Dinsmore W W, Hodges M, Hargreaves C, Osterloh I H, Smith M D, Rosen R C
Royal Victoria Hospital, Belfast, United Kingdom.
Urology. 1999 Apr;53(4):800-5. doi: 10.1016/s0090-4295(98)00586-x.
To evaluate the efficacy, safety, and tolerability of sildenafil in men with broad-spectrum erectile dysfunction (ED), with reference to age-matched healthy control subjects.
One hundred eleven patients were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, 12-week, flexible-dose study. Efficacy assessments included the International Index of Erectile Function (IIEF), a global assessment question, and patient event log data. In a separate, nontreatment study, 109 control subjects also completed the IIEF.
Mean IIEF scores at baseline were significantly lower for patients with ED than for control subjects without a history of ED. After treatment, mean IIEF scores for patients receiving sildenafil approached values observed in control subjects and were significantly higher than mean scores for patients receiving placebo (P<0.01). Responses to the global assessment question and patient log data corroborated the IIEF results. Sildenafil was well tolerated, with no discontinuations because of adverse events.
The results indicate that sildenafil, an effective oral therapy for the treatment of broad-spectrum ED, is associated with a near normalization of patient erectile function.
参照年龄匹配的健康对照受试者，评估西地那非对患有广谱勃起功能障碍（ED）男性的疗效、安全性和耐受性。
111名患者参与了一项随机、双盲、安慰剂对照、平行组、为期12周的灵活剂量研究。疗效评估包括国际勃起功能指数（IIEF）、一个整体评估问题以及患者事件日志数据。在另一项非治疗研究中，109名对照受试者也完成了IIEF评估。
ED患者的基线IIEF平均得分显著低于无ED病史的对照受试者。治疗后，接受西地那非治疗的患者的IIEF平均得分接近对照受试者的得分，且显著高于接受安慰剂治疗患者的平均得分（P<0.01）。对整体评估问题的回答以及患者日志数据证实了IIEF的结果。西地那非耐受性良好，没有因不良事件而停药的情况。
结果表明，西地那非作为一种治疗广谱ED的有效口服疗法，可使患者勃起功能接近正常化。
