The influence of finasteride on the development of prostate cancer
The influence of finasteride on the development of prostate cancer
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DOI：
10.1056/nejmoa030660
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发表时间：
2003-07-17
影响因子：
158.5
通讯作者：
Coltman, CA
中科院分区：
文献类型：
--
作者：
Thompson, IM;Goodman, PJ;Coltman, CA
背景：雄激素参与前列腺癌的发展。非那雄胺是一种 5α-还原酶抑制剂，可抑制睾酮转化为二氢睾酮（前列腺中的主要雄激素），并可能降低患前列腺癌的风险。 方法：在前列腺癌预防试验中，我们随机分配 18,882 名 55 岁或以上的男性，这些男性直肠指检正常且前列腺特异性抗原 (PSA) 水平为 使用非那雄胺（每天 5 毫克）或安慰剂治疗七年，浓度为 3.0 纳克/毫升或更低。如果根据非那雄胺的影响调整后的年度 PSA 水平超过 4.0 ng/mL，或者直肠指检异常，则建议进行前列腺活检。预计 60% 的参与者将在研究期间诊断出前列腺癌或在研究结束时接受活检。主要终点是研究七年期间前列腺癌的患病率。结果：在拥有最终分析数据的非那雄胺组 4368 名男性中，有 803 名男性（18.4%）检出前列腺癌，在安慰剂组 4692 名拥有最终分析数据的男性中，有 1147 名男性（24.4%）检出前列腺癌，七年期间患病率降低了 24.8%（95% 置信区间， 18.6 至 30.6%；磷
Background: Androgens are involved in the development of prostate cancer. Finasteride, an inhibitor of 5alpha-reductase, inhibits the conversion of testosterone to dihydrotestosterone, the primary androgen in the prostate, and may reduce the risk of prostate cancer.Methods: In the Prostate Cancer Prevention Trial, we randomly assigned 18,882 men 55 years of age or older with a normal digital rectal examination and a prostate-specific antigen (PSA) level of 3.0 ng per milliliter or lower to treatment with finasteride (5 mg per day) or placebo for seven years. Prostate biopsy was recommended if the annual PSA level, adjusted for the effect of finasteride, exceeded 4.0 ng per milliliter or if the digital rectal examination was abnormal. It was anticipated that 60 percent of participants would have prostate cancer diagnosed during the study or would undergo biopsy at the end of the study. The primary end point was the prevalence of prostate cancer during the seven years of the study.Results: Prostate cancer was detected in 803 of the 4368 men in the finasteride group who had data for the final analysis (18.4 percent) and 1147 of the 4692 men in the placebo group who had such data (24.4 percent), for a 24.8 percent reduction in prevalence over the seven-year period (95 percent confidence interval, 18.6 to 30.6 percent; P