J Sex Med.：新研究表明睾酮替代疗法并不增加前列腺癌发病率

根据2012年6月6日在线发表在Journal of Sexual Medicine期刊上的一篇论文，睾酮替代疗法(testosterone replacement therapy, TRT)似乎是安全的，并不增加前列腺癌发病率。

英国伦敦大学学院医院研究员Mark R. Feneley博士和伦敦男性健康中心研究员Malcolm Carruthers博士开展了一项最新的研究：分析接受TRT治疗的男性的长期前列腺癌发病率。研究人员对患有雄激素缺乏症并且正在接受TRT(颗粒植入、十一烷酸睾酮、美睾酮和Testogel)治疗的1365名患者(平均年龄为55岁)的临床数据进行综述，并且对这些临床数据进行高达20年的追踪。所有的患者在接受治疗前进行过前列腺癌筛查，而且他们的内分泌、生化、血液学和尿液图谱需要接受基线评估，而且每隔6个月也要进行一次。

在进行2966人工年(man-year)治疗之后，研究人员发现总共确诊出14个新的列腺癌病例(每212年治疗后产生一个病例)。平均确诊时间为6.3年(范围为1-12年)。进行睾酮替换治疗对总前列腺特异性抗原(prostate-specific antigen, t-PSA)、游离PSA(free PSA, f-PSA)或者f-PSA与t-PSA的比例并没有产生统计学上显著性的影响。研究人员并没有观察到任何初始的PSA改变和随后的前列腺癌确诊之间存在联系。

论文作者们在文中写道，“这项研究提供相当多的证据证实在采取合适的临床监控下，睾酮替换疗法对前列腺是安全的，同时也改善早期的前列腺癌检测。对个人而言，进行前列腺定期监控的睾酮替换疗法可能比任何没有监控的其他疗法更加安全。”

doi:10.1111/j.1743-6109.2012.02808.x
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Is Testosterone Treatment Good for the Prostate? Study of Safety during Long-Term Treatment

Mark R. Feneley MD, FRCS(Urol)1, Malcolm Carruthers MD

Introduction.  For men with androgen deficiency on testosterone replacement therapy (TRT), clinical concern relates to the development of prostate cancer (PCa). Aim.  An updated audit of prostate safety from the UK Androgen Study was carried out to analyze the incidence of PCa during long-term TRT. Main Outcome Measures.  Diagnosis of PCa in men receiving TRT, by serum prostate-specific antigen (PSA) testing and digital rectal examination (DRE), and its relation to different testosterone preparations. Methods.  One thousand three hundred sixty-five men aged 28–87 (mean 55) years with symptomatic androgen deficiency and receiving TRT have been monitored for up to 20 years. All patients were prescreened for PCa by DRE and PSA along with endocrine, biochemical, hematological, and urinary profiles at baseline and every 6 months. Abnormal findings or rising PSA were investigated by transrectal ultrasound and prostate biopsy. The data were compared for the four different testosterone preparations used in TRT, including pellet implants, Restandol, mesterolone, and Testogel. Results.  Fourteen new cases of PCa were diagnosed at one case per 212 years treatment, after 2,966 man-years of treatment (one case per 212 years). Time to diagnosis ranged from 1 to 12 years (mean 6.3 years). All tumors were clinically localized and suitable for potentially curative treatment. Initiating testosterone treatment had no statistically significant effect on total PSA, free PSA or free/total PSA ratio, and any initial PSA change had no predictive relationship to subsequent diagnosis of cancer. Conclusions.  The incidence of PCa during long-term TRT was equivalent to that expected in the general population. This study adds to the considerable weight of evidence that with proper clinical monitoring, testosterone treatment is safe for the prostate and improves early detection of PCa. Testosterone treatment with regular monitoring of the prostate may be safer for the individual than any alternative without surveillance.