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玻璃体内注射布罗利珠单抗治疗新生血管性 AMD 的短期真实世界结局:SHIFT 研究。

Short-term real-world outcomes following intravitreal brolucizumab for neovascular AMD: SHIFT study.

机构信息

Department of Ophthalmology, University of Bonn, Bonn, Germany.

Institute for Medical Biometry, Informatics and Epidemiology, University of Bonn, Bonn, Germany.

出版信息

Br J Ophthalmol. 2022 Sep;106(9):1288-1294. doi: 10.1136/bjophthalmol-2020-318672. Epub 2021 Apr 12.

DOI:10.1136/bjophthalmol-2020-318672
PMID:33846161
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9411904/
Abstract

BACKGROUND

Brolucizumab has recently been approved in Europe as a novel treatment for patients with neovascular age-related macular degeneration (nAMD). We report on early experiences with real-world outcomes of switch to brolucizumab therapy in previously anti-vascular endothelial growth factor (anti-VEGF)-treated patients.

METHODS

Patients with recalcitrant nAMD were switched to brolucizumab therapy. Functional and structural parameters 4 weeks after first brolucizumab injection were evaluated including best-corrected visual acuity (BCVA (logMAR)), foveal centre point (FCP (µm)), central subfield retinal thickness (CSRT (µm)) and macular volume (mm³).

RESULTS

Sixty-three eyes of 57 patients with nAMD (52.6% females) with a mean (±SD) age of 79.5±6.7 years were included. Mean change of BCVA was 0.03±0.14 logMAR (p=0.115). Significant reductions were recorded for FCP with a mean (±SD) change of -66.81±72.63 µm, -66.76±60.71 µm for CSRT and -0.27±0.24 mm³ for macular volume (all p<0.001). Intraocular inflammation was observed in seven eyes of seven patients, including one case of retinal vasculitis.

CONCLUSIONS

The results of the SHIFT study indicate that switch to brolucizumab may represent a treatment option in patients with nAMD poorly responsive to other anti-VEGF agents. Further long-term analyses appear prudent to assess efficacy and safety of brolucizumab in a routine clinical setting.

摘要

背景

布罗鲁单抗最近在欧洲被批准用于治疗新生血管性年龄相关性黄斑变性(nAMD)患者,作为一种新型治疗药物。我们报告了在先前接受过抗血管内皮生长因子(anti-VEGF)治疗的患者中,转为布罗鲁单抗治疗的真实世界结果的早期经验。

方法

对难治性 nAMD 患者进行布罗鲁单抗治疗转换。在首次注射布罗鲁单抗后 4 周评估功能和结构参数,包括最佳矫正视力(BCVA(logMAR))、中心凹点(FCP(µm))、中心视网膜下厚度(CSRT(µm))和黄斑体积(mm³)。

结果

共纳入 57 例(52.6%为女性)63 只眼 nAMD 患者,平均(±SD)年龄为 79.5±6.7 岁。BCVA 平均变化为 0.03±0.14 logMAR(p=0.115)。FCP 显著降低,平均(±SD)变化为-66.81±72.63 µm、-66.76±60.71 µm,黄斑体积平均变化为-0.27±0.24 mm³(均 p<0.001)。7 例 7 只眼出现眼内炎症,包括 1 例视网膜血管炎。

结论

SHIFT 研究的结果表明,对于对其他抗 VEGF 药物反应不佳的 nAMD 患者,转为布罗鲁单抗治疗可能是一种治疗选择。进一步的长期分析似乎有必要评估布罗鲁单抗在常规临床环境中的疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/e2240fe631b9/bjophthalmol-2020-318672f06.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/49757695b0bf/bjophthalmol-2020-318672f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/f47045ceb670/bjophthalmol-2020-318672f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/1f877b7c7668/bjophthalmol-2020-318672f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/a3b1c27bee49/bjophthalmol-2020-318672f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/eee8e981a1de/bjophthalmol-2020-318672f05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/e2240fe631b9/bjophthalmol-2020-318672f06.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/49757695b0bf/bjophthalmol-2020-318672f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/f47045ceb670/bjophthalmol-2020-318672f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/1f877b7c7668/bjophthalmol-2020-318672f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/a3b1c27bee49/bjophthalmol-2020-318672f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/eee8e981a1de/bjophthalmol-2020-318672f05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1755/9411904/e2240fe631b9/bjophthalmol-2020-318672f06.jpg

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