Centre of Reproductive Medicine and Andrology of the University, Muenster, Germany.
Andrology. 2024 Nov;12(8):1675-1696. doi: 10.1111/andr.13626. Epub 2024 Mar 15.
The longitudinal efficacy and clinical utility of Testosterone Therapy (TTh) in ameliorating functional hypogonadism (FH) remain contentious, with long-term data being scarce. To address this lacuna, a comprehensive long-term registry study, stratifying patients across a spectrum of hypogonadal etiologies, offers a robust investigative paradigm.
This 9-year registry, encompassing 650 patients (equivalent to 4,362 cumulative years of treatment), included 188 patients diagnosed with FH (mean age 42.3 ± 11.3 years) and 462 individuals with classical hypogonadism (CH). The cohort segregated into 266 men with primary hypogonadism (PH, mean age 34.0 ± 11.7 years) and 196 with secondary hypogonadism (SH, mean age 31.9 ± 12.0 years). Uniform treatment across the cohort involved intramuscular administration of testosterone undecanoate (1,000 mg). A comparative analysis was conducted focusing on anthropometric, metabolic, and safety parameters.
Serum testosterone levels increased from 6.6 ± 2.4 to 19.3 ± 2.9 nmol/L (p < 0.001). TTh was linked with weight reduction and decreased waist circumference (WC) in both CH and FH cohorts (both p < 0.001). Cox regression and Kaplan-Meier analyses delineated disparities: men with FH demonstrated a higher propensity for losing > 10% body weight and > 5% WC compared to CH (hazard ratio [HR] 1.3 [1.1-1.4], p = 0.008 and HR 1.4 [1.3-1.5], p = 0.001). Increases in hematocrit > 50% were uniform across groups, albeit amelioration of anemia was more pronounced in FH versus CH (p = 0.002). Increments of prostate-specific antigen (PSA) levels were more likely to occur in FH (HR 1.3 [1.1-1.6], p = 0.003). FH patients exhibited pronounced improvements in metabolic parameters and in aging male symptom score (AMS) and IIEF-EF questionnaire scores. These effects were markedly modulated by age and initial weight. Subgroup analysis of age-matched obese patients revealed an accentuated impact of TTh in CH compared to FH.
The therapeutic outcomes of TTh across distinct hypogonadal populations demonstrate heterogeneous responses, significantly influenced by diagnostic categorization, age, and baseline risk factor profiles.
睾酮治疗（TTh）改善功能性性腺功能减退症（FH）的长期疗效和临床实用性仍存在争议，且缺乏长期数据。为了解决这一空白，对一系列性腺功能减退病因的患者进行分层的全面长期登记研究提供了一个强大的研究范例。
这项为期 9 年的登记研究纳入了 650 名患者（相当于 4362 年的累积治疗时间），其中 188 名患者被诊断为 FH（平均年龄 42.3±11.3 岁），462 名患者患有经典性腺功能减退症（CH）。该队列分为 266 名原发性性腺功能减退症（PH，平均年龄 34.0±11.7 岁）和 196 名继发性性腺功能减退症（SH，平均年龄 31.9±12.0 岁）患者。整个队列均采用肌内注射十一酸睾酮（1000mg）进行治疗。对体重、代谢和安全性参数进行了对比分析。
血清睾酮水平从 6.6±2.4 增加到 19.3±2.9 nmol/L（p<0.001）。在 CH 和 FH 队列中，TTh 与体重减轻和腰围（WC）减少相关（均 p<0.001）。Cox 回归和 Kaplan-Meier 分析表明存在差异：与 CH 相比，FH 患者更有可能减轻>10%的体重和>5%的 WC（风险比[HR]1.3[1.1-1.4]，p=0.008 和 HR 1.4[1.3-1.5]，p=0.001）。所有组的血细胞比容增加>50%，但 FH 组的贫血改善更明显（p=0.002）。前列腺特异性抗原（PSA）水平升高更常见于 FH（HR 1.3[1.1-1.6]，p=0.003）。FH 患者的代谢参数和男性老化症状评分（AMS）和国际勃起功能指数问卷评分（IIEF-EF）均有显著改善。这些效果受到年龄和初始体重的显著调节。在年龄匹配的肥胖患者亚组分析中，与 FH 相比，CH 患者的 TTh 治疗效果更为显著。
在不同性腺功能减退人群中，TTh 的治疗效果存在异质性反应，显著受诊断分类、年龄和基线风险因素特征的影响。
