A Randomized, Placebo-Controlled, Clinical Trial Of High-Dose Supplementation With Vitamins C And E, Beta Carotene, And Zinc For Age-Related Macular Degeneration And Vision Loss - Areds Report No. 8

A Kassoff,J Kassoff,J Buehler,M Eglow,F Kaufman,M Mehu,S Kieval,M Mairs, B Graig, A Quattrocchi, D Jones, J Locatelli,A Ruby,A Capone,B Garretson,T Hassan,Mt Trese,Ga Williams,V Regan,P Manatrey,P Streasick,L Szydlowski,F Mciver,C Bridges, C Stanley,K Cumming,B Lewis,M Zajechowski,Rr Margherio,Ms Cox, J Camille,R Falk, P Siedlak, C Neubert,Ml Klein,Jt Stout,A O'Malley,Ak Lauer,Je Robertson,Dj Wilson,C Beardsley, H Anderson,P Wallace, G Smith,S Howard,Rf Dreyer,C Ma,Rg Chenoweth,Jd Zilis,M Johnson,P Rice, H Daniel,H Crider,S Parker,K Sherman,Df Martin,Tm Aaberg,P Sternberg, Lt Curtis,B Ju,J Gilman,B Myles,S Strittman, C Gentry, H Yi,A Capone, M Lambert,T Meredith,Tm Aaberg,D Saperstein,Ji Lim,B Stribling,D Armiger,R Swords,Dh Orth,Tp Flood,J Civantos,S Debustros,Kh Packo,Pt Merrill,Ja Cohen,C Figliulo,C Morrison,Da Bryant,D Doherty, M Mcvicker, T Drefcinski,Jm Seddon,Mk Pinnolis,N Davis,I Burton,T Taitsel,D Walsh, J Dubois-Moran,C Callahan,C Evans,Kk Snow,Da Jones-Devonish,Vd Crouse, Nj Rosenberg,Ey Chew,K Csaky,Fl Ferris, Kh Shimel, Ma Woods,Em Kuehl,Pf Ciatto, M Palmer,G Babilonia-Ayukawa, Ge Foster,L Goodman,Yj Kim, Ij Kivitz,D Koutsandreas,A Lareau, Rf Mercer,R Nashwinter,Sa Mccarthy,Lm Ayres,P Lopez, A Randalls,Tr Friberg,Aw Eller,Mb Gorin, S Nixon,B Mack, Dy Curtin,Pp Ostroska, E Fijewski,J Alexander, Mk Paine,Ps Corbin,J Warnicki,Sb Bressler,Nm Bressler,G Cassel,D Finkelstein,M Goldberg,Ja Haller,L Ratner,Ap Schachat,Sh Sherman,Js Sunness,S Schenning,C Sackett,D Cain,D Emmert,M Herring,J Mcdonald,R Falk,S Wheeler, M Mcmillan,T George,Mj Elman,R Ballinger,A Betancourt,D Glasser, M Herr, D Hirsh, D Kilingsworth, P Kohlhepp,J Lammlein, Rz Raden,R Seff,M Shuman,J Starr,A Carrigan,P Sotirakos,T Cain,T Mathews,C Ringrose,Sr Chandra, Jl Gottlieb, Ms Ip,R Klein,Tm Nork,Ts Stevens,Ba Blodi,M Altaweel,Bek Klein, M Olson,B Soderling,M Blatz, Jr Perry-Raymond,K Burke,G Knutson,J Peterson,D Krolnik,R Harrison,G Somers,Fl Myers, I Wallow,Tw Olsen, G Bresnik,G De Venecia,T Perkins,W Walker, Jl Miller,M Neider, Hd Wabers, G Weber, Hel Myers,Md Davis,Bek Klein,R Klein,L Hubbard,M Neider, Hd Wabers,Yl Magli,S Ansay,J Armstrong, K Lang,D Badal,Pl Geithman,Kd Miner,Kl Dohm,B Esser,C Hurtenbach, S Craanen, M Webster, J Elledge, S Reed, W Benz,J Reimers,Mr Fisher, R Gangnon, W King, Cy Gai,J Baliker,A Carr, K Osterby,L Kastorff, N Robinson,J Onofrey, Ke Glander,J Brickbauer,D Miller,A Sowell,E Gunter,B Bowman,As Lindblad,Rc Milton,Te Clemons,F Ederer,G Gensler, A Henning,G Entler, W Mcbee, K Roberts,E Stine,Sh Berlin,K Tomlin, S Pallas,Pr Scholl,Sa Mengers,R Anand,Fl Ferris,Rd Sperduto,N Kurinij,Ey Chew

Archives of ophthalmology (Chicago, Ill. : 1960)（2001）

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摘要

Background: Observational and experimental data suggest that antioxidant and/or zinc supplements may delay progression of age-related macular degeneration (AMD) and vision loss.Objective: To evaluate the effect of high-dose vitamins C and E, beta carotene, and zinc supplements on AMD progression and visual acuity.Design: The Age-Related Eye Disease Study, an 11-center double-masked clinical trial, enrolled participants in an AMD trial if they had extensive small drusen, intermediate drusen, large drusen, noncentral geographic atrophy, or pigment abnormalities in 1 or both eyes, or advanced AMD or vision loss due to AMD in 1 eye. At least 1 eye had best-corrected visual acuity of 20/32 or better. Participants were randomly assigned to receive daily oral tablets containing: (1) antioxidants (vitamin C, 500 mg; vitamin E, 400 IU; and beta carotene, 15 mg) (2) zinc, 80 mg, as zinc oxide and copper, 2 mg, as cupric oxide; (3) antioxidants plus zinc; or (4) placebo. Main Outcome Measures: (1)Photographic assessment of progression to or treatment for advanced AMD and (2) at least moderate visual acuity loss from baseline ( : 15 letters). Primary analyses used repeated-measures logistic regression with a significance level of .01, unadjusted for covariates. Serum level measurements, medical histories, and mortality rates were used for safety monitoring.Results: Average follow-up of the 3640 enrolled study participants, aged 55-80 years, was 6.3 years, with 2.4% lost to follow-up. Comparison with placebo demonstrated a statistically significant odds reduction for the development of advanced AMD with antioxidants plus zinc (odds ratio [OR], 0.72; 99% confidence interval [CI], 0.52-0.98). The ORs for zinc alone and antioxidants alone are 0.75 (99% CI, 0.55-1.03) and 0.80 (99% CI, 0.59-1.09), respectively. Participants with extensive small drusen, nonextensive intermediate size drusen, or pigment abnormalities had only a 1.3% 5-year probability of progression to advanced AMD. Odds reduction estimates increased when these 1063 participants were excluded (antioxidants plus zinc: OR, 0.66; 99% CI, 0.47-0.91; zinc: OR, 0.71; 99% CI, 0.52-0.99; antioxidants: OR, 0.76; 99% CI, 0.55-1.05). Both zinc and antioxidants plus zinc significantly reduced the odds of developing advanced AMD in this higher-risk group. The only statistically significant reduction in rates of at least moderate visual acuity loss occurred in persons assigned to receive antioxidants plus zinc (OR, 0.73; 99% CI, 0.54-0.99). No statistically significant serious adverse effect was associated with any of the formulations.Conclusions: Persons older than 55 years should have dilated eye examinations to determine their risk of developing advanced AMD. Those with extensive intermediate size drusen, at least 1 large druse, noncentral geographic atrophy in 1 or both eyes, or advanced AMD or vision loss due to AMD in 1 eye, and without contraindications such as smoking, should consider taking a supplement of antioxidants plus zinc such as that used in this study.

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