Department of Psychiatry, Leiden University Medical Center, Leiden, the Netherlands.
J Sex Med. 2010 Jul;7(7):2572-82. doi: 10.1111/j.1743-6109.2010.01859.x. Epub 2010 May 26.
Low testosterone levels in men are associated with the metabolic syndrome (MetS) as well as with depressive symptoms, low vitality, and sexual dysfunction.
To assess the effects of testosterone administration on these subjective symptoms, which have not extensively been studied in hypogonadal men with the MetS.
The Beck Depression Inventory (BDI-IA), Aging Males' Symptoms (AMS) scale, and International Index of Erectile Function 5-item (IIEF-5) scale at baseline, 18 and 30 weeks were analysed using multilevel analysis.
In a randomized, placebo-controlled, double-blind, phase III trial (ClinicalTrials.gov identifier: NCT00696748), 184 men suffering from both the MetS and hypogonadism were included. They were treated for 30 weeks with either parenteral testosterone undecanoate (TU; 1,000 mg IM TU, at baseline, and after 6 and 18 weeks; Nebido or placebo injections, 105 (92.9%) men receiving TU and 65 (91.5%) receiving placebo completed the 30-week trial.
The 184 men were aged mean 52.1 years old (standard deviation [SD] 9.6; range 35-69), with a mean body mass index of 35.5 kg/m(2) (SD 6.7; range 25.1-54.8), and a mean total testosterone level of 8.0 nmol/L (SD 4.0). There were significant improvements in BDI-IA (mean difference vs. placebo after 30 weeks: -2.5 points; 95% confidence interval [CI]: -0.9; -4.1; P = 0.003), AMS (-7.4 points; 95% CI: -4.3; -10.5; P < 0.001), and IIEF-5 (+3.1 points; 95% CI: +1.8; +4.4; P < 0.001). The effects on the BDI-IA, AMS, and IIEF-5 were strongest in men with baseline total testosterone levels <7.7 mmol/L (i.e., median value).
TU administration may improve depressive symptoms, aging male symptoms and sexual dysfunction in hypogonadal men with the MetS. The beneficial effects of testosterone were most evident in men with the lowest baseline total testosterone levels.
男性睾丸激素水平低与代谢综合征（MetS）以及抑郁症状、低活力和性功能障碍有关。
评估睾丸激素给药对这些主观症状的影响，这些症状在患有 MetS 的低睾丸激素男性中尚未广泛研究。
在基线、18 周和 30 周时使用多层次分析评估贝克抑郁量表（BDI-IA）、男性衰老症状量表（AMS）和国际勃起功能指数 5 项（IIEF-5）量表。
在一项随机、安慰剂对照、双盲、III 期试验（ClinicalTrials.gov 标识符：NCT00696748）中，纳入 184 名患有 MetS 和性腺功能减退症的男性。他们接受了 30 周的肌内注射十一酸睾酮（TU；1000mgIMTU，基线时，以及 6 周和 18 周后；Nebido 或安慰剂注射，105 名（92.9%）接受 TU 治疗的男性和 65 名（91.5%）接受安慰剂治疗的男性完成了 30 周的试验。
184 名男性的平均年龄为 52.1 岁（标准差[SD]9.6；范围 35-69），平均体重指数为 35.5kg/m2（SD6.7；范围 25.1-54.8），平均总睾酮水平为 8.0nmol/L（SD4.0）。BDI-IA（与 30 周后安慰剂相比的平均差异：-2.5 分；95%置信区间[CI]：-0.9；-4.1；P=0.003）、AMS（-7.4 分；95%CI：-4.3；-10.5；P<0.001）和 IIEF-5（+3.1 分；95%CI：+1.8；+4.4；P<0.001）均有显著改善。在基线总睾酮水平<7.7mmol/L（即中位数）的男性中，对 BDI-IA、AMS 和 IIEF-5 的影响最强。
睾丸激素给药可改善代谢综合征伴性腺功能减退男性的抑郁症状、男性衰老症状和性功能障碍。睾丸激素的有益作用在基线总睾酮水平最低的男性中最为明显。
