Efficacy and safety of aildenafil citrate in Chinese men with erectile dysfunction: a multicenter, randomized, double-blind, placebo-controlled crossover trial
单位:[1]Peking Univ, Peking Univ First Hosp, Androl Ctr, Beijing 100034, Peoples R China[2]Capital Med Univ, Beijing Chao Yang Hosp, Dept Urol, Beijing 100020, Peoples R China北京朝阳医院[3]Huazhong Univ Sci & Technol,Tongji Hosp,Tongji Med Coll,Dept Urol,Wuhan,Peoples R China外科学系华中科技大学同济医学院附属同济医院泌尿外科[4]Peking Univ, Peking Univ First Hosp, Dept Biostat, Beijing, Peoples R China[5]Peking Univ, Clin Res Inst, Beijing, Peoples R China[6]Tianjin Med Univ, Hosp 2, Dept Urol, Male Reprod & Sexual Med, Tianjin, Peoples R China[7]Tianjin Med Univ, China Korea Joint Res Ctr Male Reprod & Sexual Me, Inst Urol, Tianjin, Peoples R China
Background: To evaluate the efficacy and safety of aildenafil citrate in the treatment of erectile dysfunction (ED) in Chinese population. Methods: A multicenter, randomized, double-blind, placebo-controlled, double-cycle crossover trial was conducted in three medical centers. Male patients with mild to moderate ED were randomized into two groups and received either aildenafil citrate or placebos, followed by a crossover administration after a 7-day washout. The primary outcome was the duration of penile rigidity over 60% measured by RigiScan (R) Plus. Main secondary outcomes were the duration of penile rigidity over 80% and erectile hardness score (EHS). Results: A total of 60 patients with mild to moderate ED were enrolled in the study and 57 of them completed the trial (30 in the aildenafil group and 27 in the placebo group). The median duration of penile tip rigidity over 60% was 4.25 (0.00, 19.00) min in the aildenafil group, as compared with 0.50 (0.00, 2.75) min in the placebo group (P<0.001). The median duration of penile base rigidity over 60% was 3.25 (0.00, 12.50) min in the aildenafil group, as compared with 0.00 (0.00, 2.50) min in the placebo group (P<0.001). The duration of penile base rigidity over 80% was significantly increased in the aildenafil group versus the placebo group (P=0.002). The EHS was significantly improved in the aildenafil group (P<0.001). No severe adverse events associated with aildenafil citrate occurred in both groups. Conclusions: These results suggested that aildenafil citrate was efficient and well-tolerated in the treatment of Chinese men with mild to moderate ED.
第一作者单位:[1]Peking Univ, Peking Univ First Hosp, Androl Ctr, Beijing 100034, Peoples R China
通讯作者:
通讯机构:[1]Peking Univ, Peking Univ First Hosp, Androl Ctr, Beijing 100034, Peoples R China[6]Tianjin Med Univ, Hosp 2, Dept Urol, Male Reprod & Sexual Med, Tianjin, Peoples R China[7]Tianjin Med Univ, China Korea Joint Res Ctr Male Reprod & Sexual Me, Inst Urol, Tianjin, Peoples R China
推荐引用方式(GB/T 7714):
Cui Wan-Shou,Guan Rui-Li,Lei Hong-En,et al.Efficacy and safety of aildenafil citrate in Chinese men with erectile dysfunction: a multicenter, randomized, double-blind, placebo-controlled crossover trial[J].TRANSLATIONAL ANDROLOGY AND UROLOGY.2021,10(8):3358-3367.doi:10.21037/tau-21-441.
APA:
Cui, Wan-Shou,Guan, Rui-Li,Lei, Hong-En,Liu, Ji-Hong,Wang, Tao...&Xin, Zhong-Cheng.(2021).Efficacy and safety of aildenafil citrate in Chinese men with erectile dysfunction: a multicenter, randomized, double-blind, placebo-controlled crossover trial.TRANSLATIONAL ANDROLOGY AND UROLOGY,10,(8)
MLA:
Cui, Wan-Shou,et al."Efficacy and safety of aildenafil citrate in Chinese men with erectile dysfunction: a multicenter, randomized, double-blind, placebo-controlled crossover trial".TRANSLATIONAL ANDROLOGY AND UROLOGY 10..8(2021):3358-3367