Division of Urologic Oncology, Moores Comprehensive Cancer Center and Section of Urology, San Diego Veterans Affairs Medical Center, University of California, San Diego, La Jolla, CA 92093-0987, USA.
Eur Urol. 2012 Aug;62(2):234-41. doi: 10.1016/j.eururo.2012.03.007. Epub 2012 Mar 14.
Despite the high prevalence of clinical benign prostatic hyperplasia (BPH) among older men, there remains a notable absence of studies focused on BPH prevention.
To determine if finasteride prevents incident clinical BPH in healthy older men.
DESIGN, SETTING, AND PARTICIPANTS: Data for this study are from the Prostate Cancer Prevention Trial. After excluding those with a history of BPH diagnosis or treatment, or an International Prostate Symptom Score (IPSS) ≥ 8 at study entry, 9253 men were available for analysis.
The primary outcome was incident clinical BPH, defined as the initiation of medical treatment, surgery, or sustained, clinically significant urinary symptoms (IPSS >14). Finasteride efficacy was estimated using Cox proportional regression models to generate hazards ratios (HRs).
Mean length of follow-up was 5.3 yr. The rate of clinical BPH was 19 per 1000 person-years in the placebo arm and 11 per 1000 person-years in the finasteride arm (p<0.001). In a covariate-adjusted model, finasteride reduced the risk of incident clinical BPH by 40% (HR: 0.60; 95% confidence interval, 0.51-0.69; p<0.001). The effect of finasteride on incident clinical BPH was attenuated in men with a body mass index ≥ 30 kg/m(2) (p(interaction) = 0.04) but otherwise did not differ significantly by physical activity, age, race, current diabetes, or current smoking. The post hoc nature of the analysis is a potential study limitation.
Finasteride substantially reduces the risk of incident clinical BPH in healthy older men. These results should be considered in formulating recommendations for the use of finasteride to prevent prostate diseases in asymptomatic older men.
尽管老年男性中临床良性前列腺增生（BPH）的患病率很高，但仍缺乏针对 BPH 预防的研究。
确定非那雄胺是否可预防健康老年男性发生临床 BPH。
设计、地点和参与者：本研究的数据来自前列腺癌预防试验。排除有 BPH 诊断或治疗史，或入组时国际前列腺症状评分（IPSS）≥8 的患者后，9253 名男性可用于分析。
新发临床 BPH，定义为开始接受药物治疗、手术或持续存在有临床意义的尿症状（IPSS＞14）。使用 Cox 比例风险回归模型估计非那雄胺的疗效，计算风险比（HR）。
平均随访时间为 5.3 年。安慰剂组和非那雄胺组的临床 BPH 发生率分别为每 1000 人年 19 例和 11 例（p＜0.001）。在调整协变量的模型中，非那雄胺可使新发临床 BPH 的风险降低 40%（HR：0.60；95%置信区间：0.51～0.69；p＜0.001）。非那雄胺对临床 BPH 的影响在 BMI≥30 kg/m2 的男性中减弱（p（交互）=0.04），但在体力活动、年龄、种族、现患糖尿病或现患吸烟方面差异无统计学意义。该分析为事后分析，是本研究的一个局限性。
非那雄胺可显著降低健康老年男性发生临床 BPH 的风险。这些结果应在制定无症状老年男性使用非那雄胺预防前列腺疾病的建议时加以考虑。
