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托特罗定缓释剂在膀胱过度活动症男性和女性患者中的疗效与耐受性

Efficacy and tolerability of tolterodine extended release in male and female patients with overactive bladder.

作者信息

Dmochowski Roger, Abrams Paul, Marschall-Kehrel Daniela, Wang Joseph T, Guan Zhonghong

机构信息

Vanderbilt University Medical Center, Nashville, TN, USA.

出版信息

Eur Urol. 2007 Apr;51(4):1054-64; discussion 1064. doi: 10.1016/j.eururo.2006.10.005. Epub 2006 Oct 20.

DOI:10.1016/j.eururo.2006.10.005
PMID:17097217
Abstract

OBJECTIVES

To evaluate the efficacy and tolerability of tolterodine extended release (ER) in men and women with overactive bladder (OAB).

METHODS

We analyzed data from two 12-wk, placebo-controlled trials of tolterodine ER (4mg QD). Patients completed 7-d bladder diaries and rated the urgency sensation associated with each micturition on a 5-point urgency rating scale. Micturitions were categorized by urgency rating: total (1-5), non-OAB (1-2), OAB (3-5), or severe OAB (4-5). Changes in micturitions during 24-h, daytime, and nocturnal intervals were assessed.

RESULTS

At baseline, 73% (547 of 745) of men and 57% (539 of 953) of women were continent. By week 12, tolterodine ER (n=848) reduced OAB and severe OAB micturitions during 24-h, daytime, and nocturnal intervals in both sexes compared with placebo (n=850). Adverse event rates were low and similar across treatment and gender.

CONCLUSIONS

In men and women with OAB, tolterodine ER reduced OAB and severe OAB micturitions, and was well tolerated.

摘要

目的

评估托特罗定缓释制剂(ER)治疗膀胱过度活动症(OAB)男性和女性患者的疗效和耐受性。

方法

我们分析了两项为期12周、以安慰剂为对照的托特罗定ER(4mg每日一次)试验数据。患者完成7天膀胱日记,并采用5分制尿急评分量表对每次排尿时的尿急感进行评分。排尿根据尿急评分进行分类:总计(1-5)、非OAB(1-2)、OAB(3-5)或严重OAB(4-5)。评估24小时、白天和夜间排尿次数的变化。

结果

基线时,73%(745例中的547例)的男性和57%(953例中的539例)的女性无尿失禁。到第12周时,与安慰剂组(n=850)相比,托特罗定ER组(n=848)在24小时、白天和夜间时段均减少了男女患者的OAB和严重OAB排尿次数。不良事件发生率较低,且在治疗组和不同性别之间相似。

结论

在患有OAB的男性和女性中,托特罗定ER减少了OAB和严重OAB排尿次数,且耐受性良好。

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