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中华心脏与心律电子杂志 ›› 2022, Vol. 10 ›› Issue (03) : 159 -164. doi: 10.3877/cma.j.issn.2095-6568.2022.03.007

所属专题： 总编推荐；

临床研究

二尖瓣机械瓣置换术后凝血酶原时间-国际标准化比值检测频率与长期预后间关系的研究
耿乐1, 郦明芳2, 顾嘉玺1, 李明辉1, 孙浩亮1, 倪布清1, 邵永丰1,†()   
  1. 1. 210029　南京，南京医科大学第一附属医院（江苏省人民医院）心脏大血管外科1.
    2. 210029　南京，南京医科大学第一附属医院（江苏省人民医院）心血管内科2.
  • 收稿日期:2022-08-13 出版日期:2022-09-25
  • 通信作者: 邵永丰
  • 基金资助:
    江苏省科技厅与社会发展临床前沿技术项目(BE2017750)

Correlations between prothrombin time-international normalized ratio (PT-INR) monitoring frequency and long-term prognosis in patients with mechanical mitral valve replacement

Le Geng1, Mingfang Li2, Jiaxi Gu1, Minghui Li1, Haoliang Sun1, Buqing Ni1, Yongfeng Shao1,†()   

  1. 1. Department of Cardiovascular surgery, The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital), Nanjing 210029, China
    2. Department of Cardiology, The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital), Nanjing 210029, China
  • Received:2022-08-13 Published:2022-09-25
  • Corresponding author: Yongfeng Shao
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引用本文：

耿乐, 郦明芳, 顾嘉玺, 李明辉, 孙浩亮, 倪布清, 邵永丰. 二尖瓣机械瓣置换术后凝血酶原时间-国际标准化比值检测频率与长期预后间关系的研究[J]. 中华心脏与心律电子杂志, 2022, 10(03): 159-164.

Le Geng, Mingfang Li, Jiaxi Gu, Minghui Li, Haoliang Sun, Buqing Ni, Yongfeng Shao. Correlations between prothrombin time-international normalized ratio (PT-INR) monitoring frequency and long-term prognosis in patients with mechanical mitral valve replacement[J]. Chinese Journal of Heart and Heart Rhythm(Electronic Edition), 2022, 10(03): 159-164.

目的

探究凝血酶原时间-国际标准化比值（prothrombin time-international normalized ratio，PT-INR）检测频率与二尖瓣机械瓣置换术后长期预后之间的关系。

方法

纳入2013年6月至2018年5月于南京医科大学第一附属医院接受二尖瓣机械瓣置换并康复出院的患者。电话问卷调查患者，根据PT-INR检测间隔是否超过1个月分为频繁检测组（≤1个月）和不频繁检测组（>1个月）。主要终点为全因死亡，次要终点为缺血性卒中及大出血，比较两组之间终点事件发生情况。

结果

共收集249例患者信息，年龄（47.06±6.88）岁，其中男98例。共153例（61.4%，153/249）完成问卷者纳入分析。2013-2014年、2014-2015年、2015-2016年、2016-2017年、2017-2018年失访比例分别为76.1%，51.3%，26.7%，32.3%，15.8%；频繁检测比例分别为36.4%，36.8%，42.4%，35.7%，83.3%。随术后时间延长，失访和不频繁检测比例均显著增加（P<0.05）。80例（52.3%）纳入频繁检测组，73例（47.7%）纳入不频繁检测组。不频繁检测组共发生7例全因死亡，6例缺血性卒中，3例大出血；频繁检测组无死亡，1例缺血性卒中，2例大出血。频繁检测组累积死亡风险显著低于不频繁检测组（P=0.006）。

结论

随术后时间延长，失访比例和不频繁检测PT-INR比例均显著增加，不频繁检测总体预后差于频繁检测。

关键词: 人工心脏瓣膜, 二尖瓣机械瓣, 华法林, 凝血酶原时间-国际标准化比值, 检测频率
Objective

To investigate correlations between monitoring frequency of prothrombin time-international normalized ratio (PT-INR) and long-term prognosis in patients after mechanical mitral valve (MMV) replacement.

