Cappelleri Joseph C, Tseng Li-Jung, Luo Xuemei, Stecher Vera, Lue Tom F
Pfizer Inc, Groton, CT, USA.
Pfizer Inc, New York, NY, USA.
J Sex Med. 2016 Apr;13(4):690-6. doi: 10.1016/j.jsxm.2016.02.159. Epub 2016 Feb 28.
This report describes a post hoc analysis of data from a randomized, double-blinded, placebo-controlled, flexible-dose, sildenafil trial in men with erectile dysfunction.
To simplify interpretation of erectile function (EF) domain scores of the International Index of Erectile Function (IIEF).
Men at least 18 years old with erectile dysfunction were randomized to receive sildenafil or placebo for 12 weeks. Men taking nitrates or nitric oxide donors were excluded. Responses for each IIEF EF domain question (questions 1-5 and 15) were combined into two broad categories ("success" for responses of the two most favorable categories of a question and "no success" for other responses). Each question was expressed in a logistic regression model (sildenafil and placebo groups combined) as a function of overall EF domain score.
IIEF EF domain score and items.
A four-point increase in the IIEF EF domain score was associated with an odds ratio of success of 6.1 for getting an erection, 29.2 for having a firm erection, 10.0 for able to penetrate,12.8 for maintaining erection, 4.0 for maintaining erection to completion, and 3.7 for erection confidence. An EF domain score of 22 was associated with a probability of success of 81% for getting an erection, 86% for having a firm erection, 89% for able to penetrate, 67% for maintaining an erection, 70% for maintaining an erection to completion, and 32% for erection confidence. For an EF domain score of 16, the corresponding probabilities of success were 22%, 4%, 20%, 4%, 22%, and 6%, respectively.
These results provide stakeholders with a simplified and meaningful interpretation of IIEF EF domain scores based on six key aspects of EF.
本报告描述了一项针对勃起功能障碍男性的随机、双盲、安慰剂对照、灵活剂量西地那非试验数据的事后分析。
简化国际勃起功能指数(IIEF)勃起功能(EF)领域得分的解读。
年龄至少18岁的勃起功能障碍男性被随机分配接受西地那非或安慰剂治疗12周。服用硝酸盐或一氧化氮供体的男性被排除在外。将IIEF EF领域每个问题(问题1 - 5和15)的回答合并为两大类(一个问题中最有利的两个类别回答为“成功”,其他回答为“未成功”)。每个问题在逻辑回归模型(西地那非组和安慰剂组合并)中表示为总体EF领域得分的函数。
IIEF EF领域得分及项目。
IIEF EF领域得分增加4分与勃起成功的优势比为6.1、坚挺勃起的优势比为29.2、能够插入的优势比为10.0、维持勃起的优势比为12.8、维持勃起直至完成的优势比为4.0以及勃起信心的优势比为3.7相关。EF领域得分为22与勃起成功概率81%、坚挺勃起概率86%、能够插入概率89%、维持勃起概率67%、维持勃起直至完成概率70%以及勃起信心概率32%相关。对于EF领域得分为16,相应的成功概率分别为22%、4%、20%、4%、22%和6%。
这些结果基于勃起功能的六个关键方面为利益相关者提供了对IIEF EF领域得分的简化且有意义的解读。