枸橼酸爱地那非治疗勃起功能障碍的疗效和安全性观察

Therapeutic efficacy and safety of aildenafil citrate in the treatment of erectile dysfunction

目的评价临床枸橼酸爱地那非治疗男性勃起功能障碍(ED)的安全性和疗效。方法32例ED患者,其中24例予枸橼酸爱地那非60 mg口服(观察组),8例仅予安慰剂(对照组)。采用国际勃起功能指数表(IIEF-5)量表评价治疗效果,同时记录观察患者自签署知情同意书开始至最后一次随访之间,所发生的任何与治疗目的无关的事件。结果观察组治疗后IIEF-5量表总得分为(24.09±5.05)分,与治疗前的(14.75±3.61)分相比,P<0.05;与对照组治疗后的(19.86±4.56)分相比,P<0.05。与药物相关的主要不良事件有头晕、头痛、面部潮红和恶心,严重程度为轻至中度,呈一过性,无需处理。结论口服枸橼酸爱地那非60 mg治疗ED安全、有效。

Objective To evaluate the efficacy and safety of aildenafil citrate in the treatment of erectile dysfunction. Methods Integrated analyses were made of 12-week, randomized, double-blind, placebo-controlled phase 3 clinical trials involving 32 men with erectile dysfunction who received aildenafil citrate 60 mg or placebo. Results The statistic results of international index of erectile function（ IIEF-5 ） were significantly higher in the aildenafil citrate patients than in the placebo controls. The main drug-related adverse events induding flushing, headache, dizziness and naupathia, was mild and self-relieved. Conclusion The aildenafil citrate therapy is effective and safety for erectile dysfunction.