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地塞米松植入物治疗初治与难治性糖尿病性黄斑水肿眼的比较:国际视网膜专家组真实世界 24 个月多中心研究。IRGREL-DEX 研究。

DEXAMETHASONE IMPLANT FOR DIABETIC MACULAR EDEMA IN NAIVE COMPARED WITH REFRACTORY EYES: The International Retina Group Real-Life 24-Month Multicenter Study. The IRGREL-DEX Study.

机构信息

Private Retina Office, University of Buenos Aires, Argentina.

Department of Ophthalmology, University of Leipzig, Germany.

出版信息

Retina. 2019 Jan;39(1):44-51. doi: 10.1097/IAE.0000000000002196.

DOI:10.1097/IAE.0000000000002196
PMID:29697589
Abstract

PURPOSE

To investigate efficacy and safety of repeated dexamethasone (DEX) implants over 24 months, in diabetic macular edema (DME) eyes that were treatment naive compared with eyes refractory to anti-vascular endothelial growth factor treatment, in a real-life environment.

METHODS

This multicenter international retrospective study assessed best-corrected visual acuity and central subfield thickness (CST) of naive and refractory eyes to anti-vascular endothelial growth factor injections treated with dexamethasone implants. Safety data (intraocular pressure rise and cataract surgery) were recorded.

RESULTS

A total of 130 eyes from 125 patients were included. Baseline best-corrected visual acuity and CST were similar for naive (n = 71) and refractory eyes (n = 59). Both groups improved significantly in vision after 24 months (P < 0.001). However, naive eyes gained statistically significantly more vision than refractory eyes (+11.3 ± 10.0 vs. 7.3 ± 2.7 letters, P = 0.01) and were more likely to gain ≥10 letters (OR 3.31, 95% CI 1.19-9.24, P = 0.02). At 6, 12, and 24 months, CST was significantly decreased compared with baseline in both naive and refractory eyes; however, CST was higher in refractory eyes than in naive eyes (CST 279 ± 61 vs. 313 ± 125 μm, P = 0.10).

CONCLUSION

Over a follow-up of 24 months, vision improved in diabetic macular edema eyes after treatment with dexamethasone implants, both in eyes that were treatment naive and eyes refractory to anti-vascular endothelial growth factor treatment; however, improvement was greater in naive eyes.

摘要

目的

在真实环境中,研究与抗血管内皮生长因子治疗抵抗的糖尿病黄斑水肿(DME)眼相比,初次接受治疗的 DME 眼在 24 个月内重复使用地塞米松(DEX)植入物的疗效和安全性。

方法

本多中心国际回顾性研究评估了初次接受治疗的 DME 眼(n=71)和抗血管内皮生长因子治疗抵抗的 DME 眼(n=59)接受地塞米松植入物治疗后的最佳矫正视力和中央视网膜厚度(CST)。记录了安全性数据(眼压升高和白内障手术)。

结果

共纳入 125 例患者的 130 只眼。初次治疗组(n=71)和治疗抵抗组(n=59)的基线最佳矫正视力和 CST 相似。两组在 24 个月后视力均显著提高(P<0.001)。然而,初次治疗组比治疗抵抗组获得了更多的视力提高(+11.3±10.0 vs.+7.3±2.7 个字母,P=0.01),且更有可能提高≥10 个字母(OR 3.31,95%CI 1.19-9.24,P=0.02)。在 6、12 和 24 个月时,与基线相比,初次治疗组和治疗抵抗组的 CST 均显著降低;然而,治疗抵抗组的 CST 仍高于初次治疗组(CST 279±61 vs.313±125μm,P=0.10)。

结论

在 24 个月的随访中,接受地塞米松植入物治疗后,糖尿病黄斑水肿眼的视力均得到改善,无论是否初次接受治疗;然而,初次治疗组的改善更为明显。

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