Background Testosterone treatment rates in adult men have increased in the United States over the past 2 decades. Purpose To assess the benefits and harms of testosterone treatment for men without underlying organic causes of hypogonadism. Data Sources English-language searches of multiple electronic databases (January 1980 to May 2019) and reference lists from systematic reviews. Study Selection 38 randomized controlled trials (RCTs) of at least 6 months' duration that evaluated transdermal or intramuscular testosterone therapies versus placebo or no treatment and reported prespecified patient-centered outcomes, as well as 20 long-term observational studies, U.S. Food and Drug Administration review data, and product labels that reported harms information. Data Extraction Data extraction by a single investigator was confirmed by a second, 2 investigators assessed risk of bias, and evidence certainty was determined by consensus. Data Synthesis Studies enrolled mostly older men who varied in age, symptoms, and testosterone eligibility criteria. Testosterone therapy improved sexual functioning and quality of life in men with low testosterone levels, although effect sizes were small (low- to moderate-certainty evidence). Testosterone therapy had little to no effect on physical functioning, depressive symptoms, energy and vitality, or cognition. Harms evidence reported in trials was judged to be insufficient or of low certainty for most harm outcomes. No trials were powered to assess cardiovascular events or prostate cancer, and trials often excluded men at increased risk for these conditions. Observational studies were limited by confounding by indication and contraindication. Limitation Few trials exceeded a 1-year duration, minimum important outcome differences were often not established or reported, RCTs were not powered to assess important harms, few data were available in men aged 18 to 50 years, definitions of low testosterone varied, and study entry criteria varied. Conclusion In older men with low testosterone levels without well-established medical conditions known to cause hypogonadism, testosterone therapy may provide small improvements in sexual functioning and quality of life but little to no benefit for other common symptoms of aging. Long-term efficacy and safety are unknown. Primary Funding Source American College of Physicians. (PROSPERO: CRD42018096585).

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男性睾丸激素治疗的功效和安全性：美国医师学院临床实践指南的证据报告。

背景技术在过去的20年中，成年男性的睾丸激素治疗率有所提高。目的评估睾丸激素治疗对男性无性腺功能减退症潜在病因的危害。数据源多个电子数据库的英语搜索（1980年1月至2019年5月）和系统评价中的参考文献列表。研究选择38个随机对照试验（RCT），为期至少6个月，该试验评估了经皮或肌肉内睾丸激素疗法与安慰剂或不进行治疗的比较，并报告了以患者为中心的预先指定的结果，以及20项长期观察性研究，美国食品和药物主管部门审查数据以及报告危害信息的产品标签。数据提取一位研究人员的数据提取在一秒钟后得到确认，2名研究者评估了偏倚风险，并通过共识确定了证据确定性。数据综合研究纳入了年龄，症状和睾丸激素合格标准各不相同的大多数男性。睾丸激素疗法可改善睾丸激素水平低的男性的性功能和生活质量，尽管其影响大小很小（低至中度证据）。睾丸激素疗法对身体机能，抑郁症状，能量和活力或认知几乎没有影响。对于大多数伤害结果，审判中报告的有害证据被判断为不足或不确定性较低。没有能够评估心血管事件或前列腺癌的试验，而且试验通常排除了罹患这些疾病风险较高的男性。观察性研究因适应症和禁忌症混杂而受到限制。局限性很少有试验超过1年的持续时间，通常没有确定或报告最小的重要结局差异，RCT无法评估重要的危害，18至50岁男性的可用数据很少，低睾丸激素的定义各不相同，并且需要进行研究入学标准各不相同。结论对于睾丸激素水平低，没有公认的会导致性腺功能减退的医学疾病的老年男性，睾丸激素治疗可能对性功能和生活质量的改善不大，但对其他常见的衰老症状几乎没有益处。长期疗效和安全性未知。美国医师学院的主要资金来源。（PROSPERO：CRD42018096585）。RCT无法评估重要危害，18至50岁男性的可用数据很少，低睾丸激素的定义各异，研究入选标准也各不相同。结论对于睾丸激素水平低，没有公认的会导致性腺功能减退的医学疾病的老年男性，睾丸激素治疗可能对性功能和生活质量的改善不大，但对其他常见的衰老症状几乎没有益处。长期疗效和安全性未知。美国医师学院的主要资金来源。（PROSPERO：CRD42018096585）。RCT无法评估重要危害，18至50岁男性的可用数据很少，低睾丸激素的定义各异，研究入选标准也各不相同。结论对于睾丸激素水平低，没有公认的会导致性腺功能减退的医学疾病的老年男性，睾丸激素治疗可能对性功能和生活质量的改善不大，但对其他常见的衰老症状几乎没有益处。长期疗效和安全性未知。美国医师学院的主要资金来源。（PROSPERO：CRD42018096585）。睾丸激素疗法可能会改善性功能和生活质量，但对其他常见的衰老症状几乎没有好处。长期疗效和安全性未知。美国医师学院的主要资金来源。（PROSPERO：CRD42018096585）。睾丸激素疗法可能会在性功能和生活质量方面提供很小的改善，但对其他常见的衰老症状几乎没有或没有好处。长期疗效和安全性未知。主要资金来源美国医师学院。（PROSPERO：CRD42018096585）。