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Intervention with vitamins in patients with nonproliferative diabetic retinopathy: a pilot study

机译:非增生性糖尿病视网膜病变患者的维生素干预:一项初步研究

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Background: The purpose of this study was to determine whether a combination of vitamins B6, B9, and B12 is an effective intervention for reducing the signs and symptoms of nonproliferative diabetic retinopathy. Methods: Ten subjects with type 2 diabetes mellitus (n = 20 eyes) with clinically diagnosed mild to moderate nonproliferative diabetic retinopathy were recruited from a private practice ophthalmology clinic for this open-label, uncontrolled, prospective six-month study. Metanx? vitamin tablets (containing 3 mg L-methylfolate calcium, 35 mg pyridoxal-5′-phosphate, and 2 mg methylcobalamin) were administered at a dosage of two tablets daily. Primary outcome indicators were the percent change in mean retinal sensitivity threshold measured by macular microperimetry and the percent change in mean central retinal thickness measured by spectral-domain optical coherence tomography. Results: Three subjects were lost to follow-up. In the remaining seven subjects, two of 14 eyes had foveal edema that prevented microperimetry measurements due to poor fixation. The remaining 12 eyes showed a nonlinear improvement in mean threshold retinal sensitivity (P < 0.001). Overall change in mean central retinal thickness in 14 eyes was linear (R2 = 0.625; P = 0.034), with a significant reduction between one and six months (P = 0.012). Conclusion: In this pilot study, the Metanx intervention appeared to have some beneficial effects with respect to reducing retinal edema and increasing light sensitivity in subjects with nonproliferative diabetic retinopathy.
机译:背景:本研究的目的是确定维生素B6,B9和B12的组合是否可有效减少非增生性糖尿病性视网膜病的体征和症状。方法:从一家私人眼科诊所招募了10名临床诊断为轻度至中度非增生性糖尿病性视网膜病的2型糖尿病(n = 20眼)受试者,进行了这项开放标签,不受控制的前瞻性6个月研究。 Metanx?维生素片(含3毫克L-甲基叶酸钙,35毫克吡ido醛5'-磷酸和2毫克甲基钴胺素)的剂量为每天两片。主要结局指标是通过黄斑微视野术测得的平均视网膜敏感性阈值变化百​​分比和通过光谱域光学相干断层扫描术测得的平均中央视网膜厚度变化百分比。结果:三名受试者失去随访。在其余的七个受试者中,14只眼中有2只患有黄斑中心水肿,由于固定不良而无法进行显微视野测量。其余12只眼的视网膜平均阈值灵敏度出现非线性改善(P <0.001)。 14只眼的平均中央视网膜厚度的总体变化是线性的(R2 = 0.625; P = 0.034),在1-6个月内显着降低(P = 0.012)。结论:在该初步研究中,Metanx干预似乎在减少非增殖性糖尿病性视网膜病患者的视网膜水肿和增加光敏性方面具有一些有益的作用。

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