索利那新联合盐酸坦索罗辛治疗神经源性逼尿肌过度活动的临床研究  

The efficacy and safety of solifenacin combined with tamsulosin for neurological detrusor overactivity

作　　者：陈晖[1,2] 蒋重和 汤平[3] 欧汝彪[3] 曾健文[2] 邓向荣[3] 周理林[2] 黄马平 李青青 刘秋玲 黄杰滨 谢克基[3] 

机构地区：[1]广东省工伤康复医院泌尿外科,广东广州510440 [2]暨南大学附属广东省清远市人民医院泌尿外科,广东清远511500 [3]广州医科大学附属广州市第一人民医院泌尿外科,广东广州510180

出　　处：《现代泌尿外科杂志》2015年第10期701-704,共4页Journal of Modern Urology

基　　金：广东省医学科研基金项目(No.A2015251);广东省建设中医药强省科研项目(No.20152037)

摘　　要：目的探讨M3受体阻滞剂索利那新联合α1受体阻滞剂盐酸坦索罗辛治疗神经源性逼尿肌过度活动疗效和安全性。方法采用前瞻性、多中心、单盲、随机对照的试验方法,2011年12月至2014年8月,将172例神经源性逼尿肌过度活动患者随机分为试验组和对照组,试验组口服索利那新片5mg/d和盐酸坦索罗辛胶囊0.2mg/d,对照组口服琥珀酸索利那新片5mg/d和安慰剂,记录治疗前,服药后3月的尿失禁生活质量评分表(I-QoL)、每次排尿量(导尿+自然排尿)、储尿期膀胱逼尿肌最大压力、膀胱顺应性、膀胱安全容量,并记录相关不良事件并对数据进行统计分析。结果 162例患者完成试验,其中试验组80例,对照组82例。服药12周后,实验组和对照组I-QoL、每次排尿量、储尿期最大逼尿肌压力、膀胱顺应性、膀胱安全容量分别为(68.21±12.67,62.15±15.63)、(380.56±47.89,359.84±59.42)mL、(35.56±18.94,42.32±22.18)cmH2O、(7.38±3.84,5.84±4.12)mL/cmH2O、(225.65±54.61,207.32±48.56)mL,与治疗前比较差异均有统计学意义(P<0.00 1)。两组间I-QoL、每次排尿量、储尿期最大逼尿肌压力、膀胱顺应性、膀胱安全容量比较均有统计学差异(P=0.02,0.02,0.04,0.02,0.03)。结论索利那新联合盐酸坦索罗辛服用较单一索利那新更能保护NDO患者上尿路功能和提高患者生活质量,且副作用较少。Objective To evaluate the efficacy and safety of solifenacin combined with tamsulosin in the treatment of neurological detrusor overactivity.Methods A prospective,multicenter,single-blind and randomized controlled trial was conducted during Nov.2011 and Aug.2014.Patients with neurological detrusor overactivity were recruited and randomly divided into two groups.The experimental group（n=80）received solifenacin5 mg/d plus tamsulosin0.2 mg/d,while the control group（n=82）took solifenacin 5 mg/d plus placebo for three months.Primary outcomes were recorded,including I-QoL,voiding volume,maximum detrusor pressure,bladder compliance,safety bladder volume,and related adverse events.Results All parameters improved significantly compared to baseline 12 weeks after treatment.There were significant statistical difference between the two groups in I-QoL（68.21 vs.62.15,P=0.02）,voiding volume（380.56 mL vs.359.84 mL,P=0.02）,maximum detrusor pressure（35.56 cmH2O vs.42.32 cm H2O,P=0.04）,bladder compliance（7.38 mL/cmH2O vs.5.84 mL/cmH2O,P=0.02）,safety bladder volume（225.65 mLvs.207.32 mL,P=0.03）.Conclusion Solifenacin combined with tamsulosin is more effective and safer than solifenacin alone for patients with neurological detrusor overactivity to protect renal function and improve quality of life.

关 键 词：索利那新 盐酸坦索罗辛 神经原性逼尿肌过度活动 有效性 安全性 

分 类 号：R69[医药卫生—泌尿科学]