Rosen Raymond C, Shabsigh Ridwan, Kuritzky Louis, Wang Wei Christine, Sides Gregory D
Department of Psychiatry, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Piscataway, NJ 08854, USA.
Curr Med Res Opin. 2005 Nov;21(11):1701-9. doi: 10.1185/030079905X65538.
Satisfaction with the sexual experience is considered important when evaluating the impact of treatments for erectile dysfunction (ED), yet satisfaction has been infrequently assessed in clinical trials.
To evaluate satisfaction with, and enjoyment of, the sexual experience in men with ED enrolled in 11 placebo-controlled clinical trials of tadalafil.
Retrospective pooled analysis of data from 11 randomized, double blind, placebo-controlled clinical trials of tadalafil. Men with mild (N = 838), moderate (N = 558), or severe (N = 703) ED who were randomized to tadalafil 10 mg or 20 mg or placebo taken as needed for 12 weeks were included in this analysis. Efficacy measures included the International Index of Erectile Function (IIEF). Reported herein are the scores on the IIEF overall satisfaction domain and individual IIEF questions (IIEF-Q7, satisfaction with intercourse; and IIEF-Q8, enjoyment of intercourse).
At least moderate satisfaction (IIEF overall satisfaction domain) was reported by 55% and 72% of patients with mild ED taking tadalafil 10 mg and 20 mg, respectively, compared with 33% taking placebo (p < 0.002); 60% and 65% vs. 19% of patients with moderate ED (p < 0.001); and 32% and 49% vs. 9% with severe ED (p < 0.001). Satisfactory intercourse during most attempts or almost always/always (IIEF-Q7) was reported by 59% and 79% of patients with mild ED taking tadalafil 10 mg and 20 mg vs. 32% taking placebo (p < 0.001); 52% and 65% vs. 18% with moderate ED (p < 0.001); and 28% and 49% vs. 5% with severe ED (p < 0.001). Highly or very highly enjoyable intercourse (IIEF-Q8) was reported by 45% and 63% of patients with mild ED taking tadalafil 10 mg and 20 mg vs. 21% taking placebo (p < 0.001); 43% and 56% vs. 16% with moderate ED (p < 0.001); and 19% and 44% vs. 5% with severe ED (p < 0.001).
Compared with placebo, tadalafil 10 mg and 20 mg improved overall satisfaction with the sexual experience, intercourse satisfaction, and intercourse enjoyment in men with mild, moderate, and severe ED.
在评估勃起功能障碍（ED）治疗效果时，性体验满意度被认为很重要，但在临床试验中对满意度的评估并不常见。
评估参与11项他达拉非安慰剂对照临床试验的ED男性对性体验的满意度和愉悦感。
对11项他达拉非随机、双盲、安慰剂对照临床试验的数据进行回顾性汇总分析。纳入轻度（N = 838）、中度（N = 558）或重度（N = 703）ED且随机接受按需服用12周的10 mg或20 mg他达拉非或安慰剂的男性。疗效指标包括国际勃起功能指数（IIEF）。本文报告的是IIEF总体满意度领域得分以及IIEF各单项问题得分（IIEF-Q7，性交满意度；IIEF-Q8，性交愉悦感）。
轻度ED患者中，服用10 mg和20 mg他达拉非的患者分别有55%和72%报告至少有中度满意度（IIEF总体满意度领域），而服用安慰剂的患者为33%（p < 0.002）；中度ED患者中，相应比例分别为60%和65%，服用安慰剂的为19%（p < 0.001）；重度ED患者中，分别为32%和49%，服用安慰剂的为9%（p < 0.001）。轻度ED患者中，服用10 mg和20 mg他达拉非的患者分别有59%和79%报告在大多数性交尝试中或几乎总是/总是有满意的性交（IIEF-Q7），而服用安慰剂的为32%（p < 0.001）；中度ED患者中，相应比例分别为52%和65%，服用安慰剂的为18%（p < 0.001）；重度ED患者中，分别为28%和49%，服用安慰剂的为5%（p < 0.001）。轻度ED患者中，服用10 mg和20 mg他达拉非的患者分别有45%和63%报告有高度或非常高度愉悦的性交（IIEF-Q8），而服用安慰剂的为21%（p < 0.001）；中度ED患者中，相应比例分别为43%和56%，服用安慰剂的为16%（p < 0.001）；重度ED患者中，分别为19%和44%，服用安慰剂的为5%（p < 0.001）。
与安慰剂相比，10 mg和20 mg他达拉非改善了轻度、中度和重度ED男性对性体验的总体满意度、性交满意度和性交愉悦感。
