枸橼酸爱地那非治疗勃起功能障碍的药动学、安全性及有效性研究  

Pharmacokinetics, Safety and Efficacy of Aildenafil Citrate in the Treatment of Erectile Dysfunction

作　　者：吴友良[1] 

机构地区：[1]解放军第324医院药剂科,重庆400020

出　　处：《中国药房》2013年第2期128-130,共3页China Pharmacy

摘　　要：目的:研究枸橼酸爱地那非治疗勃起功能障碍的药动学、安全性及有效性。方法:按照相关标准入选180例男性勃起功能障碍患者,按照随机数字方法分成3组,每组60例,分别给予枸橼酸爱地那非30mg口服治疗、枸橼酸爱地那非60mg口服治疗和安慰剂。治疗后,比较3组患者的相关指标。结果:枸橼酸爱地那非30mg组与60mg组的cmax、cmax/dose、cmin、t1/2、AUC0-24h、AUC0-36h、AUC0-∞和AUC0-∞/dose相比较差异均具有统计学意义(P<0.05)。服药前,3组患者的阴茎勃起功能评分(LIEF-EF)、性生活日记提问2(SEP-Q2)和性生活日记提问3(SEP-Q3)情况差异均无统计学意义(P>0.05);服药4周后,枸橼酸爱地那非30mg组和60mg组患者的LIEF-EF评分、SEP-Q2和SEP-Q3情况与同组服药前相比较差异具有统计学意义(P<0.05),同时,60mg组患者的LIEF-EF评分、SEP-Q2和SEP-Q3情况与30mg组相比较差异也具有统计学意义(P<0.05);3组患者不良反应情况差异均无统计学意义(P>0.05)。结论:枸橼酸爱地那非60mg较30mg治疗勃起功能障碍的临床效果更好。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 

分 类 号：R969.1[医药卫生—药理学]