坦索罗辛联合索利那新治疗BPH伴膀胱过度活动症的临床观察

目的:探讨坦索罗辛联合索利那新治疗BPH伴膀胱过度活动症(OAB)患者的临床疗效及安全性。方法:2009年12月～2011年6月期间收集BPH伴有OAB患者262例,随机分成试验组(134例)和对照组(128例)。试验组患者口服坦索罗辛0.2mg,每天一次,同时口服索利那新5mg,每天一次;对照组患者仅口服坦索罗辛,用量用法同实验组。两组患者均药物治疗4周。观察两组患者治疗前后主观指标IPSS评分、OABSS评分及QOL评分和客观指标最大尿流率(Qmax)、24h排尿次数、尿急次数、急迫性尿失禁次数、夜尿次数、每次排尿量的变化,评估治疗后BPH患者OAB症状的改善情况及其安全性。结果:两组患者主观指标和客观指标治疗前后组内对比,差异均有统计学意义(P<0.05)。试验组治疗前后的主观指标和客观指标变化值与对照组相比,除Qmax和每次排尿量外,差异均有统计学意义(P<0.05)。两组患者的Qmax和每次排尿量治疗前后的变化值相比,差异均无统计学意义(P>0.05)。试验组和对照组不良事件总发生率较低,分别为4.58%和2.47%,无严重不良事件发生。结论:坦索罗辛联合索利那新治疗BPH伴有OAB患者的疗效,较单用坦索罗辛的疗效显著,且安全性好。

Efficacy and safety of combination tamsulosin with solifenacin in treatment of benign prostatic hyperplasia with overactive bladder

Objective:To assess the efficacy and safety of combination tamsulosin with solifenacin in treatment of benign prostatic hyperplasia(BPH) patients with overactive bladder(OAB). Method:262 cases were included and were randomly divided into the trial group(134 cases) and control group(128 cases).Patients in trial group were administrated with tamsulosin at 0.2 mg and solifenacin at 5mg once daily for 4 weeks.Patients in control group were administrated only with tamsulosin at 0.2mg once daily for 4 weeks.The efficacy and safety of treatment were assessed by changes before and after treatment in subjective outcome measures including IPSS,OABSS,QOL and objective outcome measures including Qmax,daily frequency of micturition,urgency,urgency incontinence,nocturia,voiding volumes. Result:There are significant differences in subjective and objective outcome measures in two groups between before and after treatment(P<0.05).Moreover,there are significant differences in changes before and after treatment of subjective and objective outcome measures except for Qmax and voiding volumes(P<0.05).There are no significant difference in the changes before and after treatment of Qmax and voiding volumes(P<0.05).The total incidences of adverse events in trial group and control group are 4.58% and 2.47% respectively,and no severe adverse event happens. Conclusion:Combination tamsulosin with solifenacin in treatment of benign prostatic BPH patients with OAB has better efficacy than tamsulosin only,nevertheless,has good safety.