Hatzimouratidis K, Buvat J, Büttner H, Vendeira P A S, Moncada I, Boehmer M, Henneges C, Boess F G
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.
Int J Impot Res. 2014 Nov-Dec;26(6):223-9. doi: 10.1038/ijir.2014.15. Epub 2014 May 1.
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.
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。