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法西单抗治疗糖尿病性黄斑水肿的疗效与安全性:初治和既往治疗眼的真实世界结果

Efficacy and Safety of Faricimab in Diabetic Macular Edema: Real-World Outcomes in Treatment-Naïve and Previously Treated Eyes.

作者信息

Esteban-Floría Olivia, Mateo Javier, Lara Javier, Bartolomé Isabel, Herrero Inmaculada, Pérez María A, Cabello Concepción, Honrubia Ana, Pinilla Isabel, Ascaso Javier

机构信息

Department of Ophthalmology, Hospital Clínico Universitario Lozano Blesa, C. de San Juan Bosco, 15, 50009 Zaragoza, Spain.

Instituto de Investigación Sanitaria de Aragon (IIS), 50009 Zaragoza, Spain.

出版信息

J Clin Med. 2025 Sep 1;14(17):6173. doi: 10.3390/jcm14176173.

Abstract

The objective of this study was to assess the efficacy and safety of faricimab in diabetic macular edema (DME) in patients who were treatment-naïve or previously treated in a real-world setting. This was a retrospective, observational, single-center study that included 105 eyes from 79 patients diagnosed with DME and treated with intravitreal faricimab between January 2024 and January 2025. Patients were categorized into two groups according to their treatment history, namely treatment-naïve eyes and eyes previously treated (switch group). Functional (best-corrected visual acuity, BCVA) and anatomical (central foveal thickness, CFT; macular volume, MV) outcomes were assessed. The safety of faricimab was evaluated from changes in intraocular pressure and the occurrence of adverse events. BCVA improved significantly in both groups, with a mean gain of +0.16 in treatment-naïve eyes and +0.10 in switch eyes. The mean reduction in CFT was -53.7 µm in the naïve group and -37.8 µm in the switch group. MV decreased by -0.4 mm overall, with significant reductions in both groups. No adverse events were reported, confirming the safety of faricimab in routine clinical practice. Faricimab showed significant improvements in functional and anatomical outcomes in patients with DME, regardless of the use of previous anti-VEGF therapies. These findings support the effectiveness and safety of faricimab in a real-world clinical setting and reinforce its potential as a valuable treatment option for DME.

摘要

本研究的目的是评估法西单抗在初治或既往在真实世界环境中接受过治疗的糖尿病性黄斑水肿(DME)患者中的疗效和安全性。这是一项回顾性、观察性、单中心研究,纳入了2024年1月至2025年1月期间79例诊断为DME并接受玻璃体内注射法西单抗治疗的患者的105只眼。根据治疗史将患者分为两组,即初治眼和既往接受过治疗的眼(转换组)。评估了功能(最佳矫正视力,BCVA)和解剖学(中心凹厚度,CFT;黄斑体积,MV)结果。通过眼压变化和不良事件的发生情况评估法西单抗的安全性。两组的BCVA均显著改善,初治眼平均提高+0.16,转换眼平均提高+0.10。初治组CFT平均降低-53.7 µm,转换组降低-37.8 µm。MV总体下降-0.4 mm,两组均有显著下降。未报告不良事件,证实了法西单抗在常规临床实践中的安全性。无论既往是否使用抗VEGF治疗,法西单抗在DME患者的功能和解剖学结果方面均有显著改善。这些发现支持了法西单抗在真实世界临床环境中的有效性和安全性,并强化了其作为DME有价值治疗选择的潜力。

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