Department of Urology, Klinikum Braunschweig, Braunschweig, Germany.
J Sex Med. 2014 Feb;11(2):543-52. doi: 10.1111/jsm.12378. Epub 2013 Nov 20.
The role of testosterone in erectile dysfunction (ED) is increasingly recognized. It is suggested that assessment of testosterone deficiency in men with ED and symptoms of hypogonadism, prior to first-line treatment, may be a useful tool for improving therapy.
In this prospective, observational, and longitudinal study, we investigated the effects of vardenafil treatment as adjunctive therapy to testosterone undecanoate in hypogonadal ED patients who failed to respond to testosterone treatment alone.
One hundred twenty-nine testosterone deficient (serum total testosterone ≤ 3.4 ng/mL) patients aged 56 ± 3.9 years received intramuscular injections of long-acting parenteral testosterone undecanoate at 3-month intervals for 8 months mean follow-up.
Scores on the International Index of Erectile Function Questionnaire-five items (IIEF-5) and partner survey scores were compared at baseline and posttreatment with testosterone therapy alone or in combination with vardenafil. Patient baseline demographics and concomitant disease were correlated with patients' IIEF-5 scores.
Seventy one (58.2%) responded well to monotherapy within 3 months. Nonresponders had lower testosterone levels and higher rates of concomitant diseases and smoking. Thirty-four of the 51 nonresponders accepted the addition of 20 mg vardenafil on demand. Efficacy assessments were measured by the IIEF-erectile function domain (IIEF-EF, questions 1-5 plus 15, 30 points) and partner self-designed survey at baseline after 4-6 weeks and at study end point. Thirty out of 34 patients responded well to this combination. IIEF-EF Sexual Health Inventory for Men score improved from 12 to 24 (P < 0.0001), and partner survey showed significantly higher satisfaction (P < 0.001). These patients reported spontaneous or nocturnal and morning erections or tumescence. No changes in adverse effects were recorded.
These data suggest that combination therapy of testosterone and vardenafil is safe and effective in treating hypogonadal ED patients who failed to respond to testosterone monotherapy.
睾酮在勃起功能障碍（ED）中的作用越来越受到重视。有人建议，在一线治疗前，对 ED 伴有性腺功能减退症状的男性进行睾酮缺乏评估，可能有助于改善治疗效果。
在这项前瞻性、观察性和纵向研究中，我们调查了在单独接受睾酮治疗反应不佳的性腺功能减退性 ED 患者中，作为辅助治疗添加伐地那非对睾酮十一酸酯治疗的效果。
129 名睾酮缺乏症（血清总睾酮≤3.4ng/ml）患者，年龄 56±3.9 岁，接受长效肌内注射睾酮十一酸酯，每 3 个月 1 次，平均随访 8 个月。
采用国际勃起功能指数问卷-5 项（IIEF-5）和伴侣调查评分，比较单独使用睾酮治疗或联合使用伐地那非治疗前后的结果。患者的基线人口统计学和合并疾病与患者的 IIEF-5 评分相关。
71 名（58.2%）患者在 3 个月内对单药治疗反应良好。无反应者的睾酮水平较低，合并疾病和吸烟的比例较高。51 名无反应者中的 34 名接受按需添加 20mg 伐地那非的治疗。疗效评估采用 IIEF-勃起功能域（IIEF-EF，问题 1-5 加 15，30 分）和伴侣自我设计调查在基线、4-6 周后和研究终点时进行。34 名患者中的 30 名对这种联合治疗反应良好。IIEF-EF 男性健康问卷调查评分从 12 分提高到 24 分（P<0.0001），伴侣调查显示满意度显著提高（P<0.001）。这些患者报告了自发或夜间和清晨勃起或勃起。没有记录到不良反应的变化。
这些数据表明，睾酮和伐地那非联合治疗对单独接受睾酮治疗反应不佳的性腺功能减退性 ED 患者是安全有效的。
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