摘要
Abstract
OBJECTIVE: To study pharmacokinetics, safety and efficacy of aildenafil citrate in the treatment of erectile dysfunction. METHODS: 180 patients with erectile dysfunction were studied and randomized into 3 groups with 60 patients in each group, i.e. oral administration of aildenafil citrate 30 mg group, oral administration of aildenafil citrate 60 mg group and placebo group. After therapy, the clinical index were compared among 3 groups. RESULTS: There were significant different in Cmax, Cmax dose, Cmin, t1/2, AUC0-24h, AUC0-36h, AUC0-∞ and AUC0-∞/dose between aildenfil citrate 30 mg group and 60 mg group (P<0.05). There was no significant different in score of LIEF-EF, SEP-Q2 and SEP-Q3 among 3 groups before treatment (P>0.05). However, there were significant different in score of LIEF-EF, SEP-Q2 and SEP-Q3 in aildenafil citrate 30 mg group and 60 mg group, after 4 weeks comared with before treatment (P<0.05); meanwhile, there were significant different in score of LIEF-EF, SEP-Q2 and SEP-Q3 between 60 mg group and 30 mg group (P<0.05). There was no significant different in the incidence of adverse drug reaction among 3 groups (P>0.05). CONCLUSION: The clinical efficacy of aildenafil citrate 60 mg is better than that of aildenafil citrate 30 mg in the treatment of erectile dysfunction.关键词
勃起功能障碍/枸橼酸爱地那非/药动学/安全性/有效性Key words
Erectile dysfunction/ Aildenafil citrate/ Pharmacokinetics/ Safety/ Efficacy分类
医药卫生
