Duloxetine compared with placebo for the treatment of women with mixed urinary incontinence
Duloxetine compared with placebo for the treatment of women with mixed urinary incontinence
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DOI：
10.1002/nau.20471
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发表时间：
2008-01-01
影响因子：
2
通讯作者：
Bump, Richard C.
中科院分区：
文献类型：
--
作者：
Bent, Alfred E.;Gousse, Angelo E.;Bump, Richard C.
目的：评价度洛西汀治疗女性混合性尿失禁（MUI）的疗效。材料与方法：女性588例，年龄19-85岁。每周尿失禁4次，随机分配至度洛西汀80 mg/天组（N = 300）或安慰剂组（N = 288）。根据患者对压力/急迫性尿失禁问卷的反应，将患者分为三个症状亚组：压力或急迫性尿失禁（SPMUI或UPMUI）或平衡性尿失禁（BMUI）。一半的人被随机分配进行尿动力学检查；SPMUI、UPMUI和BMUI的诊断基于体征、症状和尿动力学观察。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、ICI生活质量（ICIQ-SF）评分和患者总体改善印象（PGI-I）评分。结果：在基线时，患有SPMUI的女性平均每周15.9 IEF（61%的压力），患有UPMUI的女性平均13.2 IEF（70%的冲动），患有BMUI的女性平均16.5 IEF（52%的冲动）。度洛西汀组的总体IEF降低显著大于安慰剂组（中位百分比降低60% vs 47%， P < 0.001）；度洛西汀显著减少UUI和SUI发作（SUI IEF中位数减少59%对43%，P = 0.001； UUI IEF中位数减少58%对40%，P < 0.001）。对于有SPMUI状况和症状的患者，以及有UPMUI状况但无症状的患者，度洛西汀的IEF降低明显更大。度洛西汀在改善I-QOL总分（11.5分对8.1分，P= 0.002）、所有三个I-QOL亚量表评分、ICIQ-SF评分（-2.6分对-1.7分，P= 0.002）以及gi - i评分（44.2%对27.3%，P=0.001）方面也显示出显著的益处。结论：度洛西汀对MUI女性患者有显著疗效。
Aims: Evaluate duloxetine in the treatment of women with mixed urinary incontinence (MUI). Materials and Methods: 588 women, 19-85 years old. with > 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. Results: 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). Conclusion: Duloxetine demonstrated significant efficacy in this population of women with MUI.