Effect of Dutasteride on the Risk of Prostate Cancer.
Effect of Dutasteride on the Risk of Prostate Cancer.
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DOI：
10.1056/nejmoa0908127
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发表时间：
2010-04-01
影响因子：
158.5
通讯作者：
Rittmaster, Roger S.
中科院分区：
文献类型：
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作者：
Andriole, Gerald L.;Bostwick, David G.;Rittmaster, Roger S.
背景：我们进行了一项研究，以确定度他雄胺是否能降低活检发现的前列腺癌高危人群的前列腺癌发病风险。方法：在这项为期4年的多中心、随机、双盲、安慰剂对照、平行组研究中，我们比较了度他雄胺和安慰剂。如果男性年龄在50岁到75岁之间，前列腺特异性抗原(PSA)水平在每毫升2.5到10.0毫克之间，并且在登记前6个月内有一次前列腺活检阴性(6到12个核心)，那么他们就有资格参加这项研究。结果：在6729名接受活检或前列腺手术的男性中，度他司特组3305人中有659人发现癌症，而安慰剂组3424人中有858人发现癌症，在4年的研究期间，度他雄胺的相对风险降低了22.8%(95%可信区间，15.2至29.8)(P
Background: We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease.Methods: In this 4-year, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, we compared dutasteride, at a dose of 0.5 mg daily, with placebo. Men were eligible for inclusion in the study if they were 50 to 75 years of age, had a prostate-specific antigen (PSA) level of 2.5 to 10.0 ng per milliliter, and had had one negative prostate biopsy (6 to 12 cores) within 6 months before enrollment. Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years.Results: Among 6729 men who underwent a biopsy or prostate surgery, cancer was detected in 659 of the 3305 men in the dutasteride group, as compared with 858 of the 3424 men in the placebo group, representing a relative risk reduction with dutasteride of 22.8% (95% confidence interval, 15.2 to 29.8) over the 4-year study period (P