Schagen van Leeuwen Jules H, Lange Rainer R, Jonasson Aino Fianu, Chen Wei J, Viktrup Lars
Secretariaat Gynaecologie F1, Antonius Hospital, Koekoekslaan 1, Nieuwegein, The Netherlands.
Maturitas. 2008 Jun 20;60(2):138-47. doi: 10.1016/j.maturitas.2008.04.012. Epub 2008 Jun 10.
To evaluate the efficacy and safety of duloxetine in community-dwelling women > or =65 years with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (S-MUI) versus placebo.
Patients were randomly assigned for 12 weeks to placebo (N=134) or duloxetine (N=131) (20mg twice daily [BID] for 2 weeks and 40 mg BID for an additional 10 weeks), followed by a double-blind 4-week dose de-escalation/discontinuation phase. The primary efficacy variable was the percent change in incontinence episode frequency (IEF) from baseline to endpoint. Other variables included absolute IEF change, responder rate, changes in mean time between voids (MTBV), weekly continence pad usage, the impact of treatment on quality of life, patient's global impression of improvement (PGI-I), and changes in depression and cognition.
Duloxetine-treated patients had a significantly greater decrease from baseline to endpoint in mean IEF/week than placebo-treated patients (-52.47% vs. -36.70%, P<0.001). The IEF responder rate (> or =50% reduction in IEF/week) was 57.1% in the duloxetine group and 35.2% in the placebo group (P<0.001). Significant benefits of duloxetine were also demonstrated for weekly continence pad usage (P=0.011), MTBV (P<0.001), incontinence quality of life questionnaire (I-QOL) scores (P<0.001), and PGI-I ratings (P<0.001). Patients with depressive symptoms and cognitive impairments were few and changes were insignificant. The proportion of patients with > or =1 treatment-emergent adverse event (TEAE) was similar with both treatments, but dry mouth, fatigue, constipation, and hyperhidrosis were significantly more common in women taking duloxetine.
Duloxetine is a safe and effective treatment for elderly women with symptoms of SUI or S-MUI.
评估度洛西汀治疗65岁及以上社区居住的压力性尿失禁（SUI）或以压力性为主的混合性尿失禁（S-MUI）女性患者相对于安慰剂的疗效和安全性。
患者被随机分配接受为期12周的安慰剂治疗（N = 134）或度洛西汀治疗（N = 131）（20mg每日两次[BID]，持续2周，随后40mg BID，持续10周），然后是为期4周的双盲剂量递减/停药阶段。主要疗效变量是从基线到终点失禁发作频率（IEF）的变化百分比。其他变量包括IEF绝对变化、有效率、平均排尿间隔时间（MTBV）变化、每周尿垫使用情况、治疗对生活质量的影响、患者总体改善印象（PGI-I）以及抑郁和认知变化。
从基线到终点，度洛西汀治疗的患者平均每周IEF的下降幅度显著大于安慰剂治疗的患者（-52.47%对-36.70%，P<0.001）。度洛西汀组的IEF有效率（IEF/周降低≥50%）为57.1%，安慰剂组为35.2%（P<0.001）。度洛西汀在每周尿垫使用（P = 0.011）、MTBV（P<0.001）、尿失禁生活质量问卷（I-QOL）评分（P<0.001）和PGI-I评分（P<0.001）方面也显示出显著益处。有抑郁症状和认知障碍的患者较少，且变化不显著。两种治疗中出现≥1次治疗中出现的不良事件（TEAE）的患者比例相似，但口干、疲劳、便秘和多汗在服用度洛西汀的女性中更为常见。
度洛西汀是治疗有SUI或S-MUI症状老年女性的一种安全有效的疗法。
