Duloxetine versus placebo for the treatment of North American women with stress urinary incontinence
Duloxetine versus placebo for the treatment of North American women with stress urinary incontinence
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DOI：
10.1097/01.ju.0000080708.87092.cc
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发表时间：
2003-10-01
影响因子：
6.6
通讯作者：
Bump, RC
中科院分区：
文献类型：
--
作者：
Dmochowski, RR;Miklos, JR;Bump, RC
目的：度洛沙汀是一种选择性5-羟色胺和去甲肾上腺素再摄取抑制剂，通过刺激阴部运动神经元α-1肾上腺素能和5-羟色胺-2受体增加横纹括约肌收缩力。在第一个3期研究中，我们评估了度洛沙汀在压力性尿失禁（SUI）妇女中的疗效和安全性。材料和方法：共有683名22至84岁的北美妇女参加了这项双盲、安慰剂对照研究。病例定义包括SUI的主要症状，每周尿失禁发作频率（IEF）≥ 7次，无急迫性尿失禁的主要症状，昼夜频率正常，膀胱容量≥ 400 ml，咳嗽压力试验和压力垫试验阳性。在2周安慰剂导入期后，受试者被随机分配接受安慰剂（339例）或80 mg度洛沙汀每日一次（344例），40 mg每日两次，持续12周。主要结果变量包括IEF和失禁生活质量问卷。使用货车Elteren检验分析IEF的百分比变化，分层变量为每周基线IEF（小于14和14或更大）。ANCOVA被用来分析失禁生活质量scores.Results：平均基线IEF为18周，436例（64%）的基线IEF为14或更高。与安慰剂相比，度洛沙汀组IEF显著降低（50% vs 27%，p
Purpose: Duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, increases rhabdosphincter contractility via the stimulation of pudendal motor neuron alpha-1 adrenergic and 5-hydroxytryptamine-2 receptors. In this first phase 3 study we assessed the efficacy and safety of duloxetine in women with stress urinary incontinence (SUI).Materials and Methods: A total of 683 North American women 22 to 84 years old were enrolled in this double-blind, placebo controlled study. The case definition included a predominant symptom of SUI with a weekly incontinence episode frequency (IEF) of 7 or greater, the absence of predominant symptoms of urge incontinence, normal diurnal and nocturnal frequency, a bladder capacity of 400 ml or greater, and a positive cough stress test and stress pad test. After a 2-week placebo lead-in period subjects were randomly assigned to receive placebo (339) or 80 mg duloxetine daily (344) as 40 mg twice daily for 12 weeks. Primary outcome variables included IEF and an incontinence quality of life questionnaire. Van Elteren's test was used to analyze percent changes in IEF with a stratification variable of weekly baseline IEF (less than 14 and 14 or greater). ANCOVA was used to analyze incontinence quality of life scores.RESULTS: Mean baseline IEF was 18 weekly and 436 subjects (64%) had a baseline IEF of 14 or greater. There was a significant decrease in IEF with duloxetine compared with placebo (50% vs 27%, p