Endocrinology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy.
Department of Clinical Sciences and Community Health, University of Milan, 20122 Milan, Italy.
J Clin Endocrinol Metab. 2024 Nov 18;109(12):3186-3195. doi: 10.1210/clinem/dgae317.
Testosterone therapy has been variably associated with increased thrombotic risk but investigations of global coagulation in this setting are lacking.
This work aimed to compare global coagulation of hypogonadal men before (T0) and 6 months after (T1) starting testosterone replacement therapy (TRT), and healthy controls (HCs).
An observational prospective cohort study was conducted at 2 tertiary endocrinological ambulatory care centers. Patients included 38 men with hypogonadism (mean age 55 years, SD 13) and 38 age-matched HCs. Thrombin generation assay (TGA) was performed at T0 and T1 in hypogonadal men and in HCs. TGA is an in vitro procedure based on the continuous registration of thrombin generation and decay under conditions mimicking the process that occurs in vivo. The following TGA parameters were recorded: lag time; thrombin-peak concentration; time-to-reach peak, velocity index, and endogenous thrombin potential (ETP), the latter representing the total amount of thrombin generated under the driving forces of procoagulants opposed by the anticoagulants. Protein C, antithrombin, factor (F) VIII, and fibrinogen were assessed.
No changes in TGA parameters were observed between T0 and T1. Hypogonadal men displayed significantly higher ETP, fibrinogen, and significantly lower antithrombin levels both at T0 and T1 compared to HCs. Thrombin peak of hypogonadal men was significantly higher than HCs at T0 but not at T1. ETP and antithrombin were correlated with testosterone levels.
Hypogonadal men display a procoagulant imbalance detected by increased thrombin generation. Short-term TRT does not worsen global coagulation, suggesting that the treatment can be safely prescribed to men diagnosed with hypogonadism.
睾丸激素疗法与血栓形成风险的增加有关，但在这种情况下，对全球凝血的研究还很缺乏。
本研究旨在比较开始睾丸激素替代疗法（TRT）前（T0）和 6 个月后（T1）的低睾丸激素男性与健康对照者（HCs）的整体凝血情况。
在 2 个三级内分泌门诊进行了一项观察性前瞻性队列研究。纳入了 38 名患有性腺功能减退症的男性（平均年龄 55 岁，标准差 13 岁）和 38 名年龄匹配的 HCs。在 T0 和 T1 时对低睾丸激素男性和 HCs 进行凝血酶生成试验（TGA）。TGA 是一种基于在模拟体内发生过程的条件下连续记录凝血酶生成和衰减的体外程序。记录了以下 TGA 参数：延迟时间；凝血酶峰浓度；达到峰的时间，速度指数和内源性凝血酶潜能（ETP），后者代表在促凝剂的驱动力下产生的总凝血酶量，而抗凝血剂则与之抗衡。还评估了蛋白 C、抗凝血酶、因子（F）VIII 和纤维蛋白原。
T0 和 T1 之间 TGA 参数没有变化。低睾丸激素男性在 T0 和 T1 时均显示出明显更高的 ETP、纤维蛋白原和明显更低的抗凝血酶水平，而与 HCs 相比。低睾丸激素男性的凝血酶峰在 T0 时明显高于 HCs，但在 T1 时则不然。ETP 和抗凝血酶与睾丸激素水平相关。
低睾丸激素男性表现出促凝失衡，这可通过增加的凝血酶生成来检测。短期 TRT 不会使整体凝血恶化，这表明可以安全地为诊断为性腺功能减退症的男性开具该治疗药物。
