Brock Gerald, Nehra Ajay, Lipshultz Larry I, Karlin Gary S, Gleave Martin, Seger Monica, Padma-Nathan Harin
St. Joseph's Medical Center, Lawson Research Institute, London, Ontario, Canada.
J Urol. 2003 Oct;170(4 Pt 1):1278-83. doi: 10.1097/01.ju.0000086947.00547.49.
More than one-third of men may experience erectile dysfunction (ED) after nerve sparing radical retropubic prostatectomy. The efficacy and safety of vardenafil, a potent, selective, phosphodiesterase 5 inhibitor, was assessed for the treatment of ED after radical prostatectomy.
In this double-blind study 440 men with ED after nerve sparing radical prostatectomy were randomized to take placebo, or 10 or 20 mg vardenafil. Efficacy was measured after 12 weeks using the erectile function domain of the International Index of Erectile Function, diary questions measuring vaginal penetration and intercourse success rates, and a global assessment question (GAQ) on erection.
Of the intent to treat population 70% had severe ED (erectile function less than 11) at baseline. After 12 weeks both vardenafil doses were significantly superior to placebo (p <0.0001) for all efficacy variables. Improved erections (based on GAQ) were reported by 65.2% and 59.4% of patients on 20 and 10 mg vardenafil, respectively, and by only 12.5% of patients on placebo (p <0.0001). Among men with bilateral neurovascular bundle sparing, positive GAQ responses were reported by 71.1% and 59.7% of patients on 20 and 10 mg vardenafil, respectively, versus 11.5% of those on placebo (p <0.0001). The average intercourse success rate per patient receiving 20 mg vardenafil was 74% in men with mild to moderate ED and 28% in men with severe ED, compared to 49% and 4% for placebo, respectively. Few adverse events were observed. They were generally mild to moderate headache, flushing and rhinitis.
In men with severe ED after nerve sparing radical retropubic prostatectomy, vardenafil significantly improved key indices of erectile function.
超过三分之一的男性在保留神经的耻骨后根治性前列腺切除术后可能会出现勃起功能障碍（ED）。评估了强效、选择性磷酸二酯酶5抑制剂伐地那非治疗根治性前列腺切除术后ED的疗效和安全性。
在这项双盲研究中，440例保留神经的根治性前列腺切除术后出现ED的男性被随机分为服用安慰剂组，或10毫克或20毫克伐地那非组。12周后，使用国际勃起功能指数的勃起功能领域、测量阴道插入和性交成功率的日记问题以及关于勃起的总体评估问题（GAQ）来评估疗效。
在意向性治疗人群中，70%的患者在基线时患有严重ED（勃起功能低于11）。12周后，两种伐地那非剂量在所有疗效变量方面均显著优于安慰剂（p<0.0001）。分别有65.2%和59.4%服用20毫克和10毫克伐地那非的患者报告勃起改善（基于GAQ），而服用安慰剂的患者中只有12.5%报告勃起改善（p<0.0001）。在保留双侧神经血管束的男性中，分别有71.1%和59.7%服用20毫克和10毫克伐地那非的患者GAQ反应为阳性，而服用安慰剂的患者中这一比例为11.5%（p<0.0001）。接受20毫克伐地那非治疗的轻度至中度ED男性患者平均性交成功率为74%，重度ED男性患者为28%，而安慰剂组分别为49%和4%。观察到的不良事件很少。它们通常为轻度至中度的头痛、潮红和鼻炎。
在保留神经的耻骨后根治性前列腺切除术后患有严重ED 的男性中，伐地那非显著改善了勃起功能的关键指标。
