从类风湿性关节炎的随机对照试验中排除老年人
Anna Mańko1, Anna Raczkiewicz2, Andrzej Górski3
1Reuma Park Medical Center, Warsaw, Poland.
Rheumatology (Oxford, England)
|May 27, 2023
概括
近一半的类风湿性关节炎随机对照试验通过年龄限制或其他标准排除了老年人. 这限制了老龄化人口的治疗证据,需要更具包容性的试验设计.
科学领域:
- 类风湿病学 类风湿病学
- 临床试验 临床试验
- 老年医学 老年医学
背景情况:
- 风湿性关节炎 (RA) 不成比例地影响着老年人.
- 在老年人群中治疗RA的证据是有限的,因为试验排除.
研究的目的:
- 评估RA随机对照试验 (RCT) 中的资格标准,这些随机对照试验不包括老年患者.
- 在RA临床试验中确定明确和隐含的排除因素.
主要方法:
- 在clinicaltrials.gov (2013-2022) 上注册的药理干预RCT的分析.
- 评估上限年龄和其他隐性排除老年人的标准.
- 排除标准和试验特征的统计分析.
主要成果:
- 49%的RCT的上限年龄为85岁或以下.
- 53%的RCT包括了诸如并发症或含糊排除等隐含禁止老年人的标准.
- 75%的试验排除了老年患者,随着时间的推移,排除的趋势越来越大.
结论:
- 根据明确和隐含的标准,老年人经常被排除在RA RCT之外.
- 这种排除妨碍了对老年人开发有效的RA治疗方法.
- 关节炎的临床试验需要更加包容老年人群.
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