糖尿病黄斑水肿(DME)的 12 个月和 24 个月时的视力和解剖学结果。

方法

这是一项回顾性图表研究,纳入了 97 只接受 DME 治疗的眼睛,这些眼睛接受了包含 3 个月注射周期的方案治疗,这些周期基于 PRN 原则使用抗血管内皮生长因子药物。视力变化是主要观察指标。黄斑厚度、注射次数、周期数以及第 1 年和第 2 年的就诊次数是次要观察指标。

结果

96 例患者的平均年龄为 60.9±9.96 岁,平均随访时间为 22.17±12.30 个月。分别有 92(95.9%)、3(3%)和 1(1%)例患者开始接受贝伐单抗、雷珠单抗和阿柏西普治疗。贝伐单抗患者中,17 例(18.2%)最终转为阿柏西普治疗。在平均接受 5.97(2.98)次注射、平均进行 1.7(1.0)个 3 次注射周期后,12 个月时平均(标准差)视力提高了+3.3(17.4)个字母(95%置信区间[CI]:+0.36 至+7.05,<0.001)。24 个月时,平均(标准差)视力提高了+5.6(13.0)个字母(95%CI:-0.28 至+11.05,=0.0186),平均接受 8.72(6.31)次注射、平均进行 2.9(2.1)个 3 次注射周期。基线时、12 个月和 24 个月时的平均中央黄斑厚度(标准差)分别为 374±120、322±88 和 305±70µm。12 个月和 24 个月时,分别有 27.6%和 46%的眼 OCT 检查结果为无液。

结论

与真实世界研究相比,该方案在 24 个月内可使超过 85%的 DME 患者的视力稳定或改善。视力改善的最重要因素是增加注射次数和就诊次数。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e77/11495293/46ed76230a4d/MEAJO-30-141-g001.jpg

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