Objective: To evaluate the safety, efficacy and tolerability of China-made sildenafil citrate (Jinge) in the treatment of ED.
Methods: We conducted a multi-center, randomized, double-blind and placebo-controlled clinical trial among 222 ED patients in five urological or andrological clinics of China. The patients were randomly assigned to receive sildenafil citrate (SC, n = 111) or placebo (n = 111) for 8 weeks. We obtained and analyzed the demographic and clinical characteristics of the patients, the scores of International Index of Erectile Function (IIEF), the success rate of sexual intercourse, and the incidence of adverse events.
Results: No statistically significant differences were found between the patients of the SC and those of the placebo group in the mean age (［47.2±11.32］ yr vs ［46.67±13.08］ yr, 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.
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<0.01)；西地那非组性交成功率和总体疗效分别为63.87%和77.98%，均明显高于安慰剂组的29.16%和34.58%（P均 <0.01)。在对于不同种类ED的治疗上，西地那非对心理性、器质性和混合性ED的有效率分别为64.52%、83.33%和82.14%，明显高于安慰剂组的46.15%、21.21%和 25.00%（P均<0.01)。安全性评价结果显示，共有45例（20.27%）受试者出现了各种不良事件（西地那非组有32例，安慰剂组有13例），所出现的不良事件大多数 为轻度、一过性的。结论： 国产枸橼酸西地那非是一种可治疗各种病因导致ED的安全有效的药物，且患者耐受性较好。.
Keywords: China-made sildenafil citrate; International Index of Erectile Function; efficacy; erectile dysfunction; safety.