索利那新治疗膀胱过度活动症的有效性及安全性分析  

Efficacy and safety of solifenacin in the treatment of overactive bladder

作　　者：郭万松[1] 杨波[1] 孔祥波[2] 孔垂泽[3] 高泽寿[3] 李振华[3] 王元元[4] 赵利涛[4] 张智勇[4] 王巍[5] 吴波[5] 李旭东[6] 周洪革[6] 

机构地区：[1]长春市中心医院泌尿外科,130051 [2]吉林大学中日联谊医院泌尿外科 [3]中国医科大学附属第一医院泌尿外科 [4]大连医科大学附属第二医院泌尿外科 [5]沈阳市第五人民医院泌尿外科 [6]沈阳医学院奉天医院泌尿外利

出　　处：《中华泌尿外科杂志》2010年第11期745-747,共3页Chinese Journal of Urology

摘　　要：目的 评价索利那新治疗膀胱过度活动症（OAB）的有效性及安全性. 方法采用多中心临床试验方法,对216例OAB患者予每日口服5 mg索利那新,连续用药5周,记录用药前后排尿日记及用药不良反应,比较用药前后平均24 h尿急次数、平均24 h排尿次数、夜尿次数、平均尿量、尿失禁次数及QOL评分的改善情况.采用SPSS 13.0统计软件对疗效和安全性进行分析. 结果 216例患者应用索利那新治疗5周,治愈187例（86.7%）,其中43例（19.9%）用药3周后基本恢复正常排尿,29例（13.4%）明显好转,24 h平均尿急次数中位数由用药前的4.1（0.9～18.6）次减至用药后的0.6（0～17.9）次,其中27例急迫性尿失禁患者24 h尿失禁次数中位数由用药前的1.9（0.6～16.4）次减至用药后的0.5（0～3.4）次,QOL评分由用药前的4.3±0.3降至用药后的1.1±0.2,用药前后比较差异均有统计学意义（P〈0.05）.11例（5.0%）用药后发生轻微口干、眼干症状,未观察到严重不良反应. 结论 索利那新能有效改善OAB患者尿急、尿频、夜尿及尿失禁症状,不良反应小,治疗OAB安全有效.Objective To evaluate the efficacy and safety of solifenacin in patients with overactive bladder （OAB）. Methods A multicenter clinical trial was conduced. 216 patients with OAB were enrolled. All the patients received solifenacin（5 mg once daily）. With 5 weeks＇treatment, all the patients recorded the diary and the adverse events as well. The symptoms of urgency, frequency, nocturia, urine volume, incontinence were evaluated. The results of the efficacy and safety were analyzed by using SPSS 13. 0. Results After 5 week treatments, all the index obviously improved（P〈0.05）. 187 cases （86.7%）were cured and 43 cases recovered normal voiding, 29 cases improved obviously. 11cases（5.0 %）reported adverse effect as dry mouth, dry eye. Conclusion Solifenacin could be the safe and effective drug in the treatment of OAB patients.

关 键 词：膀胱过度活动症 索利那新 临床试验 

分 类 号：R686[医药卫生—骨科学]