Retinal Pathologies and New Therapies Group, Experimental Ophthalmology Laboratory, Department of Ophthalmology, Clínica Universidad de Navarra, Av. de Pío XII, 36, 31008 Pamplona, Spain.
Navarra Institute for Health Research, IdiSNA, C/Irunlarrea, 3, 31008 Pamplona, Spain.
Nutrients. 2021 Apr 10;13(4):1253. doi: 10.3390/nu13041253.
The purpose of this study is evaluate the efficacy and safety of medicinal products containing the original Age-Related Eye Disease group (AREDS) formulation at doses approved in Europe (EU, control group; = 59) with a product that adds DHA, lutein, zeaxanthin, resveratrol and hydroxytyrosol to the formula (intervention group; = 50). This was a multicenter, randomized, observer-blinded trial conducted in patients aged 50 years or older diagnosed with unilateral exudative Age related Macular Degeneration AMD. At month 12, the intervention did not have a significant differential effect on visual acuity compared with the control group, with an estimated treatment difference in Early Treatment Diabetic Retinopathy Study (ETDRS) of -1.63 (95% CI -0.83 to 4.09; = 0.192). The intervention exhibited a significant and, in most cases, relevant effect in terms of a reduction in some inflammatory cytokines and a greater improvement in the fatty acid profile and serum lutein and zeaxantin concentration. In patients with unilateral wet AMD, the addition of lutein, zeaxanthin, resveratrol, hydroxytyrosol and DHA to the AREDS EU recommended doses in the short-term did not have a differential effect on visual acuity compared to a standard AREDS EU formula but, in addition to improving the fatty acid profile and increasing carotenoid serum levels, may provide a beneficial effect in improving the proinflammatory and proangiogenic profile of patients with AMD.
本研究的目的是评估含有原始年龄相关性眼病研究（AREDS）配方的药物在欧洲批准剂量（EU，对照组；n = 59）的疗效和安全性，与添加 DHA、叶黄素、玉米黄质、白藜芦醇和羟基酪醇的产品进行比较（干预组；n = 50）。这是一项多中心、随机、观察者盲法试验，纳入了年龄在 50 岁或以上、单侧渗出性年龄相关性黄斑变性（AMD）的患者。在第 12 个月时，与对照组相比，干预组在视力方面没有显著的差异，早期治疗糖尿病视网膜病变研究（ETDRS）的估计治疗差异为-1.63（95%置信区间-0.83 至 4.09；P = 0.192）。干预组在一些炎症细胞因子的减少和脂肪酸谱以及血清叶黄素和玉米黄质浓度的改善方面表现出显著且在大多数情况下具有相关性的效果。在单侧湿性 AMD 患者中，在短期内向 AREDS EU 推荐剂量中添加叶黄素、玉米黄质、白藜芦醇、羟基酪醇和 DHA 与标准 AREDS EU 配方相比，对视力没有差异，但除了改善脂肪酸谱和增加类胡萝卜素血清水平外，可能对改善 AMD 患者的促炎和促血管生成谱有有益作用。
