叶黄素/玉米黄质治疗年龄相关性白内障：AREDS2 随机试验报告第 4 号。
Lutein/zeaxanthin for the treatment of age-related cataract: AREDS2 randomized trial report no. 4.
机构信息
National Eye Institute/National Institutes of Health, Bethesda, MD 20892, USA.
出版信息
JAMA Ophthalmol. 2013 Jul;131(7):843-50. doi: 10.1001/jamaophthalmol.2013.4412.
IMPORTANCE
Age-related cataract is a leading cause of visual impairment in the United States. The prevalence of age-related cataract is increasing, with an estimated 30.1 million Americans likely to be affected by 2020.
OBJECTIVE
To determine whether daily oral supplementation with lutein/zeaxanthin affects the risk for cataract surgery.
DESIGN, SETTING, AND PATIENTS: The Age-Related Eye Disease Study 2 (AREDS2), a multicenter, double-masked clinical trial, enrolled 4203 participants, aged 50 to 85 years, at risk for progression to advanced age-related macular degeneration.
INTERVENTIONS
Participants were randomly assigned to daily placebo; lutein/zeaxanthin, 10mg/2mg; omega-3 long-chain polyunsaturated fatty acids, 1 g; or a combination to evaluate the effects on the primary outcome of progression to advanced age-related macular degeneration.
MAIN OUTCOMES AND MEASURES
Cataract surgery was documented at annual study examination with the presence of pseudophakia or aphakia, or reported during telephone calls at 6-month intervals between study visits. Annual best-corrected visual acuity testing was performed. A secondary outcome of AREDS2 was to evaluate the effects of lutein/zeaxanthin on the subsequent need for cataract surgery.
RESULTS
A total of 3159 AREDS2 participants were phakic in at least 1 eye and 1389 of 6027 study eyes underwent cataract surgery during the study, with median follow-up of 4.7 years. The 5-year probability of progression to cataract surgery in the no lutein/zeaxanthin group was 24%. For lutein/zeaxanthin vs no lutein/zeaxanthin, the hazard ratios for progression to cataract surgery was 0.96 (95% CI, 0.84-1.10; P = .54). For participants in the lowest quintile of dietary intake of lutein/zeaxanthin, the hazard ratio comparing lutein/zeaxanthin vs no lutein/zeaxanthin for progression to cataract surgery was 0.68 (95% CI, 0.48-0.96; P = .03). The hazard ratio for 3 or more lines of vision loss was 1.03 (95% CI, 0.93-1.13; P = .61 for lutein/zeaxanthin vs no lutein/zeaxanthin).
CONCLUSIONS AND RELEVANCE
Daily supplementation with lutein/zeaxanthin had no statistically significant overall effect on rates of cataract surgery or vision loss.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00345176.
重要性
年龄相关性白内障是美国导致视力损害的主要原因。年龄相关性白内障的患病率正在上升，预计到 2020 年，美国将有 3010 万人受到影响。
目的
确定每日口服叶黄素/玉米黄质是否会影响白内障手术的风险。
设计、地点和患者：年龄相关性眼病研究 2 期（AREDS2）是一项多中心、双盲临床试验，招募了 4203 名年龄在 50 至 85 岁之间、有进展为晚期年龄相关性黄斑变性风险的参与者。
干预措施
参与者被随机分配到每日安慰剂；叶黄素/玉米黄质 10mg/2mg；ω-3 长链多不饱和脂肪酸 1g；或联合评估对主要结局（进展为晚期年龄相关性黄斑变性）的影响。
主要结果和测量
每年通过研究检查记录白内障手术情况，存在假性晶状体或无晶状体，或在研究期间每 6 个月进行一次电话随访时报告。每年进行最佳矫正视力测试。AREDS2 的次要结果是评估叶黄素/玉米黄质对随后白内障手术需求的影响。
结果
共有 3159 名 AREDS2 参与者在至少 1 只眼中有晶状体，在 6027 只研究眼中有 1389 只进行了白内障手术，中位随访时间为 4.7 年。无叶黄素/玉米黄质组 5 年内进展为白内障手术的概率为 24%。对于叶黄素/玉米黄质与无叶黄素/玉米黄质相比，进展为白内障手术的风险比为 0.96（95%CI，0.84-1.10；P=.54）。对于饮食中叶黄素/玉米黄质摄入量最低五分位的参与者，比较叶黄素/玉米黄质与无叶黄素/玉米黄质进展为白内障手术的风险比为 0.68（95%CI，0.48-0.96；P=.03）。视力丧失 3 行或更多行的风险比为 1.03（95%CI，0.93-1.13；P=.61 为叶黄素/玉米黄质与无叶黄素/玉米黄质相比）。
结论和相关性
每日补充叶黄素/玉米黄质对白内障手术或视力丧失的发生率没有统计学上的显著影响。
试验注册
clinicaltrials.gov 标识符：NCT00345176。
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