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首页> 外文期刊>The journal of sexual medicine >A Randomized Open-Label Trial with a Crossover Comparison of Sexual Self-Confidence and Other Treatment Outcomes Following Tadalafil Once a Day Vs. Tadalafil or Sildenafil On-Demand in Men with Erectile Dysfunction
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A Randomized Open-Label Trial with a Crossover Comparison of Sexual Self-Confidence and Other Treatment Outcomes Following Tadalafil Once a Day Vs. Tadalafil or Sildenafil On-Demand in Men with Erectile Dysfunction

机译：每日一次他达拉非对性自信和其他治疗结果的交叉比较的随机对照试验。男性勃起功能障碍患者按需使用他达拉非或西地那非

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Aim. To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5mg once a day (OaD) vs. tadalafil 20mg or sildenafil 100mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED). Methods. A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN. Data were analyzed with a mixed effects model for crossover design. Main Outcome Measures. The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales (PAIRS) between tadalafil OaD and sildenafil PRN. Secondary Outcomes Included. Time Concerns and Spontaneity domains of PAIRS, and the Self-Esteem and Relationship (SEAR) scale. Results. Men naive to tadalafil OaD were enrolled (N=378), with 61-69% prior PDE5 inhibitor use. There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN (P<0.001). The Sexual Self-Confidence domain improved from baseline and was 0.50±0.78 following tadalafil OaD, 0.5±0.72 for tadalafil PRN, and 0.39±0.67 for sildenafil PRN. The difference in least-squares mean was 0.12±0.04 (confidence interval [CI]=0.04, 0.19; P=0.001) between tadalafil OaD and sildenafil PRN and 0.01±0.04 (CI=-0.06, 0.08; P=0.872) between tadalafil OaD and tadalafil PRN. The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN (P<0.001). There were no differences in SEAR scores between treatments. Conclusions. Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence, Time Concerns, and Spontaneity. There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN. Changes in SEAR, the erectile function domain of the International Index of Erectile Function, and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar.
机译：目标。为了比较勃起功能障碍（ED）患者中，tadalafil 5mg每天一次（OaD）与tadalafil 20mg或sildenafil 100mg每天一次（OaD）治疗8周后的性自信心和其他治疗结果（勃起功能障碍（ED））。方法。一项随机，开放标签，交叉研究，研究对象为≥18岁且有ED史且对目前口服磷酸二酯酶5（PDE5）抑制剂PRN满意的男性。使用混合效应模型对数据进行交叉设计。主要观察指标。主要结果指标是他达拉非OaD和西地那非PRN之间的心理和人际关系量表（PAIRS）的性自信心域。包括次要结果。 PAIRS的时间问题和自发性域，以及自尊和关系（SEAR）量表。结果。初次使用他达拉非OaD的男性（N = 378）入组，先前使用PDE5抑制剂的占61-69％。比较他达拉非OaD和PRN与西地那非PRN相比，所有PAIRS域均较基线有所改善（P <0.001）。他达拉非OaD后的性自信心域有所改善，为0.50±0.78，他达拉非PRN为0.5±0.72，西地那非PRN为0.39±0.67。他达拉非OaD和西地那非PRN之间的最小二乘均方差为0.12±0.04（置信区间[CI] = 0.04，0.19; P = 0.001），而他达拉非之间的0.01±0.04（CI = -0.06，0.08; P = 0.872） OaD和他达拉非PRN。他达拉非OaD的时间关注域得分低于他达拉非PRN（P <0.001）。两种治疗之间的SEAR分数没有差异。结论。与西地那非PRN相比，他达拉非OaD和他达拉非PRN在性自信心，时间关注和自发性方面表现出更大的改善。他达拉非OaD和他达拉非PRN的性自信心没有显着差异。从基线到终点，SEAR，国际勃起功能指数的勃起功能域和勃起功能障碍库存治疗满意度评分的变化相似。

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