口服伐地那非治疗勃起功能障碍疗效和安全性的临床研究

目的 :评价伐地那非对男性勃起功能障碍 (ED)患者的疗效和安全性。　方法 :应用随机、双盲、安慰剂平行对照、剂量固定 (5、1 0和 2 0mg)方法 ,对 88例ED患者进行 1 2周的临床研究。　结果 :5、1 0和 2 0mg伐地那非使ED患者达到和维持勃起的临床主要和次要指标均明显高于安慰剂 (P <0 .0 1 ) ;伐地那非各剂量组不良事件发生率高于安慰剂组 ,均为轻至中度 ,呈一过性。　结论 :伐地那非是治疗各种病因导致ED的安全、有效的药物。

Efficacy and Safety of Oral Vardenafil in the Treatment of Erectile Dysfunction

Objective: To evaluate the efficacy and safety of vardenafil on men with erectile dysfunction (ED) of various etiologies. Methods: A total of 88 men with mild to severe erectile dysfunction were enrolled in the randomized, double-blind, placebo-controlled, fixed-dose trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil. Results: This study indicated that vardenafil dosages of 5, 10 and 20 mg were significantly superior to placebo for the treatment of ED, on the basis of the primary study endpoints of the EF domain score of the IIEF, diary-recorded success rates for penetration and maintenance of erection during the intercourse and the GAQ. Vardenafil was well tolerated. The incidence of adverse events was higher for vardenafil than for placebo. Conclusion: Oral vardenafil therapy has a high efficacy and a low incidence of adverse events for ED patients with mixed etiologies.