一项开放标签、随机、灵活剂量、交叉研究，以评估枸橼酸西地那非和盐酸阿扑吗啡对勃起功能障碍男性的相对疗效和安全性。

An open-label, randomized, flexible-dose, crossover study to assess the comparative efficacy and safety of sildenafil citrate and apomorphine hydrochloride in men with erectile dysfunction.

作者信息

Giammusso Bruno, Colpi Giovanni M, Cormio Luigi, Ludovico Giuseppe, Soli Marcello, Ponchietti Roberto, Montorsi Francesco, Panzironi Claudio, Guastella Bruno

机构信息

Department of Urology, University of Catania, Catania, Italy.

出版信息

Urol Int. 2008;81(4):409-15. doi: 10.1159/000167838. Epub 2008 Dec 10.

DOI:10.1159/000167838

PMID:19077401

Abstract

INTRODUCTION

We report the methodology and results of a study that compared a dopaminergic agonist, apomorphine, with a phosphodiesterase type-5 inhibitor, sildenafil, in terms of efficacy, tolerability, satisfaction and patient preference.

PATIENTS AND METHODS

This was a 20-week open- label, randomized, flexible-dose, crossover study to assess the comparative efficacy and safety of sildenafil and apomorphine. One sequence group received treatment with sildenafil followed by apomorphine and the other sequence group received treatment with apomorphine followed by sildenafil. The primary efficacy variable was the measurement of the score of the erectile function domain (the sum of questions 1-5 and 15) of the International Index of Erectile Function (IIEF) questionnaire. The secondary efficacy variables were: the responses to the Global Efficacy Assessment Questions; the score of the responses to all the questions of the IIEF questionnaire; the index score of the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire, and the event log variables.

RESULTS AND CONCLUSIONS

A marked increase in the mean IIEF score was observed after treatment with sildenafil, compared with a small increase following treatment with apomorphine. The mean baseline and final scores before and after treatment with sildenafil were 13.9 +/- 5.2 and 24.1 +/- 5.2, while the corresponding mean scores before and after treatment with apomorphine were 14.2 +/- 5.1 and 16.8 +/- 6.2. The comparison between treatments showed a statistically significant difference in favor of sildenafil. Furthermore, sildenafil was found to be significantly superior to apomorphine in all the other secondary variables, produced a high level of patient satisfaction, and a significantly larger number of patients indicated their preference for sildenafil compared to apomorphine.

摘要

引言

我们报告了一项研究的方法和结果，该研究在疗效、耐受性、满意度和患者偏好方面，将多巴胺能激动剂阿扑吗啡与5型磷酸二酯酶抑制剂西地那非进行了比较。

患者与方法

这是一项为期20周的开放标签、随机、灵活剂量、交叉研究，旨在评估西地那非和阿扑吗啡的相对疗效和安全性。一个序列组先接受西地那非治疗，然后接受阿扑吗啡治疗，另一个序列组先接受阿扑吗啡治疗，然后接受西地那非治疗。主要疗效变量是国际勃起功能指数（IIEF）问卷中勃起功能领域（问题1 - 5和15的总和）的得分测量。次要疗效变量包括：对总体疗效评估问题的回答；对IIEF问卷所有问题回答的得分；治疗满意度勃起功能障碍问卷的指数得分，以及事件日志变量。

结果与结论

与阿扑吗啡治疗后略有增加相比，西地那非治疗后IIEF平均得分显著增加。西地那非治疗前后的平均基线和最终得分分别为13.9±5.2和24.1±5.2，而阿扑吗啡治疗前后的相应平均得分分别为14.2±5.1和16.8±6.2。治疗之间的比较显示西地那非具有统计学上的显著优势。此外，在所有其他次要变量方面，西地那非被发现显著优于阿扑吗啡，产生了较高的患者满意度，并且与阿扑吗啡相比，有显著更多的患者表示更喜欢西地那非。