Dorschner W, Stolzenburg J-U, Griebenow R, Halaska M, Brünjes R, Frank M, Wieners F
Klinik und Poliklinik für Urologie, Universität Leipzig, Leipzig, Germany.
Aktuelle Urol. 2003 Mar;34(2):102-8. doi: 10.1055/s-2003-38906.
The efficacy of propiverine in elderly patients suffering from urge incontinence or urge-stress incontinence was intended to be investigated. Especially in elderly patients a cardiac influence of propiverine is possible due to its dual mode of action. That is why besides the efficacy especially the cardiac safety was intended to be investigated.
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 two-week placebo run-in period, the patients received propiverine (15 mg t. i. d.) or placebo (t. i. d.) for four weeks. Before (U 1, U 2) and during the treatment period (U 3, U 4), standard ECG's and 24 h long-term ECG's were recorded.
Propiverine caused a significant reduction in the micturition frequency (U 2 : 8.7 +/- 4.2, U 4 : 6.5 +/- 3.2 ml; p < 0.01) reflected in a significant increase in the average micturition volume (U 2 : 163.5 +/- 65.9, U 4 : 216.3 +/- 101.5 ml; p < 0.01) and a significant reduction in the episodes of incontinence (- 54 %; p < or = 0.05). These findings were confirmed by the overall assessment after four weeks in which approximately 90 % of patients under propiverine were either free from urge incontinence and urge symptoms or improved. The efficacy parameters demonstrated a better efficacy for urge incontinence than for mixed urge-stress incontinence. Resting and ambulatory electrocardiograms evidenced no significant changes. Neither QTc interval nor other cardiac parameters were relevantly altered. The frequency of cardiac events (Lown classes IV a/b) was fortuitous, 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 in the treatment of elderly patients suffering from urgency, urge incontinence or combined urge-stress incontinence is therefore proven for propiverine. Cardiac arrhythmia were not induced.
旨在研究丙哌维林对患有急迫性尿失禁或急迫性压力性尿失禁老年患者的疗效。尤其是在老年患者中，由于丙哌维林的双重作用模式，其对心脏可能产生影响。这就是为什么除了疗效之外，还特别要研究其心脏安全性。
98例患有尿急、急迫性尿失禁或混合性急迫性压力性尿失禁的患者（21例男性，77例女性；年龄67.7±6.3岁）纳入了这项双盲、多中心、安慰剂对照、随机研究。经过为期两周的安慰剂导入期后，患者接受丙哌维林（15毫克，每日三次）或安慰剂（每日三次）治疗四周。在治疗前（U1、U2）和治疗期间（U3、U4），记录标准心电图和24小时动态心电图。
丙哌维林使排尿频率显著降低（U2：8.7±4.2次，U4：6.5±3.2次；p<0.01），这表现为平均排尿量显著增加（U2：163.5±65.9毫升，U4：216.3±101.5毫升；p<0.01）以及尿失禁发作次数显著减少（-54%；p≤0.05）。四周后的总体评估证实了这些发现，其中接受丙哌维林治疗的患者中约90%无急迫性尿失禁和急迫症状或症状有所改善。疗效参数显示，丙哌维林对急迫性尿失禁比对混合性急迫性压力性尿失禁疗效更好。静息心电图和动态心电图均未显示有显著变化。QTc间期及其他心脏参数均未发生相关改变。心脏事件（Lown分级IV a/b）的发生频率是偶然的，安慰剂组和丙哌维林组之间无差异。不良事件发生率很低（丙哌维林组口干发生率为2%），生活质量问卷的结果也证实了这一点。
因此，已证明丙哌维林在治疗患有尿急、急迫性尿失禁或混合性急迫性压力性尿失禁的老年患者时具有良好的效益风险比。未诱发心律失常。
