Zlotta Alexandre R, Teillac Pierre, Raynaud Jean Pierre, Schulman Claude C
Department of Urology, Erasme Hospital, University Clinics of Brussels, 808 route de Lennik, B-1070 Brussels, Belgium.
Eur Urol. 2005 Aug;48(2):269-76. doi: 10.1016/j.eururo.2005.03.029. Epub 2005 Apr 18.
Sexual function is one of the aspects in the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) that has gained increasing attention. We compared the influence on men's sexuality of Permixon, a lipido-sterolic extract of Serenoa Repens, with Tamsulosin and Finasteride using a specific validated questionnaire exploring patient's sexual functions.
A database was created comprising patients from 3 main double-blind, randomized studies - Permixon vs. Finasteride, Permixon vs. Tamsulosin and Permixon 160 mg vs. 320 mg including a total of 2511 patients. Three hundred fifty four were on Tamsulosin, 545 on Finasteride and 1612 patients on Permixon. LUTS were assessed using the I-PSS questionnaire. Peak flow rates and prostate volume were recorded. The MSF-4 questionnaire, including 4 items that explore the patient's interest in sex, quality of erection, achievement of orgasm and ejaculation, was used across the studies. This questionnaire was demonstrated as highly reproducible and both psychometrically and clinically valid across different cultures. Correlation coefficients were given to assess the linear relationship between continuous variables.
At 3 months, there were no statistically significant differences between the three treatment groups in terms of I-PSS or Qmax evolutions (all p values > 0.05). At 6 months, as compared to pretreatment data, there was a slight increase in sexual disorders in Tamsulosin (+0.3) and Finasteride (+0.8) treated patients while it slightly improved with Permixon therapy (-0.2). Ejaculation disorders were the most frequently reported side effects after Tamsulosin or Finasteride (both +0.2 on the specific MSF-4 question 4). There was no correlation between the evolution of the MSF-4 scores and the evolution in I-PSS neither in patients treated with Permixon, Finasteride or Tamsulosin. However, there was a slight correlation between the MSF-4 score at baseline and the I-PSS at baseline (r2 = 0.032). Although there was a correlation between the MSF-4 and age at baseline (r2 = 0.1452), there was no correlation between the evolution in MSF-4 during therapy and the age of the patients.
The present study demonstrates that Permixon therapy has no negative impact on male sexual function. Both Finasteride and Tamsulosin had a slight impact on sexual function, especially on ejaculation, although these effects were rare and in line with previous reports about these two drugs.
性功能是良性前列腺增生（BPH）相关下尿路症状（LUTS）治疗中日益受到关注的一个方面。我们使用一份经过验证的特定问卷来探究患者的性功能，比较了锯叶棕果实提取物Permixon、坦索罗辛和非那雄胺对男性性功能的影响。
创建了一个数据库，纳入来自3项主要双盲、随机研究的患者——Permixon与非那雄胺对比、Permixon与坦索罗辛对比以及Permixon 160 mg与320 mg对比，共2511例患者。354例使用坦索罗辛，545例使用非那雄胺，1612例使用Permixon。使用国际前列腺症状评分（I-PSS）问卷评估LUTS。记录峰值尿流率和前列腺体积。在各项研究中均使用了男性性功能量表（MSF-4）问卷，该问卷包含4个项目，用于探究患者的性兴趣、勃起质量（硬度）、性高潮和射精情况。该问卷具有高度可重复性，在不同文化背景下均具有心理测量学和临床有效性。给出相关系数以评估连续变量之间的线性关系。
3个月时，三个治疗组在I-PSS或最大尿流率（Qmax）变化方面无统计学显著差异（所有p值>0.05）。6个月时，与治疗前数据相比，坦索罗辛治疗组（+0.3）和非那雄胺治疗组（+0.8）患者的性功能障碍略有增加，而Permixon治疗组患者的性功能障碍略有改善（-0.2）。射精障碍是坦索罗辛或非那雄胺治疗后最常报告的副作用（在MSF-4特定问题4中两者均为+0.2）。在Permixon、非那雄胺或坦索罗辛治疗的患者中，MSF-4评分变化与I-PSS变化之间均无相关性。然而，基线时MSF-4评分与基线时I-PSS之间存在轻微相关性（r2 = 0.032）。虽然基线时MSF-4与年龄之间存在相关性（r2 = 0.1452），但治疗期间MSF-4的变化与患者年龄之间无相关性。
本研究表明，Permixon治疗对男性性功能无负面影响。非那雄胺和坦索罗辛对性功能均有轻微影响，尤其是对射精功能，不过这些影响较为罕见，且与此前关于这两种药物的报道一致。
