Kirschner-Hermanns Ruth, Funk Petra, Leistner Nadine
Urology/Neuro-Urology, University Clinic Friedrich-Wilhelms-University Bonn and Neurologic Rehabilitation Center 'Godeshoehe' e.V., Venusberg-Campus 1, Gebäude 22, Bonn, 53127, Germany.
Dr. Willmar Schwabe GmbH & Co KG, Clinical Research Department, Karlsruhe, Germany.
Ther Adv Urol. 2019 Oct 11;11:1756287219879533. doi: 10.1177/1756287219879533. eCollection 2019 Jan-Dec.
Lower urinary tract symptoms (LUTS) caused by prostatic enlargement are a common impairing condition in men aged 50 years and older. In the management of LUTS related to benign prostatic hyperplasia (BPH), medication, particularly by α-adrenoceptor antagonists, 5α-reductase inhibitors, and phytopharmaceuticals, is considered the first-line therapy. Despite their popularity, a number of adverse effects on the cardiovascular or cognitive systems have been reported for some of the synthetic drugs. One of the promising herbal preparations for the treatment of patients suffering from LUTS related to BPH is WS PRO 160 I 120 mg, a combination of sabal fruit extract and urtica root extract.
This review of the literature summarizes clinical evidence for WS PRO 160 I 120 mg derived from four randomized placebo- or reference-controlled double-blind clinical trials including men aged 50 years and older. In all trials, symptomatic improvement was evaluated by the International Prostate Symptom Score (I-PSS) total score.
Treatment effects of WS PRO 160 I 120 mg were shown to be superior over placebo and comparable with the 5α-reductase inhibitor finasteride or the α-adrenoceptor antagonist tamsulosin with more favorable tolerability and safety profiles as compared with the reference drugs.
The results suggest WS PRO 160 I 120 mg to be considered as a valid alternative in the treatment of patients with early BPH, especially with view to sexual function and a good quality of life, especially in long-term use.
前列腺增生引起的下尿路症状（LUTS）是50岁及以上男性常见的健康问题。在良性前列腺增生（BPH）相关LUTS的治疗中，药物治疗，特别是α-肾上腺素能受体拮抗剂、5α-还原酶抑制剂和植物药，被视为一线治疗方法。尽管这些药物很受欢迎，但一些合成药物已被报道对心血管或认知系统有许多不良反应。WS PRO 160 I 120毫克（一种锯叶棕果实提取物和荨麻根提取物的组合）是治疗与BPH相关LUTS患者的一种有前景的草药制剂。
本文献综述总结了来自四项随机安慰剂或阳性对照双盲临床试验（包括50岁及以上男性）的关于WS PRO 160 I 120毫克的临床证据。在所有试验中，通过国际前列腺症状评分（I-PSS）总分评估症状改善情况。
结果显示，WS PRO 160 I 120毫克的治疗效果优于安慰剂，与5α-还原酶抑制剂非那雄胺或α-肾上腺素能受体拮抗剂坦索罗辛相当，且与对照药物相比，耐受性和安全性更佳。
结果表明，WS PRO 160 I 120毫克可被视为治疗早期BPH患者的有效替代药物，尤其是考虑到其对性功能的影响以及良好的生活质量，特别是在长期使用时。
