索利那新治疗膀胱过度活动症疗效观察

Effect Observation of Solifenacin Treatment for Overactive Bladder

目的评估索利那新治疗膀胱过度活动症的疗效及安全性。方法采用随机对照的临床试验方法,入组62例患者有尿频（24小时排尿次数≥8次）和尿急（24小时出现≥3次）情况,伴或不伴急迫性尿失禁。随机分为两组,实验组（32例）给予索利那新5mg,每日1次口服,对照组（30例）托特罗定2mg,每日2次口服,为期4周。以患者治疗前后排尿日志相关参数如24时排尿次数、每次排尿量、排尿次数、急迫性尿失禁次数和夜尿次数的变化,以及患者生活质量评估（quality-of-life,QOL）为评估指标,观察其有效性及安全性。结果治疗后可评价病例58例,两组上述排尿参数均有显著提高。托特罗定组每次排尿量平均增加28.34ml,索利那新增加40.47ml。口干是最常见的不良事件,不良反应发生率托特罗定组10.7%和索利那新3.12%。结论索利那新治疗膀胱过度活动症有效安全。

Objective We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder （OAB）. Methods The study was randomised, tolterodine-controlled trial.62 Patients had average frequency of 8 voids per 24 h and episodes of urgency or urgency incontinence 3 during 3-day voiding diary period. Patients were randomised to 4-week double-blind treatment with either tolterodine immediate release （IR） 2 mg twice daily （TOIA） or solifenacin 5 mg （SOLS） once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 4. Quality of life was assessed using QOL of IPSS. Results 58 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in two groups. Mean changes in volume voided were 29.34 ml in TOL4,40.437 ml in SOLSgroup （p〈0.05）. Dry mouth was the most common adverse event; its incidence was 7.63% in SOL5 group compared with 19.49% in TOIA. Conclusions Solifenacin 5 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg.