Page 11 - 中国全科医学2022-17

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【Abstract】 Background The stability of anticoagulation is a key indicator for assessing the efficacy of warfarin in
atrial fibrillation，which is an important anticoagulation therapy for the disease. Existing studies show that the eligible rate of
stability of warfarin anticoagulation is rather unsatisfactory，and there are few studies on how to effectively calculate the stability
of the treatment. Moreover，methods recommended in guidelines for estimating the stability of warfarin anticoagulation have
limitations，with no effective suggestions for calculating stability of warfarin anticoagulation in the early stage of treatment.
Objective To assess the practical efficacy of “double six definitions” in guideline-recommended method for estimating the
stability of warfarin anticoagulation〔using INR data monitored for at least six months but excluding the data within the first six
weeks〕，providing a reference for improving the method for calculating the stability of warfarin anticoagulation. Methods
Participants with persistent non-valvular atrial fibrillation（n=126） were recruited from Jiujiang No.1 People's Hospital from
January 2019 to December 2020. All of them received warfarin anticoagulant therapy and outpatient or inpatient follow-ups for
understanding the coagulation status. The stability of warfarin anticoagulation was described using time in therapeutic range（TTR）
calculated by different methods，namely using INR data in a 7-12-month follow-up period with or without removal of INR data in
the first 6 weeks，and INR data in 12 consecutive months of follow-up with or without removal of INR data in the first 6 weeks，
and the results were compared with the TTR calculated by "double six definitions". Results Calculating the TTR using INR data
of 7-12 months：there were no significant differences between the TTR calculated using INR data of 7，8，9，10，11 or 12
months with and without the first 6-week INR data（P>0.05）. Calculating the TTR using INR data of 12 consecutive months：
when INR data in the first 6 weeks of follow-up were removed，the TTR at the first and second months of follow-up could not be
calculated using the set formula，and it was deemed to be 0. There was significant difference between TTR calculated with and
without INR data in the first 6 weeks at 1- or 2-month follow-up（P<0.001）. There was no significant difference between TTR
calculated with and without INR data in the first 6 weeks at 3-，4-，5-，6-，7-，8-，9-，10-，11- or 12-month follow-up （P
> 0.05）. The TTR calculated using INR data of 7 to 12 months of follow-up was similar to that calculated using INR data at one
time point of the second half period（7 to 12 months） within the 12-month follow-up under the condition of removing the INR
data of the first 6 weeks （P>0.05），and the same thing was found when the INR data of the first 6 weeks were not removed（P>0.05）.
Furthermore，there were no significant differences in TTR calculated using INR data of 7 to 12 months of follow-up and using INR
data of 12 consecutive months of follow-up regardless of whether the INR data of the first 6 weeks were removed or not（P>0.05）.
Conclusion In the calculation of the stability of warfarin anticoagulation in atrial fibrillation，the INR data in the first 6 weeks
might be included，and the baseline follow-up time for monitoring INR might not necessarily be greater than 6 months.
【Key words】 Atrial fibrillation；Warfarin；Anticoagulants；Stability of anticoagulant therapy；Time within
therapeutic range；Double six definition；Guidebook

华法林是一种历史悠久且应用广泛的抗凝药物， 本研究的创新点与不足：
预防心房颤动、卒中等疾病的效果确切，即使不断 本研究为达标时间百分比（TTR）的计算提供
有新型口服抗凝药物的研发和推广使用，华法林的 了新的思路和方法，同时新方法的提出也为服药前
价值和地位仍不能被完全取代，尤其是当患者合并 6 个月患者的 TTR 管理提供了切入点，这些均是目

明显肾功能不全、中重度瓣膜病等疾病或经济条件 前医学领域研究较少的，也是现有指南亟待改进的
欠佳时 ［1］ 。指南推荐根据华法林的抗凝强度和抗凝 地方；但由于纳入的研究对象例数较少，且由于临
治疗稳定性评估其抗凝有效性，其中抗凝强度通常 床管理中存在患者定期抽血依从性较差、多服或漏
根据国际标准化比值（international normalized ratio， 服情况发生率较高等问题，使得该方面的研究开展
INR）进行判断，关于该方面的研究较为成熟 ［2-3］ ； 困难较大。
然而关于华法林抗凝治疗稳定性的研究却十分罕见。 计算方法 ［4］ ，SRIDHARAN 等 ［5］ 的研究结论也提出
目前国内外指南中均提出采用治疗范围内的达标时 “双 6 定义”的准确性和时效性有待商榷。本研究

间百分比（time in therapeutic range，TTR）对华法林 就华法林抗凝治疗稳定性计算方法中的“双 6 定义”
抗凝治疗稳定性进行评价，而在 TTR 的计算定义中 进行分析比较，以期为进一步完善 TTR 的计算方法
提出“需要不少于 6 个月的 INR 监测数据且去除前 提供参考。
6 周的数据”（以下简称“双 6 定义”），但有学者 1 资料与方法
对指南中的“双 6 定义”提出了不同的观点和改进 1.1 一般资料 选取 2019 年 1 月至 2020 年 12 月就