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他达拉非每日一次联合体外冲击波疗法治疗佩罗尼氏病和勃起功能障碍患者:一项前瞻性随机试验的结果

Tadalafil once daily and extracorporeal shock wave therapy in the management of patients with Peyronie's disease and erectile dysfunction: results from a prospective randomized trial.

作者信息

Palmieri A, Imbimbo C, Creta M, Verze P, Fusco F, Mirone V

机构信息

Department of Urology, University Federico II of Naples, Naples, Italy.

出版信息

Int J Androl. 2012 Apr;35(2):190-5. doi: 10.1111/j.1365-2605.2011.01226.x. Epub 2011 Nov 15.

DOI:10.1111/j.1365-2605.2011.01226.x
PMID:22085227
Abstract

Extracorporeal shock wave therapy improves erectile function in patients with Peyronie's disease. However, erectile dysfunction still persists in many cases. We aimed to investigate the effects of extracorporeal shock wave therapy plus tadalafil 5 mg once daily in the management of patients with Peyronie's disease and erectile dysfunction not previously treated. One hundred patients were enrolled in a prospective, randomized, controlled study. Patients were randomly allocated to receive either extracorporeal shock wave therapy alone for 4 weeks (n = 50) or extracorporeal shock wave therapy plus tadalafil 5 mg once daily for 4 weeks (n = 50). Main outcome measures were: erectile function (evaluated through the shortened version of the International Index of Erectile Function), pain during erection (evaluated through a Visual Analog Scale), plaque size, penile curvature and quality of life (evaluated through an internal questionnaire). Follow-up evaluations were performed after 12 and 24 weeks. In both groups, at 12 weeks follow-up, mean Visual Analog Scale score, mean International Index of Erectile Function score and mean quality of life score ameliorated significantly while mean plaque size and mean curvature degree were unchanged. Intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and quality of life score in patients receiving the combination. After 24 weeks, intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and mean quality of life score in patients that received extracorporeal shock wave therapy plus tadalafil. In conclusion extracorporeal shock wave therapy plus tadalafil 5 mg once daily may represent a valid conservative strategy for the management of patients with Peyronie's disease and erectile dysfunction.

摘要

体外冲击波疗法可改善佩罗尼氏病患者的勃起功能。然而,在许多情况下勃起功能障碍仍然存在。我们旨在研究体外冲击波疗法联合每日一次服用5毫克他达拉非对既往未接受治疗的佩罗尼氏病和勃起功能障碍患者的治疗效果。一百名患者参与了一项前瞻性、随机、对照研究。患者被随机分配接受单独的体外冲击波疗法治疗4周(n = 50)或体外冲击波疗法联合每日一次服用5毫克他达拉非治疗4周(n = 50)。主要观察指标包括:勃起功能(通过国际勃起功能指数简化版进行评估)、勃起时的疼痛(通过视觉模拟量表进行评估)、斑块大小、阴茎弯曲度和生活质量(通过内部问卷进行评估)。在12周和24周后进行随访评估。在两组中,随访12周时,视觉模拟量表平均得分、国际勃起功能指数平均得分和生活质量平均得分均显著改善,而斑块大小平均数值和弯曲度平均数值未发生变化。组间分析显示,接受联合治疗的患者国际勃起功能指数平均得分和生活质量得分显著更高。24周后,组间分析显示,接受体外冲击波疗法联合他达拉非治疗的患者国际勃起功能指数平均得分和生活质量平均得分显著更高。总之,体外冲击波疗法联合每日一次服用5毫克他达拉非可能是治疗佩罗尼氏病和勃起功能障碍患者的一种有效的保守策略。

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