Abstract：
BACKGROUND: Hormone replacement therapy is associated with an increased thromboembolic risk. The effects of testosterone (T) on coagulation markers in people assigned female at birth (AFAB) under gender affirming hormone therapy (GAHT) are not well described.
METHODS: Systematic review and meta-analysis on English-language articles retrieved from PubMed, Scopus and Cochrane Library up to April 2023 investigating T therapy in AFAB people. Coagulation parameters included international normalized ratio (INR), fibrinogen, activated partial thromboplastin clotting time (aPTT), plasminogen activator inhibitor-1 (PAI-1); hematological variables included hemoglobin (Hb) and hematocrit (HCT). We also reported the rate of thromboembolic events. Data were combined as mean differences (MD) with a 95 % confidence interval (CI) of pre- vs post-follow-up values, using random-effects models.
RESULTS: We included 7 studies (6 prospective and 1 retrospective) providing information on 312 subjects (mean age: 23 to 30 years) who underwent GAHT with variable T preparation. T therapy was associated with a significant increase in INR values [MD: 0.02, 95 % confidence interval (CI): 0.01-0.03; p = 0.0001], with negligible heterogeneity (I2 = 4 %). T therapy was associated with increased Hb (MD: 1.48 g/dL, 95%CI: 1.17 to 1.78; I2 = 9 %) and HCT (4.39 %, 95%CI: 3.52 to 5.26; I2 = 23 %) values. No effect on fibrinogen, aPTT and PAI-1 was found. None of the study reported thromboembolic events during the follow-up.
CONCLUSIONS: Therapy with T increased blood viscosity in AFAB men. A slight increase in INR values was also found, but the clinical relevance and mechanism(s) of this finding needs to be clarified.
METHODS: Systematic review and meta-analysis on English-language articles retrieved from PubMed, Scopus and Cochrane Library up to April 2023 investigating T therapy in AFAB people. Coagulation parameters included international normalized ratio (INR), fibrinogen, activated partial thromboplastin clotting time (aPTT), plasminogen activator inhibitor-1 (PAI-1); hematological variables included hemoglobin (Hb) and hematocrit (HCT). We also reported the rate of thromboembolic events. Data were combined as mean differences (MD) with a 95 % confidence interval (CI) of pre- vs post-follow-up values, using random-effects models.
RESULTS: We included 7 studies (6 prospective and 1 retrospective) providing information on 312 subjects (mean age: 23 to 30 years) who underwent GAHT with variable T preparation. T therapy was associated with a significant increase in INR values [MD: 0.02, 95 % confidence interval (CI): 0.01-0.03; p = 0.0001], with negligible heterogeneity (I2 = 4 %). T therapy was associated with increased Hb (MD: 1.48 g/dL, 95%CI: 1.17 to 1.78; I2 = 9 %) and HCT (4.39 %, 95%CI: 3.52 to 5.26; I2 = 23 %) values. No effect on fibrinogen, aPTT and PAI-1 was found. None of the study reported thromboembolic events during the follow-up.
CONCLUSIONS: Therapy with T increased blood viscosity in AFAB men. A slight increase in INR values was also found, but the clinical relevance and mechanism(s) of this finding needs to be clarified.
摘要：
背景：激素替代疗法与血栓栓塞风险增加相关。在性别确认激素治疗（GAHT）下，睾丸激素（T）对出生时女性（AFAB）的凝血标志物的影响尚未得到很好的描述。
方法：从PubMed检索的英语文章的系统评价和荟萃分析，截至2023年4月，Scopus和Cochrane图书馆正在调查AFAB人群的T疗法。凝血参数包括国际标准化比率(INR)，纤维蛋白原，活化部分凝血活酶凝血时间（aPTT），纤溶酶原激活物抑制剂-1（PAI-1）；血液学变量包括血红蛋白（Hb）和血细胞比容（HCT）。我们还报告了血栓栓塞事件的发生率。将数据合并为平均差异（MD）和随访前后值的95％置信区间（CI），使用随机效应模型。
结果：我们纳入了7项研究（6项前瞻性研究和1项回顾性研究），提供了312名受试者（平均年龄：23至30岁）的信息，这些受试者接受了可变T准备的GAHT。T疗法与INR值显着增加相关[MD：0.02，95％置信区间（CI）：0.01-0.03；p=0.0001]，异质性可忽略不计(I2=4%)。T疗法与Hb升高相关(MD：1.48g/dL，95CI：1.17至1.78；I2=9%）和HCT（4.39%，95CI：3.52至5.26；I2=23%）值。对纤维蛋白原没有影响，发现aPTT和PAI-1。随访期间没有一项研究报告血栓栓塞事件。
结论：T治疗可增加AFAB男性的血液粘度。还发现INR值略有增加，但这一发现的临床相关性和机制尚待阐明.
方法：从PubMed检索的英语文章的系统评价和荟萃分析，截至2023年4月，Scopus和Cochrane图书馆正在调查AFAB人群的T疗法。凝血参数包括国际标准化比率(INR)，纤维蛋白原，活化部分凝血活酶凝血时间（aPTT），纤溶酶原激活物抑制剂-1（PAI-1）；血液学变量包括血红蛋白（Hb）和血细胞比容（HCT）。我们还报告了血栓栓塞事件的发生率。将数据合并为平均差异（MD）和随访前后值的95％置信区间（CI），使用随机效应模型。
结果：我们纳入了7项研究（6项前瞻性研究和1项回顾性研究），提供了312名受试者（平均年龄：23至30岁）的信息，这些受试者接受了可变T准备的GAHT。T疗法与INR值显着增加相关[MD：0.02，95％置信区间（CI）：0.01-0.03；p=0.0001]，异质性可忽略不计(I2=4%)。T疗法与Hb升高相关(MD：1.48g/dL，95CI：1.17至1.78；I2=9%）和HCT（4.39%，95CI：3.52至5.26；I2=23%）值。对纤维蛋白原没有影响，发现aPTT和PAI-1。随访期间没有一项研究报告血栓栓塞事件。
结论：T治疗可增加AFAB男性的血液粘度。还发现INR值略有增加，但这一发现的临床相关性和机制尚待阐明.
