间歇性囊炎中的表型变异 临床试验招聘
Ryan Wong1, Emmaline Woodworth1, Charles Wood2
1Dr Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Davie, FL.
Urogynecology (Philadelphia, Pa.)
|September 30, 2025
概括
很少有间歇性囊炎/膀疼痛综合征 (IC/BPS) 临床试验使用患者表型,阻碍了向治疗的发展. 纳入表型对于推进有效的IC/BPS治疗至关重要.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 临床试验 临床试验
- 患者的表型定型
背景情况:
- 间歇性囊炎/膀疼痛综合征 (IC/BPS) 需要特定于表型的疗法才能有效治疗.
- 目前的临床试验设计往往缺乏患者的表型分层,导致普遍的治疗方法.
- 美国泌尿器官学会 (AUA) 的指导方针建议对IC/BPS进行表型识别.
研究的目的:
- 描述IC/BPS临床试验,将患者表型纳入资格标准.
- 评估IC/BPS试验设计与AUA关于表型识别的指导方针的一致性.
- 根据资金,干预类型和指南更新,评估表型纳入的趋势.
主要方法:
- 从ClinicalTrials.gov.gov网站注册的IC/BPS临床试验的系统审查.
- 纳入标准:IC/BPS诊断和与疼痛相关的结果.
- 与2015年AUA指南相比,表型识别,干预类型,资助和注册日期的评估.
主要成果:
- 在170项试验中,只有21.8%的试验按表型分层,主要集中在以膀为中心的表现上.
- 工业资助的试验 (40.5%) 比非工业资助的试验 (16.5%) 更有可能包括表型分层.
- 2015年后的AUA指南中,表型的含量增加了 (26.6%与15.8%相比),在物理治疗,心理社会和药物研究中更为常见.
结论:
- 临床试验中IC/BPS表型的有限结合阻碍了对现实世界治疗疗效的评估.
- 在调整试验设计与患者症状变异性方面存在方法上的差距.
- 将表型方法集成到试验设计中,对于开发有针对性和有效的IC/BPS疗法至关重要.
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