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阿柏西普治疗新生血管性年龄相关性黄斑变性的双倍剂量研究(DIANA):一项真实世界研究。

Double-dose investigation of aflibercept in neovascular age-related macular degeneration (DIANA): a real-world study.

机构信息

Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Wujin Road 85, Hongkou District, Shanghai, China.

Quanzhou Women's and Children's Hospital, Fujian, China.

出版信息

BMC Ophthalmol. 2024 May 17;24(1):215. doi: 10.1186/s12886-024-03476-9.

DOI:10.1186/s12886-024-03476-9
PMID:38760766
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11100152/
Abstract

BACKGROUND

To investigate the clinical effects of double-dose (4 mg) aflibercept treatment in neovascular age-related macular degeneration (nAMD), compared with the standard-dose (2 mg) treatment.

METHODS

A total of 108 eyes from 97 patients with nAMD and received intravitreal aflibercept 2 mg and/or 4 mg treatment were retrospectively reviewed. The changes of central macular thickness (CMT)/ pigmental epithelium detachment height and the recurrence rate of exudation during the 12-month follow-up were compared between the 2 mg group and the 4 mg group. Self-control comparisons (2 mg switch to 4 mg) were also made between two regimens.

RESULTS

Compared with the 2 mg group, tendencies of lower intraretinal fluid incidence and more CMT reduction were observed in the 4 mg group. The later one was also observed when eyes switching from 2 mg to 4 mg regimen. The median remission interval was 5 months in the 4 mg group, 2 months longer than the 3 months in the 2 mg group (P = 0.452). Injections needed in the 4 mg group were 3.644 ± 1.670, less than the 4.286 ± 2.334 injections in the 2 mg group within 12 months as well (P = 0.151). However, no associated vision benefits were gained from the double-douse regimen. No markedly increased-intraocular pressure events, or other adverse events were found in two groups.

CONCLUSIONS

Compared to the aflibercept 2 mg treatment in nAMD, tendencies of anatomic gains and relieving treatment burden were brought by the aflibercept 4 mg treatment. This study may have additional importance, given the further application of high-dose aflibercept in real-world settings.

摘要

背景

为了探究在新生血管性年龄相关性黄斑变性(nAMD)中,与标准剂量(2mg)相比,使用双倍剂量(4mg)阿柏西普治疗的临床效果。

方法

回顾性分析了 97 例 nAMD 患者 108 只眼,这些患者均接受了玻璃体内注射阿柏西普 2mg 和/或 4mg 治疗。比较了两组患者在 12 个月的随访过程中,中央视网膜厚度(CMT)/色素上皮脱离高度的变化情况和渗出物的复发率。同时对两种方案进行了自身对照比较(2mg 转换为 4mg)。

结果

与 2mg 组相比,4mg 组眼内液发生率较低,CMT 降低趋势更明显。在将治疗方案从 2mg 转换为 4mg 时,也观察到了这一点。4mg 组的缓解间隔中位数为 5 个月,比 2mg 组的 3 个月长 2 个月(P = 0.452)。在 12 个月内,4mg 组需要注射的次数为 3.644 ± 1.670,少于 2mg 组的 4.286 ± 2.334(P = 0.151)。然而,从双重剂量方案中并未获得明显的视力获益。两组均未发现明显的眼压升高事件或其他不良反应。

结论

与 nAMD 中的阿柏西普 2mg 治疗相比,阿柏西普 4mg 治疗具有获得解剖学改善和减轻治疗负担的趋势。鉴于高剂量阿柏西普在实际环境中的进一步应用,本研究可能具有额外的重要意义。

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