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枸橼酸西地那非可改善伴有良性前列腺增生相关勃起功能障碍和下尿路症状男性的勃起功能及尿路症状:一项随机双盲试验。

Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial.

作者信息

McVary Kevin T, Monnig William, Camps Joseph L, Young Jay M, Tseng Li-Jung, van den Ende Gene

机构信息

Northwestern University Feinberg School of Medicine, Chicago, Illinois 60611-3008, USA.

出版信息

J Urol. 2007 Mar;177(3):1071-7. doi: 10.1016/j.juro.2006.10.055.

DOI:10.1016/j.juro.2006.10.055
PMID:17296414
Abstract

PURPOSE

We evaluated sildenafil for erectile dysfunction and lower urinary tract symptoms in men with the 2 conditions.

MATERIALS AND METHODS

This was a 12-week, double-blind, placebo controlled study of sildenafil in men 45 years or older who scored 25 or less on the erectile function domain of the International Index of Erectile Function and 12 or greater on the International Prostate Symptom Score. Men with confirmed or suspected prostate malignancy, or prostate specific antigen 10 ng/ml or more were excluded. End points were changes in International Index of Erectile Function domain scores, International Prostate Symptom Score (irritative, obstructive and quality of life), the Benign Prostatic Hyperplasia Impact Index, the Self-Esteem And Relationship questionnaire and Erectile Dysfunction Inventory of Treatment Satisfaction Index Score.

RESULTS

The 189 men receiving sildenafil had significant improvements in erectile function domain score vs the 180 on placebo (9.17 vs 1.86, p<0.0001) and on all other International Index of Erectile Function domains. In men on sildenafil vs placebo significant improvements were observed in International Prostate Symptom Score (-6.32 vs -1.93, p<0.0001), Benign Prostatic Hyperplasia Impact Index (-2.0 vs -0.9, p<0.0001), mean International Prostate Symptom Score quality of life score (-0.97 vs -0.29, p<0.0001) and total Self-Esteem And Relationship questionnaire scores (24.6 vs 4.3, p<0.0001). There was no difference in urinary flow between the groups (p=0.08). Significantly more sildenafil vs placebo treated patients were satisfied with treatment (71.2 vs 41.7, p<0.0001). Sildenafil was well tolerated.

CONCLUSIONS

Improved erectile dysfunction and lower urinary tract symptoms with sildenafil in men with the 2 conditions were associated with improved quality of life and treatment satisfaction. Daily dosing with sildenafil may improve lower urinary tract symptoms. However, the lack of effect on urinary flow rates may mean that a new basic pathophysiology paradigm is needed to explain the etiology of lower urinary tract symptoms.

摘要

目的

我们评估了西地那非对同时患有勃起功能障碍和下尿路症状的男性的疗效。

材料与方法

这是一项为期12周的双盲、安慰剂对照研究,研究对象为45岁及以上的男性,他们在国际勃起功能指数的勃起功能领域得分在25分及以下,国际前列腺症状评分在12分及以上。确诊或疑似前列腺恶性肿瘤、前列腺特异性抗原为10 ng/ml或更高的男性被排除在外。终点指标包括国际勃起功能指数领域得分、国际前列腺症状评分(刺激性、梗阻性和生活质量)、良性前列腺增生影响指数、自尊与关系问卷以及治疗满意度指数评分的变化。

结果

189名接受西地那非治疗的男性在勃起功能领域得分较180名接受安慰剂治疗的男性有显著改善(9.17对1.86,p<0.0001),在国际勃起功能指数的所有其他领域也是如此。与安慰剂组相比,服用西地那非的男性在国际前列腺症状评分(-6.32对-1.93,p<0.0001)、良性前列腺增生影响指数(-2.0对-0.9,p<0.0001)、国际前列腺症状评分生活质量平均得分(-0.97对-0.29,p<0.0001)以及自尊与关系问卷总得分(24.6对4.3,p<0.0001)方面均有显著改善。两组间尿流率无差异(p=0.08)。接受西地那非治疗的患者对治疗的满意度显著高于接受安慰剂治疗的患者(7

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