福施乐治疗良性前列腺增生的临床研究

目的:观察福施乐治疗BPH的有效性和安全性。方法:采用多中心、开放性、自身前后对照的临床研究方法,对60例BPH患者采用福施乐治疗12周。以国际前列腺症状评分(IPSS)、最大尿流率(Qmax)、膀胱残余尿(PVR)和前列腺体积为主要疗效指标,以生活质量评分(QOL)和平均尿流率(Qave)为次要疗效指标,来评价福施乐治疗BPH的效果。结果:治疗12周后,患者IPSS评分、Qmax、PVR、QOL评分、Qave均比治疗前明显改善(P<0.01),而前列腺体积治疗前后无显著性差异(P>0.05)。结论:福施乐可明显改善BPH患者的排尿症状,增加尿流率,减少残余尿,无明显不良反应,治疗BPH安全、有效。

Fushile: A Safe and Effective Therapeutic for Benign Prostatic Hyperplasia

OBJECTIVE: To observe the efficacy and safety of Fushile, a compound preparation of several Chinese herbal drugs, in the treatment of benign prostatic hyperplasia (BPH). METHODS: 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. RESULTS: 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. CONCLUSION: 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.