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...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。展开更多
We compared the efficacy and safety between once-daily dosing and on-demand use of udenafil for type 2 diabetic patients with erectile dysfunction （ED）. A multi-center, randomized, open-label, parallel-group, 12-wee...We compared the efficacy and safety between once-daily dosing and on-demand use of udenafil for type 2 diabetic patients with erectile dysfunction （ED）. A multi-center, randomized, open-label, parallel-group, 12-week study was conducted. 161 patients who improved with on-demand 200 mg of udenafil according to Sexual Encounter Profile （SEP） diary Question 2 and 3 （Q2 and Q3） were randomized into 200 mg on-demand （n = 80） or 50 mg once-daily （n = 81） dosing groups for 8 weeks. The dosing period was followed by a 4-week treatment-free period. The primary efficacy endpoint was the change of the International Index of Erectile Function （IIEF） erectile function domain （EFD） score. The secondary efficacy endpoints included changes to the SEP diary Q2, Q3, IIEF Q3, Q4, other domains of IIEF, Global Assessment Question, and shift to the normal rate （EFD 〉 26）. Vascular endothelial markers were also assessed. The IIEF-EFD score of both groups improved after 8 weeks of treatment （P 〈 0.0001）. There was no statistically significant difference between two groups. Improvement was not maintained after the treatment-free follow-up period. Similar results were observed in the secondary efficacy endpoints. There was also no significant difference in vascular endothelial markers. Daily udenafil was well-tolerated, and there was no significant difference in the adverse drug reactions and adverse events between the two groups. Flushing and headache were the most frequent adverse events. Both regimens improved ED in diabetic patients and were well-tolerated. Further studies are needed to assess the effect of daily udenafil treatment in diabetic patients.展开更多
文摘目的: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。
文摘We compared the efficacy and safety between once-daily dosing and on-demand use of udenafil for type 2 diabetic patients with erectile dysfunction （ED）. A multi-center, randomized, open-label, parallel-group, 12-week study was conducted. 161 patients who improved with on-demand 200 mg of udenafil according to Sexual Encounter Profile （SEP） diary Question 2 and 3 （Q2 and Q3） were randomized into 200 mg on-demand （n = 80） or 50 mg once-daily （n = 81） dosing groups for 8 weeks. The dosing period was followed by a 4-week treatment-free period. The primary efficacy endpoint was the change of the International Index of Erectile Function （IIEF） erectile function domain （EFD） score. The secondary efficacy endpoints included changes to the SEP diary Q2, Q3, IIEF Q3, Q4, other domains of IIEF, Global Assessment Question, and shift to the normal rate （EFD 〉 26）. Vascular endothelial markers were also assessed. The IIEF-EFD score of both groups improved after 8 weeks of treatment （P 〈 0.0001）. There was no statistically significant difference between two groups. Improvement was not maintained after the treatment-free follow-up period. Similar results were observed in the secondary efficacy endpoints. There was also no significant difference in vascular endothelial markers. Daily udenafil was well-tolerated, and there was no significant difference in the adverse drug reactions and adverse events between the two groups. Flushing and headache were the most frequent adverse events. Both regimens improved ED in diabetic patients and were well-tolerated. Further studies are needed to assess the effect of daily udenafil treatment in diabetic patients.
