另一种类型的土毒素的有效性和安全性 一种用于耐火性过活性膀的注射模式
Scott MacDiarmid1, David B Glazier2, Rebecca J McCrery3,4
1Alliance Urology Specialists, Greensboro, North Carolina, USA.
Neurourology and urodynamics
|September 25, 2023
概括
一种新型的10注纳毒素A治疗过活性膀 (OAB) 有效地减少了尿失禁 (UI) 并改善了生活质量. 这种方法显示,使用干净间歇性导管 (CIC) 的发生率很低,为OAB管理提供了一个有希望的替代方案.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 过度活动的膀 (OAB) 与尿失禁 (UI) 影响了许多患者.
- 目前的毒素A治疗 (20注射模式) 有时需要干净的间歇性导管 (CIC).
- 向下膀注射可以保持上膀功能,并减少CIC的需要.
研究的目的:
- 评估替代性10注注射的药物的疗效和安全性 对于具有UI的OAB,A范式的abotulinumtoxin.
- 评估这种以下膀为重点的方法是否与标准治疗相比,减少了对CIC的需求.
主要方法:
- 第四阶段,双盲,并行组研究.
- 120名患有OAB和UI的患者被随机分组为2:1接受onabotulinumtoxinA (100U,10个位) 或安慰剂.
- 通过UI发作,排尿,夜尿,紧迫性和生活质量12周的得分的变化来评估有效性.
主要成果:
- 与安慰剂相比,onabotulinumtoxinA显著减少了每日UI发作 (-2.9比 -0.3),排尿 (-2.24比 -0.1),夜尿 (-0.71比 0.0) 和紧急情况 (-2.56比 -0.1).与安慰剂相比,它显著减少了每日UI发作 (-2.9比 -0.3),排尿 (-2.24比 -0.1),夜尿 (-0.71比 0.0),以及紧急情况 (-2.56比 -0.1).
- 在UI发作中获得50-100%的改善率更高,使用的是纳博毒素A.
- 在本质毒素A组 (LSMD: 24.2, p=0.0012) 中观察到生活质量得分的改善 (失禁生活质量).
- 只有2.6%的接受纳博毒素A治疗的患者需要CIC;没有女性使用CIC.
结论:
- 针对下膀的10注纳博毒素A模式对UI的OAB有效.
- 这种替代方法显示出显著的疗效和CIC的低发病率.
- 进一步的研究支持这种范式作为OAB的可行的治疗选择.
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