叶黄素/玉米黄质对年龄相关性黄斑变性进展影响的二次分析：AREDS2 报告第 3 号。
Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No. 3.
机构信息
Division of Epidemiology and Clinical Research, National Institutes of Health, Bethesda, Maryland.
EMMES Corp, Rockville, Maryland.
出版信息
JAMA Ophthalmol. 2014 Feb;132(2):142-9. doi: 10.1001/jamaophthalmol.2013.7376.
IMPORTANCE
The Age-Related Eye Disease Study (AREDS) formulation for the treatment of age-related macular degeneration (AMD) contains vitamin C, vitamin E, beta carotene, and zinc with copper. The Age-Related Eye Disease Study 2 (AREDS2) assessed the value of substituting lutein/zeaxanthin in the AREDS formulation because of the demonstrated risk for lung cancer from beta carotene in smokers and former smokers and because lutein and zeaxanthin are important components in the retina.
OBJECTIVE
To further examine the effect of lutein/zeaxanthin supplementation on progression to late AMD.
DESIGN, SETTING, PARTICIPANTS: The Age-Related Eye Disease Study 2 is a multicenter, double-masked randomized trial of 4203 participants, aged 50 to 85 years, at risk for developing late AMD; 66% of patients had bilateral large drusen and 34% had large drusen and late AMD in 1 eye.
INTERVENTIONS
In addition to taking the original or a variation of the AREDS supplement, participants were randomly assigned in a factorial design to 1 of the following 4 groups: placebo; lutein/zeaxanthin, 10 mg/2 mg; omega-3 long-chain polyunsaturated fatty 3 acids, 1.0 g; or the combination.
MAIN OUTCOMES AND MEASURE
S Documented development of late AMD by central, masked grading of annual retinal photographs or by treatment history. RESULTS In exploratory analysis of lutein/zeaxanthin vs no lutein/zeaxanthin, the hazard ratio of the development of late AMD was 0.90 (95% CI, 0.82-0.99; P = .04). Exploratory analyses of direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of 0.82 (95% CI, 0.69-0.96; P = .02) for development of late AMD, 0.78 (95% CI, 0.64-0.94; P = .01) for development of neovascular AMD, and 0.94 (95% CI, 0.70-1.26; P = .67) for development of central geographic atrophy. In analyses restricted to eyes with bilateral large drusen at baseline, the direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of 0.76 (95% CI, 0.61-0.96; P = .02) for progression to late AMD, 0.65 (95% CI, 0.49-0.85; P = .002) for neovascular AMD, and 0.98 (95% CI, 0.69-1.39; P = .91) for central geographic atrophy.
CONCLUSION AND RELEVANCE
The totality of evidence on beneficial and adverse effects from AREDS2 and other studies suggests that lutein/zeaxanthin could be more appropriate than beta carotene in the AREDS-type supplements.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00345176.
重要性
年龄相关性眼病研究（AREDS）配方用于治疗年龄相关性黄斑变性（AMD），包含维生素 C、维生素 E、β-胡萝卜素和锌与铜。年龄相关性眼病研究 2（AREDS2）评估了用叶黄素/玉米黄质替代 AREDS 配方中的β-胡萝卜素的价值，因为吸烟者和曾经吸烟者的β-胡萝卜素有肺癌风险，并且叶黄素和玉米黄质是视网膜的重要组成部分。
目的
进一步研究叶黄素/玉米黄质补充剂对晚期 AMD 进展的影响。
设计、地点、参与者：年龄相关性眼病研究 2 是一项多中心、双盲、随机试验，共有 4203 名年龄在 50 至 85 岁之间、有发展为晚期 AMD 风险的参与者；66%的患者双眼有大的玻璃膜疣，34%的患者一只眼有大的玻璃膜疣和晚期 AMD。
干预措施
除了服用原始或改良的 AREDS 补充剂外，参与者还被随机分配到以下 4 组中的 1 组：安慰剂；叶黄素/玉米黄质，10mg/2mg；ω-3 长链多不饱和脂肪酸 3 克；或联合组。
主要结果和测量
通过中央、盲法评估每年的视网膜照片或治疗史，记录晚期 AMD 的发展情况。
结果
在叶黄素/玉米黄质与无叶黄素/玉米黄质的探索性分析中，晚期 AMD 发展的风险比为 0.90（95%CI，0.82-0.99；P=0.04）。对叶黄素/玉米黄质与β-胡萝卜素直接比较的探索性分析显示，晚期 AMD 的发展风险比为 0.82（95%CI，0.69-0.96；P=0.02），新生血管性 AMD 的发展风险比为 0.78（95%CI，0.64-0.94；P=0.01），中心性地图状萎缩的发展风险比为 0.94（95%CI，0.70-1.26；P=0.67）。在仅限于基线时双眼有大玻璃膜疣的眼分析中，叶黄素/玉米黄质与β-胡萝卜素的直接比较显示，晚期 AMD 进展的风险比为 0.76（95%CI，0.61-0.96；P=0.02），新生血管性 AMD 的风险比为 0.65（95%CI，0.49-0.85；P=0.002），中心性地图状萎缩的风险比为 0.98（95%CI，0.69-1.39；P=0.91）。
结论和相关性
AREDS2 和其他研究的有益和不利影响的全部证据表明，叶黄素/玉米黄质在 AREDS 型补充剂中可能比β-胡萝卜素更合适。
试验注册
clinicaltrials.gov 标识符：NCT00345176。
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