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2009 年至 2019 年糖尿病性黄斑水肿真实世界治疗模式的变化及 5 年结局:来自 Fight Retinal Blindness! 注册研究的数据。

Changes in real-world treatment patterns for diabetic macular oedema from 2009 to 2019 and 5-year outcomes: Data from the Fight Retinal Blindness! Registry.

机构信息

Department of Ophthalmology, University of Zurich, Zurich, Switzerland.

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

出版信息

Clin Exp Ophthalmol. 2020 Aug;48(6):802-812. doi: 10.1111/ceo.13781. Epub 2020 Jun 11.

Abstract

IMPORTANCE

Evaluating the treatment outcomes of diabetic macular oedema (DMO) in routine clinical practice provides data for comparison with those of clinical trials.

BACKGROUND

Phase 3 clinical trials of vascular endothelial growth factor (VEGF) inhibitors for DMO have reported significant improvements in visual acuity (VA) not previously reported with laser and steroid treatments.

DESIGN

Retrospective analysis of observational data from routine clinical practice.

PARTICIPANTS

Eyes receiving treatments for DMO tracked in the Fight Retinal Blindness! Registry.

METHODS

We analysed 510 eyes (347 patients) that started DMO treatment between 2009 and 2014.

MAIN OUTCOME MEASURES

Changes in DMO treatment patterns and mean change in VA (letters logMAR) and central subfield thickness (CST) 5 years after starting treatment.

RESULTS

Treatment choice for DMO changed to predominantly VEGF inhibitors from 2009 to 2014. A total of 238 eyes (47%) were followed for at least 5 years. The mean VA at the start of treatment improved from 2009 (58 letters) to 2014 (68 letters) while mean VA change at 5 years were + 4.5 and + 5.3 letters for eyes starting treatment in 2009 and 2014, respectively. The mean CST dropped from 401 μm at baseline to 314 μm at 5 years. Eyes received a median of four injections in the first, two in the second, third and fourth and three in the fifth years.

CONCLUSIONS AND RELEVANCE

Changing the treatment of DMO from macular laser and intravitreal triamcinolone to VEGF inhibitors from 2011 onwards was associated with better VA outcomes, part of which were due to better VA at the start of treatment. The outcomes of treatment in eyes in real-world practice were, however, worse than those reported by clinical trials, likely because they were undertreated.

摘要

重要性

评估糖尿病性黄斑水肿(DMO)在常规临床实践中的治疗结果提供了与临床试验结果进行比较的数据。

背景

DMO 的血管内皮生长因子(VEGF)抑制剂的 3 期临床试验报告了视力(VA)的显著改善,这是以前激光和类固醇治疗所没有报告过的。

设计

对常规临床实践中的观察性数据进行回顾性分析。

参与者

接受 DMO 治疗的眼睛在 Fight Retinal Blindness!注册处跟踪。

方法

我们分析了 510 只眼睛(347 名患者),这些眼睛在 2009 年至 2014 年期间开始 DMO 治疗。

主要观察指标

DMO 治疗模式的变化以及开始治疗后 5 年内 VA(对数视力 logMAR)和中央眼底厚度(CST)的平均变化。

结果

2009 年至 2014 年,DMO 的治疗选择主要变为 VEGF 抑制剂。共有 238 只眼睛(47%)至少随访 5 年。治疗开始时的平均 VA 从 2009 年(58 个字母)提高到 2014 年(68 个字母),而 2009 年和 2014 年开始治疗的眼睛在 5 年内的平均 VA 变化分别为+4.5 和+5.3 个字母。平均 CST 从基线时的 401μm 下降到 5 年后的 314μm。眼睛在第一年接受中位数为 4 次注射,第二年、第三年和第四年接受 2 次,第五年接受 3 次。

结论和相关性

从 2011 年开始,将 DMO 的治疗从黄斑激光和玻璃体内曲安奈德改为 VEGF 抑制剂,与更好的 VA 结果相关,其中部分原因是治疗开始时的 VA 更好。然而,现实世界实践中治疗的结果比临床试验报告的结果更差,可能是因为治疗不足。

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