Dorschner W, Stolzenburg J U, Griebenow R, Halaska M, Schubert G, Mürtz G, Frank M, Wieners F
Department of Urology, University of Leipzig, Germany.
Eur Urol. 2000 Jun;37(6):702-8. doi: 10.1159/000020221.
The study investigated the efficacy and cardiac safety of propiverine in the elderly, because the induction of life-threatening ventricular arrhythmia has been reported for some drugs prescribed in the therapy of urinary incontinence. Ninety-eight patients (21 male, 77 female; 67.7+/-6.3 years of age) suffering from urgency, urge incontinence or mixed urge-stress incontinence were included in the double-blind, multicentre, placebo-controlled, randomized study. After a 2-week placebo run-in period, the patients received propiverine (15 mg t.i.d.) or placebo (t.i.d.) for 4 weeks. Before (V1, V2) and during the treatment period (V3, V4), standard ECGs and 24-hour long-term ECGs were recorded. Propiverine caused a significant reduction of the micturition frequency (V2: 8.7+/-4.2, V4: 6.5+/-3.2 ml; p< or =0.01), reflected in a significant increase in the average micturition volume (V2: 163.5+/-65.9, V4: 216.3+/-101.5 ml; p< or =0.01) and a significant decrease in episodes of incontinence (-54%; p = 0.048). These findings were confirmed by the overall assessment at V4, in which approximately 90% of patients under propiverine either had no urge incontinence or urge symptoms, or showed improvement. Resting and ambulatory electrocardiograms indicated no significant changes. Neither the frequency-corrected Q-T interval nor other cardiac parameters were relevantly altered. The frequency of cardiac events (Lown classes IVa/b) was random, revealing no difference between placebo and propiverine. The incidence of adverse events was very low (2% dryness of the mouth under propiverine) and confirmed by the findings from the quality of life questionnaires. A favourable benefit-risk ratio without the induction of any cardiac arrhythmia in the treatment of elderly patients suffering from urgency, urge incontinence or combined urge-stress incontinence is therefore proven for propiverine.
本研究调查了丙哌维林在老年人中的疗效及心脏安全性，因为在尿失禁治疗中所开具的某些药物曾有导致危及生命的室性心律失常的报道。98例患者（21例男性，77例女性；年龄67.7±6.3岁），患有尿急、急迫性尿失禁或混合性急迫性压力性尿失禁，被纳入这项双盲、多中心、安慰剂对照的随机研究。经过为期2周的安慰剂导入期后，患者接受丙哌维林（15mg，每日3次）或安慰剂（每日3次）治疗4周。在治疗前（V1、V2）及治疗期间（V3、V4），记录标准心电图及24小时动态心电图。丙哌维林使排尿频率显著降低（V2：8.7±4.2，V4：6.5±3.2次；p≤0.01），这表现为平均排尿量显著增加（V2：163.5±65.9，V4：216.3±101.5ml；p≤0.01）以及尿失禁发作次数显著减少（-54%；p = 0.048）。这些发现通过V4时的总体评估得到证实，在接受丙哌维林治疗的患者中，约90%的患者无急迫性尿失禁或急迫症状，或症状有所改善。静息及动态心电图显示无显著变化。频率校正后的Q-T间期及其他心脏参数均未发生相关改变。心脏事件（Lown分级IVa/b）的发生频率是随机的，安慰剂组与丙哌维林组之间无差异。不良事件发生率非常低（丙哌维林组2%出现口干），生活质量问卷的结果也证实了这一点。因此，对于患有尿急、急迫性尿失禁或混合性急迫性压力性尿失禁的老年患者，丙哌维林在治疗中具有良好的效益风险比，且不会诱发任何心律失常。
