国产枸橼酸西地那非治疗男性勃起功能障碍的安全性和有效性研究

发布时间：2018-08-28 08:10

【摘要】：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(P0.05),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%(P0.01);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。
[Abstract]:Objective: to evaluate the safety, efficacy and tolerance of sildenafil citrate (Kingo) in the treatment of male erectile dysfunction (ED). Methods: a multicenter, randomized, double-blind, placebo-controlled study was conducted in 222 patients with ED in urology or andrology outpatient clinics in 5 hospitals in China. They were randomly divided into sildenafil group (111 cases) and placebo group (111 cases) for 8 weeks. The (IIEF) score of international erectile function questionnaire, the success rate of sexual intercourse as the evaluation index, and the incidence of adverse events as the safety evaluation index. Results: the ages of patients in sildenafil group and placebo group were (47.20 卤11.32) and (46.67 卤13.08) years (P0.05). The etiology of Ed was 27.93% vs 23.42%, organic (21.62% vs 29.73%) and mixed ED (50.45% vs 46.85%) (P, respectively). There was no statistical difference in the general history of drug allergy. The significant effective rates of erectile function in the sildenafil group and the placebo group were 78.90% and 29.91% (P0.01), respectively, and the sexual intercourse success rate and the overall curative effect in the sildenafil group were 63.87% and 77.98%, respectively, which were significantly higher than those in the placebo group (29.16% and 34.58%, respectively) (P 0.01). In the treatment of different kinds of ED, the effective rates of sildenafil on psychological, organic and mixed ED were 64.52% and 82.14%, respectively, which were significantly higher than those of placebo group (46.15%, 21.21% and 25.00%, respectively). The results of safety evaluation showed that 45 (20.27%) subjects had various adverse events (32 in the sildenafil group and 13 in the placebo group), and most of the adverse events were mild and transient. Conclusion: sildenafil citrate is a safe and effective drug for the treatment of ED.
【作者单位】：北京大学第三医院生殖男科;北京大学人民医院泌尿外科;北京大学第三医院泌尿外科;北京大学第一医院泌尿外科;中山大学第三附属医院泌尿外科;大连医科大学第一附属医院泌尿外科;
【分类号】：R698

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