目的评估不同剂量新型磷酸二酯酶5(PED5)抑制剂伐地那非治疗男性勃起功能障碍(ED)的有效性和安全性。方法采用随机、双盲、安慰剂平行对照、3个药物剂量(5、10和20mg)的方法,对88例ED患者进行为期12周的临床研究。结果伐地那非5mg、10mg和20mg组均能改善患者国际勃起功能指数(IIEF)中勃起功能部分的得分、患者日记中插入和保持勃起的成功率,改善程度优于安慰剂组。伐地那非20mg组对IIEF问卷中勃起功能部分得分的改善优于伐地那非5mg组。伐地那非组不良事件的发生率高于安慰剂组,但多为轻中度,且可自行缓解。结论伐地那非是治疗男性勃起功能障碍的安全、有效药物。 Objective To evaluate the efficacy and safety of vardenafil, a new type of phosphodiesterase 5 (PED5) inhibitor, in the treatment of male erectile dysfunction (ED). Methods A randomized, double-blind, placebo-controlled, three-drug dose (5, 10, and 20 mg) regimen was used in 88 patients with ED for a 12-week clinical trial. Results Both vardenafil 5 mg, 10 mg and 20 mg groups improved scores of erectile function in patients with IIEF, and the success rate of insertion and maintenance of erectile benefits in diaries of patients was improved to a greater extent than placebo. The vardenafil 20 mg group was superior to the vardenafil 5 mg group in improving the erectile function fraction in the IIEF questionnaire. The incidence of adverse events in vardenafil group was higher than that in placebo group, but mostly mild to moderate and relieved spontaneously. Conclusion Vardenafil is a safe and effective drug for the treatment of male erectile dysfunction.