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布罗鲁单抗治疗新生血管性年龄相关性黄斑变性的有效性和安全性

[Effectiveness and safety of brolucizumab in the treatment of neovascular age-related macular degeneration].

作者信息

Kulikov A N, Zhalimova V R, Nekrash N A, Kalinicheva Y A, Vasilyev A S, Maltsev D S

机构信息

S.M. Kirov Military Medical Academy, Saint Petersburg, Russia.

出版信息

Vestn Oftalmol. 2024;140(4):40-48. doi: 10.17116/oftalma202414004140.

DOI:10.17116/oftalma202414004140
PMID:39254389
Abstract

PURPOSE

This study analyzes the effectiveness and safety of brolucizumab in the treatment of neovascular age-related macular degeneration (nAMD) in real clinical practice.

MATERIAL AND METHODS

The study included patients with nAMD who received brolucizumab treatment and evaluated the changes in best-corrected visual acuity (BCVA), central retinal thickness (CRT), macular volume, as well as the number of injections and adverse events.

RESULT

The group of previously treated patients included 28 subjects (28 eyes) that were switched to brolucizumab with a loading phase. By 12 months, BCVA changed from 0.43±0.29 to 0.33±0.27 LogMAR (=0.11), CRT decreased from 281.5±58.2 to 239.9±45.6 µm (=0.02). The group of previously untreated patients included 29 subjects (29 eyes). By 12 months, BCVA changed from 0.47±0.32 to 0.40±0.30 LogMAR (=0.09), CRT decreased from 333.2±77.3 to 226.2±49.6 µm (<0.001). Patients received 6.3±0.7 injections. In this group, baseline choroidal thickness showed a statistically significant correlation with final visual acuity (=0.54; <0.05) and CRT (= -0.5; <0.05). The group of previously treated patients switched without a loading phase included 18 patients (18 eyes). By 6 months, BCVA changed from 0.42±0.2 to 0.37±0.26 LogMAR (=0.42). CRT remained stable at 285.6±56.9 µm (=0.97). No adverse events related to intraocular inflammation were reported during the course of 385 injections.

CONCLUSION

Brolucizumab therapy helps achieve significant anatomical and functional improvements in real clinical practice both in patients switched from previous treatments and in treatment-naïve patients. Greater baseline choroidal thickness may be associated with better anatomical and functional outcomes with brolucizumab treatment.

摘要

目的

本研究分析了布罗卢izumab在实际临床实践中治疗新生血管性年龄相关性黄斑变性(nAMD)的有效性和安全性。

材料与方法

该研究纳入接受布罗卢izumab治疗的nAMD患者,评估最佳矫正视力(BCVA)、视网膜中央厚度(CRT)、黄斑体积的变化,以及注射次数和不良事件。

结果

既往接受过治疗的患者组包括28例受试者(28只眼),这些患者在进行负荷期治疗后改用布罗卢izumab。到12个月时,BCVA从0.43±0.29 LogMAR变为0.33±0.27 LogMAR(=改善0.11),CRT从281.5±58.2 µm降至239.9±45.6 µm(=改善0.02)。既往未接受过治疗的患者组包括29例受试者(29只眼)。到12个月时,BCVA从0.47±0.32 LogMAR变为0.40±0.30 LogMAR(=改善0.09),CRT从333.2±77.3 µm降至226.2±49.6 µm(<0.001)。患者接受了6.3±0.7次注射。在该组中,基线脉络膜厚度与最终视力(=0.54;<0.05)和CRT(=-0.5;<0.05)呈统计学显著相关性。既往接受过治疗且未进行负荷期治疗而改用布罗卢izumab的患者组包括18例患者(18只眼)。到6个月时,BCVA从0.42±0.2 LogMAR变为0.37±0.26 LogMAR(=改善0.42)。CRT保持稳定,为285.6±56.9 µm(=改善0.97)。在385次注射过程中未报告与眼内炎症相关的不良事件。

结论

在实际临床实践中,布罗卢izumab治疗有助于既往接受过治疗的患者和初治患者在解剖结构和功能方面取得显著改善。基线脉络膜厚度越大,布罗卢izumab治疗的解剖结构和功能结局可能越好。

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