Padma-Nathan Harin, Yeager James L
The Keck School of Medicine of the University of Southern California, The Male Clinic, Beverly Hills, California 90212, USA.
Urology. 2006 Aug;68(2):386-91. doi: 10.1016/j.urology.2006.02.027.
To assess the safety and efficacy of topical alprostadil cream for erectile dysfunction (ED).
Patients with an ED score of 25 or less on the erectile function domain of the International Index of Erectile Function (IIEF) were randomly assigned to placebo or topical alprostadil cream (100, 200, or 300 microg) for at-home use for 12 weeks in two multicenter, double-blind, parallel-group studies. Patients receiving organic nitrates and patients with diabetes were included. Primary end points included the change in score for the erectile function domain of the IIEF and the change from baseline for the Sexual Encounter Profile (SEP) questions 2 (vaginal penetration success) and 3 (maintenance of erection to ejaculation). Safety was based on observed and reported adverse events and clinical laboratory results. Data from each study were pooled into a single integrated analysis.
A total of 1732 patients received placebo (n = 434) or topical alprostadil cream at 100 microg (n = 434), 200 microg (n = 430), or 300 microg (n = 434). The mean changes from baseline to end point in IIEF erectile function (EF) domain scores were -0.7, 1.6, 2.5, and 2.4 points for each group, respectively (P <0.001). Scores on SEP questions 2 and 3 improved slightly but significantly for all drug treatment groups compared with placebo (P <0.001). Most adverse events were localized to the application site and resolved within 2 hours.
Topical alprostadil cream significantly improves ED in a broad range of patients. Most adverse events were limited to the application site and were generally well tolerated.
评估外用前列地尔乳膏治疗勃起功能障碍（ED）的安全性和有效性。
在两项多中心、双盲、平行组研究中，将国际勃起功能指数（IIEF）勃起功能领域得分25分及以下的ED患者随机分配至安慰剂组或外用前列地尔乳膏组（100、200或300微克），在家使用12周。纳入正在接受有机硝酸盐治疗的患者和糖尿病患者。主要终点包括IIEF勃起功能领域得分的变化以及性体验问卷（SEP）问题2（阴道插入成功）和问题3（勃起维持至射精）相对于基线的变化。安全性基于观察到的和报告的不良事件以及临床实验室结果。将每项研究的数据汇总进行单一综合分析。
共有1732例患者接受了安慰剂（n = 434）或100微克（n = 434）、200微克（n = 430）或300微克（n = 434）的外用前列地尔乳膏治疗。每组从基线到终点时IIEF勃起功能（EF）领域得分的平均变化分别为-0.7、1.6、2.5和2.4分（P <0.001）。与安慰剂相比，所有药物治疗组SEP问题2和3的得分均有轻微但显著的改善（P <0.001）。大多数不良事件局限于用药部位，且在2小时内缓解。
外用前列地尔乳膏可显著改善广泛患者的ED。大多数不良事件局限于用药部位，且一般耐受性良好。
