前列地尔尿道栓治疗勃起功能障碍附78例随机、双盲、安慰剂对照、剂量可调的临床研究

Effect of alprostadil urethral suppository on erectile dysfunction: a double blind,randomized,flexible dose escalation study for seventy eight patients

为了解前列地尔尿道栓 (AUS)治疗勃起功能障碍 (ED)的疗效。作者对 78例ED患者进行随机、双盲(前列地尔 :安慰剂为 2∶1 )、安慰剂对照、剂量可调、持续 6周的临床研究 ;结果主要疗效指标IIEF中问题 3和 4显示 ,AUS对ED患者达到和维持勃起能力的改善作用显著优于安慰剂组 (P <0 .0 1 ) ,AUS总有效率为 5 5 .5 5 % ,显著高于安慰剂组的 2 5 .0 0 % ;受试者记事表数据显示AUS组受试者在研究结束时性交成功率为 75 .5 6 % ,显著高于安慰剂组的 2 1 .43% ;有 77.78%的AUS组受试者认为研究药物改善了其勃起功能 ,显著高于安慰剂组的 2 1 .43% ;作者认为AUS是一种效果肯定、侵袭性少、使用简便、可多次重复使用的治疗ED的药物。

In order to investigate the effect of the Alprostadil Urethral Suppository (AUS,also called MUSE?Medicated Urethral System for Erection) on Erectile Dysfunction (ED) patients,double blind,randomized (1∶2,placebo:AUS),flexible dose escalation study was taken over an six week period on 78 subjects with erectile dysfunction of psychogenic,organic,or mixed etiology.The results showed that the primary efficacy variables (Question 3 and 4 from the International Index of Erectile Function IIEF) revealed a statistically significant( P <0.01) improvement on sexual function over placebo,along with a clinical efficacy change score with an effective rate of 55.55% on AUS vs .25% on placebo.Event log data shows that the proportion of successful attempts at sexual intercourse is 75.56% on AUS vs .21.43% on placebo,and the global assessment question shows 77.78% improvement of their erection on AUS vs .21.43% on placebo.So AUS used as a therapy for ED is reliable,less invasive,simple to use and permitting discreet administration.