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抗 VEGF 治疗持续与早期转换为地塞米松植入物治疗无应答性糖尿病黄斑水肿的真实世界结局:2 年结果。

Real-world outcomes of non-responding diabetic macular edema treated with continued anti-VEGF therapy versus early switch to dexamethasone implant: 2-year results.

机构信息

Department of Ophthalmology, University Hospital Leipzig, Liebigstr. 10-14, 04103, Leipzig, Germany.

Department of Ophthalmology, Sydney University, Sydney, Australia.

出版信息

Acta Diabetol. 2019 Dec;56(12):1341-1350. doi: 10.1007/s00592-019-01416-4. Epub 2019 Sep 21.

Abstract

AIMS

To provide 2-year follow-up data on eyes with diabetic macular edema (DME) that were non-responsive after three initial anti-vascular endothelial growth factor (VEGF) injections, comparing functional and anatomical outcomes under continued anti-VEGF therapy versus dexamethasone (DEX) implant.

METHODS

Multicenter, retrospective chart review comparing eyes with treatment-naïve DME and a suboptimal response to a loading phase of anti-VEGF therapy (3 injections given monthly) which were then treated with (a) further anti-VEGF (n = 72) or (b) initially switched to DEX implant (n = 38). Main outcome measures were change in visual acuity (VA) and central subfield thickness (CST) from the end of the loading phase to 24 months.

RESULTS

In 79% of the 12-month study population (87/110 eyes), 24-month data were available. One quarter of eyes in each group switched treatments during the second year. Eyes that were switched early to DEX implant maintained the functional and anatomical improvements at 24 months which were seen in the first year (from month 3: + 8.9 letters, - 214 µm). Eyes that were switched from anti-VEGF therapy to steroids in the second year improved VA and reduced CST at 24 months (from month 12: + 6.8 letters, p = 0.023; - 226 µm, p = 0.004). In eyes continued on anti-VEGF therapy, VA and CST were stable at 24 months (from month 3: + 2.8 letters, p = 0.254; - 24 µm, p = 0.243). Eyes that were non-responsive to anti-VEGF therapy for 12 months had similar chances to experience a VA gain from further therapy as eyes that were non-responsive for 3 months only (23.8 vs. 31.0%, p = 0.344).

CONCLUSIONS

The beneficial effect of an early switch to DEX implant in DME non-responders seen at month 12 was maintained during the second year. A later switch from anti-VEGF to steroids still provided significant improvement. Eyes continued on anti-VEGF over a period of 24 months maintained vision. A quarter of eyes, which had not improved vision at 12 months, exhibited a delayed response to treatment.

摘要

目的

提供糖尿病黄斑水肿(DME)患者在接受三次初始抗血管内皮生长因子(VEGF)注射后无反应的两年随访数据,比较继续抗 VEGF 治疗与地塞米松(DEX)植入物治疗下的功能和解剖结果。

方法

多中心回顾性图表审查比较了治疗初发性 DME 和对负荷期抗 VEGF 治疗(每月 3 次注射)反应不佳的眼睛,然后用(a)进一步的抗 VEGF(n=72)或(b)最初改用 DEX 植入物(n=38)治疗。主要观察指标是从负荷期结束到 24 个月时视力(VA)和中央视网膜厚度(CST)的变化。

结果

在 12 个月研究人群的 79%(110 只眼中的 87 只)中,可获得 24 个月的数据。两组中各有四分之一的眼睛在第二年更换了治疗方法。在第二年早期转换为 DEX 植入物的眼睛在 24 个月时保持了第一年观察到的功能和解剖改善(从第 3 个月开始:+8.9 个字母,-214μm)。第二年从抗 VEGF 治疗转换为类固醇的眼睛在 24 个月时改善了 VA 并减少了 CST(从第 12 个月开始:+6.8 个字母,p=0.023;-226μm,p=0.004)。在继续接受抗 VEGF 治疗的眼睛中,VA 和 CST 在 24 个月时保持稳定(从第 3 个月开始:+2.8 个字母,p=0.254;-24μm,p=0.243)。对 12 个月抗 VEGF 治疗无反应的眼睛与仅对 3 个月抗 VEGF 治疗无反应的眼睛相比,进一步治疗获得 VA 增益的机会相似(23.8%对 31.0%,p=0.344)。

结论

在第 12 个月时观察到的 DME 无反应者早期转换为 DEX 植入物的有益效果在第二年保持。从抗 VEGF 到类固醇的后期转换仍提供了显著的改善。在 24 个月的时间内继续接受抗 VEGF 治疗的眼睛保持了视力。四分之一的眼睛在 12 个月时视力没有改善,表现出治疗的延迟反应。

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