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Korobelnik, J.F., Rougier, M.B., Delyfer, M.N., et al.

期刊名称:JAMA Ophthalmology



摘要:重要性:叶黄素,玉米黄质和ω-3多不饱和脂肪酸的摄取可以增加黄斑色素光密度(MPOD),从而预防年龄相关性黄斑变性(AMD)的发生。目的:旨在评估含有叶黄素,玉米黄质,ω-3多不饱和脂肪酸和维生素的膳食补充剂是否可增加新生血管性AMD患者父母第一代后代的黄斑色素密度。设计,设置和研究对象:本研究是一项随机临床试验(叶黄素对AMD父母所生者的黄斑影响[LIMPIA]),治疗期6个月,之后是6个月的随访期。分析基于意向治疗原则。从20111月(第一例参加者首次随访)到20132月(最后一例参加者末次随访)在法国的2所大学医院(波尔多和第戎)进行。20161月至11月进行分析。研究对象120例无任何视网膜眼病者。他们是患有新生血管性AMD父母的第一代后代。干预:参与者以11比例随机接受2种日常膳食补充胶囊或安慰剂6个月。主要预后指标:主要评估标准是使用改良的MPD-Visucam 200Carl Zeiss Meditec)和改良的海德堡视网膜血管造影仪(Heidelberg Engineering)(HRA)在0.98°偏心率下测量的6个补充剂治疗后的MPOD(两只合格眼的值)。结果:共有120名受试者(每组60名)纳入研究,共分析了239只眼(叶黄素加玉米黄质[L + Z]119只,安慰剂组120只)。平均年龄为56.76.6)岁,女性为71.7%(86例)。治疗3个月和6个月后,与安慰剂组相比,L + Z组血浆叶黄素和玉米黄质的统计学显着增加。然而,以HRA 0.98°偏心率测量的6个月和基线之间的MPOD组间差异为0.03695CI-0.0370.110)(P = 0.33)。结论和相关性:LIMPIA试验第一代新生血管性AMD父母所生后代中,采用改良的HRAMPD-Visucam测量的MPOD在叶黄素和玉米黄质膳食补充剂6个月后没有被改变,尽管血浆水平显示连续暴露于叶黄素和玉米黄质。进一步的研究对于了解这些营养素在黄斑中的吸收和代谢机制,测量MPOD的最佳方法以及患者的临床获益是必要的。试验注册:clinicaltrials.gov标识符:NCT01269697

Importance:Nutritional uptake of lutein, zeaxanthin, and ω-3 polyunsaturated fatty acids may increase macular pigment optical density (MPOD) and thereby protect against the development of age-related macular degeneration (AMD).Objectives:To estimate the efficiency of dietary supplementation containing lutein, zeaxanthin, ω-3 polyunsaturated fatty acids, and vitamins to increase the density of macular pigment in first-generation offspring of parents with neovascular AMD.Design, Setting, and Participants:This study was a randomized clinical trial (Lutein Influence on Macula of Persons Issued From AMD Parents [LIMPIA]) with a 6-month treatment period, followed by a 6-month follow-up period. Analyses were based on the intent-to-treat principle. The setting was 2 university hospitals in France (at Bordeaux and Dijon) from January 2011 (first participant first visit) to February 2013 (last participant last visit). The analysis was conducted from January to November 2016. Participants were 120 individuals free of any retinal ocular disease. They were first-generation offspring of parents with neovascular AMD.Interventions:Participants were randomized in a 1:1 ratio to receive either 2 daily dietary supplementation capsules or placebo for 6 months.Main Outcomes and Measures:The primary assessment criterion was the evolution of MPOD after 6 months of supplementation (value of both eligible eyes) measured using the modified MPD-Visucam 200 (Carl Zeiss Meditec) and the modified Heidelberg Retina Angiograph (Heidelberg Engineering) (HRA) at 0.98° eccentricity. The statistical analysis was adjusted for hospital and for risk factors.Results:Overall, 120 participants (60 in each group) were included, and 239 eyes were analyzed (119 in the lutein plus zeaxanthin [L+Z] group and 120 in the placebo group). Their mean (SD) age was 56.7 (6.6) years, and 71.7% (n=86) were female. A statistically significant increase in plasma lutein and zeaxanthin was shown in the L+Z group after 3 months and 6 months of treatment compared with the placebo group. However, the difference between groups in the evolution of MPOD measured by HRA 0.98° eccentricity between 6 months and baseline was 0.036 (95% CI, -0.037 to 0.110) (P=.33).Conclusions and Relevance:Among first-generation offspring of parents with neovascular AMD in the LIMPIA trial, MPOD as measured with the modified HRA and the MPD-Visucam was not modified after 6 months of lutein and zeaxanthin dietary supplementation despite plasma levels showing continuous exposure to lutein and zeaxanthin. Further research is necessary to understand the mechanism of absorption and metabolism of these nutrients in the macula, the best way to measure MPOD, and the clinical benefit for the patients.Trial Identifier: NCT01269697.


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