多剂量伐地那非治疗男性勃起功能障碍的临床研究

Efficacy and safety of oral multidoses Vardenafil in the treatment of erectile dysfunction

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 on men with erectile dysfunction caused by various etiologies. Methods A total of 88 patients with erectile dysfunction were enrolled in the randomized, double-blind, placebo-controlled, multidoses clinical trial of 12 weeks treatment with either Vardenafil of 5, 10 and 20 mg or placebo. Results Therapeutic effect of mutildoses Vardenafil were superior than placebo based on the EF domain score of IIEF, and also diary recorded success rate for penetration and maintenance of erection during the intercourse. And the EF domain score of IIEF of patients treated with Vardenafil of 20mg was higher than that of Vardenafil of 5mg. The incidence of adverse event was higher for Vardenafil than for placebo. Conclusion Oral Vardenafil therapy has a high efficacy and a low incidence of advers events for ED patients caused by various etiologies.