[Safety and efficacy of China-made sildenafil citrate in the treatment of erectile dysfunction].

: 目的: 评价国产枸橼酸西地那非（金戈）治疗男性勃起功能障碍（ED）的安全性、有效性和耐受性。方法： 采用多中心、随机、双盲、安慰剂对照研究方法 ，在国内5家医院泌尿外科或男科门诊纳入222例ED患者，随机分为西地那非组（111例）和安慰剂组（111例），进行为期8周的临床治疗观察。以国际勃起功能问卷（ IIEF）评分、性交成功率作为有效性评价指标，以不良事件发生率作为安全性评价指标。结果： 西地那非组和安慰剂组患者年龄分别为（47.20±11.32）岁和（ 46.67±13.08）岁（P>0.05），ED病因分别为心理性（27.93% vs 23.42%）、器质性（21.62% vs 29.73%）和混合性ED（50.45% vs 46.85%）(P均>0.05) ，其他流行病学数据如身高、体重、民族、吸烟、饮酒、药物过敏史等一般情况也均无统计学差异。对主要疗效指标的分析结果显示，西地那非组与安慰剂组对勃起 功能显著有效率分别为78.90%和29.91%（P 0.05), psychological etiology (27.93% vs 23.42%, P>0.05), organic etiology (21.62% vs 29.73%, P>0.05) or mixed etiology (50.45% vs 46.85%, P>0.05), nor in height, weight, nationality, or history of smoking, drinking or allergy. Compared with the placebo controls, the SC-treated patients showed significant increases in the excellence rate of effectiveness (29.91% vs 78.90%, P<0.01), success rate of sexual intercourse (29.16% vs 63.87%, P<0.01), and total effectiveness rate (34.58% vs 77.98%, P<0.01). The effectiveness rates on organic, psychogenic and mixed types ED were remarkably higher in the SC group (64.52%, 83.33%, and 82.14%) than in the placebo control (46.15%, 21.21%, and 25.00%) (P<0.01). Mild or temporary adverse events were observed in 32 cases in the SC group as compared with 13 in the placebo control. CONCLUSIONS: China-made sildenafil citrate is an effective, safe and well-tolerated drug for ED of different etiologies in the Chinese population.