Montorsi Francesco, Padma-Nathan Harin, Glina Sidney
Department of Urology, Università Vita e Salute San Raffaele, Milan, Italy.
Urology. 2006 Sep;68(3 Suppl):26-37. doi: 10.1016/j.urology.2006.06.027.
We aimed to determine whether erectile function (EF) and assessments of erection hardness correlate positively with measures of psychosocial outcomes (ie, emotional well-being, sexual satisfaction, and satisfaction with erectile dysfunction [ED] treatment) in men treated with sildenafil citrate (Viagra; Pfizer Inc, New York, NY). Data were collected from 33 worldwide phase 2, 3, and 4 sildenafil clinical trials, which included almost 10,000 men with ED. Most of these trials were randomized, double-blind, and placebo-controlled (n = 27) and were undertaken to assess doses of 50 mg adjustable to 25 mg or 100 mg, depending on efficacy and tolerability (n = 32). Doses were taken approximately 1 hour before anticipated sexual activity but not more often than once daily. EF was assessed with use of the EF domain of the International Index of Erectile Function (IIEF) and with assessments of erection hardness (Erection Hardness Grading Scale [EHGS] and IIEF Q2 [the frequency of erections hard enough for penetration]). Change (baseline to end point) in emotional well-being in men treated for ED was assessed with the Self-Esteem and Relationship (SEAR) questionnaire, which consisted of the Confidence domain (ie, the Self-Esteem subscale and Overall Relationship subscale) and the Sexual Relationship domain. End point treatment satisfaction (overall, speed of onset, and duration of action) was assessed with the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). The IIEF was used to assess change and end point sexual satisfaction by means of the Intercourse Satisfaction domain, Q7 (frequency of satisfactory sexual intercourse), and the Overall Satisfaction domain (ie, Q13, satisfaction with sex life, and Q14, satisfaction with sexual relationship). In men treated with sildenafil for ED, scores for measures of EF (IIEF EF domain, IIEF Q2) and the percentage of erections graded completely hard and fully rigid (EHGS grade 4) correlated positively with scores for measures of psychosocial outcomes (SEAR emotional well-being, IIEF sexual satisfaction, and EDITS ED treatment satisfaction), indicating that when EF improved and erection hardness increased, these measures of psychosocial function also improved.
我们旨在确定，在接受枸橼酸西地那非（万艾可；辉瑞公司，纽约州纽约市）治疗的男性中，勃起功能（EF）及勃起硬度评估与心理社会结局指标（即情绪健康、性满意度以及对勃起功能障碍[ED]治疗的满意度）之间是否呈正相关。数据收集自全球范围内33项西地那非2期、3期和4期临床试验，这些试验纳入了近10,000例ED男性患者。其中大多数试验为随机、双盲且安慰剂对照试验（n = 27），旨在评估50 mg剂量，可根据疗效和耐受性调整为25 mg或100 mg（n = 32）。剂量在预期性活动前约1小时服用，但每天服用次数不超过1次。使用国际勃起功能指数（IIEF）的EF领域以及勃起硬度评估（勃起硬度分级量表[EHGS]和IIEF Q2[足以插入的勃起频率]）来评估EF。使用自尊与关系（SEAR）问卷评估接受ED治疗男性的情绪健康变化（基线至终点），该问卷由信心领域（即自尊子量表和总体关系子量表）和性关系领域组成。使用治疗满意度勃起功能障碍量表（EDITS）评估终点治疗满意度（总体、起效速度和作用持续时间）。IIEF用于通过性交满意度领域、Q7（满意性交频率）和总体满意度领域（即Q13，对性生活的满意度，以及Q14，对性关系的满意度）来评估变化和终点性满意度。在接受西地那非治疗ED的男性中，EF指标（IIEF EF领域、IIEF Q2）得分以及完全坚硬和完全勃起分级（EHGS 4级）的勃起百分比与心理社会结局指标（SEAR情绪健康、IIEF性满意度和EDITS ED治疗满意度）得分呈正相关，这表明当EF改善且勃起硬度增加时，这些心理社会功能指标也会改善。
