前列腺素E1乳膏治疗勃起功能障碍的疗效和安全性

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

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 。

Objectives: To evaluate the efficacy and safety of PGE1 cream[Befar, 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.