托特罗定缓释片治疗膀胱过度活动症的临床研究

目的评价酒石酸托特罗定缓释片治疗膀胱过度活动症的有效性与安全性。方法采用随机、双盲、双模拟平行对照的方法对膀胱过度活动症220例进行托特罗定缓释片剂型组（观察组,110例）和托特罗定原剂型组（对照组,110例）对比研究。托特罗定缓释片,每片4 mg,每日1次,口服;托特罗定片,每片2 mg,每日2次,口服。各连服6周。结果治疗后观察组24 h平均排尿次数由（12.21±3.10）次降至（8.50±2.31）次,24 h平均每次排尿量由（119.80±30.54）ml增至（215.50±68.52）ml、24 h平均尿失禁次数由（2.88±2.5）次减至（0.07±0.38）次。治疗前后比较,有极显著差异（P〈0.01）。两组治疗后相比较,无显著性差异。观察组对药物不良反应发生率为38.0%,中毒发生率为18.5%;对照组分别为40.8%和20.0%,总发生率两者无显著性差异（P〉0.05）。结论托特罗定缓释片与托特罗定片,其疗效与不良反应基本相同。但托特罗定缓释片,用药次数少,服用方便,为膀胱过度活动症治疗药物的最佳选择。

Clinical study on treatment of overactive bladder with sustained release tablet tolterodine

Objective To evaluate the efficacy and safety of sustained release tablet tolterodine tartrate in treatment of overactive bladder.Methods 220 cases of patients with overactive bladder were divided into A group that treated with tolterodine sustained release tablet and B group that treated with tolterodine with a double-blind,double dummy parallel control method.Tolterodine sustained release tablets was administered in each tablet 4 mg and once daily by oral.Tolterodine tablets was administered in each tablet 2 mg and 2 times per day orally.The treatment was carried out for 6 weeks.Results In A group after treatment,the average voiding frequency decreased from the（12.21 ± 3.10） to（8.50 ± 2.31） times in 24 h.The average 24 h urine volume time increased from（119.80 ± 30.54） to（215.50 ± 68.52） ml.24 h average number of incontinence episodes reduced from（2.88 ± 2.5） to（0.07 ± 0.38）.Before and after treatment,there was significant difference（P0.01）.There was no significant difference between A and B group after treatment.The drug adverse reaction rate in A group was 38.0% and moderate rate was 18.0%.In B group,drug adverse reaction rate and moderate rate were 41.1% and 20.0%.There was no significant difference between the two groups in total incidence.Conclusion Tolterodine sustaind release tablets and Tolterodine tablets have similar efficacy and side effects.The tolterodine sustaind release tablet is easy to take and is a best choice for overactive bladder.