阴茎海绵体内注射前列地尔治疗勃起功能障碍男性的疗效与安全性。前列地尔研究组

Efficacy and safety of intracavernosal alprostadil in men with erectile dysfunction. The Alprostadil Study Group.

作者信息

Linet O I, Ogrinc F G

机构信息

Upjohn Company, Kalamazoo, MI 49001-0199, USA.

出版信息

N Engl J Med. 1996 Apr 4;334(14):873-7. doi: 10.1056/NEJM199604043341401.

DOI:10.1056/NEJM199604043341401

PMID:8596569

Abstract

BACKGROUND

Erectile dysfunction is a common medical problem affecting many men. Although several intracavernosal therapies are available, their efficacy and safety have not been studied systematically.

METHODS

We investigated the efficacy and safety of alprostadil formulated for intracavernosal treatment in three separate multi-institutional, prospective studies in men with erectile dysfunction of vasculogenic, neurogenic, psychogenic, and mixed causes. Clinical and laboratory evaluations of erection and the feasibility of satisfactoriness of sexual activity as assessed both by the men and by their partners were the primary measures of efficacy.

RESULTS

In a dose-response study of 296 men, all doses of alprostadil were superior to placebo and there was a significant dose-response relation (P < / = 0.001), resulting in higher response rates with increasing doses of alprostadil (from 2.5 to 20 microg). In a dose-finding study of 201 men, the minimal effective dose was < / = 2 microg in 23, 20, 38 and 23 percent of men with erectile dysfunction of neurogenic, vasculogenic, psychogenic, or mixed causes, respectively. In a six-month self-injection study in 683 men, the participants reported being able to have sexual activity after 94 percent of the injections. The men and their partners rated the sexual activity as satisfactory after 87 and 86 percent of the injections, respectively. Penile pain, usually mild, occurred in 50 percent of the men at some time but after only 11 percent of the injections. Prolonged erections occurred in 5 percent of the men, priapism in 1 percent, penile fibrotic complications in 2 percent, and hematoma or ecchymosis in 8 percent.

CONCLUSIONS

In men with erectile dysfunction, intracavernosal injection of alprostadil is an effective therapy with tolerable side effects.

摘要

背景

勃起功能障碍是一个影响众多男性的常见医学问题。尽管有几种海绵体内治疗方法可供使用，但其疗效和安全性尚未得到系统研究。

方法

我们在三项独立的多机构前瞻性研究中，调查了用于海绵体内治疗的前列地尔对血管性、神经性、心理性及混合性病因所致勃起功能障碍男性的疗效和安全性。勃起的临床和实验室评估以及男性及其伴侣评估的性活动满意度的可行性是疗效的主要衡量指标。

结果

在一项对296名男性的剂量反应研究中，所有剂量的前列地尔均优于安慰剂，且存在显著的剂量反应关系（P≤0.001），随着前列地尔剂量增加（从2.5至20微克），有效率更高。在一项对201名男性的剂量探索研究中，对于神经性、血管性、心理性或混合性病因所致勃起功能障碍的男性，分别有23%、20%、38%和23%的人最小有效剂量≤2微克。在一项对683名男性的为期六个月的自我注射研究中，参与者报告在94%的注射后能够进行性活动。男性及其伴侣分别在87%和86%的注射后将性活动评为满意。50%的男性在某些时候出现阴茎疼痛，通常为轻度，但仅在11%的注射后出现。5%的男性出现持续性勃起，1%出现阴茎异常勃起，2%出现阴茎纤维化并发症，8%出现血肿或瘀斑。