从2000年到2024年进行的膜心脏病干预试验:系统性审查
Frederick Berro Rivera1, Chieh-Mei Tsai1, Polyn Luz S Pine2
1Division of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.
JACC. Advances
|November 30, 2025
概括
膜心脏病 (VHD) 试验的招生正在增长,年龄较大的参与者和更大的研究. 然而,显著的性别差异仍然存在,这表明需要更具包容性的VHD临床试验设计.
科学领域:
- 心血管医学 心血管医学
- 临床试验 临床试验
- 医疗干预 医疗干预
背景情况:
- 膜心脏病 (VHD) 是心血管疾病的重要原因之一,并且在不断增长,特别影响着老年人群.
- 跨导管疗法的扩展需要对临床试验招生趋势和人口代表性的评估,以确保证据的概括性和公平性.
研究的目的:
- 分析膜心脏病干预试验参与者的特征和人口代表,特别是年龄和性别的时间趋势.
- 评估2000年至2024年的VHD试验中试验范围,干预类型和参与者人口统计数据的变化.
主要方法:
- 对从2000年到2024年在PubMed上索引的干预性VHD试验进行了系统审查.
- 包括专注于对大动脉, mitra,三管和肺病的皮肤或手术干预的试验.
- 使用描述性和非参数统计数据来评估招生趋势,参与者人口统计,门类型,干预方式和试验范围.
主要成果:
- 这项研究包括487项试验,有87,412名参与者;44.9%是女性.
- 随着时间的推移,中位数试验大小和参与者年龄显著增加 (P < 0.01).
- 通过皮肤干预,生物假体门,大动脉门试验和跨国研究的显著增加. 女性入学率没有显著改善 (P = 0.63),但在关和三管的试验中,以及穿皮与外科手术研究中,这一比例更高. 在参与者的年龄和女性代表之间发现了正相关性 (P < 0.01).
结论:
- VHD试验在规模和范围上有所增长,对老年参与者的趋势更为明显.
- 尽管试验规模和年龄增加,但在入学率上持续存在的性别差异凸显了需要更具包容性的试验设计的必要性.
- 在VHD临床试验中公平代表对于开发有利于所有患者群体的疗法至关重要.
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