Department of Urology, Russian Medical Academy of Postgraduate Education, 2nd Botkinsky Street, 5 Moscow Russian Federation 125101, Moscow, Russia.
J Sex Med. 2009 Oct;6(10):2826-35. doi: 10.1111/j.1743-6109.2009.01428.x.
Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction (ED); however, most men are later titrated to sildenafil 100 mg for improved efficacy.
Assess the tolerability and efficacy of sildenafil initiated at the 100-mg dose in men with ED.
Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function) who had received < or =6 total doses of a phosphodiesterase type 5 inhibitor and none within 4 weeks were randomized to 8 weeks of double-blind, placebo-controlled (DBPC), fixed-dose treatment (50 or 100 mg sildenafil or placebo) followed by 4 weeks of open-label flexible-dose sildenafil (50 or 100 mg).
Efficacy, tolerability, treatment satisfaction, and other end points were measured at baseline and/or the end of the double-blind and open-label phases and compared between placebo and sildenafil initiated at doses of 50 and 100 mg.
Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and 100 mg compared with placebo. At the end of DBPC treatment, 56% of men on the 100-mg dose felt no anxiety about the next intercourse attempt compared with 39% in the 50-mg group (odds ratio 2.03; P = 0.0197). Changes in functional scores from baseline were not statistically significant with the 100-mg dose compared with the 50-mg dose in the DBPC. Measures of treatment satisfaction and sexual experience significantly favored the 100-mg dose compared with the 50-mg dose in the DBPC. There was no increase in adverse events with the higher dose.
Sildenafil at 50 mg or 100 mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. Sildenafil 100 mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the 50-mg dose.
枸橼酸西地那非 50 毫克是勃起功能障碍（ED）患者的推荐起始剂量；然而，大多数患者随后会将剂量增加至 100 毫克以提高疗效。
评估 ED 患者使用起始剂量为 100 毫克的西地那非的耐受性和疗效。
勃起功能障碍评分（国际勃起功能指数的勃起功能域得分<或=25）、接受<或=6 次磷酸二酯酶 5 抑制剂治疗且 4 周内未服用任何药物的患者被随机分为 8 周的双盲、安慰剂对照（DBPC）、固定剂量治疗（西地那非 50 或 100 毫克或安慰剂），随后进行 4 周的开放性、灵活剂量西地那非（50 或 100 毫克）治疗。
在双盲和开放性阶段的基线和/或结束时测量疗效、耐受性、治疗满意度和其他终点，并比较安慰剂和起始剂量为 50 毫克和 100 毫克的西地那非之间的差异。
与安慰剂相比，西地那非 50 毫克和 100 毫克在 DBPC 患者报告的结果方面均有统计学意义的改善。在 DBPC 治疗结束时，100 毫克剂量组有 56%的男性对下一次性尝试无焦虑感，而 50 毫克组为 39%（比值比 2.03；P = 0.0197）。与 50 毫克剂量相比，100 毫克剂量在 DBPC 中对功能评分的变化无统计学意义。与 50 毫克剂量相比，治疗满意度和性体验的测量在 DBPC 中显著倾向于 100 毫克剂量。较高剂量未增加不良反应。
与安慰剂相比，在 DBPC 期间，西地那非 50 毫克或 100 毫克显著改善了勃起质量、治疗满意度、焦虑水平和性体验。与 50 毫克剂量相比，100 毫克剂量改善了性体验和治疗满意度，并减轻了焦虑感。
