将老年患者排除在帕金森病随机临床试验中
Danuta Kłosowska1, Urszula Fiszer2, Jarosław Dulski3,4,5
1Department of Clinical Immunology, Medical University of Warsaw, Nowogrodzka 59, 02-006, Warsaw, Poland.
GeroScience
|February 23, 2024
概括
大多数帕金森病临床试验都不包括老年人,限制了结果的概括性. 资格标准需要修改,以包括这个不断增长的患者群体.
科学领域:
- 神经学 神经学
- 临床试验方法论 临床试验方法论
背景情况:
- 帕金森病 (PD) 的患病率随着年龄的增长而显著增加.
- 老年人代表了PD患者群体中快速增长的人口.
研究的目的:
- 评估帕金森病随机临床试验 (RCT) 的资格标准.
- 具体评估限制老年参与者的入学标准.
主要方法:
- 在clinicaltrials.gov (2013-2022) 上注册的420个药理学和非药理学PDRCT的分析.
- 检查的上限年龄 (≤85岁) 和其他排除标准.
- 后勤回归用于确定试验特征和年龄限制之间的关联.
主要成果:
- 57%的RCT的上限年龄为85岁或以下,随着时间的推移而增加.
- 85%的试验有其他标准 (例如,认知障碍) 限制了老年人的入学.
- 总体而言,92%的RCT间接或明确地排除了老年人.
结论:
- 目前的PD临床试验资格标准显著低于老年人.
- 这限制了试验结果对更广泛的PD人群的概括性.
- 修改标准对于评估老年PD患者的治疗益处和危害至关重要.
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