伐地那非治疗勃起功能障碍的多中心、随机、双盲、对照研究

目的　观察伐地那非治疗勃起功能障碍的安全性和有效性。　方法　采用多中心、随机、双盲、安慰剂对照的方法 ,在国内 7家中心对 6 2 4例勃起功能障碍者口服伐地那非的勃起功能改善情况进行临床观察。患者随机按 1∶1∶1∶1进入安慰剂组及伐地那非 5、10、2 0mg组 ,每组各 15 6例 ,完成 4周洗脱期和 12周治疗期。患者按需在性交前 1h服用 1片研究药物。每日最多服用 1次研究药物。观察治疗 12周后国际勃起功能指数 (IIEF)问卷中有关勃起功能部分 (问题 1～ 5和 15 )的得分 ,患者日记中有关插入的成功率及成功保持勃起的成功率。　结果　共有 6 0 2例 (96 .5 % )进入安全性评估和意向性分析 ,各组分别为安慰剂组 14 8例 (94 .9% )、5mg组 15 1例 (96 .8% )、10mg组 15 0例 (96 .2 % )、2 0mg组 15 3例 (98.1% )。完全符合方案人群共 4 6 8例 (75 .0 % ) ,各组分别为 :安慰剂组 12 0例 (76 .9% )、5mg组 118例 (75 .6 % )、10mg组 10 6例 (6 8.0 % )、2 0mg组 12 4例 (79.5 % )。意向性分析人群的IIEF勃起功能部分 (问题 1～ 5 ,15 )得分的统计结果 ,用药 12周后 ,伐地那非 5mg组、10mg组和 2 0mg组的平均得分基线分别为 13.3分、14 .1分和 13.6分 ,分别增加到 2 2 .2分、2 2 .8分和 2 3.6分 ,与安慰剂组

The effect of vardenafil, a new potent highly selective phosphodiesterase type 5 inhibitor in the treatment of erectile dysfunction

Objective To investigate the safety and efficacy of vardenafil,a novel selective phosphodiesterase type 5 inhibitor, in the treatment of male erectile dysfunction (ED). Methods This multicenter,randomized,double blind,placebo controlled study was performed at 7 domestic sites.A total of 624 men with mild to severe ED were enrolled in this trial of 4 weeks of washout and 12 weeks of treatment with either placebo or 5,10,20 mg of vardenafil on demand but not more than once a day. Results Analysis of safety and efficacy of vardenafil was performed on 602 cases who completed the trial.Primary endpoints were Q3 (vaginal penetration) and Q4 (maintenance of erection) of the International Index of Erectile Function (IIEF).In the intent to treat population (n=602),the changes from baseline with 5,10,20 mg vardenafil groups were all improved ( P < 0.0001 ) for Q3,and were similarly improved for Q4,compared with placebo group ( P < 0.0001 ).All doses of vardenafil improved all IIEF domains compared with placebo ( P < 0.0001 ).The percentage of successful intercourses was between 59% and 71% for the 3 doses of vardenafil groups.The main drug related adverse events were flushing (9%-13%) and headache/dizziness (7%-13%),which were mild and could be self relieved. Conclusions Vardenafil at doses of 5,10,20 mg is safe,efficacious and well tolerated in the treatment of patients with mixed ED etiologies.