Dmochowski Roger R, Sand Peter K, Zinner Norman R, Staskin David R
Department of Urology, Vanderbilt University School of Medicine, Nashville, Tennessee 37232, USA.
Urology. 2008 Mar;71(3):449-54. doi: 10.1016/j.urology.2007.11.008.
A once-daily (QD) formulation of trospium chloride has been developed for the management of overactive bladder syndrome (OAB). This randomized controlled trial evaluated the efficacy and tolerability of this new extended-release formulation, trospium chloride 60 mg QD.
Adults with OAB with urinary urgency, frequency, and urgency urinary incontinence (UUI) were eligible for inclusion. Subjects received trospium 60 mg QD or placebo for 12 weeks. Change in the mean number of toilet voids per day and UUI episodes per day were the primary outcome variables. Changes in urgency severity were also assessed and adverse events (AEs) were recorded.
Overall, 564 subjects participated in the study (trospium QD 280; placebo 284). Trospium QD demonstrated significant improvement in both primary outcome variables. The mean number of toilet voids per day was reduced from approximately 13 at baseline to 10.3 for trospium QD versus 11.1 for placebo (P <0.001) at week 12, whereas the number of UUI episodes per day was reduced from approximately 4 at baseline to 1.7 at week 12 with trospium QD versus 2.4 for placebo (P <0.001). Trospium QD also reduced urgency severity (P <0.001) and increased voided volume (P <0.01) compared with placebo. Benefits over placebo were apparent within the first week of treatment. Trospium QD was well tolerated; the most frequent AEs being dry mouth (trospium QD 12.9%; placebo 4.6%) and constipation (7.5% versus 1.8%, respectively). Central nervous system side effects were rarely observed and were comparable between groups.
Trospium QD represents a convenient, effective, and well-tolerated treatment option for OAB.
已研发出一种每日一次（QD）服用的氯化托品制剂，用于治疗膀胱过度活动症（OAB）。这项随机对照试验评估了这种新型缓释制剂（每日60毫克氯化托品）的疗效和耐受性。
患有尿急、尿频和急迫性尿失禁（UUI）的OAB成年患者符合纳入标准。受试者接受每日60毫克氯化托品或安慰剂治疗12周。每日平均排尿次数和每日UUI发作次数的变化是主要结局变量。还评估了尿急严重程度的变化并记录不良事件（AE）。
总体而言，564名受试者参与了研究（每日一次氯化托品组280人；安慰剂组284人）。每日一次氯化托品在两个主要结局变量上均显示出显著改善。每日平均排尿次数从基线时的约13次减少到每日一次氯化托品组在第12周时的10.3次，而安慰剂组为11.1次（P<0.001）；每日UUI发作次数从基线时的约4次减少到每日一次氯化托品组在第12周时的1.7次，而安慰剂组为2.4次（P<0.001）。与安慰剂相比，每日一次氯化托品还降低了尿急严重程度（P<0.001）并增加了排尿量（P<0.01）。在治疗的第一周内，与安慰剂相比的益处就很明显。每日一次氯化托品耐受性良好；最常见的不良事件是口干（每日一次氯化托品组12.9%；安慰剂组4.6%）和便秘（分别为7.5%和1.8%）。很少观察到中枢神经系统副作用，且两组之间相当。
每日一次氯化托品是一种方便、有效且耐受性良好的OAB治疗选择。
