酒石酸托特罗定缓释片治疗膀胱过度活动症的多中心双盲双模拟随机对照临床研究

目的 评价国产酒石酸托特罗定缓释片（抗膀胱过度活动症药）治疗膀胱过度活动症的有效性和安全性.方法 用随机双盲双模拟多中心临床试验设计,232例（试验组和对照组均为116例）托特罗定缓释片每日1次,每次4 mg;对照组口服托特罗定片每日2次,每次2 mg.均服药6周.结果 试验组（n=111）和对照组（n=112）24 h平均排尿次数减少、平均尿失禁次数均减少;平均每次尿量均增加,2组比较无统计学意义（P＞0.05）.试验组和对照组总药物不良反应发生率分别为39.3%和41.2%,主要表现为口干,发生率分别为35.7%,30.7%,经比较无统计学意义（P＞0.05）.结论 酒石酸托特罗定缓释片治疗膀胱过度活动症的疗效及安全性与其普通片相当.

Double-blind double-dummy randomized controlled multicenter clinical trial of tolterodine extended release tablet in the treatment of overactive bladder

Objective To evaluate the efficacy and safety of extended release (ER) tolterodine in patients with an overactive bladder. Me-thods A double-blind double-dummy randomized controlled multicenter clinical trial was designed. Two hundred thirty two patients with bladder overactivity were enrolled, patients received either ER tolterodine (trial group,4 mg once daily) or immediate release (IR) tolterodine (control group,2 mg twice daily).Results After 6 weeks treatment, the mean decrease of frequency of micturition, the mean decrease of incontinence episodes and the volume increase of every micturition were statistically equivalent in those receiving ER tolterodine (n=111) and IR tolterodine (n=112). The total incidence of adverse reaction was 39.3 % in the ER group and 41.2% in the IR group.Treatment-related adverse reaction consisted of xerocheillia,occurred in 35.7% of patients in the trial group, 30.7% in the control group.(P>0.05).Drymouth was the most important adverse reaction. The incidence was 35.7% in the ER group and 30.7% in the IR group. Conclusion ER tolterodine 20 mg once daily had the equivalent efficacy and safety on patients with overactive bladder compared to IR tolterodine 2 mg twice daily.