本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2308836

摘要内容如下：

背景

睾酮治疗男性性腺功能减退症可改善骨密度和骨质量，但需要足够大的样本和足够长的持续时间来确定睾酮对骨折发生率的影响。

方法

在一项评估睾酮治疗中老年男性性腺功能减退症的心血管安全性的双盲、随机、安慰剂对照试验的子试验中，我们在时间-事件分析中检查了临床骨折的风险。符合条件的男性为45至80岁，既往患有心血管疾病或心血管疾病风险高；一种或多种性腺功能减退症状；在间隔至少48小时获得的空腹血浆样品中，两个早晨的睾酮浓度低于300ng/DL（10.4nmol/L）。参与者被随机分配每天使用睾酮凝胶或安慰剂凝胶。在每一次访问中，参与者都会被问及自上次访问以来是否发生过骨折。如果有，则获取医疗记录并进行裁决。

结果

全分析人群包括5204名参与者（睾酮组2601名，安慰剂组2603名）。经过中位数为3.19年的随访，睾酮组有91名受试者（3.50%）发生临床骨折，安慰剂组有64名受试者（2.46%）发生临床骨折（风险比为1.43；95%置信区间，1.04至1.97）。对于所有其他骨折终点，睾酮组的骨折发生率似乎也更高。

结论

在患有性腺功能减退症的中老年男性中，睾酮治疗并未导致临床骨折发生率低于安慰剂。在接受睾酮治疗的男性中，骨折发生率在数字上高于接受安慰剂的男性。（由艾伯维和其他公司资助；Traverse ClinicalTrials.gov编号，NCT03518034。）

英文原文如下：

Abstracts

BACKGROUND  Testosterone treatment in men with hypogonadism improves bone density and quality, but trials with a sufficiently large sample and a sufficiently long duration to determine the effect of testosterone on the incidence of fractures are needed.

METHODS  In a subtrial of a double-blind, randomized, placebo-controlled trial that assessed the cardiovascular safety of testosterone treatment in middle-aged and older men with hypogonadism, we examined the risk of clinical fracture in a time-to-event analysis. Eligible men were 45 to 80 years of age with preexisting, or high risk of, cardiovascular disease; one or more symptoms of hypogonadism; and two morning testosterone concentrations of less than 300 ng per deciliter (10.4 nmol per liter), in fasting plasma samples obtained at least 48 hours apart. Participants were randomly assigned to apply a testosterone or placebo gel daily. At every visit, participants were asked if they had had a fracture since the previous visit. If they had, medical records were obtained and adjudicated.

RESULTS  The full-analysis population included 5204 participants (2601 in the testosterone group and 2603 in the placebo group). After a median follow-up of 3.19 years, a clinical fracture had occurred in 91 participants (3.50%) in the testosterone group and 64 participants (2.46%) in the placebo group (hazard ratio, 1.43; 95% confidence interval, 1.04 to 1.97). The fracture incidence also appeared to be higher in the testosterone group for all other fracture end points.

CONCLUSIONS  Among middle-aged and older men with hypogonadism, testosterone treatment did not result in a lower incidence of clinical fracture than placebo. The fracture incidence was numerically higher among men who received testosterone than among those who received placebo. (Funded by AbbVie and others; TRAVERSE ClinicalTrials.gov number, NCT03518034.).

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