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：
10.33589/13.6.0471
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发表时间：
2003-03
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通讯作者：
Ian M. Thompson;P. Goodman;C. Tangen;M. S. Lucia;Gary J. Miller;Leslie G. Ford;Michael M. Lieber;R. D. Cespedes;James N. Atkins;Scott M. Lippman;Susie M. Carlin;Anne Ryan;Connie M Szczepanek;John J. Crowley;C. Coltman
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作者：
Ian M. Thompson;P. Goodman;C. Tangen;M. S. Lucia;Gary J. Miller;Leslie G. Ford;Michael M. Lieber;R. D. Cespedes;James N. Atkins;Scott M. Lippman;Susie M. Carlin;Anne Ryan;Connie M Szczepanek;John J. Crowley;C. Coltman
背景雄激素参与前列腺癌的发展。非那雄胺是一种5 α-还原酶抑制剂，可抑制睾酮转化为双氢睾酮（前列腺中的主要雄激素），并可降低前列腺癌的风险。在前列腺癌预防试验中，我们将18，882名年龄在55岁或以上的男性随机分配，他们的直肠指检正常，前列腺特异性抗原（PSA）水平为3.0 ng/ml或更低，接受非那肽（每天5 mg）或安慰剂治疗7年。如果年PSA水平（根据非那肽的影响进行调整）超过4.0 ng/ml或直肠指检异常，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。主要终点是在七年的研究中前列腺癌的患病率。结果：在有最终分析数据的4368名男性中，有803人被检测出前列腺癌而安慰剂组的4692名男性中有1147名有这样的数据（24.4%），在7年期间患病率降低了24.8%（95%置信区间，18.6%至30.6%; P<0.001）。Gleason分级为7、8、9或10级的肿瘤在芬氟拉明组中更常见（757个肿瘤中的280个[37.0%]，或最终分析中包括的4368名男性中的6.4%）（1068个肿瘤中的237个[22.2%]，组间比较P<0.001;或最终分析中包括的4692名男性中的5.1%，组间比较P=0.005）。性方面的副作用在接受芬氟拉明治疗的男性中更常见，而泌尿系统症状在接受安慰剂的男性中更常见。结论：芬那肽可预防或延迟前列腺癌的出现，但这种可能的益处和降低泌尿系统问题的风险必须与性副作用和高级别前列腺癌风险增加相权衡。
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<0.001). Tumors of Gleason grade 7, 8, 9, or 10 were more common in the finasteride group (280 of 757 tumors [37.0 percent], or 6.4 percent of the 4368 men included in the final analysis) than in the placebo group (237 of 1068 tumors [22.2 percent], P<0.001 for the comparison between groups; or 5.1 percent of the 4692 men included in the final analysis, P=0.005 for the comparison between groups). Sexual side effects were more common in finasteride-treated men, whereas urinary symptoms were more common in men receiving placebo. CONCLUSIONS Finasteride prevents or delays the appearance of prostate cancer, but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high-grade prostate cancer.