临床试验:在患有严重慢性便秘的患者中使用振动囊治疗的影响
Anthony Lembo1, Madison Simons1, Jack Loesch1
1Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Digestive Disease Institute, Cleveland, Ohio, USA.
一个振动囊显著改善了严重的慢性便秘症状和生活质量. 这种疗法为患有慢性便秘的患者提供了有效和安全的选择.
科学领域:
- 胃肠病学 胃肠病学
- 临床药理学 临床药理学
- 患者报告的结果
背景情况:
- 关于严重慢性便秘的有效治疗方法的数据有限.
- 以前的第三期试验表明,振动囊在慢性便秘中比安慰剂更有效.
研究的目的:
- 评估振动囊与安慰剂对严重慢性便秘患者症状和与健康相关的生活质量 (HRQoL) 的影响.
- 具体分析患者在基线报告零完全自发性肠道排便 (CSBMs) 的结果.
主要方法:
- 一个阶段3,多中心,随机,双盲,安慰剂控制的8周试验的后期分析.
- 包括重度慢性便秘患者,在基线期内0个CSBM.
- 评估肠道症状,患者满意度和HRQoL;CSBM响应者定义为比基线增加的每周CSBM.
主要成果:
- 严重慢性便秘小组包括175名患者 (56%).
- 与安慰剂相比,显著更多的振动囊接受者实现了CSBM1,CSBM2和CSBM3响应者状态 (p <0.017).
- 应力,便一致性,患者满意度和HRQoL的改善;10%的人报告轻微的振动.
结论:
- 振动囊在改善严重慢性便秘患者的便秘症状和HRQoL方面表现出显著的有效性.
- 该疗法被证实在慢性便秘的全谱中是安全和有效的.
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