Department of Urology and Reproductive Medicine, Weill Cornell Medical College, New York, NY 10065, USA.
BJU Int. 2013 Feb;111(2):334-43. doi: 10.1111/j.1464-410X.2012.11656.x.
To compare effects of tadalafil on ejaculatory and orgasmic function in patients presenting with erectile dysfunction (ED). To determine the effects of post-treatment ejaculatory dysfunction (EjD) and orgasmic dysfunction (OD) on measures of sexual satisfaction.
Data from 17 placebo-controlled 12-week trials of tadalafil (5, 10, 20 mg) as needed in patients with ED were integrated. EjD and OD severities were defined by patient responses to the International Index of Erectile Function, question 9 (IIEF-Q9; ejaculation) and IIEF-Q10 (orgasm), respectively. Satisfaction was evaluated using the intercourse and overall satisfaction domains of the IIEF and Sexual Encounter Profile question 5. Analyses of covariance were performed to compare mean ejaculatory function and orgasmic function, and chi-squared tests evaluated differences in endpoint responses to IIEF-Q9 and IIEF-Q10.
A total of 3581 randomized subjects were studied. Treatment with tadalafil 10 or 20 mg was associated with significant increases in ejaculatory and orgasmic function (vs placebo) across all baseline ED, EjD, and OD severity strata. In the tadalafil group, 66% of subjects with severe EjD reported improved ejaculatory function compared with 36% in the placebo group (P < 0.001). Similarly, 66% of the tadalafil-treated subjects (vs 35% for placebo; P < 0.001) with severe OD reported improvement. Residual severe EjD and OD after treatment had negative impacts on sexual satisfaction. Limitations of the analysis include its retrospective nature and the use of an instrument (IIEF) with as yet unknown performance in measuring treatment responses for EjD and OD.
Tadalafil treatment was associated with significant improvements in ejaculatory function, orgasmic function and sexual satisfaction. Proportions of subjects reporting improved ejaculatory or orgasmic function were ≈ twofold higher with tadalafil than with placebo. These findings warrant corroboration in prospective trials of patients with EjD or OD (without ED).
比较他达拉非对勃起功能障碍（ED）患者射精和性高潮功能的影响。确定治疗后射精功能障碍（EjD）和性高潮功能障碍（OD）对性满意度测量的影响。
整合了按需使用他达拉非（5、10、20mg）治疗 ED 的 17 项安慰剂对照 12 周试验的数据。EjD 和 OD 的严重程度由患者对国际勃起功能指数问卷 9（IIEF-Q9；射精）和 IIEF-Q10（性高潮）的回答来定义。满意度使用 IIEF 的性交和整体满意度领域以及性遭遇概况问卷 5 进行评估。使用协方差分析比较平均射精功能和性高潮功能，采用卡方检验评估 IIEF-Q9 和 IIEF-Q10 终点反应的差异。
共纳入 3581 名随机受试者。与安慰剂相比，他达拉非 10 或 20mg 治疗与所有基线 ED、EjD 和 OD 严重程度分层的射精和性高潮功能的显著改善相关。在他达拉非组中，66%的重度 EjD 患者报告射精功能改善，而安慰剂组为 36%（P <0.001）。同样，66%的重度 OD 治疗患者（与安慰剂组的 35%相比；P <0.001）报告改善。治疗后仍存在重度 EjD 和 OD 对性满意度产生负面影响。分析的局限性包括其回顾性性质和使用尚不清楚在测量 EjD 和 OD 治疗反应方面表现的工具（IIEF）。
他达拉非治疗与射精功能、性高潮功能和性满意度的显著改善相关。与安慰剂相比，报告改善射精或性高潮功能的患者比例约为他达拉非的两倍。这些发现需要在没有 ED 的 EjD 或 OD 患者的前瞻性试验中加以证实。
