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他达拉非每日一次初始治疗勃起功能障碍、按需服用他达拉非或按需服用枸橼酸西地那非后的心理社会结局:一项随机、开放标签研究的结果

Psychosocial outcomes after initial treatment of erectile dysfunction with tadalafil once daily, tadalafil on demand or sildenafil citrate on demand: results from a randomized, open-label study.

作者信息

Hatzimouratidis K, Buvat J, Büttner H, Vendeira P A S, Moncada I, Boehmer M, Henneges C, Boess F G

机构信息

2nd Department of Urology, Aristotle University of Thessaloniki, Thessaloniki, Greece.

Centre d'Etude et de Traitement de la Pathologie de l'Appareil Reproducteur et de la Psychosomatique (CETPARP), Lille, France.

出版信息

Int J Impot Res. 2014 Nov-Dec;26(6):223-9. doi: 10.1038/ijir.2014.15. Epub 2014 May 1.

Abstract

Initiation of ED treatment with a particular PDE5I may influence treatment-adherence and other outcomes. In this multicenter, open-label study, men with ED, naïve to PDE5I, were randomized to tadalafil 5 mg once-a-day (OaD; N=257), 10 mg on demand (PRN; N = 252) or sildenafil-citrate (sildenafil) 50 mg PRN (N = 261) for 8 weeks (dose adjustments allowed), followed by 16 weeks of pragmatic treatment (switching between PDE5I allowed). Primary outcomes (treatment-adherence) were reported previously. Here, we report effects on: Psychological and Interpersonal Relationship Scales, Self-Esteem and Relationship (SEAR) questionnaire, ED Inventory of Treatment Satisfaction (EDITS), International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) and Global Assessment Questions (GAQ). Mixed-model for repeated measures and analysis of covariance were used to analyze changes from baseline; GAQ-responses were evaluated by logistic regression. Analyses were adjusted for treatment, country, ED-severity, baseline and baseline-by-treatment interaction. Patients randomized to tadalafil OaD or PRN reported greater improvement (least-square mean (s.e.) change) in Sexual Self-Confidence (OaD +0.90 (0.048), PRN +0.93 (0.050), vs +0.73 (0.049); P=0.006 and P=0.001) and Spontaneity (OaD +0.11 (0.035), PRN +0.13 (0.035), vs +0.02 (0.035); P = 0.044 and P = 0.010) compared with sildenafil. Improvements in GAQ and SEP responses, IIEF-EF, orgasmic function, sexual desire, overall satisfaction domains, SEAR and EDITS scores did not differ significantly between treatment groups.

摘要

使用特定的磷酸二酯酶5抑制剂(PDE5I)开始治疗勃起功能障碍(ED)可能会影响治疗依从性和其他结果。在这项多中心、开放标签研究中,对PDE5I初治的ED男性患者随机分组,分别给予他达拉非5毫克每日一次(OaD;N = 257)、按需服用10毫克(PRN;N = 252)或枸橼酸西地那非(西地那非)50毫克PRN(N = 261),疗程8周(允许调整剂量),随后进行16周的实用治疗(允许在PDE5I之间切换)。主要结果(治疗依从性)此前已报告。在此,我们报告对以下方面的影响:心理和人际关系量表、自尊与关系(SEAR)问卷、ED治疗满意度量表(EDITS)、国际勃起功能指数(IIEF)、性经历概况(SEP)和总体评估问题(GAQ)。采用重复测量混合模型和协方差分析来分析与基线相比的变化;GAQ反应通过逻辑回归进行评估。分析针对治疗、国家、ED严重程度、基线以及基线与治疗的交互作用进行了调整。随机接受他达拉非OaD或PRN治疗的患者在性自信心(OaD +0.90(0.048),PRN +0.93(0.050),对比+0.73(0.049);P = 0.006和P = 0.001)和自发性(OaD +0.11(0.035),PRN +0.13(0.035),对比+0.02(0.035);P = 0.044和P = 0.010)方面报告有更大改善,与西地那非相比。治疗组之间在GAQ和SEP反应、IIEF - EF、性高潮功能、性欲、总体满意度领域、SEAR和EDITS评分方面的改善没有显著差异。

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