Moinpour Carol M, Darke Amy K, Donaldson Gary W, Thompson Ian M, Langley Connie, Ankerst Donna Pauler, Patrick Donald L, Ware John E, Ganz Patricia A, Shumaker Sally A, Lippman Scott M, Coltman Charles A
Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center/M3-C102, 1100 Fairview Ave North, Box 19024, Seattle, WA 98109-1024, USA.
J Natl Cancer Inst. 2007 Jul 4;99(13):1025-35. doi: 10.1093/jnci/djm023. Epub 2007 Jun 27.
The Prostate Cancer Prevention Trial (PCPT) was a randomized, double-blind, placebo-controlled study of the efficacy of finasteride in preventing prostate cancer in 18,882 men aged 55 years or older. The PCPT offered an opportunity to prospectively study the effects of finasteride and other covariates on sexual dysfunction.
We assessed sexual dysfunction in 17,313 PCPT participants during a 7-year period. A battery of questionnaires assessed sexual dysfunction (Sexual Activity Scale score); age; race; SF-36 Mental Health Inventory-5, Physical Function, and Vitality scores; body mass index; smoking status; and the presence of diabetes and hypertension. Assessments began at month 6 after random assignment and included the Sexual Activity Scale score at randomization as a covariate. Two-sided general t tests, with a cutoff of P value less than .05, were used to determine the statistical significance for mixed model effects with correlated random time slopes and intercepts. The changing impact of covariates on sexual dysfunction was also assessed at 6 months, 3.5 years, and 6.5 years after randomization.
Finasteride increased sexual dysfunction only slightly and its impact diminished over time; the increase in the Sexual Activity Scale score relative to placebo of 3.21 points (95% confidence interval [CI] = 2.83 to 3.59 points; P<.001) at the first assessment decreased to 2.11 points (95% CI = 1.44 to 2.81 points; P<.001) at the end of study. These Sexual Activity score values were small on a scale of 0-100, the range observed in the study, and in comparison with individual variation. After adjustment for all covariates, mean sexual dysfunction increased in both arms from baseline (6 months after randomization) by 1.26 Sexual Activity points (95% CI = 1.16 to 1.36 points; P<.001) per year, corresponding to a cumulative increase of 8.22 points (95% CI = 7.52 to 8.92 points; P<.001) over the study period.
The effect of finasteride on sexual functioning is minimal for most men and should not impact the decision to prescribe or take finasteride.
前列腺癌预防试验（PCPT）是一项针对18882名55岁及以上男性进行的随机、双盲、安慰剂对照研究，旨在探讨非那雄胺预防前列腺癌的疗效。PCPT为前瞻性研究非那雄胺及其他协变量对性功能障碍的影响提供了契机。
我们在7年时间里对17313名PCPT参与者的性功能障碍情况进行了评估。通过一系列问卷对性功能障碍（性活动量表评分）、年龄、种族、SF-36心理健康量表-5、身体功能及活力评分、体重指数、吸烟状况以及糖尿病和高血压的存在情况进行了评估。评估在随机分组后第6个月开始，将随机分组时的性活动量表评分作为协变量纳入。采用双侧一般t检验，以P值小于0.05为界值，用于确定具有相关随机时间斜率和截距的混合模型效应的统计学显著性。还在随机分组后的6个月、3.5年和6.5年评估了协变量对性功能障碍影响的变化情况。
非那雄胺仅轻微增加性功能障碍，且其影响随时间减弱；首次评估时相对于安慰剂，性活动量表评分增加3.21分（95%置信区间[CI]=2.83至3.59分；P<0.001），至研究结束时降至2.11分（95%CI=1.44至2.81分；P<0.001）。在本研究观察到的0至100分的量表范围内，以及与个体差异相比，这些性活动评分值较小。在对所有协变量进行调整后，两组的平均性功能障碍从基线（随机分组后6个月）开始每年增加1.26个性活动评分点（95%CI=1.16至1.36分；P<0.001），相当于在研究期间累计增加8.22分（95%CI=7.52至8.92分；P<0.001）。
非那雄胺对大多数男性性功能的影响极小，不应影响开具或服用非那雄胺的决策。
