Institute of Urology, Key Laboratory of Diseases of Urological System, Gansu Province, Gansu Nephro-Urological Clinical Center, Second Hospital of Lanzhou University, Lanzhou, China.
Urology. 2012 Jul;80(1):134-9. doi: 10.1016/j.urology.2012.02.014. Epub 2012 Apr 11.
To systematically review the evidence on the efficacy and safety of udenafil as treatment of erectile dysfunction from randomized controlled trials.
We searched PubMed, Embase, and the Cochrane Library database up to October 2011. The outcome measures assessed were the change from baseline for the International Index of Erectile Function erectile function domain score (primary), the change from baseline for Sexual Encounter Profile questions 2 and 3, the shift to normal rate (erectile function domain ≥ 26), the response to the Global Assessment Questionnaire and adverse effects (secondary). Two of us independently assessed the study quality and extracted data. All data were analyzed using Review Manager, version 5.0.2.
Five randomized controlled trials totaling 1109 patients were included. At the follow-up endpoints, udenafil was found to be more effective than placebo, and the tolerability was good. The pooled results showed that the udenafil group was significantly greater than the placebo group in the change from baseline for the International Index of Erectile Function erectile function domain score (mean difference 5.65, 95% confidence interval 4.41-6.89, P < .00001). All included studies indicated that most adverse events were mild or moderate in severity, and no serious adverse events were reported during the study period. The most common drug-related adverse events were flushing and headache (udenafil vs placebo, 5.6% vs 1.8% and 3.1% vs 0%, respectively).
The results from the current meta-analysis have suggested that udenafil is an effective and well-tolerated therapy for erectile dysfunction. The findings of the present review highlight the need for more efficient performance of higher quality, large-sample, various-race, long-term, randomized controlled trials to verify the efficacy and safety of udenafil.
系统评价乌地那非治疗勃起功能障碍的疗效和安全性的证据，来源于随机对照试验。
我们检索了 PubMed、Embase 和 Cochrane Library 数据库，截止到 2011 年 10 月。评估的结局指标为：国际勃起功能指数（erectile function domain score，IIEF-5）的基线变化（主要指标）、性经历概况问卷 2 和 3 的基线变化、正常率（erectile function domain≥26）的转变、全球评估问卷的反应和不良反应（次要指标）。我们 2 人独立评估了研究质量并提取了数据。所有数据均采用 Review Manager，版本 5.0.2 进行分析。
共有 5 项随机对照试验，总计 1109 例患者纳入研究。在随访终点时，乌地那非被发现比安慰剂更有效，且耐受性良好。汇总结果显示，乌地那非组在 IIEF-5 的基线变化方面明显优于安慰剂组（均数差 5.65，95%置信区间 4.41-6.89，P<0.00001）。所有纳入研究表明，大多数不良事件的严重程度为轻度或中度，且在研究期间未报告严重不良事件。最常见的与药物相关的不良事件为潮红和头痛（乌地那非与安慰剂相比，5.6%与 1.8%和 3.1%与 0%）。
当前荟萃分析的结果表明，乌地那非是一种有效且耐受良好的勃起功能障碍治疗方法。本综述的结果强调需要开展更多的、高效率的、高质量的、大样本的、多种族的、长期的、随机对照试验，以验证乌地那非的疗效和安全性。
