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根据真实生活中不同形态的糖尿病性黄斑水肿的形态学模式,玻璃体内注射治疗后一年的功能和形态预后:MARMASIA 研究组报告第 13 号。

One-Year Functional and Morphological Prognosis After Intravitreal Injection Treatments According to Different Morphological Patterns of Diabetic Macular Edema in Real-Life: MARMASIA Study Group Report No.13.

机构信息

Ümraniye Education and Research Hospital, Department of Ophthalmology, University of Health Sciences, Istanbul, Turkey.

Fatih Sultan Mehmet Education and Research Hospital, Department of Ophthalmology, University of Health Sciences, Istanbul, Turkey.

出版信息

Semin Ophthalmol. 2024 Aug;39(6):460-467. doi: 10.1080/08820538.2024.2324450. Epub 2024 Mar 5.

Abstract

PURPOSE

To evaluate the responses of different optical coherence tomography (OCT) patterns of diabetic macular edema (DME) to intravitreal injection therapy.

METHODS

In this retrospective, comparative, and multicenter study, patients who had previously untreated DME, who received intravitreal ranibizumab (IVR) or aflibercept (IVA) and/or steroid treatment with the pro re nata (PRN) treatment regimen after a 3-month loading dose, and had a 12-month follow-up in the MARMASIA Study Group were included. Morphological patterns of DME were divided into four groups based on OCT features diffuse/spongious edema (Group 1), cystoid edema (Group 2), diffuse/spongious edema+subretinal fluid (SRF) (Group 3), and cystoid edema+SRF (Group 4). Changes in central macular thickness (CMT) and best-corrected visual acuity (BCVA) at months 3, 6, and 12, and the number of injections at month 12 were compared between the DME groups.

RESULTS

455 eyes of 299 patients were included in the study. The mean baseline BCVAs [Logarithm of the Minimum Angle of Resolution (logMAR)] in groups 1, 2, 3, and 4 were 0.54 ± 0.24, 0.52 ± 0.25, 0.55 ± 0.23, and 0.57 ± 0.27, respectively. There was no significant difference between the baseline mean BCVAs between the groups ( = .35). The mean BCVAs were significantly improved to 0,47 ± 0,33 in group 1, 0,42 ± 0,33 in group 2, 0,47 ± 0,31 in group 3, and 0,45 ± 0,43 at month 12. There was no significant difference between the groups in terms of BCVA change at month 12 ( = .71). The mean baseline CMTs in groups 1, 2, 3, and 4 were 387,19 ± 128,19, 447,02 ± 132,39, 449,12 ± 109,24, and 544,19 ± 178,61, respectively. At baseline, the mean CMT was significantly higher in Group 4 than in the other groups ( = .000). The mean CMTs were significantly decreased to 325,16 ± 97,55, 334,94 ± 115,99, 324,33 ± 79,20, and 332,08 ± 150,40 in four groups at month 12 respectively ( > .05). The groups had no significant difference in mean CMT at month 12 ( = .835). The change in CMT was significantly higher in Group 4 than in the other groups at month 12 ( = .000). The mean number of intravitreal anti-VEGF injections at month 12 was 4.51 ± 1.57 in Group 1, 4.63 ± 1.54 in Group 2, 4.88 ± 1.38 in Group 3, and 5.07 ± 1.49 in Group 4. The mean number of anti-VEGF injections in Group 1 and Group 2 was significantly lower than in Group 4 ( = 0,014 and  = 0,017).

CONCLUSIONS

In real life, there was no significant difference between the DME groups in terms of visual improvement at month 12. However, better anatomical improvement was achieved in Group 4 than in the other DME groups.

摘要

目的

评估不同光学相干断层扫描(OCT)模式的糖尿病黄斑水肿(DME)对玻璃体内注射治疗的反应。

方法

在这项回顾性、对比性和多中心研究中,纳入了先前未经治疗的 DME 患者,这些患者接受了玻璃体内雷珠单抗(IVR)或阿柏西普(IVA)治疗,并在 3 个月的负荷剂量后接受了 pro re nata(PRN)治疗方案,并且在 MARMASIA 研究组中进行了 12 个月的随访。根据 OCT 特征将 DME 的形态模式分为四组:弥漫性/海绵状水肿(第 1 组)、囊样水肿(第 2 组)、弥漫性/海绵状水肿+视网膜下液(SRF)(第 3 组)和囊样水肿+SRF(第 4 组)。比较了 DME 组在第 3、6 和 12 个月时中央黄斑厚度(CMT)和最佳矫正视力(BCVA)的变化,以及第 12 个月时的注射次数。

结果

研究纳入了 299 例患者的 455 只眼。第 1、2、3 和 4 组的基线平均 BCVA[最小角分辨率的对数(logMAR)]分别为 0.54±0.24、0.52±0.25、0.55±0.23 和 0.57±0.27。各组间基线平均 BCVA 无显著差异( = .35)。第 1 组的平均 BCVA 在第 12 个月时显著提高至 0.47±0.33,第 2 组提高至 0.42±0.33,第 3 组提高至 0.47±0.31,第 4 组提高至 0.45±0.43。各组在第 12 个月时的 BCVA 变化无显著差异( = .71)。第 1、2、3 和 4 组的基线平均 CMT 分别为 387.19±128.19、447.02±132.39、449.12±109.24 和 544.19±178.61。在基线时,第 4 组的平均 CMT 显著高于其他组( = .000)。第 1、2、3 和 4 组在第 12 个月时的平均 CMT 分别显著降低至 325.16±97.55、334.94±115.99、324.33±79.20 和 332.08±150.40。各组在第 12 个月时的平均 CMT 无显著差异( = .835)。第 4 组在第 12 个月时的 CMT 变化显著高于其他组( = .000)。第 12 个月时,第 1 组和第 2 组的平均抗 VEGF 注射次数分别为 4.51±1.57、4.63±1.54、4.88±1.38 和 5.07±1.49。第 1 组和第 2 组的平均抗 VEGF 注射次数明显低于第 4 组( = 0.014 和  = 0.017)。

结论

在现实生活中,各组在第 12 个月时的视力改善无显著差异。然而,第 4 组在解剖学改善方面优于其他 DME 组。

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