Efficacy and safety of solifenacin plus tamsulosin oral controlled absorption system in men with lower urinary tract symptoms： a meta-analysis  

索非那新联合坦索罗辛缓释剂治疗男性下尿路症状的疗效与安全性的荟萃分析

作　　者：Ming-Chao Li Zheng-Yun Wang Jun Yang Xiao-Lin Guo Tao Wang Shao-Gang Wang Ji-Hong Liu Zhang-Qun Ye 

机构地区：[1]Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [2]Department of Respiratory and Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

出　　处：《Asian Journal of Andrology》2015年第1期124-134,I0011,共12页亚洲男性学杂志（英文版）

摘　　要：We performed a meta-analysis to compare treatment with a combination of solifenacin plus tamsulosin oral controlled absorption system （TOCAS） with placebo or TOCAS monotherapy. The aim of the meta-analysis was to clarify the efficacy and safety of the combination treatments method for lower urinary tract symptoms （LUTS）. We searched for trials of men with LUTS that were randomized to combination treatment compared with TOCAS monotherapy or placebo. We pooled data from three placebo-controlled trials meeting inclusion criteria. Primary outcomes of interest included changes in International Prostate Symptom Score （IPSS） and urinary frequency. We also assessed postvoid residual, maximum urinary flow rate, incidence of urinary retention （UR）, adverse events. Data were pooled using random or fixed effect models for continuous outcomes and the ManteI-Haenszel method to generate risk ratio. Reductions in IPSS storage subscore and total urgency and frequency score （TUFS） were observed with solifenacin 6 mg plus TOCAS compared with placebo （P 〈 0.0001 and P 〈 0.0001, respectively）. Reductions in IPSS storage subscore and TUFS were observed with solifenacin 9 mg plus TOCAS compared with placebo （P= 0.003 and P = 0.0006, respectively）. Reductions in TUFS was observed with solifenacin 6 mg plus TOCAS compared with TOCAS （P = 0.01）. Both combination treatments were well tolerated, with low incidence of UR. Solifenacin 6 mg plus TOCAS significantly improved total IPSS, storage and voiding symptoms compared with placebo. Solifenacin 6 mg plus TOCAS also improved storage symptoms compared with TOCAS alone. There was no additional benefit of solifenacin 9 mg compared with 6 mg when used in combination with TOCAS.We performed a meta-analysis to compare treatment with a combination of solifenacin plus tamsulosin oral controlled absorption system （TOCAS） with placebo or TOCAS monotherapy. The aim of the meta-analysis was to clarify the efficacy and safety of the combination treatments method for lower urinary tract symptoms （LUTS）. We searched for trials of men with LUTS that were randomized to combination treatment compared with TOCAS monotherapy or placebo. We pooled data from three placebo-controlled trials meeting inclusion criteria. Primary outcomes of interest included changes in International Prostate Symptom Score （IPSS） and urinary frequency. We also assessed postvoid residual, maximum urinary flow rate, incidence of urinary retention （UR）, adverse events. Data were pooled using random or fixed effect models for continuous outcomes and the ManteI-Haenszel method to generate risk ratio. Reductions in IPSS storage subscore and total urgency and frequency score （TUFS） were observed with solifenacin 6 mg plus TOCAS compared with placebo （P 〈 0.0001 and P 〈 0.0001, respectively）. Reductions in IPSS storage subscore and TUFS were observed with solifenacin 9 mg plus TOCAS compared with placebo （P= 0.003 and P = 0.0006, respectively）. Reductions in TUFS was observed with solifenacin 6 mg plus TOCAS compared with TOCAS （P = 0.01）. Both combination treatments were well tolerated, with low incidence of UR. Solifenacin 6 mg plus TOCAS significantly improved total IPSS, storage and voiding symptoms compared with placebo. Solifenacin 6 mg plus TOCAS also improved storage symptoms compared with TOCAS alone. There was no additional benefit of solifenacin 9 mg compared with 6 mg when used in combination with TOCAS.

关 键 词：combination therapy lower urinary tract symptoms SOLIFENACIN tamsulosin oral controlled absorption system 

分 类 号：R[医药卫生]