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阿柏西普联合普拉洛芬滴眼液或欧米伽-3 营养支持治疗渗出性年龄相关性黄斑变性:一项随机试验。

Treatment of exudative age-related macular degeneration with aflibercept combined with pranoprofen eye drops or nutraceutical support with omega-3: A randomized trial.

机构信息

Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.

Eye Clinic, Department of Health Sciences, University of Molise, Campobasso, Italy.

出版信息

Br J Clin Pharmacol. 2019 May;85(5):908-913. doi: 10.1111/bcp.13871. Epub 2019 Feb 28.

Abstract

AIMS

The aim of this study was to determine whether a combination of intravitreal aflibercept (IVA) and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization (CNV) in age-related macular degeneration.

METHODS

This was a prospective, randomized, pilot study in 60 patients with treatment-naïve CNV. Patients were randomized 1:1:1 into three groups: aflibercept monotherapy (AM), aflibercept plus pranoprofen (AP) or aflibercept plus nutraceutical (AN) tablets containing multivitamin antioxidant and mineral supplementation plus omega-3.

RESULTS

At 12 months, all groups showed significant improvement in both best-corrected visual acuity (BCVA) and central retinal thickness (CRT). The mean BCVA change from baseline to 12 months was -0.26 ± 0.06 LogMAR, -0.30 ± 0.06 LogMAR and -0.24 ± 0.04 LogMAR in the AM, AP and AN groups, respectively. The mean CRT change from baseline to 12 months was -76.9 ± 10.9 μm, -129 ± 19.9 μm and -105 ± 11.6 μm in the AM, AP and AN groups, respectively. The AN group required one less IVA injection than the AM group.

CONCLUSIONS

Compared with AM, both combination groups acted synergistically, although no significant benefits in BCVA were found over AM. Nutraceutical support with omega-3 leads to a reduced need for IVA.

摘要

目的

本研究旨在确定玻璃体内注射阿柏西普(IVA)联合普拉洛芬滴眼液或营养支持治疗与 IVA 单药治疗相比,是否能为年龄相关性黄斑变性脉络膜新生血管(CNV)患者带来更多获益。

方法

这是一项针对 60 例初治 CNV 患者的前瞻性、随机、初步研究。患者按 1:1:1 随机分为三组:阿柏西普单药治疗(AM)组、阿柏西普联合普拉洛芬(AP)组或阿柏西普联合含多种维生素、抗氧化剂和矿物质补充剂及欧米伽-3 的营养支持治疗(AN)组。

结果

在 12 个月时,所有组的最佳矫正视力(BCVA)和中心视网膜厚度(CRT)均有显著改善。从基线到 12 个月时,AM、AP 和 AN 组的平均 BCVA 变化分别为-0.26±0.06 LogMAR、-0.30±0.06 LogMAR 和-0.24±0.04 LogMAR。从基线到 12 个月时,AM、AP 和 AN 组的 CRT 平均变化分别为-76.9±10.9μm、-129±19.9μm 和-105±11.6μm。AN 组的 IVA 注射次数比 AM 组少一次。

结论

与 AM 相比,联合治疗组均有协同作用,尽管在 BCVA 方面并未发现明显优于 AM 的获益。添加欧米伽-3 的营养支持治疗可减少 IVA 的使用。

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