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评估接受传统抗 VEGF 治疗的糖尿病黄斑水肿患者对 brolucizumab 的初始反应:一项回顾性、单中心、观察性研究。

Evaluating initial responses to brolucizumab in patients undergoing conventional anti-VEGF therapy for diabetic macular edema: a retrospective, single-center, observational study.

机构信息

Department of Ophthalmology, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.

Department of Ophthalmology, Suwa Red Cross Hospital, Suwa, Nagano, Japan.

出版信息

Sci Rep. 2023 Jul 5;13(1):10901. doi: 10.1038/s41598-023-37726-5.

Abstract

Our retrospective, single-center, observational study aimed to evaluate the initial responses to intravitreal injection of brolucizumab (IVBr) in patients undergoing anti-vascular endothelial growth factor (VEGF) therapy for diabetic macular edema (DME). In total, 23 eyes of 20 patients with DME treated with at least one intravitreal injection of ranibizumab or aflibercept within one year and then switched to IVBr were included. Best corrected visual acuity (BCVA), central macular thickness (CMT), and macular volume (MV) on optical coherence tomography images were evaluated just before the most recent conventional anti-VEGF (ranibizumab/aflibercept) injection therapy (V1), one month after the most recent traditional anti-VEGF therapy (V2), just before the first IVBr (V3), and one month after the first IVBr (V4). BCVA, CMT, MV, and presence of intraocular inflammation (IOI) were evaluated at each visit. Anterior chamber flare values were also examined at V3 and V4. BCVA showed significant improvement at V2 (0.30 ± 0.23) than V1 (0.39 ± 0.29) and at V4 (0.34 ± 0.26) than V3 (0.48 ± 0.34) (P = 0.002, P < 0.001). However, no significant difference was observed between V2 and V4 (P = 0.257). CMT was significantly thinner at V2 (346.8 ± 90.2 µm) than V1 (495.5 ± 123.8 µm), and at V4 (322.2 ± 95.7 µm) than V3 (536.5 ± 166.0 µm) (P < 0.001, P < 0.001), but no significant difference was observed between V2 and V4 (P = 0.140). MV was significantly smaller at V2 (11.6 ± 2.0 mm) than V1 (12.6 ± 1.9 mm) and at V4 (11.2 ± 2.0 mm) than V3 (12.6 ± 2.0 mm) (P < 0.001, P < 0.001), and even significantly smaller at V4 than V2 (P = 0.009). No patient had IOI. No significant changes were observed in anterior chamber flare values between V3 and V4 (25.6 ± 14.6 vs. 24.0 ± 11.5 photon count/ms; P = 0.543). Both CMT and MV significantly reduced without any adverse events one month after switching from conventional anti-VEGF to IVBr therapy for DME, including IOI. MV was significantly lower for IVBr than anti-VEGF therapy after one month of treatment. Therefore, brolucizumab may be a viable treatment option for DME patients considering switching from conventional anti-VEGF agents for various reasons, such as poor response or inability to extend dosing intervals.

摘要

我们的回顾性、单中心、观察性研究旨在评估玻璃体内注射 brolucizumab(IVBr)在接受抗血管内皮生长因子(VEGF)治疗糖尿病性黄斑水肿(DME)的患者中的初始反应。共有 20 名患者的 23 只眼接受了至少一次玻璃体内注射 ranibizumab 或 aflibercept 治疗,并在一年内转为 IVBr。在最近的常规抗 VEGF(ranibizumab/aflibercept)治疗(V1)前、最近的传统抗 VEGF 治疗(V2)后 1 个月、首次 IVBr 前(V3)和首次 IVBr 后 1 个月(V4)评估最佳矫正视力(BCVA)、中央黄斑厚度(CMT)和光学相干断层扫描图像上的黄斑体积(MV)。每次就诊时均评估 BCVA、CMT、MV 和眼内炎症(IOI)的存在情况。还在 V3 和 V4 时检查前房闪光值。V2 时 BCVA 显著改善(0.30 ± 0.23),优于 V1(0.39 ± 0.29),V4 时(0.34 ± 0.26)优于 V3(0.48 ± 0.34)(P=0.002,P<0.001)。然而,V2 和 V4 之间无显著差异(P=0.257)。V2 时 CMT 显著变薄(346.8 ± 90.2 µm),优于 V1(495.5 ± 123.8 µm)和 V4(322.2 ± 95.7 µm)(P<0.001,P<0.001),但 V2 和 V4 之间无显著差异(P=0.140)。V2 时 MV 显著较小(11.6 ± 2.0 mm),优于 V1(12.6 ± 1.9 mm)和 V4(11.2 ± 2.0 mm)(P<0.001,P<0.001),甚至 V4 时比 V2 时更小(P=0.009)。无患者出现 IOI。V3 和 V4 之间前房闪光值无显著变化(25.6 ± 14.6 与 24.0 ± 11.5 光子计数/ms;P=0.543)。从传统抗 VEGF 药物转换为 IVBr 治疗 DME 1 个月后,CMT 和 MV 均显著降低,且无任何不良事件,包括 IOI。转换为 IVBr 治疗后 1 个月,MV 显著低于抗 VEGF 治疗。因此,对于因各种原因(如反应不佳或无法延长给药间隔)考虑从传统抗 VEGF 药物转换的 DME 患者,brolucizumab 可能是一种可行的治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/183d/10322981/c3e10246f5dd/41598_2023_37726_Fig1_HTML.jpg

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