CAJ | 학술논문

索利那新治疗膀胱过度活动症的有效性及安全性分析
색리나신치료방광과도활동증적유효성급안전성분석
Efficacy and safety of solifenacin in the treatment of overactive bladder

万方数据

中华泌尿外科杂志中華泌尿外科雜誌 중화비뇨외과잡지
CHINESE JOURNAL OF UROLOGY
2010年 11期 745-747 ,共3页

郭万松%杨波%孔祥波%孔垂泽%高泽寿%李振华%王元元%赵利涛%张智勇%王巍%吴波%李旭东%周洪革

곽만송%양파%공상파%공수택%고택수%리진화%왕원원%조리도%장지용%왕외%오파%리욱동%주홍혁

膀胱过度活动症%索利那新%临床试验膀胱過度活動癥%索利那新%臨床試驗
방광과도활동증%색리나신%림상시험
Overactive bladder%Solifenacin%Clinical trials

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.
목적 평개색리나신치료방광과도활동증(OAB)적유효성급안전성. 방법채용다중심림상시험방법,대216례OAB환자여매일구복5 mg색리나신,련속용약5주,기록용약전후배뇨일기급용약불량반응,비교용약전후평균24 h뇨급차수、평균24 h배뇨차수、야뇨차수、평균뇨량、뇨실금차수급QOL평분적개선정황.채용SPSS 13.0통계연건대료효화안전성진행분석. 결과 216례환자응용색리나신치료5주,치유187례(86.7%),기중43례(19.9%)용약3주후기본회복정상배뇨,29례(13.4%)명현호전,24 h평균뇨급차수중위수유용약전적4.1(0.9～18.6)차감지용약후적0.6(0～17.9)차,기중27례급박성뇨실금환자24 h뇨실금차수중위수유용약전적1.9(0.6～16.4)차감지용약후적0.5(0～3.4)차,QOL평분유용약전적4.3±0.3강지용약후적1.1±0.2,용약전후비교차이균유통계학의의(P<0.05).11례(5.0%)용약후발생경미구간、안간증상,미관찰도엄중불량반응. 결론 색리나신능유효개선OAB환자뇨급、뇨빈、야뇨급뇨실금증상,불량반응소,치료OAB안전유효.
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.