Yeh Yi-Chun, Chen Pei-Chun
National Center for Geriatrics and Welfare Research, National Health Research Institutes, 35, Keyan Road, Miaoli, 350, Taiwan.
Department of Public Health, China Medical University, Taichung, Taiwan.
Eur J Epidemiol. 2024 Dec;39(12):1341-1351. doi: 10.1007/s10654-024-01181-x. Epub 2024 Dec 3.
Contemporary data from randomized clinical trials focusing on the effect of oral hormone therapy (HT) on venous thromboembolism (VTE) in women aged 50-60 years are scarce despite evolving HT regimens. Here, we evaluated the association between HT and the risk of developing VTE using a target trial emulation among women of menopausal age. This retrospective cohort study applied a target trial emulation framework using claims data from a universal health insurance program in Taiwan. We emulated a sequence of trials in which women aged 50-60 years with no previous history of HT, hysterectomy, gynecologic disorders, or cardiovascular events were enrolled. Eligibility and HT use were evaluated monthly from 2011 to 2019. Eligible women were classified as either HT initiators or non-initiators for each consecutive month. Observational analogs of the intention-to-treat and per-protocol effects were estimated using pooled logistic regression models. Of the 150,686,148 eligible person-trials (3,001,112 women), 192,215 initiators and 768,860 propensity score-matched non-initiators were included in the analysis. The average duration of the HT was 1.25 years. Over a median follow-up of 5.83 years, 3,334 women developed VTE. The estimated hazard ratio (95% confidence interval) was 0.96 (0.88, 1.04) in the intention-to-treat analysis and 0.66 (0.41, 1.05) in per-protocol analysis. The estimated intention-to-treat and per-protocol 5-year VTE-free survival differences (95% confidence interval) were 0.1‰ (- 0.3‰, 0.7‰) and 0.3‰ (- 2.8‰, 4.0‰), respectively. In the contemporary clinical setting, we did not observe an increased VTE risk associated with HT in women aged 50-60 years.
尽管口服激素疗法（HT）方案不断演变，但针对50至60岁女性静脉血栓栓塞（VTE）的口服激素疗法效果的当代随机临床试验数据仍然稀少。在此，我们通过在绝经年龄女性中模拟目标试验，评估了HT与发生VTE风险之间的关联。这项回顾性队列研究采用了目标试验模拟框架，使用了台湾全民健康保险计划的理赔数据。我们模拟了一系列试验，纳入了50至60岁、既往无HT史、子宫切除术史、妇科疾病史或心血管事件史的女性。从2011年至2019年每月评估入选资格和HT使用情况。符合条件的女性在每个连续月份被分类为HT启动者或非启动者。使用汇总逻辑回归模型估计意向性治疗和符合方案效应的观察性类似物。在150,686,148例符合条件的人-试验（3,001,112名女性）中，192,215名启动者和768,860名倾向评分匹配的非启动者纳入分析。HT的平均持续时间为1.25年。在中位随访5.83年期间，3,334名女性发生了VTE。在意向性治疗分析中，估计风险比（95%置信区间）为0.96（0.88，1.04），在符合方案分析中为0.66（0.41，1.05）。估计的意向性治疗和符合方案的5年无VTE生存率差异（95%置信区间）分别为0.1‰（-0.3‰，0.7‰）和0.3‰（-2.8‰，4.0‰）。在当代临床环境中，我们未观察到50至60岁女性中HT与VTE风险增加相关。
