McCullough Andrew R, Steidle Christopher P, Klee Brian, Tseng Li-Jung
New York University School of Medicine, New York, New York 10016, USA.
Urology. 2008 Apr;71(4):686-92. doi: 10.1016/j.urology.2007.12.025.
To clarify the period of responsiveness to sildenafil.
Under a double-blind protocol, men with mild to moderate erectile dysfunction (International Index of Erectile Function [IIEF] Erectile Function domain score, 11 to 25) were randomized to sildenafil (100 mg) or placebo and attempted intercourse 8 hours (range, 7 to 9 hours) postdose (first 4-week phase) and 12 hours (11 to 13 hours) postdose (second 4-week phase after treatment crossover). The primary outcome was the per-patient proportion (PPP; least squares means [95% confidence interval]) of affirmative responses to the Sexual Encounter Profile question 3 (SEP3: "Did your erection last long enough for you to have successful intercourse?").
For sildenafil (n = 174) versus placebo (n = 177), baseline values were similar but the PPP of successful intercourse attempts increased to 76% (69% to 82%) versus 50% (43% to 57%) in phase 1 (odds ratio [OR] = 3.2) and 79% (72% to 85%) versus 52% (44% to 60%) in phase 2 (OR = 3.5), and the PPP of Erection Hardness Score 4 erections (completely hard and fully rigid) was 41% (34% to 48%) versus 10% (7% to 15%) in phase 1 (OR = 6.2) and 44% (37% to 51%) versus 17% (12% to 23%) in phase 2 (OR = 4.0). Thus, at 12 hours, the odds of successful intercourse tripled and of a completely hard erection quadrupled. The sildenafil group achieved greater (P <0.001) PPP of successful penetration (SEP2), satisfaction with erection hardness (SEP4), and satisfaction with the sexual experience (SEP5); improvement in IIEF domain scores; and treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction.
In men with mild to moderate ED, responsiveness to sildenafil may persist much longer than 4 hours.
明确西地那非的有效作用时间。
在双盲试验方案下，将轻度至中度勃起功能障碍（国际勃起功能指数[IIEF]勃起功能领域评分，11至25分）的男性随机分为西地那非组（100毫克）或安慰剂组，并在给药后8小时（范围为7至9小时）（第一个4周阶段）和给药后12小时（11至13小时）（治疗交叉后的第二个4周阶段）尝试性交。主要结局是对性体验问卷问题3（SEP3：“您的勃起持续时间是否足够长，使您能够成功性交？”）肯定回答的患者比例（PPP；最小二乘均值[95%置信区间]）。
对于西地那非组（n = 174）与安慰剂组（n = 177），基线值相似，但在第一阶段，成功性交尝试的PPP从50%（43%至57%）增至76%（69%至82%）（优势比[OR] = 3.2），第二阶段从52%（44%至60%）增至79%（72%至85%）（OR = 3.5）；勃起硬度评分4级（完全坚硬且完全勃起）的PPP在第一阶段为41%（34%至48%），而安慰剂组为10%（7%至15%）（OR = 6.2），第二阶段为44%（37%至51%），而安慰剂组为17%（12%至23%）（OR = 4.0）。因此，在12小时时，成功性交的几率增加两倍，完全坚硬勃起的几率增加四倍。西地那非组在成功插入（SEP2）、对勃起硬度的满意度（SEP4）、对性体验的满意度（SEP5）方面达到了更高的（P <0.001）PPP；IIEF领域评分有所改善；在治疗满意度勃起功能障碍量表上的治疗满意度也更高。
在轻度至中度勃起功能障碍的男性中，对西地那非的反应可能持续超过4小时。
