【摘要翻译】曲司氯铵改善膀胱过度活动症状：多中心III期研究

[文题]TROSPIUM CHLORIDE IMPROVES OVERACTIVE BLADDER SYMPTOMS: A MULTICENTER PHASE III TRIAL.
曲司氯铵改善膀胱过度活动症状：多中心III期研究
[来源]Journal of Urology.
[年、卷、期、页]2004. 171(6, Part 1 of 2):2311-2315
[作者]ZINNER, NORMAN; GITTELMAN, MARC; HARRIS, RICHARD; SUSSET, JACQUES; KANELLOS, ANGELO; AUERBACH, STEPHEN; FOR THE TROSPIUM STUDY GROUP
[原文摘要]
Purpose: Trospium chloride is an anticholinergic agent with predominantly peripheral nonselective antimuscarinic activity lacking central nervous system effects. It has no known drug-drug interactions, an advantage for patients taking many medications. Because these qualities may provide added benefit when treating patients with symptoms associated with overactive bladder （OAB） and urge incontinence, we studied the effectiveness of trospium in treating these conditions.
Materials and Methods: Patients with OAB with urge incontinence were randomized 1:1 to 20 mg trospium twice daily or placebo in this 12-week, multicenter, parallel, double-blind, placebo controlled trial. Dual primary end points were change in average number of toilet voids and change in urge incontinent episodes per 24 hours. Secondary efficacy variables were change in average of volume per void, voiding urge severity, urinations during day and night, time to onset of action and change in Incontinence Impact Questionnaire.
Results: A total of 523 patients were entered at 51 sites. Trospium significantly decreased average frequency of toilet voids and urge incontinent episodes compared to placebo. It significantly increased average volume per void, and decreased average urge severity and daytime frequency. All effects occurred by week 1 and all were sustained throughout the study. Nocturnal frequency decreased significantly by week 4 and Incontinence Impact Questionnaire scores improved at week 12. Trospium was well tolerated.
Conclusions: Trospium was found to have sustained effectiveness beginning at the end of week 1 in decreasing the number of voids, urge incontinent episodes, total daily micturitions and urge severity, and in increasing volume per void. It also improved symptoms of OAB and quality of life.
[中文译文]
曲司氯铵（Trospium chloride）是一种抗胆碱能药物，它具有突出的外周非选择性抗毒蕈样活性而无中枢神经作用。目前尚未发现药物间相互作用，有利于服用多种药物的患者。因为这些特性可能使具有膀胱过度活动（OAB）和急迫性尿失禁症状的患者受益，我们研究了曲司氯铵治疗这些症状的有效性。
材料与方法：本研究为多中心、平行、双盲、安慰剂对照试验，有急迫性尿失禁的OAB患者随机按照1：1的比例分组，一组服用20mg曲司氯铵，2次/日，另一组服用安慰剂，共治疗12周。两个主要的终点（end points）*是平均在厕所排尿次数的改变和24小时急迫性尿失禁发生次数的改变。次要有效性参数有平均每次排尿量、尿急的严重性、白天和夜间排尿、发作时间以及尿失禁影响问卷调查结果的改变。
结果：51个单位共523例患者参与研究。曲司氯铵较安慰剂明显降低平均在厕所排尿次数和急迫性尿失禁的发生次数。它明显增加平均每次排尿量，减轻平均尿急严重性和白天的尿频。以上所有的效果均于1周时显现并持续到试验结束。夜间尿频于4周时明显减轻，尿失禁影响问卷评分于12周时明显改善。曲司氯铵具有良好的耐受性。
结论：曲司氯铵于服用后1周开始显现持续的效果，包括减少排尿次数和急迫性尿失禁的发生，减轻白天尿频和尿急的严重性，增加每次排尿量。它能够改善OAB的症状和生活质量。
------------------------------
[个人评论]一个三期临床试验。