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

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

目的 评价枸橼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 ,2 4 0名受试者在 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 (InternationalIndexofErectileFunction ,IIEF)。研究者根据受试者记事表、IIEF和总评题对受试者进行疗效评价。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 2 5 .0 0 % ,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 .0 0 %、89.39%。总评题 :西地那非组有 88.0 3%的受试者认为研究药物改善了其勃起功能 ,安慰剂组 2 4 .5 8%。受试者记事表显示 :西地那非组受试者的性生活成功率为 77.77% ,安慰剂组 2 4 .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。仅一名受试者因不良反应而终止研究。结论 枸橼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。

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.