Long-term effects of vitamins C and E, β-carotene, and zinc on age-related macular degeneration: AREDS report no. 35.
Long-term effects of vitamins C and E, β-carotene, and zinc on age-related macular degeneration: AREDS report no. 35.
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DOI：
10.1016/j.ophtha.2013.01.021
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发表时间：
2013-08
期刊：
影响因子：
13.7
通讯作者：
Age-Related Eye Disease Study Research Group
中科院分区：
文献类型：
--
作者：
Chew EY;Clemons TE;Agrón E;Sperduto RD;Sangiovanni JP;Kurinij N;Davis MD;Age-Related Eye Disease Study Research Group
描述高剂量抗氧化剂和锌补充剂对年龄相关性黄斑变性（AMD）进展的长期（10年）影响。多中心、随机、对照临床试验;随后进行流行病学随访研究。4757名患有不同严重程度AMD的参与者参加了临床试验。3549名幸存的参与者同意进行后续研究。在临床试验期间，参与者被随机分配到抗氧化剂C，E和β-胡萝卜素和/或锌与安慰剂。在一只眼睛患有中度AMD或晚期AMD的参与者中，AREDS制剂延迟了向晚期AMD的进展。然后参与者被纳入后续研究。每年进行眼底照片和最佳矫正视力评估的眼睛检查。获得病史和死亡率用于安全性监测。在主要分析中使用重复测量logistic回归。(1)晚期AMD进展或治疗史的影像学评估[新生血管性（NV）或中央地图状萎缩（CGA）]，和（2）相对于基线的中度视力丧失（≥ 15个字母）。在基线时最初分配至AREDS 3和4类安慰剂组的受试者与10年时最初分配至AREDS制剂组的受试者的比较显示，（p<0.001）发展为晚期AMD或NV AMD的风险的比值降低（优势比和99%可信区间：OR 0.66，CI：（0.53-0.83）和OR 0.60，CI：（0.47- 0.83）。（78）分别）。未观察到CGA（OR 1.02，CI：0.71-1.45）的统计学显著性降低（p=0.93）。中度视力丧失的发生率在统计学上显著降低（p=0.002）（OR 0.71，CI：0.57-0.88）。没有与AREDS制剂相关的不良反应。在分配给锌的参与者中，死亡率降低，特别是死于循环系统疾病。临床试验结束后五年，AREDS制剂对NV AMD的发展持续有益，但对CGA则无。这些结果与最初的建议一致，即单眼患有中度AMD或晚期AMD的人应考虑服用AREDS制剂。
To describe the long-term effects (10 years) of the Age-Related Eye Disease Study (AREDS) formulation of high-dose antioxidants and zinc supplement on progression of age-related macular degeneration (AMD). Multi-centered, randomized, controlled clinical trial; followed by epidemiologic follow-up study. 4757 participants with varying severity of AMD were enrolled in the clinical trial. 3549 surviving participants consented to the follow-up study. Participants were randomly assigned to antioxidants C, E, and beta-carotene and/or zinc vs. placebo during the clinical trial. In participants with intermediate AMD or advanced AMD in one eye, the AREDS formulation delayed the progression to advanced AMD. Participants were then enrolled in a follow-up study. Eye exams were conducted with annual fundus photographs and best-corrected visual acuity assessments. Medical histories and mortality were obtained for safety monitoring. Repeated measures logistic regression was used in the primary analyses. (1) Photographic assessment of progression to, or history of treatment for, advanced AMD [neovascular (NV) or central geographic atrophy (CGA)], and (2) moderate visual acuity loss from baseline (≥ 15 letters). Comparison of the participants originally assigned to placebo in AREDS categories 3 and 4 at baseline with those originally assigned to AREDS formulation at 10 years demonstrated a statistically significant (p<0.001) odds reduction in the risk of developing advanced AMD or the development of NV AMD (odds ratios and 99% confidence intervals: OR 0.66, CI: (0.53–0.83) and OR 0.60, CI: (0.47–0. 78), respectively). No statistically significant reduction (p=0.93) was seen for the CGA (OR 1.02, CI: 0.71–1.45). A statistically significant reduction (p=0.002) for the development of moderate vision loss was seen (OR 0.71, CI: 0.57–0.88). No adverse effects were associated with the AREDS formulation. Mortality was reduced in participants assigned to zinc, especially death from circulatory diseases. Five years after the clinical trial ended, the beneficial effects of the AREDS formulation persisted for development of NV AMD but not for CGA. These results are consistent with the original recommendations that persons with intermediate AMD or advanced AMD in one eye should consider taking the AREDS formulation.