OBJECTIVES:To assess the efficacy and safety of trospium chloride (TCl, 20 mg twice daily) in the treatment of detrusor instability, compared with placebo. PATIENTS AND METHODS:In all, 208 patients were allocated at random to either TCl or placebo in a double-blind clinical study; the patients were treated for 3 weeks. Urodynamic values were measured at the beginning and end of the treatment period. Adverse events were recorded on patient diary cards. A confirmatory adaptive procedure with one planned interim analysis was used to evaluate efficacy. RESULTS:Trospium chloride produced significant improvements in maximum cystometric bladder capacity (median treatment effect 22.0 mL, mean 37.3 mL, one-sided P = 0. 0054) and urinary volume at first unstable contraction (median treatment effect 45.0 mL, mean 63.6 mL, one-sided P = 0.0015). The patients' assessment of efficacy showed significantly greater clinical improvement in the TCl group than in the placebo group (two-sided P = 0.0047). Furthermore, TCl was well tolerated, with similar frequencies of adverse events reported in both groups (68% in the TCl and 62% in the placebo group). CONCLUSION:Trospium chloride (20 mg twice daily) is an effective and safe option for the treatment of detrusor instability.

译文

目的:与安慰剂相比,评估氯化钾(TC1,每天两次,每次20 mg)在治疗逼尿肌不稳中的疗效和安全性。
病人和方法:在一项双盲临床研究中,共有208名患者被随机分配为TCl或安慰剂。患者接受了3周的治疗。在治疗期的开始和结束时测量尿动力学值。不良事件记录在患者的日记卡上。验证性的适应性程序和一个计划中的中期分析用于评估疗效。
结果:氯化ros的最大膀胱容量(中位治疗效果为22.0 mL,平均37.3 mL,单侧P = 0. 0054)和首次不稳定收缩时的尿量(中位治疗效果为45.0 mL,平均为63.6 mL)产生了显着改善。一侧P = 0.0015)。患者对疗效的评估显示,TC1组的临床改善明显高于安慰剂组(双面P = 0.0047)。此外,TC1的耐受性良好,两组中不良事件的发生频率相似(TCI中为68%,安慰剂组为62%)。
结论:氯化ros(20 mg,每天两次)是治疗逼尿肌不稳定的有效且安全的选择。

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