Althof Stanley E, Eid J Francois, Talley David R, Brock Gerald B, Dunn Marian E, Tomlin Molly E, Natanegara Fanni, Ahuja Sanjeev
Department of Urology, Case School of Medicine, Cleveland, Ohio, USA.
Urology. 2006 Sep;68(3):631-5. doi: 10.1016/j.urology.2006.03.054. Epub 2006 Sep 18.
To evaluate patient and female partner responses on the efficacy of, and overall satisfaction with, tadalafil to treat erectile dysfunction using sexual encounter profile (SEP) diaries.
Data were pooled from four double-blind, placebo-controlled, 12-week trials that included 746 couples. Patients were randomized to placebo or tadalafil 10 or 20 mg. Efficacy was evaluated by the mean per-patient/per-partner percentage of "yes" responses to patient SEP questions 1, 2, and 5 and partner SEP questions 1 to 3 (erection achievement, penetration, and overall satisfaction with the sexual experience, respectively) for tadalafil versus placebo. For each SEP question, the number of postbaseline intercourse attempts when each couple agreed on the outcome was tabulated and divided by the total number of postbaseline attempts to calculate the mean percentage of agreement by couple. The overall satisfaction with successful postbaseline intercourse attempts was determined.
Tadalafil significantly improved the responses for the patient and partner-evaluated SEP questions (P <0.001, both doses versus placebo). Partners tended to report greater overall satisfaction than patients at baseline and postbaseline. The mean percentage of agreement by couple was approximately 98% for erection achievement and penetration and 85% for overall satisfaction. For successful intercourse attempts, patients and partners treated with tadalafil reported more overall satisfaction than those treated with placebo (P <0.05, tadalafil versus placebo comparisons).
Partners reported significantly improved overall sexual satisfaction and corroborated the man's report of improved erections and penetration ability with tadalafil 10 mg or 20 mg. Men reported improved erection achievement, penetration, and overall satisfaction with the sexual experience after taking tadalafil.
使用性接触概况(SEP)日记评估患者及其女性伴侣对他达拉非治疗勃起功能障碍的疗效和总体满意度。
汇总来自四项双盲、安慰剂对照、为期12周试验的数据,这些试验纳入了746对夫妇。患者被随机分配至安慰剂组或10毫克或20毫克他达拉非组。通过他达拉非与安慰剂相比,患者SEP问题1、2和5以及伴侣SEP问题1至3(分别为勃起实现、插入以及对性体验的总体满意度)的“是”回答的每位患者/每位伴侣的平均百分比来评估疗效。对于每个SEP问题,将每对夫妇对结果达成一致时基线后性交尝试的次数制成表格,并除以基线后尝试的总数,以计算每对夫妇的平均一致百分比。确定对成功的基线后性交尝试的总体满意度。
他达拉非显著改善了患者和伴侣评估的SEP问题的回答(两种剂量与安慰剂相比,P<0.001)。伴侣在基线和基线后往往比患者报告更高的总体满意度。勃起实现和插入方面,每对夫妇的平均一致百分比约为98%,总体满意度方面为85%。对于成功的性交尝试,接受他达拉非治疗的患者和伴侣比接受安慰剂治疗的患者和伴侣报告了更高的总体满意度(他达拉非与安慰剂比较,P<0.05)。
伴侣报告总体性满意度显著提高,并证实男性服用10毫克或20毫克他达拉非后勃起和插入能力有所改善。男性报告服用他达拉非后勃起实现、插入以及对性体验的总体满意度有所改善。