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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。
Objective To evaluate the clinical efficacy and safety of oral sildenafil citrate tablets in the treatment of male erectile dysfunction. Methods A multicenter, randomized, double-blind, placebo-controlled and placebo-controlled study was performed in 240 patients for 8 weeks. The evaluation criteria included IIEF, Notepad, and total comment. Results The level of IIEF in sildenafil group was significantly higher than that in placebo group (P <0.01). Notepad, the total score of sildenafil group was also significantly better than placebo group, no adverse reactions were interrupted researchers. Conclusion Domestic sildenafil citrate tablets are effective and safe drugs for the treatment of male erectile dysfunction.