Olsson A M, Speakman M J, Dinsmore W W, Giuliano F, Gingell C, Maytom M, Smith M D, Osterloh I
Department of Urology, University Hospital, 221 85 Lund, Sweden.
Int J Clin Pract. 2000 Nov;54(9):561-6.
Sildenafil citrate (Viagra) has been shown to be an effective treatment for erectile dysfunction (ED) of organic aetiology. This study assessed the efficacy and tolerability of sildenafil for treating ED of psychogenic and mixed psychogenic/organic aetiology. Men with ED of psychogenic and mixed aetiology were randomised in a double-blind, fixed-dose study to placebo (n = 95) or sildenafil 10 mg (n = 90), 25 mg (n = 85), or 50 mg (n = 81) once daily for 28 days. Efficacy was evaluated with two global efficacy questions, a patient log of erectile activity, a sexual function questionnaire and a partner questionnaire. Patients receiving sildenafil had significantly more grade 3 (hard enough for penetration) or grade 4 (fully hard) erections per week than patients receiving placebo, and a greater proportion of patients receiving sildenafil reported that treatment had improved their erections (p < 0.001). Results of the sexual function questionnaire demonstrated significant improvement for patients with ED receiving sildenafil compared with patients receiving placebo for frequency, hardness and duration of erections (p < 0.01), and for enjoyment of sexual intercourse and satisfaction with sex life (p < 0.05). The results of the partner questionnaire were consistent with the results reported by patients and showed that treatment with sildenafil was associated with significant improvement in the partners' own sex lives (p < 0.001). Adverse events were mostly mild to moderate in nature. The commonest adverse events were headache, dyspepsia, flushing, myalgia, arthralgia and flu syndrome. Discontinuations due to treatment-related adverse events were few, ranging from 1.1% to 6.2% for patients receiving different doses of sildenafil and 4.2% for patients receiving placebo. Sildenafil is an effective and well-tolerated treatment for ED of psychogenic or mixed aetiology with once-daily dosing.
枸橼酸西地那非（万艾可）已被证明是治疗器质性病因勃起功能障碍（ED）的有效药物。本研究评估了西地那非治疗心因性及心因性/器质性混合病因ED的疗效和耐受性。患有心因性及混合病因ED的男性在一项双盲、固定剂量研究中被随机分为安慰剂组（n = 95）或西地那非10毫克组（n = 90）、25毫克组（n = 85）或50毫克组（n = 81），每日一次，共28天。通过两个总体疗效问题、患者勃起活动记录、性功能问卷和伴侣问卷来评估疗效。接受西地那非治疗的患者每周出现3级（硬度足以插入）或4级（完全坚硬）勃起的次数显著多于接受安慰剂的患者，且接受西地那非治疗的患者中报告治疗改善了勃起功能的比例更高（p < 0.001）。性功能问卷结果显示，与接受安慰剂的患者相比，接受西地那非治疗的ED患者在勃起频率、硬度和持续时间方面有显著改善（p < 0.01），在性交愉悦度和性生活满意度方面也有显著改善（p < 0.05）。伴侣问卷结果与患者报告的结果一致，表明西地那非治疗与伴侣自身性生活的显著改善相关（p < 0.001）。不良事件大多为轻至中度。最常见的不良事件是头痛、消化不良、潮红、肌痛、关节痛和流感样综合征。因治疗相关不良事件而停药的情况很少，接受不同剂量西地那非的患者停药率在1.1%至6.2%之间，接受安慰剂的患者停药率为4.2%。西地那非是一种治疗心因性或混合病因ED的有效且耐受性良好的药物，每日一次给药即可。
