Cappelleri Joseph C, Althof Stanley E, O'Leary Michael P, Tseng Li-Jung
Pfizer Inc, Global Research and Development, Groton, CT 06340, USA.
BJU Int. 2008 Apr;101(7):861-6. doi: 10.1111/j.1464-410X.2007.07354.x. Epub 2007 Dec 5.
To evaluate the effect of sildenafil citrate on each item of the 14-item Self-Esteem And Relationship (SEAR) questionnaire, which is used to measure self-esteem, confidence, satisfaction with sexual relationship, and overall relationship satisfaction in men with erectile dysfunction (ED).
Data were combined from two 12-week, double-blind, placebo-controlled, flexible-dose sildenafil trials having identical protocols, one conducted in the USA and the other in Mexico, Brazil, Australia and Japan. All men had ED and were aged >or=18 years. Response categories of each SEAR item used a 4-week reference period and were based on a five-point scale (1, almost never/never; 2, a few times; 3, sometimes; 4, most times; 5, almost always/always). The difference (sildenafil vs placebo) in the change from baseline to week 12 was evaluated with a Wilcoxon rank sum test using ridit analysis, and an analysis of covariance model that included treatment group, centre, study and baseline item score.
Compared with the 274 patients receiving placebo, the 279 receiving sildenafil reported significantly greater mean and median improvements (P < 0.001) in each of the 14 SEAR items. The probability of increased psychosocial benefit from baseline to week 12 was higher with sildenafil for each SEAR item, and ranged from 0.60 ('My partner was unhappy with the quality of our sexual relations'[item reverse-scored]) to 0.72 ('I was satisfied with my sexual performance'). Across all items, the mean (sd) probability was 0.67 (0.04) that a randomly selected patient in the sildenafil group would have a more favourable change relative to a randomly selected patient in the placebo group.
Sildenafil produced substantial and meaningful improvements at the item-specific level. This analysis complements previously published work on self-esteem, confidence and relationship satisfaction.
评估枸橼酸西地那非对14项自尊与关系（SEAR）问卷各项内容的影响，该问卷用于测量勃起功能障碍（ED）男性的自尊、自信、对性关系的满意度以及总体关系满意度。
数据来自两项为期12周、双盲、安慰剂对照、灵活剂量西地那非试验，两项试验方案相同，一项在美国进行，另一项在墨西哥、巴西、澳大利亚和日本进行。所有男性均患有ED，年龄≥18岁。SEAR问卷各项目的回答类别采用4周参考期，基于五点量表（1，几乎从不/从不；2，几次；3，有时；4，大多数时候；5，几乎总是/总是）。使用ridit分析的Wilcoxon秩和检验以及包含治疗组、中心、研究和基线项目得分的协方差模型分析，评估从基线到第12周变化的差异（西地那非与安慰剂）。
与274名接受安慰剂的患者相比，279名接受西地那非治疗的患者在14项SEAR问卷各项内容上的平均和中位数改善均显著更大（P<0.001）。从基线到第12周，西地那非使各SEAR项目心理社会益处增加的概率更高，范围从0.60（“我的伴侣对我们性关系的质量不满意”[项目反向计分]）到0.72（“我对自己的性表现满意”）。在所有项目中，西地那非组中随机选择的患者相对于安慰剂组中随机选择的患者有更有利变化的平均（标准差）概率为0.67（±0.04）。
西地那非在项目特定水平上产生了实质性且有意义的改善。该分析补充了先前发表的关于自尊、自信和关系满意度的研究。
