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在台湾医疗服务环境中玻璃体内注射阿柏西普与雷珠单抗治疗糖尿病性黄斑水肿的比较

Intravitreal Aflibercept versus Ranibizumab for Diabetic Macular Edema in a Taiwanese Health Service Setting.

作者信息

Tsai Meng-Ju, Cheng Cheng-Kuo

机构信息

Department of Ophthalmology, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.

Department of Ophthalmology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.

出版信息

Semin Ophthalmol. 2021 Apr 3;36(3):132-138. doi: 10.1080/08820538.2021.1889620. Epub 2021 Mar 4.

DOI:10.1080/08820538.2021.1889620
PMID:33661709
Abstract

To compare the visual and anatomical outcomes between intravitreal aflibercept and ranibizumab for diabetic macular edema A total of 194 eyes from 194 patients (aflibercept n = 95, ranibizumab n = 99) were retrospectively enrolled in the study. All eyes fulfilled the key criteria including a baseline best-corrected visual acuity (BCVA) between 20 and 70 ETDRS letters, a central subfield thickness (CST) 300 µm or more. Primary outcomes were BCVA and CST at 1, 3, 6, and 12 months. Maintenance of vision was defined as visual loss of less than 5 letters over 6 to 12 months. Predictors for final visual acuity and visual maintenance were analyzed using multivariate regression models. Both agents achieved comparable visual and anatomical outcomes at any time point over the course of follow-up (all > .05). At 12 months, aflibercept group had higher proportions of visual gains 5, 10 and 15 letters or more ( = .014, = .011, and = .034, respectively). The mean number of injections was 5.0 ± 1.9 in ranibizumab group and 4.5 ± 1.9 in aflibercept group ( = .09). Ranibizumab predicted poor maintenance of vision ( = .009), but not the final visual acuity (univariate = .1). Ranibizumab was more likely to have recurrence of subretinal fluid than aflibercept in 12 months after resolution of subretinal fluid at baseline ( = .016). Both aflibercept and ranibizumab had similar rates of loss to follow-up ( = .47) and occurrence of vitreous hemorrhage ( = .21). While both agents improved vision with resolution of edema, aflibercept maintained vision more effectively with less recurrence of subretinal fluid at 12 months in real-world settings.

摘要

比较玻璃体内注射阿柏西普与雷珠单抗治疗糖尿病性黄斑水肿的视力和解剖学结局 本研究回顾性纳入了194例患者的194只眼(阿柏西普组95只眼,雷珠单抗组99只眼)。所有患眼均符合关键标准,包括基线最佳矫正视力(BCVA)在20至70个ETDRS字母之间,中心子野厚度(CST)为300 µm或更高。主要结局指标为1、3、6和12个月时的BCVA和CST。视力维持定义为在6至12个月内视力下降少于5个字母。使用多因素回归模型分析最终视力和视力维持的预测因素。在随访过程中的任何时间点,两种药物的视力和解剖学结局均相当(所有P>0.05)。在12个月时,阿柏西普组视力提高5、10和15个字母或更多的比例更高(分别为P = 0.014、P = 0.011和P = 0.034)。雷珠单抗组的平均注射次数为5.0±1.9次,阿柏西普组为4.5±1.9次(P = 0.09)。雷珠单抗预示视力维持不佳(P = 0.009),但对最终视力无影响(单因素分析P = 0.1)。在基线视网膜下液消退后的12个月内,雷珠单抗比阿柏西普更易发生视网膜下液复发(P = 0.016)。阿柏西普和雷珠单抗的失访率(P = 0.47)和玻璃体出血发生率(P = 0.21)相似。虽然两种药物均通过消退水肿改善了视力,但在实际临床中,阿柏西普在12个月时能更有效地维持视力,且视网膜下液复发较少。

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