西地那非联合坦索罗辛治疗LUTS/BPH的对比研究

Comparative study on effect of tamsulosin combined with sildenafil in the treatment of LUTS/BPH

目的 观察西地那非联合坦索罗辛及单独应用坦索罗辛治疗良性前列腺增生症（BPH）所致下尿路症状（LUTS）的临床疗效.方法 国际前列腺症状评分（IPSS）≥12分的本院2010年7月～2011年6月BPH患者50例,随机分为两组,每组25例.治疗组口服西地那非25mg,每日一次＋坦索罗辛0.2mg,每日两次;对照组服用坦索罗辛0.2mg,每日两次,疗程8周.治疗后组间比较IPSS、最大尿流率（Qmax）、残余尿量（PVR）、生活质量（QOL）和勃起功能国际问卷（IIEF-5）,并进行统计学分析.结果 与对照组比较,治疗组IPSS明显下降,IIEF-5明显改善,QOL明显改善（P＜0.05）,两组Qmax和PVR无明显差异（P＞0.05）.结论 西地那非联合坦索罗辛治疗前列腺增生症所致下尿路症状优于单独应用坦索罗辛,并可以改善患者的勃起功能.

Objectives To assess the efficacy and safety of tamsulosin vs tamsulosin plus sildenafil in patients with LUTS/BPH.Methods A randomized,double-blind study was conducted from July 2010 to June 2011 in our hospital.Fifty men,with a history of LUTS/BPH,were randomized into two groups to receive tamsulosin 0.4 mg/day vs.tamsulosin 0.4 mg/day plus sildenafil 25 mg/day for 8 weeks.Then,Recording and statistical analysis with International Prostate Symptoms Score （IPSS）,maximum flow rate （Qmax）,quality of life （QOL）,post-void residual volume（PVR）,International Index of Erectile Function-5 （IIEF-5） in two groups.Results All forty patients completed the study.Improvements of IPSS score,QOL score and IIEF score were significant with both treatments but greater with the drug combination.Both regimens similarly improved the Qmax and decreased the PVR volume from baseline（P 〈0.01） with no significant differences between two groups（P 〉0.05）.Conclusions amsulosin 0.4 mg/day plus sildenafil 25 mg/day was more effective than tamsulosin 0.4 mg/day alone to improve LUTS,QOL and erectile dysfunction and was also well tolerated.