Ryu Young Woo, Lim Song Won, Kim Jung Hoon, Ahn Seung Hyun, Choi Jae Duck
Department of Urology, KEPCO Medical Center, Seoul, Korea.
Urol Int. 2015;94(2):187-93. doi: 10.1159/000366521. Epub 2015 Jan 23.
In Korea, increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH. Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies. The present study was designed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH.
One hundred forty men with symptomatic BPH (IPSS≥10) were recruited in our hospital for a 12-month, open-label, randomized trial. Patients were randomly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day (n=60) or tamsulosin 0.2 mg/day only (n=60). Prostate volume and PSA were measured at baseline and at end-point, whereas total IPSS, and its storage and voiding subscores, LUTS-related QoL, Qmax, and PVR were evaluated at baseline and later every 6 months.
Total 103 patients were finally available: 50 in the TAM+SR group and 53 in the TAM group. At 12 months, total IPSS decreased by 5.8 with TAM+SR and 5.5 with TAM (p=0.693); the storage symptoms improved significantly more with TAM+SR (-1.7 vs. -0.8 with TAM, p=0.024). This benefit with regard to storage symptom in the TAM+SR group lasts at 12 months (-1.9 vs. -0.9, p=0.024). The changes of voiding subscore, LUTS-related QoL, Qmax, PVR, PSA, and prostate volume showed no significant differences between the TAM+SR and TAM groups. During the treatment period, 8 patients (16.9%) with TAM and 10 (20%) with TAM+SR had drug-related adverse reactions, which included ejaculatory disorders, postural hypotension, dizziness, headache, gastro-intestinal disorders, rhinitis, fatigue and asthenia.
The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment.
在韩国，最近人们越来越关注使用植物治疗药物来缓解良性前列腺增生（BPH）的症状。在先前的研究中，锯叶棕已被证明在治疗BPH方面具有与非那雄胺或坦索罗辛相当的疗效。本研究旨在比较锯叶棕加坦索罗辛与单用坦索罗辛在12个月内对BPH继发下尿路症状（LUTS）男性患者的疗效和安全性。
140例有症状的BPH患者（国际前列腺症状评分[IPSS]≥10）被纳入我院进行一项为期12个月的开放标签随机试验。患者被随机分为两组，一组每天服用0.2毫克坦索罗辛加320毫克锯叶棕（n = 60），另一组仅每天服用0.2毫克坦索罗辛（n = 60）。在基线和终点时测量前列腺体积和前列腺特异性抗原（PSA），而总IPSS及其储尿和排尿子评分、与LUTS相关的生活质量（QoL）、最大尿流率（Qmax）和残余尿量（PVR）在基线时以及之后每6个月进行评估。
最终共有103例患者可供分析：坦索罗辛+锯叶棕组50例，坦索罗辛组53例。在12个月时，坦索罗辛+锯叶棕组的总IPSS下降了5.8，坦索罗辛组下降了5.5（p = 0.693）；坦索罗辛+锯叶棕组的储尿症状改善更为显著（-1.7 vs坦索罗辛组的-0.8，p = 0.024）。坦索罗辛+锯叶棕组在储尿症状方面的这种优势在12个月时仍然存在（-1.9 vs -0.9，p = 0.024）。排尿子评分、与LUTS相关的QoL、Qmax、PVR、PSA和前列腺体积的变化在坦索罗辛+锯叶棕组和坦索罗辛组之间无显著差异。在治疗期间，坦索罗辛组有8例患者（16.9%）出现药物相关不良反应，坦索罗辛+锯叶棕组有10例患者（20%）出现药物相关不良反应，包括射精障碍、体位性低血压、头晕、头痛、胃肠道疾病、鼻炎、疲劳和乏力。
在治疗6个月至12个月后，锯叶棕与坦索罗辛联合治疗在减轻BPH患者的储尿症状方面比坦索罗辛单药治疗更有效。
