Effects of Selenium Supplementation for Cancer Prevention in Patients With Carcinoma of the Skin: A Randomized Controlled Trial
Effects of Selenium Supplementation for Cancer Prevention in Patients With Carcinoma of the Skin: A Randomized Controlled Trial
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DOI：
10.1001/jama.1996.03540240035027
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发表时间：
1996-12
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影响因子：
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通讯作者：
L. Clark;G. Combs;B. Turnbull;E. Slate;D. Chalker;J. Chow;L. Davis;R. A. Glover;G. Graham;E. G. Gross;A. Krongrad;J. Lesher;H. K. Park;B. B. Sanders-B.;Cameron L Smith;J. Taylor
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文献类型：
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作者：
L. Clark;G. Combs;B. Turnbull;E. Slate;D. Chalker;J. Chow;L. Davis;R. A. Glover;G. Graham;E. G. Gross;A. Krongrad;J. Lesher;H. K. Park;B. B. Sanders-B.;Cameron L Smith;J. Taylor
客观的。 —确定硒的营养补充剂是否会降低癌症的发病率。设计。 ——一项多中心、双盲、随机、安慰剂对照的癌症预防试验。环境。 —美国东部的七家皮肤科诊所。患者。 —从 1983 年到 1991 年，共有 1312 名有皮肤基底细胞癌或鳞状细胞癌病史的患者（平均年龄 63 岁；范围 18-80 岁）被随机分组。患者的平均治疗时间 (SD) 为 4.5 (2.8) 年，总随访时间为 6.4 (2.0) 年。干预措施。 — 每天口服 200 μg 硒或安慰剂。主要成果措施。 —试验的主要终点是皮肤基底细胞癌和鳞状细胞癌的发生率。 1990 年设立的次要终点是全因死亡率和癌症总死亡率、癌症总发病率以及肺癌、前列腺癌和结直肠癌的发病率。结果。 —经过总计 8271 人年的随访，硒治疗并没有显着影响基底细胞或鳞状细胞皮肤癌的发病率。硒组患者中有 377 例新发基底细胞皮肤癌病例，对照组有 350 例（相对风险 [RR]，1.10；95% 置信区间 [CI]，0.95-1.28）；硒组患者中有 218 例新发鳞状细胞皮肤癌，对照组有 190 例（RR，1.14；95% CI， 0.93-1.39）。次要终点分析显示，与对照组相比，接受硒治疗的患者全因死亡率无显着降低（硒组死亡 108 例，对照组死亡 129 例 [RR，0.83；95% CI，0.63-1.08]），癌症总死亡率显着降低（硒治疗组死亡 29 例，对照组死亡 57 例 [RR，0.50；95% CI，0.63-1.08]）。 95% CI，0.31-0.80]）、总癌症发病率（硒组中有 77 例癌症，对照组有 119 例癌症 [RR，0.63；95% CI，0.47-0.85]），以及肺癌、结直肠癌和前列腺癌的发病率。主要是因为硒组的癌症总死亡率和癌症总发病率明显降低，该试验的盲法阶段提前停止。没有发生硒中毒病例。结论。 —硒治疗不能预防皮肤基底细胞癌或鳞状细胞癌的发展。然而，次要终点分析的结果支持这样的假设：补充硒可以降低多个部位癌症的发病率和死亡率。硒的这些影响需要在适当设计的独立试验中得到确认，然后才能提出有关补充硒的新的公共卫生建议。
Objective. —To determine whether a nutritional supplement of selenium will decrease the incidence of cancer. Design. —A multicenter, double-blind, randomized, placebo-controlled cancer prevention trial. Setting. —Seven dermatology clinics in the eastern United States. Patients. —A total of 1312 patients (mean age, 63 years; range, 18-80 years) with a history of basal cell or squamous cell carcinomas of the skin were randomized from 1983 through 1991. Patients were treated for a mean (SD) of 4.5 (2.8) years and had a total follow-up of 6.4 (2.0) years. Interventions. —Oral administration of 200 μg of selenium per day or placebo. Main Outcome Measures. —The primary end points for the trial were the incidences of basal and squamous cell carcinomas of the skin. The secondary end points, established in 1990, were all-cause mortality and total cancer mortality, total cancer incidence, and the incidences of lung, prostate, and colorectal cancers. Results. —After a total follow-up of 8271 person-years, selenium treatment did not significantly affect the incidence of basal cell or squamous cell skin cancer. There were 377 new cases of basal cell skin cancer among patients in the selenium group and 350 cases among the control group (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28), and 218 new squamous cell skin cancers in the selenium group and 190 cases among the controls (RR, 1.14; 95% CI, 0.93-1.39). Analysis of secondary end points revealed that, compared with controls, patients treated with selenium had a nonsignificant reduction in all-cause mortality (108 deaths in the selenium group and 129 deaths in the control group [RR, 0.83; 95% CI, 0.63-1.08]) and significant reductions in total cancer mortality (29 deaths in the selenium treatment group and 57 deaths in controls [RR, 0.50; 95% CI, 0.31-0.80]), total cancer incidence (77 cancers in the selenium group and 119 in controls [RR, 0.63; 95% CI, 0.47-0.85]), and incidences of lung, colorectal, and prostate cancers. Primarily because of the apparent reductions in total cancer mortality and total cancer incidence in the selenium group, the blinded phase of the trial was stopped early. No cases of selenium toxicity occurred. Conclusions. —Selenium treatment did not protect against development of basal or squamous cell carcinomas of the skin. However, results from secondary end-point analyses support the hypothesis that supplemental selenium may reduce the incidence of, and mortality from, carcinomas of several sites. These effects of selenium require confirmation in an independent trial of appropriate design before new public health recommendations regarding selenium supplementation can be made.