枸橼酸西地那非片治疗男性勃起功能障碍有效性及安全性评价

目的：评价枸椽酸西地那非片治疗男性勃起功能障碍的有效性及安全性。方法：采用多中心、随机双盲、安慰剂平行对照、剂量视情增减的设计方案，240名受试在4周筛选期后进入8周的治疗期，在筛选期及研究结束时填写国际勃起功能问卷（International Index of Erectile Function，IIEF）。研究根据受试记事表、IIEF和总评题对受试进行疗效评价。结果：主要疗效指标临床总有效率西地那非组为83.33%，安慰剂组25.00%，西地那非对心理性、器质性和混合性勃起功能障碍的有效率分别为70.83%、80.00%、89.39%。总评题：西地那非组有88.03%的受试认为研究药物改善了其勃起功能，安慰剂组24.58%。受试记事表显示：西地那非组受试的性生活成功率为77.77%，安慰剂组24.17%，不良反应发生率西地那非组30.83%，安慰剂组8.33%，表现为轻度和短暂的面部潮红、头晕、头痛、鼻塞、口干及消化道不适。仅一名受试因不良反应而终止研究。结论：枸椽酸西地那非片为一种安全、有效的治疗男性勃起功能障碍的药物。

Evaluation of efficacy and safety of oral sildenafil citrate therapy for men with erectile dysfunction

Aim To evaluate the efficacy and safety of oral sildenafil citrate therapy for men with erectile dysfunction(ED).Methods The multi-center,randomized double-blind,placebo-controlled studies were used to assess the efficacy and safety of sildenafil in patients with erectile dysfunction.After 4 weeks screening therapy,240 volunteers randomized to receive sildenafil or placebo in 8 weeks double-blind,placebo-controlled studies.Efficacy was assessed using end-of-treatment responses to the International Index of Erectile Function (IIEF).Results At the end of treatment,main efficacy marker (clinical effectiveness) demonstrated significant increases for sildenafil-treated patients(83.33%) compared with those receiving placebo(25.00%) (P<0.001).The efficiency of oral sildenafil citrate was approved for the treatment of psychological,physical and mixture ED (70.83%,80.00% and 89.39% respectively).Mean end-of-treatment scores for the IIEF improved erections were reported by 88.03% of patients who received sildenafil and by 24.58% of those in the placebo group(P<0.001).The volunteers' record suggested that the efficacy of sexual intercourse in sildenafil citrate group was 77.77% and the efficacy in placebo group was 24.17%(P<0.001).For the sildenafil group,the incidences of the most common adverse events (mild and transitory flushing,dizziness,headache,nasal obstruction,dry mouth and dyspepsia) were 30.83% compared with placebo group (8.33%).Moreover,only one volunteer was out of investigation for severe adverse events.Conclusion The sildenafil citrate tablets had been demonstrated excellent efficacy and safety profiles in men with erectile dysfunction of various etiologies.