Stief Christian G, Porst Hartmut, Neuser Dieter, Beneke Manfred, Ulbrich Ernst
Department of Urology, Ludwig-Maximilians-University, Munich, Germany.
Eur Urol. 2008 Jun;53(6):1236-44. doi: 10.1016/j.eururo.2008.01.075. Epub 2008 Feb 4.
Benign prostatic hyperplasia (BPH) is associated with bothersome lower urinary tract symptoms (LUTS) and reduced patient quality of life (QoL). Phosphodiesterase (type) 5 (PDE5) inhibitors such as vardenafil are commonly used for the treatment of erectile dysfunction (ED), but have also been shown to improve the symptoms of BPH. This randomised, double-blind, placebo-controlled study investigated the effects of vardenafil on LUTS and QoL in men with BPH/LUTS, with or without concomitant ED.
Men aged 45-64 yr with BPH/LUTS and an International Prostate Symptom Score (IPSS) > or =12 were randomised to receive either 10mg vardenafil or placebo twice daily. LUTS were assessed with the use of two primary efficacy parameters, IPSS score and maximum urinary flow rate (Qmax), as well as postvoid residual (PVR) urine volume; ED was measured with the use of the erectile function (EF) domain score of the International Index of Erectile Function (IIEF-EF); and QoL was assessed with the Urolifetrade mark QoL-9 questionnaire.
After 8 wk of treatment, there was a significant improvement in the IPSS total score in the vardenafil group compared with placebo (-5.9 and -3.6, respectively; p=0.0013). Nominally significant improvements in irritative and obstructive IPSS subscores (p=0.0017 and p=0.0081, respectively), EF (p=0.0001), and Urolife QoL-9 (p<0.0001) were also associated with vardenafil treatment. Qmax and PVR urine volume did not change significantly with treatment, although baseline values were already considered close to normal. Vardenafil was generally well tolerated, with most adverse events considered mild or moderate in severity.
Vardenafil treatment significantly improved LUTS, EF, and QoL in men with BPH/LUTS. Vardenafil may be considered a promising treatment option for men with symptoms secondary to BPH.
良性前列腺增生（BPH）与令人困扰的下尿路症状（LUTS）以及患者生活质量（QoL）下降相关。磷酸二酯酶5（PDE5）抑制剂如伐地那非常用于治疗勃起功能障碍（ED），但也已显示可改善BPH症状。这项随机、双盲、安慰剂对照研究调查了伐地那非对伴有或不伴有ED的BPH/LUTS男性患者的LUTS和QoL的影响。
年龄在45 - 64岁、患有BPH/LUTS且国际前列腺症状评分（IPSS）≥12的男性被随机分为两组，分别每日两次服用10mg伐地那非或安慰剂。使用两个主要疗效参数评估LUTS，即IPSS评分和最大尿流率（Qmax），以及残余尿量（PVR）；使用国际勃起功能指数（IIEF - EF）的勃起功能（EF）领域评分测量ED；使用Urolifetrade mark QoL - 9问卷评估QoL。
治疗8周后，与安慰剂组相比，伐地那非组的IPSS总分有显著改善（分别为 - 5.9和 - 3.6；p = 0.0013）。伐地那非治疗还与刺激性和梗阻性IPSS子评分（分别为p = 0.0017和p = 0.0081）、EF（p = 0.0001）以及Urolife QoL - 9（p < 0.0001）的名义上显著改善相关。尽管基线值已被认为接近正常，但治疗后Qmax和PVR尿量没有显著变化。伐地那非总体耐受性良好，大多数不良事件的严重程度被认为是轻度或中度。
伐地那非治疗显著改善了BPH/LUTS男性患者的LUTS、EF和QoL。伐地那非可能被认为是BPH继发症状男性患者的一种有前景的治疗选择。
