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原发性开角型青光眼口服抗氧化剂补充剂的两年随访:一项开放标签、随机、对照试验。

A two-year follow-up of oral antioxidant supplementation in primary open-angle glaucoma: an open-label, randomized, controlled trial.

作者信息

Garcia-Medina Jose Javier, Garcia-Medina Manuel, Garrido-Fernandez Pablo, Galvan-Espinosa Jose, Garcia-Maturana Carlos, Zanon-Moreno Vicente, Pinazo-Duran Maria Dolores

机构信息

Department of Ophthalmology, Huercal Overa Hospital, Almeria, Spain.

Department of Ophthalmology, Reina Sofia University Hospital, Murcia, Spain.

出版信息

Acta Ophthalmol. 2015 Sep;93(6):546-54. doi: 10.1111/aos.12629. Epub 2014 Dec 28.

DOI:10.1111/aos.12629
PMID:25545196
Abstract

PURPOSE

To evaluate the effect of oral antioxidant supplementation (OAS) on primary open-angle glaucoma (POAG) over a 2-year follow-up period.

PATIENTS AND METHODS

In this open-label, randomized controlled trial, 117 eyes of 117 patients with mild or moderate POAG and intraocular pressure under control with topical antiglaucoma medications were recruited and randomly divided into three groups according to supplementation: (1) OAS with (ICAPS R(®) - Alcon Laboratories, n = 26); (2) OAS without ω-3 fatty acids (OFTAN MACULA(®) - Laboratorios Esteve, n = 28); and (3) a control group without OAS (n = 63). They all underwent visual field (VF) tests (Humphrey 24-2) and scans using a Fourier-domain optical coherence tomography (FD-OCT) device (RTVue-100) at the beginning of the study and 2 years later. Mean deviation (MD), standard pattern deviation (PSD), peripapillary retinal nerve fibre layer (RNFL) and macular ganglion cell complex (GCC) parameters were considered for the analysis. Patients were also classified according to MD deterioration (fast deterioration vs. slow deterioration).

RESULTS

Visual field global indices, peripapillary RNFL thickness and macular GCC thickness showed no differences among the groups at the beginning and end of the follow-up. Besides all the comparisons among groups for differences before and after the follow-up of the MD, PSD, RNFL and GCC parameters were also non-significant. The proportions of patients according to MD deterioration were similar among the groups and subgroups (p > 0.05 for all the comparisons).

CONCLUSION

Oral antioxidant supplementation with or without ω-3 fatty acids does not appear useful as an adjuvant treatment of mild/moderate POAG in the short term.

摘要

目的

评估口服抗氧化剂补充剂(OAS)在2年随访期内对原发性开角型青光眼(POAG)的影响。

患者与方法

在这项开放标签的随机对照试验中,招募了117例轻度或中度POAG且眼压通过局部抗青光眼药物控制的患者的117只眼睛,并根据补充剂随机分为三组:(1)含ω-3脂肪酸的OAS(ICAPS R® - 爱尔康实验室,n = 26);(2)不含ω-3脂肪酸的OAS(OFTAN MACULA® - 埃斯特维实验室,n = 28);(3)无OAS的对照组(n = 63)。在研究开始时和2年后,他们均接受了视野(VF)测试(Humphrey 24-2)以及使用傅里叶域光学相干断层扫描(FD-OCT)设备(RTVue-100)进行扫描。分析时考虑平均偏差(MD)、标准模式偏差(PSD)、视乳头周围视网膜神经纤维层(RNFL)和黄斑神经节细胞复合体(GCC)参数。患者还根据MD恶化情况进行分类(快速恶化与缓慢恶化)。

结果

随访开始和结束时,各组之间的视野总体指标、视乳头周围RNFL厚度和黄斑GCC厚度均无差异。此外,MD、PSD、RNFL和GCC参数随访前后组间差异的所有比较也均无统计学意义。各组及亚组中根据MD恶化情况的患者比例相似(所有比较的p>0.05)。

结论

短期而言,含或不含ω-3脂肪酸的口服抗氧化剂补充剂作为轻度/中度POAG的辅助治疗似乎并无用处。

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