Vinarov A Z, Rozhivanov R V
I.M. Sechenov First MSMU of Minzdrav of Russia, Moscow, Russia.
National Medical Research Center of Endocrinology of Minzdrav of Russia, Moscow, Russia.
Urologiia. 2018 Mar(1):71-76.
To evaluate the effect of Androgel on the quality of life of patients with androgen deficiency (hypogonadism) and chronic prostatitis in everyday practice.
This open multicenter observational non-interventional study comprised 401 men with testosterone deficiency and chronic prostatitis who were treated with topical applications of 1% testosterone gel of (Androgel) at a dose of 50 or 100 mg in routine clinical practice for three months. The primary endpoint was the health related quality of life. Also, the patients filled out AMS, I-PSS, NIH-CPSI questionnaires to assess the quality of life related to chronic prostatitis, lower urinary tract symptoms, and aging. Secondary endpoints included changes in the overall score of the International Index of Erectile Function (IIEF-5), changes in body weight and waist circumference, the reasons for treatment discontinuation and any adverse events that occurred during treatment.
Mean total testosterone levels at baseline and three months were 9.5 (95% CI 9.2-9.7) nmol/L and 16.5 (95% CI 16.1-16.9) nmol/l (p<0.001), respectively. There were statistically significant (p<0.001) differences in scores on all questionnaires. Mean scores at baseline and at three months for AMS, IIEF-5, I-PSS, NIH-CPSI questionnaires were 44.6 (95% CI 43.2-45.9) and 25.8 (95% CI 24.8-26.7); 12.7 (95% CI 12.2-13.2) and 19.3 (95% CI, 18.8-19.8); 14.5 (95% CI 13.7-15.3) and 5.6 (95% CI 5.2-6.1); 27.8 (95% CI 26,5-29.1) and 10.0 (95% CI 9.1-10.9), respectively. There were positive changes in body weight and waist circumference: at baseline and three months these parameters were 95 (95% CI 93.6-96.3) and 91.4 (95% CI 90.1-92.7) kg and 102.9 (95% CI 101.8-104.1) and 98.3 (95% CI 97.3-99.3) cm, respectively. No clinically significant adverse events were observed during follow-up.
Transdermal therapy with 1% testosterone gel (Androgel) is highly effective and safe in the management of androgen deficiency (hypogonadism). Its use in patients with chronic prostatitis and hypogonadism results in an improvement in low urinary tract symptoms, symptoms of chronic prostatitis, alleviates pelvic pain and thus leads to significant improvements in the quality of life.
在日常医疗实践中评估安特尔（Androgel）对雄激素缺乏（性腺功能减退）和慢性前列腺炎患者生活质量的影响。
这项开放性多中心观察性非干预研究纳入了401例睾酮缺乏和慢性前列腺炎男性患者，在常规临床实践中给予局部应用1%睾酮凝胶（安特尔），剂量为50或100mg，治疗三个月。主要终点是健康相关生活质量。此外，患者填写美国泌尿症状评分（AMS）、国际前列腺症状评分（I-PSS）、美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）问卷，以评估与慢性前列腺炎、下尿路症状和衰老相关的生活质量。次要终点包括国际勃起功能指数（IIEF-5）总分的变化、体重和腰围的变化、治疗中断的原因以及治疗期间发生的任何不良事件。
基线和三个月时的平均总睾酮水平分别为9.5（95%可信区间9.2 - 9.7）nmol/L和16.5（95%可信区间16.1 - 16.9）nmol/L（p<0.001）。所有问卷得分均有统计学显著差异（p<0.001）。AMS、IIEF-5、I-PSS、NIH-CPSI问卷在基线和三个月时的平均得分分别为44.6（95%可信区间43.2 - 45.9）和25.8（95%可信区间24.8 - 26.7）；12.7（95%可信区间12.2 - 13.2）和19.3（95%可信区间18.8 - 19.8）；14.5（95%可信区间13.7 - 15.3）和5.6（95%可信区间5.2 - 6.1）；27.8（95%可信区间26.5 - 29.1）和10.0（95%可信区间9.1 - 10.9）。体重和腰围有正向变化：基线和三个月时这些参数分别为95（95%可信区间93.6 - 96.3）和91.4（95%可信区间90.1 - 92.7）kg以及102.9（95%可信区间101.8 - 104.1）和98.3（95%可信区间97.3 - 99.3）cm。随访期间未观察到具有临床意义的不良事件。
1%睾酮凝胶（安特尔）经皮治疗在雄激素缺乏（性腺功能减退）的管理中高效且安全。其用于慢性前列腺炎和性腺功能减退患者可改善下尿路症状、慢性前列腺炎症状，减轻盆腔疼痛，从而显著改善生活质量。
