May 25, 2007（安那罕讯）－根据几项发表于美国泌尿学会年会的研究显示，用来治疗勃起功能障碍的药物，在治疗与良性摄护腺肥大（BPH）相关的下泌尿道症状（LUTS）具有潜力。
Boris Schlenker医师于壁报讨论会中表示，除了对于性功能的影响，磷酸酯酶-5（PDE-5）抑
制剂已于
临床前研究证实可以放松摄护腺平滑肌，因而相对地缓解BPH与LUTS的症状；他与其同事研究针对221位有LUTS男性使用vardenafil（Levitra），在Bayer Vital GmbH公司的资助下以多中心、双盲试验进行。
这些男性被随机分派接受安慰剂（113位）或是10 mg的vardenafil，每天两次（108位），共使用8周；在试验进行前，两组病患的国际射护腺症状分数（IPSS）平均为16.8，表示LUTS的严重度为中度；在第8周时，接受vardenafil的男性，其IPSS平均为10.9，相较于安慰剂组的男性则是13.2分，相较于试验前达到显著差异（P＝0.013）。
接受vardenafil男性的生活品质也显著提升，这项指标以UROLIFE QoL问卷评估；在试验前，两组病患以此问卷评估的分数大约为43分，但是到第8周时，接受vardenafil男性的分数上升11.7分，相较于安慰剂组仅上升2.9分（P＜0.0001）；LUTS的改善与勃起功能改善有关。
德国慕尼黑Klinikum Grosshadern der Ludwig-Maximilians大学泌尿科Schlenker医师表示，我们对这项发现偏好的假说是，vardenafil的主要作用在于膀胱；然而，他也承认这项研究的时间相对较短，需要长期的研究数据来确认这些发现。
另外一项发表于座谈会的研究，追踪受试者12周，且看到相似的结果；在这项由辉瑞药厂资助的随机试验中，主要作者Kevin T. McVary医师与其同事随机分派369位男性每天接受50 mg的sildenafil（Viagra，共189位病患）、或安慰剂（共180位病患）。
在试验前，46%的病患有中度LUTS，以IPSS分数8至19分定义，且54%病患有严重的LUTS（IPSS分数为20至35分）；Sildenafil组与安慰剂组整体试验前IPSS平均分数相似，但是到第12周时，使用sildenafil病患的分数平均下降了6.32分，而安慰剂组平均下降了1.93分（P<0.0001）；严重LUTS的男性改善幅度最大。
伊利诺州芝加哥西北大学Feinberg医学院McVary医师表示，IPSS分数的改善与勃起功能改善有关；如同Schlenker医师说的，他表示sildenafil透过作用在膀胱，而不是摄护腺，而改善LUTS症状。
座谈会主持人Steven A. Kaplan医师指出，使用sildenafil的男性，当他们使用这些药物，因为勃起功能的改善，他们知道他们在治疗组或是安慰剂组，揭露了双盲试验设计；Kaplan医师指出，或许这真的是像安慰剂试验；Kaplan医师是纽约市威尔康乃尔医学院泌尿科教授。
在会议的某处，研究者表示LUTS的严重度与勃起功能不全的严重度之间有关；他们发表来自随机分派、双盲，由礼来药厂与ICOS赞助的研究，这项研究结果显示，使用tadalafil（Cialis）12周的中重度LUTS男性，相较于使用安慰剂男性，其勃起功能显著改善，且与LUTS的严重度无关。
Erectile Dysfunction Drugs Show Promise in Treatment of Lower Urinary Tract Symptoms
By Norra MacReady
Medscape Medical News
May 25, 2007 (Anaheim) — Drugs that treat erectile dysfunction also show promise in the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), according to several studies presented here at the annual meeting of the American Urological Association.
In addition to their effect on sexual function, phosphodiesterase-5 (PDE-5) inhibitors have been shown in preclinical studies to relax prostatic smooth muscle, leading to a corresponding relief of BPH symptoms and LUTS, Boris Schlenker, MD, said during a moderated poster presentation. He and his colleagues studied the effect of vardenafil (Levitra) on 221 men with LUTS in a multicenter, double-blind trial supported by Bayer Vital GmbH.
The men were randomized to receive either a placebo (n = 113) or 10 mg of vardenafil twice a day (n = 108) for 8 weeks. At baseline, each group had a mean International Prostate Symptom Score (IPSS) of 16.8, suggesting LUTS of moderate severity. By week 8, the men who received vardenafil had a mean IPSS of 10.9 compared with a mean of 13.2 for men in the placebo group, a significant difference in change from baseline (P = .013).
The men receiving vardenafil also experienced a significantly larger increase in quality of life, as measured by the UROLIFE QoL questionnaire. At baseline, both groups scored about 43 points on the questionnaire, but by week 8, the scores had increased by 11.7 points for men receiving vardenafil and by 2.9 points for men in the placebo group (P < .0001). The improvement in LUTS was associated with improved erectile function.
"Our favorite hypothesis about these findings is that the main effect of vardenafil is on the bladder," said Dr. Schlenker, a urologist at the Klinikum Grosshadern der Ludwig-Maximilians-Universitaet in Munich, Germany. However, he acknowledged that the study duration was relatively short and said that longer-term data are needed to confirm these findings.
A second study presented at the session followed the participants for 12 weeks and saw similar results. In this double-blind trial, supported by Pfizer, lead author Kevin T. McVary, MD, and colleagues randomized 369 men to receive either 50 mg of sildenafil (Viagra; n = 189) or placebo (n = 180) daily.
At baseline, 46% of the patients had moderate LUTS, defined as an IPSS of 8 to 19 points, and 54% had severe LUTS (IPSS = 20-35 points). The mean overall baseline IPSS was similar between the sildenafil and placebo groups, but by week 12, the scores had dropped by a mean of 6.32 points among the men receiving sildenafil compared with a decrease of 1.93 points in the placebo group (P < .0001). Men with the most severe LUTS experienced the greatest improvement.
Improvement in IPSS correlated with improved erectile function, said Dr. McVary, associate professor of urology at the Feinberg School of Medicine at Northwestern University in Chicago, Illinois. Like Dr. Schlenker, he suggested that sildenafil may ameliorate LUTS by acting on the bladder rather than the prostate.
Steven A. Kaplan, MD, one of the session moderators, pointed out that men given sildenafil may have realized which group they were in when their erectile function improved, unmasking the double-blind condition. "Maybe this really was a placebo study," said Dr. Kaplan, a professor of urology at Weill Cornell Medical College in New York City.
Elsewhere at the meeting, investigators noted an association between the severity of LUTS and the severity of erectile dysfunction. They presented data from a randomized, double-blind study, sponsored by Lilly and ICOS, showing that men with moderate to severe LUTS who took tadalafil (Cialis) for 12 weeks experienced improved erections compared with men in the placebo group, independent of LUTS severity.
AUA 2007 Annual Meeting: Abstracts 956, 1547, 1565.
J Urol. 2007;177(4 suppl):316, 510, 517.
作者：
Norra MacReady 2007-6-16