斋月期间维生素K拮抗剂治疗质量和临床结果的变化：一项荷兰人群队列研究

IF 3.4 3区医学 Q2 HEMATOLOGY

Research and Practice in Thrombosis and Haemostasis Pub Date : 2025-08-01 DOI:10.1016/j.rpth.2025.103010

Eva K. Kempers , Qingui Chen , Nienke van Rein , Ferdows Atiq , Roger K. Schindhelm , Nynke M. Wiersma , Charlotte E.A. Dronkers , Maarten Beinema , Arina J. ten Cate-Hoek , Melchior C. Nierman , Alexander D.M. Stork , Patricia Moriarty , Frederikus A. Klok , Suzanne C. Cannegieter , Marieke J.H.A. Kruip

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引用次数: 0

摘要

斋戒改变了食物的时间和含量，包括饮食中的维生素K和药物摄入，潜在地影响了维生素K拮抗剂（VKA）治疗的稳定性和临床结果。目的评估荷兰斋月期间VKA治疗质量和临床事件（包括出血、静脉和动脉血栓栓塞）发生率的人群水平变化。方法来自荷兰17家抗凝诊所的数据与荷兰统计局相关联。从斋月前2个月到斋月后2个月，研究了2013-2019年可能在斋月期间禁食的移民背景的流行VKA用户（即斋月队列）。在每30天的间隔时间内，评估VKA治疗质量和临床事件风险。一组荷兰本土VKA使用者作为阴性对照进行研究。结果斋月队列包括3835名VKA使用者（中位年龄65.8岁，男性55.2%）。在整个斋月期间，国际标准化比率（INR）监测频率、INR变异性和在目标范围内的时间保持相似。然而，在斋月期间（18.9%±31.5% [mean±SD]）和斋月后（+1月，19.9%±32.7%和+2月，19.7%±32.8%）的超治疗INRs比例略高于斋月前（-2月，18.1±30.9%和-1月，17.8±31.5%）。同时，斋月期间临床相关剂量减少比例（4.7%）高于其他月份（3.6%-4.3%）。这些在荷兰本土队列中未观察到（N = 139,207）。在两个队列中，在斋月期间出血和血栓栓塞事件复合的月风险保持不变。结论在斋月期间，VKA治疗质量和临床结果没有临床相关的人群水平变化，除了超治疗inr和剂量减少的比例略高。

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Changes in quality of vitamin K antagonist treatment and clinical outcomes during Ramadan: a Dutch population-based cohort study

Background

Ramadan fasting alters the timing and content of food, including dietary vitamin K, and medication intake, potentially affecting stability of vitamin K antagonist (VKA) treatment and clinical outcomes.

Objectives

To assess population-level changes in VKA treatment quality and incidence of clinical events, including bleeding and venous and arterial thromboembolism, during Ramadan in the Netherlands.

Methods

Data from 17 Dutch anticoagulation clinics were linked to Statistics Netherlands. Prevalent VKA users in 2013-2019 with an immigration background who were likely to fast during Ramadan (ie, the Ramadan cohort) were studied from 2 months preceding Ramadan until 2 months after. During each 30-day interval, VKA treatment quality and risk of clinical events were assessed. A cohort of native Dutch VKA users was studied as negative control.

Results

The Ramadan cohort included 3835 VKA users (median age 65.8 years, 55.2% male). Frequency of international normalized ratio (INR) monitoring, INR variability, and time within target range remained similar across Ramadan. However, the proportion of supratherapeutic INRs was slightly higher during (18.9% ± 31.5% [mean ± SD]) and after Ramadan (month +1, 19.9% ± 32.7% and month +2, 19.7% ± 32.8%) compared with before (month –2, 18.1 ± 30.9% and month –1, 17.8 ± 31.5%). Meanwhile, there was a higher proportion of clinically relevant dose reductions during Ramadan (4.7%) than the other months (3.6%-4.3%). These were not observed in the native Dutch cohort (N = 139,207). Monthly risk of the composite of bleeding and thromboembolic events remained unchanged across Ramadan in both cohorts.

Conclusion

There were no clinically relevant population-level changes across Ramadan in VKA treatment quality and clinical outcomes, except for a slightly higher proportion of supratherapeutic INRs and dose reductions.

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