Effects of long-term oral testosterone undecanoate therapy on urinary symptoms: data from a 1-year, placebo-controlled, dose-ranging trial in aging men with symptomatic hypogonadism
Effects of long-term oral testosterone undecanoate therapy on urinary symptoms: data from a 1-year, placebo-controlled, dose-ranging trial in aging men with symptomatic hypogonadism
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DOI：
10.3109/13685538.2015.1032925
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发表时间：
2015-06
期刊：
影响因子：
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通讯作者：
E. Meuleman;J. Legros;P. Bouloux;A. Johnson-Levonas;Marion J. G. H. Kaspers;J. Elbers;T. Geurts;A. Meehan
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文献类型：
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作者：
E. Meuleman;J. Legros;P. Bouloux;A. Johnson-Levonas;Marion J. G. H. Kaspers;J. Elbers;T. Geurts;A. Meehan
摘要背景：关于睾酮治疗是否会导致或恶化老年男性的泌尿系统症状，一直存在一个长期存在的问题。我们研究了 1 年口服十一酸睾酮 (TU) 治疗对老年性腺功能减退男性泌尿系统症状的影响。方法：共有 322 名 50 岁以上有睾酮缺乏症状的男性参与了一项为期 1 年的随机、多中心、双盲试验。患者接受安慰剂或口服 TU 80 mg/天、160 mg/天或 240 mg/天。结果和局限性：与安慰剂相比，口服 TU 剂量 80 mg/天和 160 mg/天的治疗并未导致 IPSS 泌尿系统症状或生活质量 (QoL) 评分发生显着变化。口服 TU 240 mg/天的治疗导致 IPSS 总分有统计学上显着但临床上不显着的改善，并且 IPSS 生活质量评分也有显着改善。所测试的 TU 剂量均未对 PSA 或 PV 产生显着影响。结论：长期口服 TU 治疗对 IPSS 总分没有有害影响，并且不会改变老年性腺功能减退男性的 PV 和 PSA。口服 TU 治疗剂量为 240 毫克/天甚至可以改善 IPSS 生活质量评分。
Abstract Background: There has been a longstanding question as to whether testosterone therapy could precipitate or worsen urinary symptoms in aging men. We investigated the effects of 1-year oral testosterone undecanoate (TU) therapy on urinary symptoms in aging, hypogonadal men. Methods: A total of 322 men ≥50 years with symptomatic testosterone deficiency participated in a 1-year, randomized, multicenter, double-blind trial. Patients received placebo or oral TU 80 mg/day, 160 mg/day, or 240 mg/day. Results and limitations: Compared with placebo, treatment with oral TU at doses of 80 mg/day and 160 mg/day resulted in no significant change in IPSS urinary symptoms or quality of life (QoL) scores. Treatment with oral TU 240 mg/day led to a statistically significant, but clinically insignificant, improvement in IPSS total score and a significant improvement in IPSS QoL score. None of the TU doses tested had a significant effect on PSA or PV. Conclusions: Long-term oral TU therapy had no deleterious effects on IPSS total score and did not change PV and PSA in aging, hypogonadal men. Oral TU therapy at a dose of 240 mg/day may even improve IPSS QoL score.