国产枸橼酸西地那非片治疗男性勃起功能障碍疗效和安全性的临床研究

Efficacy and Safety of Oral Domestic Sildenafil in the Treatment of Erectile Dysfunction

目的 评价口服国产枸橼酸西地那非片治疗男性勃起功能障碍的临床有效性和安全性。方法 采用多中心、随机、双盲、安慰剂、平行对照的方法 ,对 2 40例患者进行为期 8周的临床观察 ,评价标准包括 :国际勃起功能指数 (IIEF)、记事本、总评题。结果 西地那非组IIEF评分明显高于安慰剂组 (P <0 0 1) ,记事本、总评题结果西地那非组亦明显优于安慰剂组 ,无不良反应中断研究者。结论 国产枸橼酸西地那非片是治疗男性勃起功能障碍的有效和安全的药物。

Objectives To evaluate the efficacy and safety of oral domestic sildenafil in men with erectile dysfunction.Methods 240 patients were enrolled in a randomized,double-blind, placebo-controlled, parallel-group,multi-center,8-week flexible-dose observation. Efficacy assessment criteria included the intenational index of Erectile Function(IIEF),a global assessment question, and patient event log data. Result After treatment, mean IIEF score for patients taking sildenafil approached values observed in control subjects and were significantly higher than mean scores for patients taking placebo(.P.<0.01). Responses to the global assessment question and patient log data corroborated the IIEF result. Sildenafil was well tolerated,with no discontinuations because of side effects.Conclusions Oral domestic sildenafil is an effective, well-tolerated drug for men with erectile dysfunction.\;