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他达拉非两种给药方案对糖尿病合并勃起功能障碍男性的疗效、安全性及性活动模式：14个欧洲国家的按需治疗与规律用药方案评估（SURE）研究

Efficacy and safety of two dosing regimens of tadalafil and patterns of sexual activity in men with diabetes mellitus and erectile dysfunction: Scheduled use vs. on-demand regimen evaluation (SURE) study in 14 European countries.

作者信息

Buvat Jacques, van Ahlen Hermann, Schmitt Henry, Chan Melanie, Kuepfer Christine, Varanese Lucio

机构信息

Centre d'Etude et de Traitement de la Pathologie de l'Appareil Reproducteur et de la Psychosomatique, Lille, France.

出版信息

J Sex Med. 2006 May;3(3):512-20. doi: 10.1111/j.1743-6109.2006.00249.x.

DOI:10.1111/j.1743-6109.2006.00249.x

PMID:16681477

Abstract

AIM

The aim of this article is to evaluate the efficacy and safety of 20-mg tadalafil taken on demand or three times per week and its effect on the sexual activity of patients with diabetes mellitus and erectile dysfunction (ED).

METHODS

The scheduled use vs. on-demand regimen evaluation (SURE) was a randomized, crossover, open-label study with 4,262 patients in 14 European countries. The efficacy measures for the 762 patients with diabetes and ED included changes from baseline in the erectile function (EF) domain of the International Index of Erectile Function (IIEF), and the proportion of "yes" responses to patient Sexual Encounter Profile (SEP) questions 2 (SEP2) and 3 (SEP3). The treatment satisfaction was measured with responses to SEP question 4 (SEP4) and SEP question 5 (SEP5), and sexual attempts data were collected. Patient preference for either regimen was determined by the treatment preference question (TPQ).

RESULTS

At end point on both regimens, the mean IIEF EF domain score was 22, and >40% of the patients had a normal EF domain score (> or =26). The proportion of "yes" responses was > or =73% for SEP2 (penetration), > or =58% for SEP3 (successful intercourse), >46% for SEP4 (hardness of erection), and > or =45% for SEP5 (overall satisfaction). Efficacy was maintained up to 36 hours post-dosing. More than 70% of sexual attempts while on the three-times-per-week regimen and approximately 50% of the attempts on the on-demand treatment occurred >4 hours post-dosing. Tadalafil was well tolerated, with dyspepsia and headache as the most frequent adverse events reported. Treatment preference was 57.2% for on demand and 42.8% for three times per week.

CONCLUSIONS

Tadalafil, when taken on demand or three times per week, is efficacious and safe in men with diabetes and ED.

摘要

目的

本文旨在评估按需服用或每周三次服用20毫克他达拉非的疗效和安全性，以及其对糖尿病合并勃起功能障碍（ED）患者性功能的影响。

方法

按需服用与定期服用方案评估（SURE）是一项在14个欧洲国家开展的随机、交叉、开放标签研究，共有4262例患者参与。762例糖尿病合并ED患者的疗效指标包括国际勃起功能指数（IIEF）勃起功能（EF）领域相对于基线的变化，以及对患者性经历问卷（SEP）问题2（SEP2）和问题3（SEP3）回答“是”的比例。通过对SEP问题4（SEP4）和SEP问题5（SEP5）的回答来衡量治疗满意度，并收集性尝试数据。通过治疗偏好问题（TPQ）确定患者对两种方案的偏好。

结果

在两种方案的终点，IIEF EF领域的平均得分均为22，超过40%的患者EF领域得分正常（≥26）。SEP2（插入）回答“是”的比例≥73%，SEP3（成功性交）回答“是”的比例≥58%，SEP4（勃起硬度）回答“是”的比例>46%，SEP5（总体满意度）回答“是”的比例≥45%。给药后长达36小时疗效得以维持。在每周三次服用方案中，超过70%的性尝试以及按需治疗中约50%的性尝试发生在给药后4小时以上。他达拉非耐受性良好，最常报告的不良事件为消化不良和头痛。按需服用的治疗偏好为57.2%，每周三次服用的治疗偏好为42.8%。