Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease
Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease
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DOI：
10.1056/nejm199605023341802
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发表时间：
1996-05-02
影响因子：
158.5
通讯作者：
Hammar, S
中科院分区：
文献类型：
--
作者：
Omenn, GS;Goodman, GE;Hammar, S
背景。肺癌和心血管疾病是美国的主要死亡原因，有人提出类胡萝卜素和类维生素A是可以预防这些疾病的药物。方法。我们进行了一项多中心、随机、双盲、安慰剂对照的一级预防试验 - β-胡萝卜素和视黄醇功效试验 - 总共涉及 18,314 名吸烟者、前吸烟者和接触石棉的工人。每天 30 毫克 β 胡萝卜素和每天 25,000 IU 视黄醇棕榈酸酯形式的视黄醇（维生素 A）的组合对主要终点（肺癌发病率）的影响与安慰剂进行了比较。结果。在 73,135 人年的随访期间（平均随访时间为 4.0 年），总共诊断出 388 例新肺癌病例。与安慰剂组相比，积极治疗组患肺癌的相对风险为 1.28（95% 置信区间，1.04 至 1.57；P=0.02）。其他类型癌症的风险没有统计学上的显着差异。在积极治疗组中，全因死亡的相对风险为 1.17（95% 置信区间，1.03 至 1.33）；肺癌死亡人数，1.46（95% 置信区间，1.07 至 2.00）；心血管疾病死亡率为 1.26（95% 置信区间为 0.99 至 1.61）。根据这些发现，随机试验比计划提前 21 个月停止；随访将再持续5年。结论。平均补充四年后，β-胡萝卜素和维生素 A 的组合并没有任何益处，反而可能对肺癌的发病率以及吸烟者和接触石棉的工人死于肺癌、心血管疾病和任何原因的死亡风险产生不利影响。 (C) 1996 年，马萨诸塞州医学会。
Background. Lung cancer and cardiovascular disease are major causes of death in the United States, It has been proposed that carotenoids and retinoids are agents that may prevent these disorders.Methods. We conducted a multicenter, randomized, double-blind, placebo-controlled primary prevention trial - the Beta-Carotene and Retinol Efficacy Trial - involving a total of 18,314 smokers, former smokers, and workers exposed to asbestos. The effects of a combination of 30 mg of beta carotene per day and 25,000 IU of retinol (vitamin A) in the form of retinyl palmitate per day on the primary end point, the incidence of lung cancer, were compared with those of placebo.Results. A total of 388 new cases of lung cancer were diagnosed during the 73,135 person-years of follow-up (mean length of follow-up, 4.0 years). The active-treatment group had a relative risk of lung cancer of 1.28 (95 percent confidence interval, 1.04 to 1.57; P=0.02), as compared with the placebo group. There were no statistically significant differences in the risks of other types of cancer. in the active-treatment group, the relative risk of death from any cause was 1.17 (95 percent confidence interval, 1.03 to 1.33); of death from lung cancer, 1.46 (95 percent confidence interval, 1.07 to 2.00); and of death from cardiovascular disease, 1.26 (95 percent confidence interval, 0.99 to 1.61). On the basis of these findings, the randomized trial was stopped 21 months earlier than planned; follow-up will continue for another 5 years.Conclusions. After an average of four years of supplementation, the combination of beta carotene and vitamin A had no benefit and may have had an adverse effect on the incidence of lung cancer and on the risk of death from lung cancer, cardiovascular disease, and any cause in smokers and workers exposed to asbestos. (C) 1996, Massachusetts Medical Society.