Division of Endocrinology, Department of Medicine, The Lundquist Institute and Harbor-UCLA Medical Center, Torrance, CA, USA.
Clinical and Translational Science Institute, The Lundquist Institute and Harbor-UCLA Medical Center, Torrance, CA, USA.
Andrology. 2020 Nov;8(6):1512-1518. doi: 10.1111/andr.12901. Epub 2020 Oct 17.
This manuscript is a review and discussion of the published results of the T Trials.
To re-examine the efficacy of testosterone replacement of hypogonadal men >65 years of age in the T Trials.
The T Trials were a complex collection of seven double blind, placebo-controlled trials of the efficacy of testosterone as replacement therapy for older men with unequivocal hypogonadism. There were three main trials (sexual function; physical function; vitality) and four sub-trials (cognition; bone; anemia; and cardiovascular). All subjects participated in the main trials while more selective inclusion/exclusion criteria existed for the sub-trials. Subjects were excluded for perceived higher risk of prostate cancer and recent myocardial or cerebral vascular events.
The previously published results are reviewed here as seen in the context of this special issue on late-onset hypogonadism. In the T Trials, positive benefits were seen in the sexual function, bone, and anemia trials with small but significant benefits in the vitality trial. No benefit was seen in the cognition trial, partial benefit in physical function, and a negative benefit outcome seen in the cardiovascular trial. The later trial was underpowered and the results were described as exploratory. Adverse events were relatively uncommon in the 12-month treatment phase and additional 12-month post-treatment phase. The most frequent adverse effect ascribed to testosterone was erythrocytosis.
The T Trials studied the efficacy of testosterone replacement therapy on 788 men with low testosterone and symptoms of hypogonadism. The studies demonstrated benefits in four trials (sexual function, vitality, bone, and anemia); partial benefit in the physical function trial; no effect in the cognition trial; and a negative effect in the exploratory cardiovascular trial. The T Trials were not designed to assess long-term risks of testosterone in men.
本文是对 T 试验已发表结果的综述和讨论。
重新检验 T 试验中睾酮替代治疗 65 岁以上性腺功能减退男性的疗效。
T 试验是七项双盲、安慰剂对照试验的复杂集合，旨在研究睾酮作为明确性腺功能减退老年男性替代疗法的疗效。有三个主要试验（性功能；身体机能；活力）和四个子试验（认知；骨骼；贫血；心血管）。所有受试者均参加了主要试验，而子试验则有更具选择性的纳入/排除标准。由于前列腺癌风险较高和近期心肌或脑血管事件，受试者被排除在外。
此处回顾了之前发表的结果，详见本期关于迟发性性腺功能减退的特刊。在 T 试验中，性功能、骨骼和贫血试验中观察到阳性益处，活力试验中观察到较小但有统计学意义的益处。认知试验未见益处，身体机能试验部分受益，心血管试验则出现负面结果。后期试验的效力不足，结果被描述为探索性的。在 12 个月的治疗期和随后的 12 个月的治疗后阶段，不良反应相对较少见。归因于睾酮的最常见不良反应是红细胞增多症。
T 试验研究了睾酮替代治疗对 788 名低睾酮和性腺功能减退症状男性的疗效。研究表明，四项试验（性功能、活力、骨骼和贫血）中有四项获益；身体机能试验部分受益；认知试验无效果；探索性心血管试验出现负面效果。T 试验并非旨在评估睾酮对男性的长期风险。
