Steidle Christopher, Padma-Nathan Harin, Salem Shawki, Tayse Natalie, Thwing Denise, Fendl Jane, Yeager James, Harning Ronald
Northeast Indiana Research, Fort Wayne, Indiana, USA.
Urology. 2002 Dec;60(6):1077-82. doi: 10.1016/s0090-4295(02)01980-5.
To present a meta-analysis of the efficacy and safety data of two recently completed Phase II studies examining a novel alprostadil topical cream for the treatment of erectile dysfunction (ED).
Patients (n = 303) with ED of at least 3 months' duration were randomized to receive placebo or 50, 100, 200, or 300 microg alprostadil in two nearly identical 11-dose, multicenter, at-home studies of a novel topical cream containing alprostadil and a proprietary skin permeation enhancer. The primary efficacy endpoint was the change in erectile function domain score from baseline to the final visit. Secondary endpoints included changes in scores for questions 3 and 4 of the International Index of Erectile Function and standard diary analyses. Safety was assessed by analysis of adverse events, changes in laboratory test results, and physical examination findings.
The mean baseline parameters for the erectile function score, ED history, and secondary diagnoses suggested no significant differences among the treatment groups. The changes from baseline to the final visit erectile function scores were 0.98 +/- 0.84, 3.4 +/- 1.3, 3.4 +/- 0.88 (P <0.05), 5.3 +/- 0.92 (P <0.001), and 9.4 +/- 1.43 (P <0.001) for the ascending dose groups. Most secondary efficacy endpoints were significant for the 200 and 300-microg dose groups. Dose-related trends in efficacy were observed. Adverse events were localized to the application site, were of mild or moderate intensity, and were of short duration.
These results suggest topical alprostadil cream, when combined with a novel dermal permeation-enhancer, to be a potentially useful agent for the treatment of ED.
对两项近期完成的II期研究的疗效和安全性数据进行荟萃分析，这两项研究旨在探究一种新型前列地尔外用乳膏治疗勃起功能障碍（ED）的效果。
在两项几乎相同的、含11个剂量的多中心家庭研究中，将病程至少3个月的303例ED患者随机分为安慰剂组，以及分别接受50、100、200或300微克前列地尔治疗的组，研究使用的是一种含有前列地尔和一种专利皮肤渗透促进剂的新型外用乳膏。主要疗效终点是从基线到末次访视时勃起功能领域评分的变化。次要终点包括国际勃起功能指数第3和第4个问题的评分变化以及标准日记分析。通过分析不良事件、实验室检查结果变化和体格检查结果来评估安全性。
勃起功能评分、ED病史和次要诊断的平均基线参数表明各治疗组之间无显著差异。递增剂量组从基线到末次访视时的勃起功能评分变化分别为0.98±0.84、3.4±1.3、3.4±0.88（P<0.05）、5.3±0.92（P<0.001）和9.4±1.43（P<0.001）。大多数次要疗效终点在200和300微克剂量组中具有统计学意义。观察到了疗效的剂量相关趋势。不良事件局限于用药部位，强度为轻度或中度，持续时间较短。
这些结果表明，前列地尔外用乳膏与一种新型皮肤渗透促进剂联合使用时，可能是一种治疗ED的有效药物。
