Department of Urology, Kyoto Prefectural University of Medicine, Kyoto City, Kyoto, Japan.
Int J Urol. 2021 Apr;28(4):376-381. doi: 10.1111/iju.14468. Epub 2020 Dec 19.
To examine the efficacy and safety of combination treatment with testosterone replacement therapy plus alternate-day tadalafil (10 mg) in patients with late-onset hypogonadism.
In this open-label, randomized, crossover study, 29 patients with late-onset hypogonadism were randomly assigned to receive testosterone replacement therapy for 12 weeks followed by combination treatment for 12 weeks (Group 1) or combination treatment for 12 weeks followed by testosterone replacement therapy (Group 2). Symptom questionnaires were administered and blood tests were performed prior to and following each treatment to assess safety and efficacy. At the end of the study, participants were asked about their treatment preferences.
An adverse effect, a rheum symptom, occurred in only one participant, and 26 participants completed the study without any toxicity. Scores on the Aging Male Symptoms scale and the modified short version of the International Index of Erectile Function, and Overactive Bladder Symptom scores were significantly improved in the combination treatment phase of Group 2, whereas no significant difference between the phases were observed in Group 1. In total, 12 out of the 14 participants in Group 1 and 11 out of the 12 participants in Group 2 preferred combination treatment, which reached statistical significance (P = 0.008 and 0.004 for Groups 1 and 2, respectively).
Testosterone replacement therapy with add-on alternate-day tadalafil is a safe and satisfactory treatment for patients with late-onset hypogonadism.
研究睾酮替代疗法联合隔日他达拉非（10mg）治疗迟发性性腺功能减退症的疗效和安全性。
这是一项开放标签、随机、交叉研究，将 29 例迟发性性腺功能减退症患者随机分为两组，一组先接受睾酮替代疗法治疗 12 周，再联合治疗 12 周（第 1 组）；另一组先联合治疗 12 周，再接受睾酮替代疗法治疗（第 2 组）。在每个治疗阶段前后进行症状问卷评估和血液检查，以评估安全性和疗效。研究结束时，询问参与者对治疗的偏好。
仅 1 名参与者出现不良反应（关节痛症状），26 名参与者完成了研究，无任何毒性反应。第 2 组联合治疗阶段的男性衰老症状量表评分、改良国际勃起功能指数短表评分和膀胱过度活动症症状评分均显著改善，而第 1 组各阶段评分无显著差异。第 1 组的 14 名参与者中有 12 名，第 2 组的 12 名参与者中有 11 名，均更倾向于联合治疗，差异具有统计学意义（第 1 组 P=0.008，第 2 组 P=0.004）。
睾酮替代疗法联合隔日他达拉非治疗迟发性性腺功能减退症安全且令人满意。
