前列腺素E1乳膏治疗勃起功能障碍的疗效和安全性

目的 :评估前列腺素E1(PGE1)乳膏治疗男性勃起功能障碍 (ED)的有效性和安全性。　方法 :按 1∶1(安慰剂∶乳膏 )双盲、随机、安慰剂对照的临床研究 ,共有 4 2例符合标准的各种病因的ED病人入选。研究结束时 ,根据受试者对勃起功能国际指数 (IIEF) 2次回答的得分差值、临床疗效评估 (记事表 )及总体疗效评估 (总评题 )、不良事件登记和实验室检查等 ,对受试者用药的有效性和安全性进行综合分析。　结果 :主要疗效评估显示 :使用本研究药物后病人阴茎勃起程度达到显效和有效改善的 ,在乳膏组与安慰剂组分别为 6 3.16 %和 9.5 2 % (P <0 .0 1) ;同时总体疗效评估 (乳膏组与安慰剂组分别为 73.6 8%和 19.0 5 % ,P <0 .0 1)的分析结果 ,也支持主要疗效评估。 2例中止试验 (4 .76 % ) ,不良事件发生乳膏组 6例 (30 .0 0 % )、安慰剂组 1例 (4 .76 % ) ,均为轻度、一过性的 ,以泌尿生殖道刺激症状为主。结论 :PGE1乳膏是一种可治疗各种病因导致ED的安全有效的药物 ,按需使用时能很好耐受

Efficacy and Safety of PGE1 Cream in the Treatment of Erectile Dysfunction

OBJECTIVES: To evaluate the efficacy and safety of PGE1 creamBefar, NexMed Pharmaceuticals(Zhongshan) Ltd] on men with ED of various etiologies in China. METHODS: This was a double-blind, randomized (1:1, placebo: PGE1 cream), placebo-controlled clinic study of PGE1 cream performed at Peking University Pepole's Hospital for 8 weeks. A total of 42 subjects suffered from erectile dysfunction of psychologic, organic or mixed etiology were screened and randomized, and visited occurred at weeks -4, 0, 2 and 4 weeks covering a 4-week no treatment run-in period and a 4-week period of double blind treatment. RESULTS: At week four PGE1 cream was shown to be significantly (P < 0.01) effective over placebo in the sexual function endpoints analyses. The primary efficacy variables (Questions 3 and 4 from IIEF) revealed a statistically significant (P < 0.01) improvement over placebo along with a clinical efficacy change score with an effective rate of 63.16% on PGE1 cream vs 9.52% on placebo. The secondary efficacy variables supported the conclusion of the primary efficacy (assessing the proportion of successful attempts at sexual intercourse 68.42% on PGE1 cream vs 19.05% on placebo), and the global assessment question (treatment had improved their erections, 73.68% on PGE1 cream vs 19.05% on placebo). PGE1 cream was well tolerated when given prn. Subjects in the study had a low discontinuation rate (4.76%), only one subject (2.38%) discontinued due to adverse events. The incidence of adverse events was higher for PGE1 cream (30.00%) than for placebo (4.76%). The common adverse events were mild pain of penis and urethra. CONCLUSIONS: PGE1 cream is an effective, safe and well-tolerated treatment in subjects with erectile dysfunction of organic, psychologic or mixed etiology.