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结果的可取性排名终点的开发框架用于侵入性真菌病的临床试验
Jose Portugal Gonzales1, Neil M Ampel2, David R Boulware3
1Division of Infectious Diseases, Department of Internal Medicine, University of Texas Health Science Center, Houston, Texas, USA.
Open forum infectious diseases
|February 2, 2026
概括
新的临床试验终点,DOOR尺度,被开发用于侵袭性真菌感染,如角膜病和阿斯伯吉洛症. 这些标准旨在更好地捕捉临床试验中的患者体验和治疗结果.
科学领域:
- 医学真菌学 医学真菌学
- 临床试验设计 临床试验设计
- 传染性疾病 传染性疾病
背景情况:
- 目前的响应标准由菌病研究小组教育和研究联盟 (MSGERC) 和欧洲医学真菌学联合会 (ECMM) 不充分评估临床试验的完整的患者体验.
- 需要改进的方法来评估真菌感染研究的结果.
研究的目的:
- 为评估侵入性真菌感染的临床试验制定新的,基于共识的终点.
- 创建一个全面的评估工具,反映患者的总体经验.
主要方法:
- 一个经过修改的Delphi过程,涉及通过在线平台向MSGERC和ECMM成员分发的调查.
- 专家意见指导了最初的调查,随后的调查回合建立在之前的回复基础上.
- 共识是指指导委员会成员对于每个调查组件达成的>70%的共识.
主要成果:
- 开发了DOOR尺度 (治疗失败,并发症和不良事件的复合物) 用于侵袭性 кандидоз,阿斯伯吉洛症,密码球菌病和粘菌菌病.
- 针对每个真菌感染,建立了特定的终点和时间框架:候群病 (2周),阿斯伯吉洛症 (6周),密码菌病 (4周) 和粘菌菌病 (6周和12周).
结论:
- 对于关键的侵入性真菌感染,已成功开发出共识终点.
- 这些新的终点旨在在未来的临床试验中使用,以提供对治疗疗效和患者结果的更全面的评估.
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