在具有里程碑意义的妇女健康倡议临床试验中,仪器变量方法揭示了更年期激素治疗的更大影响
Joshua Angrist1, Amanda E Kowalski2, Ljubica Ristovska3
1Massachusetts Institute of Technology.
概括
更年期激素治疗 (MHT) 的风险比以前认为的要大. 仪器变量方法显示,坚持MHT的妇女的实际风险和益处远远大于先前的治疗意图分析.
科学领域:
- 生殖健康
- 临床流行病学
- 生物统计学
背景情况:
- 妇女健康倡议 (WHI) 试验显示更年期激素治疗 (MHT) 增加了乳腺癌和不良事件的风险.
- 最近的分析表明MHT风险是最小的,主要依赖于治疗意向 (ITT) 影响估计.
- 由于干预组的不遵守和对照组的治疗开始,ITT分析可能会误导MHT的真实影响.
研究的目的:
- 重新评估更年期激素治疗 (MHT) 的风险和益处.
- 使用仪器变量 (IV) 方法估计MHT对坚持女性的因果关系.
- 将IV估计与传统ITT估计进行比较.
主要方法:
- 使用仪器变量 (IV) 方法,结合来自妇女健康倡议 (WHI) 试验的坚持数据.
- 估计了MHT对那些坚持治疗的妇女的影响.
- 将这些IV估计与预期治疗效果 (ITT) 估计进行比较.
主要成果:
- 仪器变量 (IV) 估计表明,与更年期激素治疗 (MHT) 相关的风险和益处远大于之前报告的风险和益处.
- 与意向治疗 (ITT) 结果相比,依附性调整后的分析显示MHT的效果更为明显.
- 这表明MHT对实际使用女性的真正影响与人口水平ITT估计有很大不同.
结论:
- 更年期激素治疗 (MHT) 对坚持使用者的实际风险和益处远高于意图治疗 (ITT) 分析所表明的.
- 仪表变量 (IV) 方法可以更准确地估计MHT的影响,强调考虑依从的重要性.
- 这些发现挑战了以前对MHT安全性和有效性的解释,可能会影响临床指南和患者咨询.
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