雷洛昔芬对尿失禁的影响：一项随机对照试验。

Effect of raloxifene on urinary incontinence: a randomized controlled trial.

作者信息

Waetjen L Elaine, Brown Jeanette S, Modelska Katharina, Blackwell Terri, Vittinghoff Eric, Cummings Steven R

机构信息

Department of Obstetrics and Gynecology, University of California-Davis, 4860 Y Street, Suite 2500, Sacramento, CA 95817, USA.

出版信息

Obstet Gynecol. 2004 Feb;103(2):261-6. doi: 10.1097/01.AOG.0000109429.67671.d1.

DOI:10.1097/01.AOG.0000109429.67671.d1

PMID:14754693

Abstract

OBJECTIVE

To estimate the effect of 3 years of treatment with raloxifene on urinary incontinence in postmenopausal women.

METHODS

We used measures of urinary incontinence severity, frequency, and type in the Multiple Outcomes of Raloxifene trial, a multicenter randomized, controlled trial of women who were at least 2 years postmenopausal with osteoporosis. At 10 U.S. sites of this trial, 963 women randomly assigned to raloxifene or placebo completed questionnaires about incontinence at baseline and 3 years later. We analyzed the odds of worsening severity and frequency of incontinence and type of incontinence after 3 years of treatment with raloxifene.

RESULTS

The mean age of our subjects was 68.3 +/- 7 years. After 3 years of treatment, there was no significant difference between raloxifene and placebo groups in urinary incontinence severity (multivariable odds ratio [OR] 1.02; 95% [CI] 0.78, 1.34). The majority of the women (60%) had no change in urinary incontinence episodes from baseline to year 3. The odds of worsening urinary incontinence severity after 3 years of raloxifene treatment were 1.05 (95% CI 0.75, 1.48). Similarly, the odds of developing new onset incontinence were 0.95 (95% CI 0.59, 1.52). Finally, raloxifene did not effect the odds of having stress (OR 1.01; 95% CI 0.71, 1.43) or urge (OR 1.20; 95% CI 0.86, 1.68) incontinence after 3 years of use.

CONCLUSION

In postmenopausal women with osteoporosis, 3 years of treatment with raloxifene had no effect on urinary incontinence.

LEVEL OF EVIDENCE

摘要

目的

评估雷洛昔芬治疗3年对绝经后女性尿失禁的影响。

方法

我们在雷洛昔芬多结局试验中采用了尿失禁严重程度、频率和类型的测量方法，该试验是一项针对绝经后至少2年且患有骨质疏松症女性的多中心随机对照试验。在该试验的美国10个地点，963名随机分配接受雷洛昔芬或安慰剂治疗的女性在基线时和3年后完成了关于尿失禁的问卷调查。我们分析了雷洛昔芬治疗3年后尿失禁严重程度、频率恶化以及尿失禁类型的几率。

结果

我们研究对象的平均年龄为68.3±7岁。治疗3年后，雷洛昔芬组和安慰剂组在尿失禁严重程度方面无显著差异（多变量优势比[OR]为1.02；95%[CI]为0.78，1.34）。大多数女性（60%）从基线到第3年尿失禁发作次数无变化。雷洛昔芬治疗3年后尿失禁严重程度恶化的几率为1.05（95%CI为0.75，1.48）。同样，出现新发尿失禁的几率为0.95（95%CI为0.59，1.52）。最后，使用雷洛昔芬3年后，其对压力性尿失禁（OR为1.01；95%CI为0.71，1.43）或急迫性尿失禁（OR为1.20；95%CI为0.86，1.68）的几率没有影响。