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他达拉非、西地那非和伐地那非治疗6个月后的治疗效果及患者满意度:勃起功能障碍观察性研究(EDOS)结果

Therapeutic effectiveness and patient satisfaction after 6 months of treatment with tadalafil, sildenafil, and vardenafil: results from the erectile dysfunction observational study (EDOS).

作者信息

Martin-Morales Antonio, Haro Josep Maria, Beardsworth Anthony, Bertsch Jordan, Kontodimas Stathis

机构信息

Hospital Carlos Haya, Servicio de Urologia, Malaga, Spain.

出版信息

Eur Urol. 2007 Feb;51(2):541-50; discussion 550. doi: 10.1016/j.eururo.2006.09.027. Epub 2006 Oct 16.

DOI:10.1016/j.eururo.2006.09.027
PMID:17084518
Abstract

OBJECTIVE

This observational study was conducted across Europe to assess health outcomes in men with erectile dysfunction (ED) who took tadalafil, sildenafil citrate (sildenafil), or vardenafil HCl (vardenafil) for 6 mo.

METHODS

Therapy effectiveness and patient satisfaction were evaluated using established and new questions on erectile function. Behavioural, psychological, and relationship outcomes were assessed using the short form of the Psychological and Interpersonal Relationship Scales (SF-PAIRS).

RESULTS

In nine European countries at 904 sites, 8047 patients were enrolled and 94% (7560) selected either tadalafil (5315), sildenafil (1252), or vardenafil (993) for treatment at baseline. Of the 7560, 3998 (52.9%) took the same drug for 6 mo. Baseline characteristics across the three treatment groups were comparable: mean age approximately 56 yr, moderate or severe ED, and mean International Index of Erectile Function-Erectile Function domain score about 13. Tadalafil, sildenafil, and vardenafil were therapeutically effective and improved patient satisfaction in the 40-58% of men who completed 6 mo of a single therapy. Patients taking tadalafil consistently had numerically higher levels of therapeutic effectiveness and satisfaction compared with patients who took sildenafil or vardenafil. The three cohorts had statistically significant changes from baseline in response to SF-PAIRS and there were significant differences, in favour of tadalafil, among cohorts in the Time Concerns domain.

CONCLUSION

In a large observational study that mimics a routine clinical setting, most patients selected an inhibitor of phosphodiesterase 5 to treat ED, which resulted in a high level of therapeutic effectiveness and patient satisfaction.

摘要

目的

这项观察性研究在欧洲各地开展,旨在评估服用他达拉非、枸橼酸西地那非(西地那非)或盐酸伐地那非(伐地那非)6个月的勃起功能障碍(ED)男性的健康结局。

方法

使用关于勃起功能的既定问题和新问题评估治疗效果和患者满意度。使用心理和人际关系量表简表(SF-PAIRS)评估行为、心理和人际关系结局。

结果

在欧洲9个国家的904个地点,共纳入8047例患者,94%(7560例)在基线时选择他达拉非(5315例)、西地那非(1252例)或伐地那非(993例)进行治疗。在这7560例患者中,3998例(52.9%)服用同一种药物6个月。三个治疗组的基线特征具有可比性:平均年龄约56岁,中度或重度ED,国际勃起功能指数-勃起功能领域平均得分约为13。他达拉非、西地那非和伐地那非治疗有效,在完成6个月单一治疗的40%-58%的男性中提高了患者满意度。与服用西地那非或伐地那非的患者相比,服用他达拉非的患者在治疗效果和满意度方面的数值始终更高。三个队列在SF-PAIRS方面与基线相比有统计学显著变化,在时间关注领域,各队列之间存在显著差异,他达拉非更具优势。

结论

在一项模拟常规临床环境的大型观察性研究中,大多数患者选择5型磷酸二酯酶抑制剂治疗ED,从而获得了较高的治疗效果和患者满意度。

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