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临床实践中使用华法林患者的治疗范围内时间及随时间的稳定性:一项使用加拿大艾伯塔省常规收集的关联健康数据的回顾性队列研究。

Time in therapeutic range and stability over time for warfarin users in clinical practice: a retrospective cohort study using linked routinely collected health data in Alberta, Canada.

作者信息

McAlister Finlay A, Wiebe Natasha, Hemmelgarn Brenda R

机构信息

Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.

Division of Nephrology, Cumming School of Medicine, University of Calgary, Calgary, Canada.

出版信息

BMJ Open. 2018 Jan 29;8(1):e016980. doi: 10.1136/bmjopen-2017-016980.

Abstract

OBJECTIVES

Whether warfarin-treated patients with non-valvular atrial fibrillation (NVAF) who exhibit good control will experience deterioration in control over time is uncertain. We designed this study to examine the time in therapeutic range (TTR) in a population-based cohort of patients with NVAF recently initiated on warfarin.

DESIGN

Retrospective cohort study using routinely collected health data from 2008 to 2015.

SETTING

The Canadian province of Alberta.

PARTICIPANTS

All adults with NVAF who were taking warfarin for >1 month.

MAIN OUTCOME MEASURES

Frequency of international normalised ratio (INR) monitoring and the Rosendaal TTR with time zero set at 31 days after the first warfarin dispensation.

RESULTS

Of 57 669 patients with NVAF dispensed warfarin for >1 month, 17 099 (29.7%) had <3 INRs measured in months 1-6. Of the 40 570 who went for regular INR monitoring in months 1-6 (median number of INRs 11, IQR 7-16), 16 639 (41.0%) met the definition of good control (TTR 65%); good control continued to be exhibited by 8177 (57.1% of those who remained on warfarin) during months 7-12 and 6804 (56.8% of continuing warfarin users) in months 13-18. Good control in the first 6 months predicted good control over the subsequent year: adjusted OR (aOR) 4.0(95%CI 3.8 to 4.2), c index 0.685(95%CI 0.679 to 0.691) for months 7-12 and aOR 3.2(95%CI 3.1 to 3.3), c index 0.665(95%CI 0.659 to 0.671) for months 13-18.

CONCLUSIONS

Nearly one-third of warfarin-treated patients had insufficient INR monitoring-this could influence the initial choice of anticoagulant and identifies a target for future quality improvement efforts. Of those warfarin-treated patients who went for regular INR monitoring, 41% exhibited levels of control similar to that in randomised trials and this deteriorated by half over time. However, in patients who have already exhibited adherence with regular monitoring and good TTR, warfarin may still be a reliable anticoagulation option.

摘要

目的

对于接受华法林治疗且控制良好的非瓣膜性心房颤动(NVAF)患者,其控制效果是否会随时间恶化尚不确定。我们设计了这项研究,以检查近期开始使用华法林的基于人群队列的NVAF患者的治疗范围内时间(TTR)。

设计

回顾性队列研究,使用2008年至2015年常规收集的健康数据。

地点

加拿大艾伯塔省。

参与者

所有服用华法林超过1个月的成年NVAF患者。

主要观察指标

国际标准化比值(INR)监测频率以及将时间零点设定为首次使用华法林后31天的Rosendaal TTR。

结果

在57669例服用华法林超过1个月的NVAF患者中,17099例(29.7%)在第1至6个月的INR测量次数少于3次。在第1至6个月进行定期INR监测的40570例患者中(INR中位数为11,四分位间距为7 - 16),16639例(41.0%)符合良好控制的定义(TTR≥65%);在第7至12个月,8177例(继续使用华法林患者的57.1%)保持良好控制,在第13至18个月,6804例(继续使用华法林患者的56.8%)保持良好控制。前6个月的良好控制可预测随后一年的良好控制:第7至12个月的调整后比值比(aOR)为4.0(95%置信区间3.8至4.2),c指数为0.685(95%置信区间0.679至0.691),第13至18个月的aOR为3.2(95%置信区间3.1至3.3),c指数为0.665(95%置信区间0.659至0.671)。

结论

近三分之一接受华法林治疗的患者INR监测不足——这可能会影响抗凝剂的初始选择,并确定未来质量改进工作的目标。在那些接受华法林治疗且进行定期INR监测的患者中,41%的控制水平与随机试验相似,且随着时间推移控制水平下降了一半。然而,对于那些已经坚持定期监测且TTR良好的患者,华法林可能仍然是一种可靠的抗凝选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b57f/5829778/8d8894f85f6d/bmjopen-2017-016980f01.jpg

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