被遗弃的青少年:在喘随机对照试验中代表人数不足
Amy G Nuttall1, Catherine McNamara2, William Bedson3
1Institute in the Park, University of Liverpool Department of Women's and Children's Health, Liverpool, Merseyside, UK amynuttall@doctors.org.uk.
BMJ paediatrics open
|October 23, 2025
概括
青少年喘研究是有限的,因为大多数临床试验没有报告青少年的参与. 在报告时,用于喘治疗的随机对照试验 (RCT) 中青少年的比例通常很低.
科学领域:
- 临床药理学 临床药理学
- 儿科肺病学 儿科肺病学
- 基于证据的医学基于证据的医学.
背景情况:
- 在青少年中有效的喘管理需要对治疗有效性和安全性的强有力的证据.
- 青少年代表着一个独特的生理群体,需要特定的数据来提供最佳的护理.
- 目前的研究环境可能没有充分反映喘药物治疗中的青少年特异性结果.
研究的目的:
- 评估青少年在喘治疗的随机对照试验 (RCT) 的招募和报告情况.
- 确定2015年至2023年期间发表的制药性喘RCT中包括的青少年的比例.
- 评估已发表的喘RCT中青少年子组数据的可用性.
主要方法:
- 在多个数据库中系统搜索涉及药物喘治疗的RCT.
- 纳入标准:2015年至2023年期间招募青少年和成年人的试验.
- 数据提取的重点是招募的青少年数量/比例,并报告了子组数据.
主要成果:
- 确定了81个RCT;49个 (60.5%) 没有报告青少年招募人数或比例.
- 在报告青少年纳入试验的试验中,这一比例在1%至49%之间,中位数为6.1%.
- 只有7个 (8.6%) 的试验提供了针对青少年子组的具体数据进行分析.
结论:
- 发表的喘RCT经常缺乏关于青少年招募的明确性.
- 在报告时,喘RCT中纳入的青少年比例通常很低.
- 建议在推断成年人对于青少年喘管理的数据时谨慎使用,这是由于潜在的代表性不足和缺乏子组分析.
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