Vardenafil improves satisfaction rates, depressive symptomatology, and self-confidence in a broad population of men with erectile dysfunction.
Vardenafil improves satisfaction rates, depressive symptomatology, and self-confidence in a broad population of men with erectile dysfunction.
复制标题
伐地那非可提高广大勃起功能障碍男性的满意度、抑郁症状和自信心。
DOI：
10.1111/j.1743-6109.2005.20111.x
复制
发表时间：
2005
影响因子：
3.5
通讯作者：
F. Montorsi
中科院分区：
文献类型：
--
作者：
D. Hatzichristou;B. Cuzin;A. Martín;J. Buvat;H. Porst;N. Laferriere;T. Bandel;F. Montorsi
简介
伐地那非是一种有效的选择性磷酸二酯酶 5 (PDE5) 抑制剂，专为治疗勃起功能障碍 (ED) 而开发。固定剂量和灵活剂量研究先前已经确定了伐地那非的功效和耐受性。
目的
除了通常的疗效指标外，还评估勃起质量、性体验满意度、抑郁症状和整体信心。
方法
这项为期 12 周的双盲、安慰剂对照、灵活剂量研究对一般 ED 人群中的患者进行了评估。患者在随机分配至伐地那非或匹配安慰剂之前经历了 4 周的无治疗期。初始剂量为伐地那非 10 mg，持续 4 周。第 4 周时，患者可以改用 5 或 20 mg（或相应的安慰剂），或继续维持 10 mg 治疗 4 周；在过去 4 周内，剂量转换也是可选的。本文描述了每位患者对勃起硬度的满意度、对整体性体验的满意度、对整体自信心的影响以及使用流行病学研究中心抑郁量表对抑郁症状的评估。
结果
伐地那非治疗后第 4、8 和 12 周时，每位患者对勃起硬度的平均满意度分别增加至 43%、59% 和 63%，而安慰剂组为 10%、21% 和 23%（与安慰剂相比，所有 P < 0.005）。在 4-12 周的研究期间，伐地那非还将每位患者的平均总体满意度提高了 50-65%，而安慰剂为 17-28%（P < 0.005）。与安慰剂相比，抑郁症状在统计学上显着减轻（P = 0.02）；这种效果在基线时抑郁的患者中尤其明显（P = 0.01）。与接受安慰剂的患者相比，伐地那非治疗组中有更多患者报告自信心有所改善（P < 0.005）。
结论
伐地那非的灵活剂量方案可改善满意度、抑郁症状和自信心，为患者提供有效的 ED 治疗，有助于全面改善性功能和自信心。
INTRODUCTION
Vardenafil is a potent and selective phosphodiesterase 5 (PDE5) inhibitor developed for the treatment of erectile dysfunction (ED). Fixed-dose and flexible-dose studies have previously established the efficacy and tolerability of vardenafil.
AIM
To assess, besides the usual measures of efficacy, the quality of erection, satisfaction with the sexual experience, symptoms of depression, and overall confidence.
METHODS
This 12-week double-blind, placebo-controlled flexible-dose study assessed patients from the general ED population. Patients underwent a 4-week treatment-free period before randomization to vardenafil or matching placebo. Initial dosage was vardenafil 10 mg for 4 weeks. At 4 weeks, patients could switch to 5 or 20 mg (or corresponding placebo), or remain on 10 mg for an additional 4 weeks; dose switching was also optional for the last 4 weeks. This paper describes per-patient success in satisfaction with hardness of erection, satisfaction with overall sexual experience, effect on overall self-confidence, and an assessment of symptoms of depression using the Center for Epidemiologic Studies Depression Scale.
RESULTS
Mean per-patient satisfaction rates with erection hardness increased after vardenafil treatment to 43%, 59%, and 63% at weeks 4, 8, and 12, respectively, compared to placebo with 10%, 21%, and 23% (all P < 0.005 vs. placebo). Vardenafil also improved mean per-patient overall satisfaction 50-65% over the 4-12 week study period compared with 17-28% for placebo (P < 0.005). Symptoms of depression were statistically significantly reduced compared to placebo (P = 0.02); the effect was observed particularly in patients who were depressed at baseline (P = 0.01). Significantly more patients in the vardenafil treatment group reported improved self-confidence than those who received placebo (P < 0.005).
CONCLUSIONS
A flexible-dose regimen of vardenafil improved satisfaction rates, symptoms of depression, and self-confidence, providing patients with an effective ED therapy that contributes to overall improvements in sexual function and confidence.