Testosterone Replacement in Men with Age-Related Low Testosterone: What Did We Learn From The Testosterone Trials?
Testosterone Replacement in Men with Age-Related Low Testosterone: What Did We Learn From The Testosterone Trials?
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DOI：
10.1016/j.coemr.2019.04.004
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发表时间：
2019-06-01
影响因子：
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通讯作者：
Matsumoto, Alvin M
中科院分区：
文献类型：
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作者：
Matsumoto, Alvin M
T试验是一组协调的7项双盲、安慰剂对照试验，以评估睾酮与安慰剂凝胶治疗的有效性和安全性，为期一年的788名患有性腺功能减退的65岁或65岁以上的老年男性，他们有自我报告和客观的性和身体功能和/或活力受损，平均两个早晨的血清睾酮浓度为275 ng/dL。年轻男性的睾丸素剂量被调整到中等正常范围。与安慰剂相比，睾酮治疗适度改善了性功能、血红蛋白浓度和纠正的贫血，并略微改善了步行距离、活力、情绪和抑郁症状以及骨密度和力量，但没有改善认知功能。睾酮治疗使非钙化斑块体积和总斑块体积略有增加；但令人担忧的是，这一发现的临床意义尚不清楚。睾酮治疗还增加了PSA水平和泌尿科评估的转诊，并导致一些男性的红细胞增多。T试验为睾酮治疗患有明确的年龄相关性性腺功能减退症的老年男性提供了明确的证据，尽管其益处和风险不大，但在短期内具有临床意义。需要进行更大规模和更长期的安慰剂对照临床试验，以评估睾酮治疗对虚弱、抑郁、骨折、前列腺癌和心血管事件等临床结果的长期益处和风险。
The T Trials were a coordinated set of seven double-blind, placebo-controlled trials to assess efficacy and safety of testosterone versus placebo gel treatment for one year in 788 older men 65 years or older with hypogonadism who had self-reported and objective impairment of sexual and physical function and/or vitality and an average of two morning serum testosterone concentrations < 275 ng/dL. Testosterone dose was adjusted to the mid-normal range for young men. Compared to placebo, testosterone treatment moderately improved sexual function, hemoglobin concentration and corrected anemia, and slightly improved walking distance, vitality, mood and depressive symptoms and bone density and strength, but did not improve cognitive function. Testosterone treatment slightly increased non-calcified and total plaque volume; while concerning, the clinical significance of this finding is not clear. Testosterone treatment also increased PSA levels and referral for urological evaluation, and caused erythrocytosis in some men. The T Trials provided definitive evidence for short-term clinically meaningful, albeit modest benefits and risks of testosterone treatment in older men with unequivocal age-related hypogonadism. Larger and longer-term placebo-controlled clinical trials are needed to assess the long-term benefits and risks of testosterone treatment on clinical outcomes such as frailty, depression, fractures, prostate cancer and cardiovascular events.