Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men
Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men
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DOI：
10.1210/jc.2003-032006
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发表时间：
2004-05-01
影响因子：
5.8
通讯作者：
Swerdloff, RS
中科院分区：
文献类型：
--
作者：
Wang, C;Cunningham, G;Swerdloff, RS
经皮睾酮（T）递送代表了可注射雄激素的有效替代方案。我们研究了163名性腺功能减退的男性，他们每天使用5，7.5或10 g AndroGel（T凝胶）1% CIII，长达42个月。提供了123例可评价受试者的疗效数据。连续AndroGel治疗使平均血清T和游离T水平正常化。平均血清5 α-二氢睾酮浓度和5 α-二氢睾酮/T比值略有增加，平均血清雌二醇/T比值加倍，平均血清FSH和LH水平受到T替代的抑制。性功能和情绪参数迅速改善，并在整个T治疗过程中得到维持。瘦体重增加（P = 0.0001），脂肪量减少（P = 0.0001），这些变化与治疗保持，但不伴随着肌肉力量的显着增加。血清骨标记物升高提示骨形成增加，随后脊柱（P = 0.0001）的骨密度逐渐和进行性增加多于髋关节（P = 0.0004）。12例受试者发生轻度局部皮肤刺激，仅1例受试者停药。除红细胞压积和血红蛋白的预期增加外，血细胞计数或生化无临床显著变化。在三名血清前列腺特异性抗原升高的受试者中，前列腺活检显示癌症。我们的结论是，AndroGel的持续应用导致类似于注射剂和其他经皮制剂的有益效果。这项研究既不是安慰剂对照，也没有把握度来确定T治疗对前列腺癌风险的影响。因此，强烈建议监测前列腺疾病和评估红细胞增多症，以降低T治疗性腺功能减退男性的不良事件风险。
Transdermal testosterone ( T) delivery represents an effective alternative to injectable androgens. We studied 163 hypogonadal men who applied 5, 7.5, or 10 g AndroGel (T gel) 1% CIII per day for up to 42 months. Efficacy data were presented in 123 subjects considered evaluable. Continuous AndroGel treatment normalized mean serum T and free T levels. Mean serum 5alpha-dihydrotestosterone concentrations and 5alpha-dihydrotestosterone/T ratio slightly increased, mean serum estradiol/T ratio doubled, and mean serum FSH and LH levels were suppressed by T replacement. Sexual function and mood parameters improved rapidly and were maintained throughout T treatment. Lean body mass increased (P = 0.0001) and fat mass decreased (P = 0.0001), and these changes were maintained with treatment but were not accompanied by significant increases in muscle strength. Increases in serum bone markers suggestive of increased bone formation were followed by gradual and progressive increases in bone mineral density more in the spine (P = 0.0001) than the hip (P = 0.0004). Mild local skin irritation occurred in 12 subjects, resulting in discontinuation in only one subject. Except for the anticipated increase in hematocrit and hemoglobin, there were no clinically significant changes in blood counts or biochemistry. In three subjects with elevated serum prostate-specific antigen, prostate biopsies showed cancer. We conclude that continued application of AndroGel resulted in beneficial effects similar to those with injectables and other transdermal preparations. This study was neither placebo controlled nor powered to determine the effects of T treatment on prostate cancer risk. Thus, monitoring for prostatic disease and assessment for erythrocytosis are strongly advised to reduce the risk of adverse events with T treatment of hypogonadal men.