Sökeland J, Albrecht J
Urologische Klinik Dortmund, Lehrkrankenhaus der Universitat Münster.
Urologe A. 1997 Jul;36(4):327-33. doi: 10.1007/s001200050106.
Therapeutic equivalence should be demonstrated in a randomised, reference-controlled multicentric double blind clinical trial with PRO 160/120, a combination of Sabal- and Urtica-Extract, and Finasteride, respectively, in patients suffering from benign prostatic hyperplasia (BPH, Stage I to II according to Aiken). The study involved 543 patients, who were treated for 48 weeks with two capsules of PRO 160/120 or one capsule of Finasteride per day, in a double dummy design. Primary variable was the change of the maximum urinary flow after 24 weeks of therapy in comparison to therapy start. As secondary variables urodynamic parameters such as average urinary flow, miction volume and miction time were monitored. Urinary symptoms were recorded by the International-Prostate-Symptom-Score (I-PSS, Paris 1993). Additionally, the impacts of the symptoms on quality of life had been assessed by a quality of life questionnaire according to The American Urological Association Measurement Committee (1991). An increase of the urinary flow rate could be observed in both treatment groups (1.9 ml/s with PRO 160/ 120; 2.4 ml/s with Finasteride). During the trial, the average urinary flow increased, whereas the miction time decreased in both groups in a similar extent. The miction volume did not show any relevant differences after treatment with either PRO 160/120 or Finasteride. The I-PSS decreased from 11.3 at the therapy start to 8.2 after 24 weeks and 6.5 (week 48) under PRO 160/120 and from 11.8 to 8.0 and 6.2, under Finasteride, respectively. Accordingly, life quality improved between therapy start and therapy end from 7.5 to 4.3 with PRO 160/120 and from 7.7 to 4.1 with Finasteride. In terms of safety aspects less adverse events occurred with the Sabal/Urtica-Extract as with Finasteride. Especially less cases of diminished ejaculation volume, erectile dysfunction and headache have been reported.
应在一项随机、对照、多中心双盲临床试验中证明治疗等效性，该试验分别纳入患有良性前列腺增生（根据艾肯分类为I至II期）的患者，使用PRO 160/120（锯叶棕提取物和荨麻提取物的组合）和非那雄胺进行治疗。该研究共纳入543名患者，采用双盲双模拟设计，患者分别接受每日两粒PRO 160/120胶囊或一粒非那雄胺胶囊治疗，为期48周。主要变量为治疗24周后与治疗开始时相比最大尿流率的变化。作为次要变量，监测尿动力学参数，如平均尿流率、排尿量和排尿时间。采用国际前列腺症状评分（I-PSS，1993年巴黎）记录尿路症状。此外，根据美国泌尿外科学会测量委员会（1991年）的生活质量问卷评估症状对生活质量的影响。两个治疗组均观察到尿流率增加（PRO 160/120组为1.9 ml/s；非那雄胺组为2.4 ml/s）。在试验期间，两组的平均尿流率均增加，排尿时间均有相似程度的缩短。使用PRO 160/120或非那雄胺治疗后，排尿量均未显示出任何显著差异。在PRO 160/120组，I-PSS从治疗开始时的11.3降至24周后的8.2以及48周后的6.5；在非那雄胺组，I-PSS分别从11.8降至8.0和6.2。相应地，在治疗开始至结束期间，PRO 16从7.5改善至4.3，非那雄胺从7.7改善至4.1。在安全性方面，锯叶棕提取物/荨麻提取物组发生的不良事件少于非那雄胺组。尤其是射精量减少、勃起功能障碍和头痛的病例报告较少。
