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首页> 外文期刊>The journal of sexual medicine >Testosterone Replacement Therapy with Long-Acting Testosterone Undecanoate Improves Sexual Function and Quality-of-Life Parameters vs. Placebo in a Population of Men with Type 2 Diabetes
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Testosterone Replacement Therapy with Long-Acting Testosterone Undecanoate Improves Sexual Function and Quality-of-Life Parameters vs. Placebo in a Population of Men with Type 2 Diabetes

机译：长效睾丸酮十一酸酯替代睾丸激素疗法可改善男性2型糖尿病人群的性功能和生活质量参数（与安慰剂相比）

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Introduction: Sexual dysfunction, particularly erectile dysfunction (ED), is common in men with type 2 diabetes, occurring in up to 75% of cases. The prevalence of hypogonadism is also high in men with diabetes and low testosterone is associated with both sexual dysfunction and a reduced response to oral therapy for ED. Aim: This study aimed to determine the effect of testosterone replacement with long-acting Testosterone Undecanoate (TU) on sexual function, mood and quality of life vs. placebo over a treatment period of 30 weeks followed by 52 weeks of open-label medication. The study was conducted in a primary care population of men with type 2 diabetes attending their primary care physician for routine visits. Methods: The male diabetic populations of seven general practices were screened at routine diabetes visits to detect symptomatic men with total testosterone levels of 12nmol/L or less or with free testosterones of 250pmol/L or less. Two hundred eleven men were screened. A double-blind placebo-controlled study was conducted in 199 men with type 2 diabetes and hypogonadism treated for 30 weeks with either 1,000mg of TU or matching placebo followed by 52-week open-label follow on. Main Outcome Measures: The primary outcome measure, International Index of Erectile Function (IIEF), was used to evaluate sexual dysfunction, and the Ageing Male Symptom (AMS), Hospital Anxiety and Depression Scale, and Global Efficacy Question were used as secondary outcome measures to assess mood and self-reported quality of life. Results: Testosterone replacement therapy with long-acting TU improved all domains of sexual function at 30 weeks (erectile function [EF], P=0.005; intercourse satisfaction, P=0.015; sexual desire, P=0.001; overall satisfaction, P=0.05; and orgasm, P=0.04), with benefit as early as 6 weeks. Improvements in AMS score were significant in men without depression (P=0.02) and the presence of depression at baseline was associated with marked reduction in response to both sexual function and psychological scores. All responses in sexual function continued to improve significantly up to 18 months with an improvement in EF score of 4.31 from baseline. In a small cohort of 35 men taking phosphodiesterase type 5 inhibitors, there was no change during the double-blind phase but a nine-point improvement in EF domain during 52-week open-label treatment. After 30 weeks, 46% vs. 17% of patients on active therapy vs. placebo felt that the treatment had improved their health, reaching 70% after open-label therapy. Less obese and older patients responded better to testosterone therapy. There were no significant adverse events. Conclusion: TU significantly improved all domains of the IIEF and patient reported quality of life at 30 weeks and more significantly after 52-week open-label extension. Improvement was most marked in less obese patient and those without coexisting depression. In men with type 2 diabetes, trials of therapy may need to be given for much longer than 3-6 months suggested in current guidelines.
机译：简介：性功能障碍，特别是勃起功能障碍（ED）在2型糖尿病患者中很常见，发生率高达75％。性腺机能减退的患病率在糖尿病男性中也很高，睾丸激素水平低下与性功能障碍和对口服ED治疗的反应降低有关。目的：本研究旨在确定使用长效十一酸睾丸激素（TU）替代睾丸激素对安慰剂的性功能，情绪和生活质量的影响，其治疗期为30周，随后是52周的开放标签药物治疗。这项研究是在2型糖尿病男性的初级保健人群中进行的，他们正在其初级保健医生那里进行常规就诊。方法：在常规的糖尿病访视中筛查七个常规的男性糖尿病人群，以检测总睾丸激素水平低于或等于12nmol / L或游离睾丸激素低于或等于250pmol / L的有症状男性。筛选了211名男子。在199名2型糖尿病和性腺功能低下的男性中进行了一项双盲安慰剂对照研究，接受1,000 mg TU或相匹配的安慰剂治疗30周，然后进行52周开放标签随访。主要结局指标：主要结局指标是国际勃起功能指数（IIEF）来评估性功能障碍，男性衰老症状（AMS），医院焦虑和抑郁量表以及整体疗效问题被用作辅助结局指标评估情绪和自我报告的生活质量。结果：长效TU的睾丸激素替代疗法在30周时改善了性功能的所有方面（勃起功能[EF]，P = 0.005;性交满意度，P = 0.015;性欲，P = 0.001;总体满意度，P = 0.05 ;以及性高潮，P = 0.04），最早可在6周内受益。在没有抑郁的男性中，AMS评分的改善非常显着（P = 0.02），基线时抑郁的存在与对性功能和心理评分的反应显着降低有关。直至18个月，所有性功能反应均持续显着改善，EF评分较基线水平提高4.31。在35名服用5型磷酸二酯酶抑制剂的男性队列中，在双盲阶段无变化，但在52周开放标签治疗期间EF域改善了9点。 30周后，接受积极治疗的患者中有46％的患者与接受安慰剂的患者中的17％相比，认为治疗改善了他们的健康，在开放标签治疗后达到70％。较少的肥胖和老年患者对睾丸激素治疗的反应更好。没有明显的不良事件。结论：TU显着改善了IIEF的所有领域，患者报告了30周时的生活质量，而52周开放标签扩展后的患者生活质量更显着。肥胖程度较低的患者和没有并存抑郁症的患者改善最为明显。对于患有2型糖尿病的男性，可能需要进行超过现行指南建议的3-6个月的治疗试验。

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