妇女在减少喷射心力衰竭临床试验中的代表性不足,改善死亡率或住院治疗
Eson Ekpo1, Sujana Balla2, Summer Ngo3
1Department of Cardiovascular Medicine, Scripps Clinic, La Jolla, California, USA.
JACC. Advances
|February 26, 2024
概括
妇女在临床试验中缺少心力衰竭与减少喷射率 (HFrEF),这影响了指导方针的制定. 需要进一步努力,以确保妇女在HFrEF研究中得到公平的纳入.
科学领域:
- 心脏病学 心脏病学
- 临床试验 临床试验
- 医学中的性别差异.
背景情况:
- 已确定的性别差异存在于心力衰竭与减少喷射率 (HFrEF) 结果.
- 目前的HFrEF治疗指南受到随机临床试验 (RCT) 的严重影响,这些试验证明了心血管结果的好处.
研究的目的:
- 评估HFrEFRCT中女性的代表性,这些RCT报告了心力衰竭 (HHF) 死亡率或住院治疗的显著好处.
主要方法:
- 在主要数据库 (CINAHL,EMBASE,MEDLINE,PubMed) 搜索了具有显著死亡率或HHF受益 (1980-2021) 的HFrEF RCT.
- 计算出参与率与流行率 (PPR) 来估计女性的代表性,其中0.8-1.2被认为是代表性的.
- 分析了符合纳入标准的33个相关RCT.
主要成果:
- 在33个分析的RCT中,女性仅占参与者的23.2%.
- 妇女的总体参与率与患病率 (PPR) 为0.58,表明代表性不足.
- 只有15.2%的试验实现了女性的代表性PPR;代表性随着时间的推移没有显著变化.
结论:
- 妇女在关键的HFrEF RCT中仍然不足,这些RCT为临床实践准则提供了信息.
- 解决这种代表性不足问题对于理解和解决HFrEF的性别差异至关重要.
- 持续的举措是必要的,以确保在未来的HFrEF试验中公平地纳入女性.
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