Testosterone Therapy in Men With Hypogonadism: An Endocrine Society* Clinical Practice Guideline
Testosterone Therapy in Men With Hypogonadism: An Endocrine Society* Clinical Practice Guideline
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DOI：
10.1210/jc.2018-00229
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发表时间：
2018-05-01
影响因子：
5.8
通讯作者：
Yialamas, Maria A.
中科院分区：
文献类型：
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作者：
Bhasin, Shalender;Brito, Juan P.;Yialamas, Maria A.
目的：更新2010年发布的“男性雄激素缺乏综合征的特发性治疗”指南。参与者：参与者包括内分泌学会指定的由10名医学内容专家和一名临床实践指南方法学家组成的工作组。该循证指南是使用建议、评估、发展、和评价方法来描述建议的力度和证据的质量。工作组委托两个系统的评价，并使用最好的证据，从其他已发表的系统评价和individualstudy.Consensus过程：一个小组会议，几个电话会议，和电子邮件通信促进共识的发展。邀请内分泌学会委员会和成员以及共同发起组织对指南的初稿进行审查和评论。结论：我们建议仅对症状和体征与睾酮（T）缺乏一致且血清T浓度明确且持续较低的男性进行性腺功能减退症的诊断。我们建议使用准确可靠的检测方法测量空腹早晨总T浓度作为初始诊断试验。我们建议通过重复测量晨空腹总T浓度来确诊。对于总T接近正常下限或有改变性激素结合球蛋白的情况的男性，我们建议使用平衡透析或使用精确公式估计游离T浓度。在确定有雄激素缺乏的男性，我们建议额外的诊断评估，以确定雄激素缺乏的原因。在讨论了治疗的潜在获益和风险、监测治疗并让患者参与决策后，我们建议对有症状的T缺乏男性进行T治疗，以诱导和维持第二性征，纠正性腺功能减退症的症状。我们建议近期计划生育或有以下任何情况的患者不要开始T治疗：乳腺癌或前列腺癌，可触及的前列腺结节或硬结，前列腺特异性抗原水平> 4 ng/mL，前列腺癌风险增加的男性前列腺特异性抗原> 3 ng/mL（例如，非裔美国人和一级亲属诊断为前列腺癌的男性），未接受进一步泌尿系统评价，红细胞压积升高，未接受治疗的重度阻塞性睡眠呼吸暂停，重度下尿路症状，不受控制的心力衰竭，过去6个月内的心肌梗死或卒中，或血栓形成倾向。我们建议，当临床医生开始T治疗时，他们的目标是在使用任何批准的制剂治疗期间达到中等正常范围的T浓度，同时考虑患者偏好、药代动力学、制剂特异性不良反应、治疗负担和成本。临床医生应使用标准化计划监测接受T治疗的男性，该计划包括：评估症状，不良反应和依从性;测量血清T和红细胞压积浓度;并在开始T治疗后的第一年内评估前列腺癌风险。
Objective: To update the "Testosterone Therapy in Men With Androgen Deficiency Syndromes" guideline published in 2010.Participants: The participants include an Endocrine Society-appointed task force of 10 medical content experts and a clinical practice guideline methodologist.Evidence: This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies.Consensus Process: One group meeting, several conference calls, and e-mail communications facilitated consensus development. Endocrine Society committees and members and the cosponsoring organization were invited to review and comment on preliminary drafts of the guideline.Conclusions: We recommend making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations. We recommend measuring fasting morning total T concentrations using an accurate and reliable assay as the initial diagnostic test. We recommend confirming the diagnosis by repeating the measurement of morning fasting total T concentrations. In men whose total T is near the lower limit of normal or who have a condition that alters sex hormone-binding globulin, we recommend obtaining a free T concentration using either equilibrium dialysis or estimating it using an accurate formula. In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. We recommend T therapy for men with symptomatic T deficiency to induce and maintain secondary sex characteristics and correct symptoms of hypogonadism after discussing the potential benefits and risks of therapy and of monitoring therapy and involving the patient in decision making. We recommend against starting T therapy in patients who are planning fertility in the near term or have any of the following conditions: breast or prostate cancer, a palpable prostate nodule or induration, prostate-specific antigen level > 4 ng/mL, prostate-specific antigen > 3 ng/mL in men at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer) without further urological evaluation, elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the last 6 months, or thrombophilia. We suggest that when clinicians institute T therapy, they aim at achieving T concentrations in the mid-normal range during treatment with any of the approved formulations, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost. Clinicians should monitor men receiving T therapy using a standardized plan that includes: evaluating symptoms, adverse effects, and compliance; measuring serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy.