在男性低雄性恋患者的丸激素替代疗法期间发生的前列腺安全事件:一项随机临床试验
Shalender Bhasin1, Thomas G Travison2, Karol M Pencina1
1Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
JAMA network open
|December 27, 2023
概括
替代疗法 (TRT) 并没有显著增加前列腺癌或其他前列腺不良事件的风险. 这项研究为有关TRT安全的明智决策提供了关键数据.
科学领域:
- 内分泌学 在内分泌学.
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 在瘤学瘤学.
背景情况:
- 替代疗法 (TRT) 对前列腺健康的影响仍然是一个重要的临床问题.
- 低阴腺男性经常考虑TRT,需要清楚地了解潜在的前列腺相关风险.
研究的目的:
- 评估TRT与安慰剂相比对高度前列腺癌和其他前列腺不良事件的发病率的影响.
- 评估风险,包括任何前列腺癌,急性尿路滞留,和侵袭性前列腺手术在男性.
主要方法:
- 这是一项双盲,安慰剂控制的随机临床试验,涉及5246名患有心血管疾病或心血管疾病风险的男性 (年龄在45-80岁).
- 参与者接受了局部1.62%的丸激素凝或安慰剂,分层对先前的心血管疾病.
- 主要终点是高度前列腺癌发病率;次要终点包括任何前列腺癌,尿路保留和侵入性手术.
主要成果:
- 在14304人年中,高度前列腺癌发病率为TRT的0.19%,与安慰剂的0.12%相比 (HR,1.62;P=.51),没有显著差异.
- 任何前列腺癌,急性尿,侵入性手术和前列腺活检的发病率在各组之间也相似.
- 丸激素治疗导致PSA度增加,但没有显著改变国际前列腺症状得分.
结论:
- 在精心挑选的男性中,TRT并没有增加前列腺癌或其他前列腺不良事件的风险.
- 这些发现支持对TRT的潜在风险和好处进行更明智的评估.
- 在这两组中前列腺事件的发病率很低,这凸显了基线查的重要性.
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