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一项关于西地那非和阿扑吗啡对有动脉源性勃起功能障碍证据的男性疗效和安全性的对照交叉研究。

A comparative, crossover study of the efficacy and safety of sildenafil and apomorphine in men with evidence of arteriogenic erectile dysfunction.

作者信息

Perimenis P, Gyftopoulos K, Giannitsas K, Markou S A, Tsota I, Chrysanthopoulou A, Athanasopoulos A, Barbalias G

机构信息

Departments of Urology, University of Patras, Patras, Grece.

出版信息

Int J Impot Res. 2004 Feb;16(1):2-7. doi: 10.1038/sj.ijir.3901119.

Abstract

The aim of the study was to establish and compare the efficacy and safety of sildenafil and apomorphine in men with arteriogenic erectile dysfunction (ED). In all, 43 men with ED and postinjection max penile systolic velocity <25 cm/s in repeated Doppler ultrasonography were included. Of these, 24 men started on apomorphine 2 mg and 19 on sildenafil 50 mg, the doses titrated up to 3 and 100 mg according to effectiveness and tolerability. Safety was evaluated according to adverse events (AEs) and patient withdrawal. Efficacy was the percentage of attempts resulting in erections firm enough for intercourse, based on event log data. The incidence of AEs with apomorphine 3 mg was higher than with sildenafil 100 mg. Two men on apomorphine 3 mg discontinued treatment due to AEs. The overall success rate of sildenafil was 63.7% compared to 32.1% of apomorphine (Pearson chi(2), P<0.01). Of all men, 25 (58.1%) responded to sildenafil 50 mg without the need for dose increase, while only one responded to apomorphine 2 mg. The response to sildenafil 50 mg was age related (analysis of variance, p=0.04). Satisfaction was reported by 76.75 and 13.95% of patients for sildenafil and apomorphine, respectively, but 20.9% were not satisfied with any of the two drugs. In conclusion, this study provides clear evidence that sildenafil, even at 50 mg dose, is more effective than apomorphine 3 mg in men with arteriogenic ED. The fact that one out of five patients is not satisfied with the above-studied drugs shows that new oral agents need to be evaluated for the treatment of this disorder.

摘要

该研究的目的是确定并比较西地那非和阿扑吗啡对患有动脉源性勃起功能障碍(ED)男性的疗效和安全性。共有43名患有ED且在重复多普勒超声检查中注射后阴茎最大收缩速度<25 cm/s的男性被纳入研究。其中,24名男性开始服用2 mg阿扑吗啡,19名男性开始服用50 mg西地那非,剂量根据疗效和耐受性分别上调至3 mg和100 mg。根据不良事件(AE)和患者停药情况评估安全性。疗效是根据事件日志数据得出的能够勃起至足以进行性交的尝试次数百分比。3 mg阿扑吗啡的AE发生率高于100 mg西地那非。两名服用3 mg阿扑吗啡的男性因AE停药。西地那非的总体成功率为63.7%,而阿扑吗啡为32.1%(Pearson卡方检验,P<0.01)。在所有男性中,25名(58.1%)对50 mg西地那非有反应且无需增加剂量,而只有1名对2 mg阿扑吗啡有反应。对50 mg西地那非的反应与年龄相关(方差分析,p = 0.04)。分别有76.75%和13.95%的患者对西地那非和阿扑吗啡表示满意,但20.9%的患者对这两种药物均不满意。总之,本研究提供了明确证据,表明即使是50 mg剂量的西地那非,在患有动脉源性ED的男性中也比3 mg阿扑吗啡更有效。五分之一的患者对上述研究药物不满意这一事实表明,需要评估新的口服药物用于治疗这种疾病。

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