Bent Alfred E, Gousse Angelo E, Hendrix Susan L, Klutke Carl G, Monga Ash K, Yuen Chui K, Muram David, Yalcin Ilker, Bump Richard C
Greater Baltimore Medical Center, Baltimore, Maryland, USA.
Neurourol Urodyn. 2008;27(3):212-21. doi: 10.1002/nau.20471.
Evaluate duloxetine in the treatment of women with mixed urinary incontinence (MUI).
588 women, 19-85 years old with >or=4 incontinence episodes/week were randomly assigned to duloxetine 80 mg/day (N = 300) or placebo (N = 288). Patients were classified into three symptom subgroups: stress or urge predominant MUI (SPMUI or UPMUI) or balanced MUI (BMUI) based on their responses to the validated Stress/Urge Incontinence Questionnaire. Half the population was randomly assigned to have urodynamics; SPMUI, UPMUI, and BMUI condition diagnoses were based on signs, symptoms, and urodynamic observations. The primary outcome measure was the change in incontinence episode frequency (IEF). Secondary outcome measures included the Incontinence Quality of Life (I-QOL) scores, the ICI Quality of Life (ICIQ-SF) score, and the Patient Global Impression of Improvement (PGI-I) rating.
At baseline, women with SPMUI averaged 15.9 IEF/week (61% stress), those with UPMUI averaged 13.2 (70% urge), and those with BMUI averaged 16.5 (52% urge). Overall IEF decreases were significantly greater with duloxetine than placebo (median percent reduction 60% vs. 47%, P < 0.001); both UUI and SUI episodes were significantly decreased with duloxetine (median SUI IEF reduction 59% vs. 43%, P = 0.001; UUI IEF reduction 58% vs. 40%, P < 0.001). Duloxetine IEF decreases were significantly greater for patients with SPMUI conditions and symptoms and for those with UPMUI conditions but not symptoms. Significant benefits were also demonstrated with duloxetine for improvements in I-QOL total score (11.5 points vs. 8.1 points, P = 0.002), all three I-QOL subscale scores, and for the ICIQ-SF score (-2.6 vs. -1.7, P = 0.002) as well as for PGI-I ratings (much/very much better 44.2% vs. 27.3%, P = 0.001).
Duloxetine demonstrated significant efficacy in this population of women with MUI.
评估度洛西汀治疗混合性尿失禁（MUI）女性患者的效果。
588名年龄在19至85岁之间、每周尿失禁发作次数≥4次的女性被随机分为两组，一组接受每日80毫克度洛西汀治疗（N = 300），另一组接受安慰剂治疗（N = 288）。根据患者对经验证的压力性/急迫性尿失禁问卷的回答，将患者分为三个症状亚组：以压力性为主的MUI（SPMUI）或急迫性为主的MUI（UPMUI）或平衡性MUI（BMUI）。一半的患者被随机分配接受尿动力学检查；SPMUI、UPMUI和BMUI的诊断基于体征、症状和尿动力学观察结果。主要结局指标是尿失禁发作频率（IEF）的变化。次要结局指标包括尿失禁生活质量（I-QOL）评分、国际尿失禁咨询委员会生活质量问卷简表（ICIQ-SF）评分以及患者总体改善印象（PGI-I）评级。
在基线时，SPMUI女性患者的IEF平均为每周15.9次（压力性占61%），UPMUI女性患者平均为13.2次（急迫性占70%），BMUI女性患者平均为16.5次（急迫性占52%）。度洛西汀治疗组的总体IEF下降幅度显著大于安慰剂组（中位数降低百分比为60%对47%，P < 0.001）；度洛西汀治疗使急迫性尿失禁（UUI）和压力性尿失禁（SUI）发作次数均显著减少（SUI的IEF中位数降低59%对43%，P = 0.001；UUI的IEF降低58%对40%，P < 0.001）。对于有SPMUI症状的患者以及有UPMUI症状但无该症状表现的患者，度洛西汀使IEF下降的幅度显著更大。度洛西汀在改善I-QOL总分（11.5分对8.1分，P = 0.002）、I-QOL所有三个子量表评分、ICIQ-SF评分（-2.6对-1.7，P = 0.002）以及PGI-I评级（改善很多/非常多的比例为44.2%对27.3%，P = 0.001）方面也显示出显著益处。
度洛西汀在这组MUI女性患者中显示出显著疗效。
