Chair of Endocrinology and Medical Sexology (ENDOSEX), Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
Department of Biotechnological and Applied Clinical Sciences and Division of Radiotherapy and Radiobiology, University of L'Aquila, L'Aquila, Italy.
Andrology. 2017 Sep;5(5):863-872. doi: 10.1111/andr.12403. Epub 2017 Aug 8.
The impact of phosphodiesterase type 5 inhibitor (PDE5I) treatment modality (on-demand vs. daily), PDE5I half-life and time from surgery to PDE5I prescription on the achievement of drug-assisted erectile function (EF) recovery is uncertain. We systematically reviewed published randomized clinical trials (RCTs). We performed meta-analyses of data on 2317 men treated with PDE5Is after nerve-sparing radical prostatectomy (NSRP). A PubMed and SCOPUS search was performed for trials published from 1 January 1969 to 30 June 2016. PDE5Is are effective in achieving drug-assisted recovery of erectile function (EF). From a statistical standpoint, these studies were subjected to Trial Sequential Analysis to determine whether the pooled data were adequately powered to verify the study outcomes. On-demand treatment with PDE5Is was significantly better than daily treatment in recovering drug-assisted EF. This effect was maintained even when the drugs were stratified according with half-life. Although not based on head-to-head trials, Avanafil used on-demand was the most effective PDE5I in recovering drug-assisted EF. Whereas tadalafil was equally effective when used both on-demand and daily, vardenafil significantly improved drug-assisted EF recovery only when used on-demand. The start of PDE5I treatment six months or more after surgery compared to treatment started earlier did not negatively affect the rate of drug-assisted EF recovery or the possibility to have successful intercourse based on the Sexual Encounter Profile question-3 (SEP-3). Current trials do not support the hypothesis that PDE5I use recovers drug-unassisted EF, although chronic low-dose tadalafil administration may help to preserve erectile tissue integrity. Potential shortcomings in the trials design may partially explain these disappointing results and several questions concerning the recovery of drug-unassisted EF remain unanswered. Thus, there is a need for well-designed new RCTs requiring changes in the timing of PDE5I administration as well as in the dose and the treatment duration.
磷酸二酯酶 5 抑制剂 (PDE5I) 治疗方式（按需与每日）、PDE5I 半衰期以及手术至 PDE5I 处方时间对药物辅助勃起功能（EF）恢复的影响尚不确定。我们系统地回顾了已发表的随机临床试验 (RCT)。我们对 2317 例接受神经保留根治性前列腺切除术 (NSRP) 后接受 PDE5I 治疗的男性进行了荟萃分析。在 1969 年 1 月 1 日至 2016 年 6 月 30 日期间，我们在 PubMed 和 SCOPUS 上进行了试验搜索。PDE5I 可有效实现药物辅助的勃起功能恢复。从统计学角度来看，这些研究受到了试验序贯分析的检验，以确定汇总数据是否具有足够的效力来验证研究结果。按需使用 PDE5I 治疗在恢复药物辅助的 EF 方面明显优于每日治疗。即使根据半衰期对药物进行分层，这种效果仍然存在。虽然不是基于头对头试验，但按需使用阿伐那非是恢复药物辅助的 EF 最有效的 PDE5I。虽然按需使用他达拉非和每日使用他达拉非同样有效，但只有按需使用伐地那非才能显著改善药物辅助的 EF 恢复。与更早开始治疗相比，手术后 6 个月或更长时间开始 PDE5I 治疗不会对药物辅助的 EF 恢复率或基于性体验描述问题-3（SEP-3）进行成功性交的可能性产生负面影响。目前的试验不支持 PDE5I 使用恢复药物非辅助的 EF 的假设，尽管慢性低剂量他达拉非给药可能有助于保持勃起组织的完整性。试验设计中的潜在缺陷可能部分解释了这些令人失望的结果，并且药物非辅助的 EF 恢复的几个问题仍然没有答案。因此，需要进行设计良好的新 RCT，这些 RCT 需要改变 PDE5I 给药的时间以及剂量和治疗持续时间。
