中国全科医学 ›› 2022, Vol. 25 ›› Issue (17): 2055-2060.DOI: 10.12114/j.issn.1007-9572.2022.0066

所属专题: 指南/共识最新文章合集

• 指南·新证据 • 上一篇    下一篇

关于指南推荐华法林抗凝治疗稳定性计算方法中"双6定义"的探索与再思考

罗潇1, 陈艳梅2, 黄青霞3, 陈玲1,*(), 罗云1, 袁明清1   

  1. 1.332000 江西省九江市第一人民医院心血管内科
    2.330000 江西省南昌市,南昌大学医学部研究生院
    3.332000 江西省九江市,九江学院附属医院骨关节外科
  • 收稿日期:2022-01-14 修回日期:2022-04-01 出版日期:2022-04-14 发布日期:2022-04-14
  • 通讯作者: 陈玲
  • 罗潇,陈艳梅,黄青霞,等.关于指南推荐华法林抗凝治疗稳定性计算方法中"双6定义"的探索与再思考[J].中国全科医学,2022,25(17):2055-2060.[www.chinagp.net]
    作者贡献:罗潇进行文章的构思与设计、总体把握文章行文思路和撰写;陈艳梅、黄青霞、袁明清对数据进行收集、分析和处理并参与撰写文章和制表;陈玲、罗云指导思路和技术路线,对研究中的存疑点进行分析、解读并对英文部分进行修正;陈玲进行文章审校和总体监督管理。 注:罗潇和陈艳梅为共同第一作者
  • 基金资助:
    江西省卫健委科技计划项目(SKJP-220217645); 九江市第一人民医院2021年青年课题(JJSDYRMYYQNKT2021-08)

"Double Six Definitions" in Guideline-recommended Methods for Estimating the Stability of Warfarin Anticoagulation: Practical Exploration and Reconsideration

Xiao LUO1, Yanmei CHEN2, Qingxia HUANG3, Ling CHEN1,*(), Yun LUO1, Mingqing YUAN1   

  1. 1.Cardiovascular Department, Jiujiang No.1 People's Hospital, Jiujiang 332000, China
    2.Graduate School, Nanchang University Health Science Center, Nanchang 330000, China
    3.Bone and Joint Surgery, Jiujiang University Affiliated Hospital, Jiujiang 332000, China
  • Received:2022-01-14 Revised:2022-04-01 Published:2022-04-14 Online:2022-04-14
  • Contact: Ling CHEN
  • About author:
    LUO X, CHEN Y M, HUANG Q X, et al. "Double Six Definitions" in guideline-recommended methods for estimating the stability of warfarin anticoagulation: practical exploration and reconsideration[J]. Chinese General Practice, 2022, 25 (17) : 2055-2060. LUO Xiao and CHEN Yanmei are co-first authors

摘要: 背景 华法林在心房颤动患者的抗凝治疗中具有重要地位,而其抗凝治疗稳定性是评价药物疗效的重要指标,现有研究均显示华法林抗凝治疗稳定性的达标率较低,对于如何有效计算抗凝治疗稳定性的研究少见;现有指南中推荐的计算方法存在局限性,对于服药前期患者的达标率计算则未能提出有效建议。 目的 探索指南中华法林抗凝治疗稳定性计算方法"需要不少于6个月的国际标准化比值(INR)监测数据且需要去除前6周的数据"定义(以下简称"双6定义")对抗凝治疗稳定性计算结果的影响,以期为改进华法林抗凝治疗稳定性的计算方法提供参考。 方法 选取2019年1月至2020年12月就诊于九江市第一人民医院的126例诊断为持续性非瓣膜性心房颤动且采用华法林抗凝治疗、同时进行了门诊或住院凝血功能随访检查的患者作为研究对象,计算"去除与不去除前6周INR数据"以及"随访时间>6个月与随访时间为12个月"的达标时间百分比(TTR),并与"双6定义"计算的TTR进行对比分析。 结果 随访时间>6个月:随访7、8、9、10、11、12个月去除与不去除前6周INR数据计算的TTR比较,差异均无统计学意义(P>0.05)。随访时间为12个月:当TTR计算时间基线设置为12个月且去除前6周INR数据时,随访第1个月与第2个月时的TTR无法按设定的公式进行计算,视TTR为0;随访1、2个月去除与不去除前6周INR数据计算的TTR比较,差异有统计学意义(P<0.001);随访3、4、5、6、7、8、9、10、11、12个月去除与不去除前6周INR数据计算的TTR比较,差异均无统计学意义(P>0.05)。去除前6周INR数据:随访时间>6个月与随访时间12个月时随访7~12个月TTR比较,差异均无统计学意义(P>0.05);不去除前6周INR数据:随访时间>6个月与随访时间为12个月时随访7~12个月TTR比较,差异均无统计学意义(P>0.05)。随访7~12个月随访时间>6个月且去除前6周INR数据、随访时间为12个月且去除前6周INR数据、随访时间>6个月且不去除前6周INR数据、随访时间12个月且不去除前6周INR数据计算的TTR比较,差异均无统计学意义(P>0.05)。 结论 华法林抗凝治疗稳定性的计算中可以考虑不去除前6周的数据,计算基线时间不一定必须要求>6个月。

关键词: 心房颤动, 华法林, 抗凝药, 抗凝治疗稳定性, 治疗范围内次数达标百分比, 双6定义, 指南

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