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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。
Objective: To investigate the clinical efficacy and safety of tamsulosin in combination with solifenacin in the treatment of BPH with overactive bladder (OAB). Methods: From December 2009 to June 2011, 262 BPH patients with OAB were collected and randomly divided into experimental group (134 cases) and control group (128 cases). Patients in the test group were given tamsulosin 0.2 mg orally once a day while oral administration of solifenacin 5 mg once daily. Patients in the control group were given tamsulosin only orally, and the usage and dosage were the same as those in the experimental group. Two groups of patients were treated for 4 weeks. The subjective index IPSS score, OABSS score, QOL score and objective index Qmax, 24h urination frequency, urinary urgency, urge incontinence frequency, nocturnal urinary incontinence number, urine output per visit, Changes in assessment of treatment of BPH patients OAB symptoms and safety improvement. Results: There was significant difference between the two groups before and after subjective index and objective index treatment group (P <0.05). Compared with the control group, subjective index and objective index before and after treatment in the experimental group were significantly different (P <0.05) except Qmax and urine output. There was no significant difference in Qmax between two groups of patients before and after treatment (P> 0.05). The total incidence of adverse events in the experimental group and the control group was relatively low, 4.58% and 2.47% respectively, with no serious adverse events. Conclusion: Tamsulosin combined with solifenac in the treatment of BPH with OAB patients is more effective than tamsulosin alone and has good safety.