Methods

Patients underwent MMV replacement in the First Affiliated Hospital with Nanjing Medical University and discharged from June 2013 to May 2018 were enrolled. Patients were followed with a telephone questionnaire survey. Based on monitoring intervals, patients were divided into frequent monitoring group (FMG) (monitoring intervals≤1 month) and infrequent monitoring group (IMG) (monitoring intervals >1 month). Primary endpoint was all-cause death' and secondary endpoints were ischemic stroke and major bleeding. Occurrences of endpoints in the two groups were analyzed.

Results

A total of 249 patients [age (47.06±6.88) years old, 98 male] were enrolled ,and 153 (61.4%) patients who finished questionnaire were included to analysis. Based on the year of operation, proportions of loss to follow-up were 76.1%, 51.3%, 26.7%, 32.3%,15.8%; proportions of frequent PT-INR monitoring were 36.4%,36.8%,42.4%,35.7%,83.3%, respectively. As post-operation time prolonged, proportions of loss to follow-up and infrequent PT-INR monitoring increased significantly (P<0.05). Eighty (52.3%) patients were grouped into FMG and 73 patients (47.7%) into IMG. There were 7 all-cause deaths, 6 ischemic stokes and 3 major bleedings in IMG, while no all-cause death, 1 ischemic stroke and 2 major bleedings happened in FMG. Compared with IMG, cumulative incidence of death in FMG was significantly lower (P=0.006).

Conclusion

As post-operation time prolonged, proportions of loss to follow-up and infrequent PT-INR monitoring increased significantly. Patients with infrequent monitoring had worse general prognosis than patients with frequent monitoring.

Key words: Heart valve prosthesis, Mechanical mitral valve, Warfarin, Prothrombin time-international normalized ratio (PT-INR), Monitoring frequency
表1 249例二尖瓣机械瓣置换术的患者基线资料
项目 纳入 剔除 P值
例数 153 96
人口学资料
男［例（%）］ 59（38.6） 39（40.6） 0.75
年龄（岁，
x¯±s
）		 47.59±6.85 46.22±6.89 0.12
左心房内径（mm，
x¯±s
）		 51.11±9.96 51.37±11.35 0.85
左心室舒张末期内径（mm，
x¯±s
）		 52.60±9.16 50.58±7.10 0.69
左心室射血分数（%，
x¯±s
）		 59.89±6.63 61.93±6.38 0.18
肌酐清除率（ml/min，
x¯±s
）		 101.17±30.97 95.27±28.42 0.19
既往病史［例（%）］
高血压 25（16.3） 9（9.4） 0.17
糖尿病 4（2.6） 3（3.1） 0.81
冠心病 8（5.2） 1（1.0） 0.17
心房颤动 99（64.7） 58（60.4） 0.50
卒中 25（16.3） 6（6.2） 0.03
术中资料［例（%）］
单纯二尖瓣置换 88（57.5） 40（41.7） 0.02
二尖瓣+主动脉瓣双瓣置换 64（41.8） 52（54.2） 0.07
同期心房颤动消融 89（58.2） 57（59.4） 0.95
同期左心耳切除 99（64.7） 58（60.4） 0.50
表2 不同手术年度随访与失访患者人数及失访比例
项目 2013-2014 2014-2015 2015-2016 2016-2017 2017-2018 P值
失访人数（例） 35 20 12 20 9
随访人数（例） 11 19 33 42 48
总人数（例） 46 39 45 62 57
失访比例（%） 76.1 51.3 26.7 32.3 15.8 <0.01
表3 不同手术年度各检测间歇人数及频繁检测比例
项目 2013-2014 2014-2015 2015-2016 2016-2017 2017-2018 P值
频繁检测人数（例） 4 7 14 15 40
不频繁检测人数（例） 7 12 19 27 8
总人数（例） 11 19 33 42 48
频繁检测比例（%） 36.4 36.8 42.4 35.7 83.3 <0.05
表4 频繁检测组和不频繁检测组终点事件发生情况Cox分析（校正因素为年龄、性别）
终点事件 每100人年事件（事件数） 校正前 校正后
不频繁检测组 频繁检测组 HR（95% CI） P HR（95% CI） P
全因死亡 2.15（7） 0（0）
缺血性卒中 1.89（6） 0.33（1） 5.39（0.64~45.18） 0.12 6.02（0.70~52.63） 0.10
大出血 0.92（3） 0.66（2） 1.45（0.24~8.75） 0.69 1.71（0.28~10.63） 0.56
图1 频繁检测组和不频繁检测组累积死亡事件发生率
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