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贝伐单抗治疗糖尿病性黄斑水肿:来自 Fight Retinal Blindness! 注册研究的一年治疗结果。

Bevacizumab for diabetic macular oedema: one-year treatment outcomes from the Fight Retinal Blindness! Registry.

机构信息

Save Sight Institute, Discipline of Ophthalmology and Eye Health, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.

Auckland District Health Board, Auckland, New Zealand.

出版信息

Eye (Lond). 2022 Mar;36(3):594-602. doi: 10.1038/s41433-021-01509-x. Epub 2021 Mar 25.

DOI:10.1038/s41433-021-01509-x
PMID:33767407
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8873324/
Abstract

OBJECTIVES

This study evaluated the 1-year treatment outcomes of bevacizumab for diabetic macular oedema (DMO) in routine clinical practice.

METHODS

A retrospective analysis was performed on 298 eyes of 220 patients with DMO that received intra-vitreal bevacizumab between 1 September 2013 and 31 August 2018 that were tracked by a prospectively designed, web-based observational registry-the Fight Retinal Blindness! Registry.

RESULTS

The mean visual acuity (95% confidence interval [CI]) at 1-year was 3 (2, 5) letters better than a mean (SD) of 68 (15) letters at study entry. Nearly a quarter of eyes achieved ≥20/40. Eyes presenting with better vision (≥20/40) tended to maintain that vision during the period of observation, whereas those presenting with worse vision (<20/40) gained a mean (95% CI) of 9 (5, 13) letters. A mean reduction in the macular thickness was observed over the study period with the central subfield improving by 29 µm (95% CI 17, 40) from a mean (SD) of 402 (109) µm at study entry. Eyes that completed 1 year of follow-up received a median (Q1, Q3) of 7 (4, 9) bevacizumab injections. Sixty-two eyes, ~20%, that started with bevacizumab changed to either another VEGF inhibitor or steroid (triamcinolone) during the period of observation. This did not lead to functional improvement for eyes changed to either ranibizumab or aflibercept despite a further reduction in macular thickness. An improvement in vision and reduction in macular thickness was noted in the 13 eyes that subsequently received triamcinolone. Approximately 10% of eyes dropped out over 12 months, even though their mean visual acuity had improved by seven letters from the initial visit.

CONCLUSIONS

Bevacizumab is an effective treatment for DMO in unselected populations.

摘要

目的

本研究评估了贝伐单抗治疗糖尿病黄斑水肿(DMO)的 1 年治疗效果。

方法

对 2013 年 9 月 1 日至 2018 年 8 月 31 日期间接受玻璃体内贝伐单抗治疗的 220 例 298 只 DMO 患者进行回顾性分析,这些患者由一个前瞻性设计的基于网络的观察性登记系统——“抗击视网膜盲!登记系统”进行跟踪。

结果

1 年时的平均视力(95%置信区间[CI])比研究入组时的平均(标准差)68(15)个字母提高了 3(2,5)个字母。近四分之一的眼睛视力达到≥20/40。视力较好(≥20/40)的眼睛在观察期间往往保持这种视力,而视力较差(<20/40)的眼睛平均提高了 9(5,13)个字母。在研究期间观察到黄斑厚度有平均下降,中央子区从入组时的平均(标准差)402(109)µm 改善了 29µm(95%CI 17,40)。完成 1 年随访的眼睛接受了中位数(第 1 四分位数,第 3 四分位数)7(4,9)次贝伐单抗注射。62 只眼睛,约 20%,在观察期间从贝伐单抗改用另一种 VEGF 抑制剂或皮质类固醇(曲安奈德)。尽管黄斑厚度进一步下降,但改用雷珠单抗或阿柏西普的眼睛并没有导致功能改善。在随后接受曲安奈德治疗的 13 只眼睛中,视力和黄斑厚度均有改善。尽管平均视力从初次就诊时提高了 7 个字母,但约 10%的眼睛在 12 个月内退出。

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