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男性使用枸橼酸西地那非(伟哥)治疗勃起功能障碍时异性恋伴侣的性功能及满意度:一项多中心、随机、双盲、安慰剂对照试验

Sexual function and satisfaction in heterosexual couples when men are administered sildenafil citrate (Viagra) for erectile dysfunction: a multicentre, randomised, double-blind, placebo-controlled trial.

作者信息

Heiman J R, Talley D R, Bailen J L, Oskin T A, Rosenberg S J, Pace C R, Creanga D L, Bavendam T

机构信息

Kinsey Institute for Research in Sex, Gender and Reproduction, Indiana University, Bloomington, IN 47405-3700, USA.

出版信息

BJOG. 2007 Apr;114(4):437-47. doi: 10.1111/j.1471-0528.2006.01228.x. Epub 2007 Feb 5.

DOI:10.1111/j.1471-0528.2006.01228.x
PMID:17284249
Abstract

OBJECTIVE

To investigate the effect of improvement in erectile dysfunction (ED) on sexual function and satisfaction measures in heterosexual couples in which the woman reports that sexual intercourse is unsatisfactory at least half of the time.

DESIGN

Multicentre, double-blind, placebo-controlled study.

SETTING

Outpatient medical clinics.

POPULATION

Hundred and eighty men with ED and their female partners in whom sexual intercourse was satisfactory about half the time or less (score of < or =3 on the Female Partner of ED Subject Questionnaire question 3 [FePEDS Q3]).

METHODS

Men were randomised to flexible-dose sildenafil (25, 50, and 100 mg) or placebo as needed for 12 weeks.

MAIN OUTCOME MEASURES

Primary: FePEDS Q3 ('Over the past four weeks, when you had sexual intercourse, how often was it satisfactory for you?') scored as 0 (no sexual activity) and 1 (almost never or never) to 5 (almost always or always). Secondary, partners: Sexual Function Questionnaire, Female Sexual Function Index (FSFI), and ED Inventory of Treatment Satisfaction (EDITS) partner version (EDITS-Partner). Secondary, men: International Index of Erectile Function (IIEF), General Efficacy Questions, event log data, Self-Esteem And Relationship questionnaire, and EDITS. Secondary, partners and men: Dyadic Adjustment Scale.

RESULTS

The intention-to-treat population included 85 sildenafil recipients (mean age 59 +/- 12 years) and 91 placebo recipients (mean age 57 +/- 11 years). Most partners (aged 20-79 years; mean, 54 years) were postmenopausal. Sildenafil compared with placebo couples had greater improvement in the primary outcome (FePEDS Q3 [P < 0.0001]) and in sexual function, intercourse success rates, and secondary sexual satisfaction measures (FSFI satisfaction domain [P < 0.0001] and IIEF satisfaction domains [P < 0.001]) and had higher treatment satisfaction (EDITS and EDITS-Partner; P < 0.0001). Several predictors of improvement were identified, and improvement in one member of the couple correlated positively with improvement in the other member.

CONCLUSIONS

The interdependence of sexual function and sexual satisfaction measures between members of couples consisting of men with ED and sexually healthy women reporting infrequent satisfactory sexual intercourse underscores the importance of including partners in ED treatment discussions.

摘要

目的

调查改善勃起功能障碍(ED)对异性恋伴侣性功能及满意度指标的影响,这些伴侣中女性报告至少半数时间性交不满意。

设计

多中心、双盲、安慰剂对照研究。

地点

门诊医疗诊所。

研究对象

180名患有ED的男性及其女性伴侣,其性交满意度约为半数时间或更少(在ED患者伴侣问卷问题3[FePEDS Q3]上得分为≤3分)。

方法

男性根据需要随机分配接受灵活剂量的西地那非(25、50和100毫克)或安慰剂,为期12周。

主要结局指标

主要指标:FePEDS Q3(“在过去四周内,当您进行性交时,您对性交的满意度如何?”)评分从0(无性行为)、1(几乎从不或从不)到5(几乎总是或总是)。次要指标,伴侣:性功能问卷、女性性功能指数(FSFI)以及ED治疗满意度量表(EDITS)伴侣版(EDITS-伴侣)。次要指标,男性:国际勃起功能指数(IIEF)、总体疗效问题、事件日志数据、自尊与关系问卷以及EDITS。次要指标,伴侣和男性:二元调适量表。

结果

意向性分析人群包括85名接受西地那非治疗者(平均年龄59±12岁)和91名接受安慰剂治疗者(平均年龄57±11岁)。大多数伴侣(年龄20 - 79岁;平均54岁)已绝经。与安慰剂组伴侣相比,西地那非组伴侣在主要结局指标(FePEDS Q3[P < 0.0001])、性功能、性交成功率以及次要性满意度指标(FSFI满意度领域[P < 0.0001]和IIEF满意度领域[P < 0.001])方面有更大改善,且治疗满意度更高(EDITS和EDITS-伴侣;P < 0.0001)。确定了几个改善的预测因素,伴侣一方的改善与另一方的改善呈正相关。

结论

在患有ED的男性和报告性交不满意情况不频繁的性健康女性组成的伴侣中,伴侣双方性功能和性满意度指标相互依存,这突出了在ED治疗讨论中纳入伴侣的重要性。

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