一个随机临床试验:女性耐火性急性尿失禁的onabotulinumtoxinA与神经调节
Cindy L Amundsen1, Holly E Richter2, Shawn A Menefee3
1Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina.
JAMA
|October 5, 2016
概括
与神经神经调节相比,onabotulinumtoxinA对女性的每日急性失禁发作有轻微的减少. 然而,它增加了尿路感染的风险和需要自导管.
科学领域:
- 尿道病学
- 女性的骨盆医学和重建性手术
背景情况:
- 强迫性尿失禁 (UUI) 严重影响女性的生活质量.
- 目前的治疗方法包括神经神经调节 (SNM) 和内毒素A (BTX-A),但对比数据有限.
研究的目的:
- 为了比较onabotulinumtoxinA与神经神经调节的疗效和安全性,用于治疗女性难治性尿失禁.
主要方法:
- 一个多中心的,开放的,随机的试验,涉及381名耐火性UUI的妇女.
- 参与者接受了内毒素A注射 (n=192) 或神经神经调节 (n=189).
- 通过每日日记和验证的问卷,在6个月内评估结果.
主要成果:
- 与SNM相比,onabotulinumtoxinA的每日UUI发作数量在统计学上显著减少 (- 3. 9 vs - 3.3发作/ 天).
- 在过度活性膀问卷 (SF) 中,对症状困扰,治疗满意度和支持度的改善较大.
- 然而,胺毒素A与尿路感染的发病率 (35% vs 11%) 和过渡性自导管需求的增加有关.
结论:
- 与SNM相比,onabotulinumtoxinA在UUI发作中提供了具有统计意义的,但可能不是临床意义的改善.
- 在治疗决策中,必须考虑尿路感染的增加风险和需要自导管治疗的需要.
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