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基线高反射点对玻璃体内曲安奈德植入物(Ozurdex®)治疗糖尿病性黄斑水肿结局的预测能力:一项多中心研究。

Predictive capacity of baseline hyperreflective dots on the intravitreal dexamethasone implant (Ozurdex®) outcomes in diabetic macular edema: a multicenter study.

机构信息

Begiker-Ophthalmology Research Group, Ophthalmology Department, BioCruces Health Research Institute, Cruces Hospital, University of the Basque Country, Bilbao, Vizcaya, Spain.

Ophthalmology Department, Hospital Universitario Cruces, plaza de Cruces s/n CP 48903, Cruces-Baracaldo, Vizcaya, Spain.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2381-2390. doi: 10.1007/s00417-019-04446-4. Epub 2019 Aug 26.

Abstract

PURPOSE

The purpose of this study is to evaluate the predictive capacity of the baseline hyperreflective dots (HRDs) on the functional and anatomical response in patients with diabetic macular edema (DME). Additionally, we assessed the impact of the intravitreal dexamethasone (DEX) implant on the functional and anatomic outcomes.

METHODS

Retrospective, multicenter study. The number of HRDs was graded in four different stages: [A] none HRDs; [B] few, 1-10 HRDs; [C] moderate, 11-20 HRDs; and [D] many, ≥ 21 HRDs. For statistical purposes, groups A and B were combined [scarce HRDs (S-HRDs)] and group D was renamed as [abundant HRDs (A-HRDs)]. The primary endpoints were the mean change in best corrected visual acuity (BCVA) and central macular thickness (CMT) according to baseline HRD stage.

RESULTS

One hundred eyes from one hundred patients were included in the study. Mean BCVA significantly improved from 52.9 (50.0 to 55.8) letters ETDRS at baseline to 57.2 (54.0 to 60.4) letters at month 6, p = 0.0039. There were no significant differences between the S-HRDs and A-HRD study groups in BCVA. As compared to baseline, CMT reduction was 106.3 (59.8 to 152.7) μm and 94.2 (34.7 to 153.7) μm in S-HRDs and A-HRD groups, respectively (p < 0.0001 each, respectively). Twenty-three (65.7%) and 18 (62.1%) eyes achieved a CMT reduction ≥ 10% in the S-HRD and A-HRD groups, respectively, p = 0.7640. DEX implant significantly reduced the presence of outer nuclear layer (ONL) disruptions (p = 0.0010).

CONCLUSIONS

The number of HRDs did not influence either functional or anatomic outcomes. DEX implant significantly decreases the number of eyes with ONL disruptions, which might improve retinal integrity.

摘要

目的

本研究旨在评估糖尿病黄斑水肿(DME)患者基线高反射点(HRD)数量对功能和解剖学反应的预测能力。此外,我们评估了玻璃体内地塞米松(DEX)植入对功能和解剖结果的影响。

方法

回顾性、多中心研究。HRD 的数量分为四个不同阶段进行分级:[A] 无 HRD;[B] 少量,1-10 HRD;[C] 中度,11-20 HRD;和 [D] 大量,≥21 HRD。出于统计目的,将 A 组和 B 组合并为[稀少 HRD(S-HRD)],并将 D 组重新命名为[丰富 HRD(A-HRD)]。主要终点是根据基线 HRD 阶段评估最佳矫正视力(BCVA)和中央黄斑厚度(CMT)的平均变化。

结果

本研究纳入了 100 例 100 只眼。BCVA 从基线时的 52.9(50.0 至 55.8)个 ETDRS 字母显著提高到 6 个月时的 57.2(54.0 至 60.4)个字母,p=0.0039。S-HRD 组和 A-HRD 组之间的 BCVA 无显著差异。与基线相比,S-HRD 组和 A-HRD 组的 CMT 分别减少了 106.3(59.8 至 152.7)μm 和 94.2(34.7 至 153.7)μm(均 p<0.0001)。S-HRD 组和 A-HRD 组分别有 23(65.7%)和 18(62.1%)只眼的 CMT 减少≥10%,p=0.7640。DEX 植入显著减少了外核层(ONL)中断的存在(p=0.0010)。

结论

HRD 的数量对功能和解剖学结果均无影响。DEX 植入显著减少了 ONL 中断的眼睛数量,这可能改善了视网膜的完整性。

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