Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, Minnesota 55905, USA.
J Clin Endocrinol Metab. 2010 Jun;95(6):2560-75. doi: 10.1210/jc.2009-2575.
The risks of testosterone therapy in men remain poorly understood.
The aim of this study was to conduct a systematic review and meta-analyses of testosterone trials to evaluate the adverse effects of testosterone treatment in men.
We searched MEDLINE, EMBASE, and Cochrane CENTRAL from 2003 through August 2008. Review of reference lists and contact with experts further identified candidate studies.
Eligible studies were comparative, randomized, and nonrandomized and reported the effects of testosterone on outcomes of interest (death, cardiovascular events and risk factors, prostate outcomes, and erythrocytosis). Reviewers, working independently and in duplicate, determined study eligibility.
Reviewers working independently and in duplicate determined the methodological quality of studies and collected descriptive, quality, and outcome data.
The methodological quality of the 51 included studies varied from low to medium, and follow-up duration ranged from 3 months to 3 yr. Testosterone treatment was associated with a significant increase in hemoglobin [weighted mean difference (WMD), 0.80 g/dl; 95% confidence interval (CI), 0.45 to 1.14] and hematocrit (WMD, 3.18%; 95% CI, 1.35 to 5.01), and a decrease in high-density lipoprotein cholesterol (WMD, -0.49 mg/dl; 95% CI, -0.85 to -0.13). There was no significant effect on mortality, prostate, or cardiovascular outcomes.
The adverse effects of testosterone therapy include an increase in hemoglobin and hematocrit and a small decrease in high-density lipoprotein cholesterol. These findings are of unknown clinical significance. Current evidence about the safety of testosterone treatment in men in terms of patient-important outcomes is of low quality and is hampered by the brief study follow-up.
男性睾酮治疗的风险仍知之甚少。
本研究旨在对睾酮试验进行系统评价和荟萃分析，以评估男性睾酮治疗的不良反应。
我们检索了 2003 年至 2008 年 8 月期间的 MEDLINE、EMBASE 和 Cochrane 中心数据库。通过查阅参考文献和与专家联系，进一步确定了候选研究。
合格的研究是比较性、随机和非随机的，并报告了睾酮对感兴趣的结局（死亡、心血管事件和危险因素、前列腺结局和红细胞增多症）的影响。审查员独立并重复审查研究的合格性。
审查员独立并重复确定研究的方法学质量，并收集描述性、质量和结局数据。
51 项纳入研究的方法学质量从低到中不等，随访时间从 3 个月到 3 年不等。睾酮治疗与血红蛋白显著增加相关[加权均数差（WMD），0.80 g/dl；95%置信区间（CI），0.45 至 1.14]和血细胞比容（WMD，3.18%；95%CI，1.35 至 5.01），高密度脂蛋白胆固醇降低（WMD，-0.49 mg/dl；95%CI，-0.85 至-0.13）。死亡率、前列腺或心血管结局无显著影响。
睾酮治疗的不良反应包括血红蛋白和血细胞比容增加，高密度脂蛋白胆固醇略有下降。这些发现的临床意义尚不清楚。目前关于男性睾酮治疗安全性的证据，就患者重要结局而言，质量较低，且受到研究随访时间短的限制。
