Shang Xue-Jun, Liu Zhi-Yong, Liu Zhi-Fa, Sun Ying-Hao, Huang Yu-Feng
Department of Andrology, Clinical School, Nanjing University Medical College, Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu 210002, China.
Zhonghua Nan Ke Xue. 2008 Mar;14(3):227-30.
To observe the efficacy and safety of Fushile, a compound preparation of several Chinese herbal drugs, in the treatment of benign prostatic hyperplasia (BPH).
A multi-centered, open and self-controlled clinical trial was performed in 60 BPH patients, who were treated with Fushile for 12 weeks. The efficacy of the compound was evaluated by the International Prostate Syndrome Score (IPSS), maximum flow rate (Qmax), post void residual (PVR) and prostate volume as the primary indexes and by the quality of life (QOL) score and average urinary flow rate (Qave) as the secondary indexes.
After 12 weeks of Fushile treatment, IPSS, Qmax, PVR, QOL and Qave of the BPH patients were significantly improved (P < 0.01), but there was no significant difference in the volume of the prostate before and after the treatment (P > 0.05). No adverse events were observed in any of the patients.
Fushile can significantly improve voiding symptoms, increase urinary flow and reduce PVR in BPH patients. It is effective and safe in the treatment of BPH.
观察由多种中药组成的复方制剂复施乐治疗良性前列腺增生（BPH）的疗效及安全性。
对60例BPH患者进行多中心、开放、自身对照临床试验，给予复施乐治疗12周。以国际前列腺症状评分（IPSS）、最大尿流率（Qmax）、残余尿量（PVR）和前列腺体积作为主要指标，以生活质量（QOL）评分和平均尿流率（Qave）作为次要指标评估该复方制剂的疗效。
复施乐治疗12周后，BPH患者的IPSS、Qmax、PVR、QOL和Qave均有显著改善（P<0.01），但治疗前后前列腺体积无显著差异（P>0.05）。所有患者均未观察到不良事件。
复施乐可显著改善BPH患者的排尿症状，增加尿流率并减少残余尿量。其治疗BPH有效且安全。
