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两种低剂量华法林治疗方案在中国患者中的分析和比较

Guy-Armel Bounda*, Cosette Ngarambe, 葛卫红, 于锋

  

  1. 1. 中国药科大学 药学院 临床药学教研室, 江苏 南京 210009
    2. 东南大学医学院, 江苏 南京 210096
    3. 南京大学医学院附属鼓楼医院 药剂科, 江苏 南京 210008
  • 收稿日期:2012-08-12 修回日期:2012-11-20 出版日期:2013-01-20 发布日期:2013-01-20
  • 通讯作者: Guy-Armel Bounda*

Analysis and comparison of two low-dosage warfarin regimens in Chinese patients

Guy-Armel Bounda*, Cosette Ngarambe, Weihong Ge, Feng Yu   

  1. 1. Department of Clinical Pharmacy, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China
    2. Medical School, Southeast University, Nanjing 210096, China
    3. The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing 210008, China
  • Received:2012-08-12 Revised:2012-11-20 Online:2013-01-20 Published:2013-01-20
  • Contact: Guy-Armel Bounda*

摘要:

口服华法林可用于预防和治疗动静脉血栓形成和栓塞, 但由于华法林治疗指数窄, 需要认真监测以达治疗目标。本研究旨在观察和评估两种不同剂量华法林治疗方案在中国患者中的疗效。查阅2008年9月至2009年12月心脏瓣膜手术患者的病历, 筛选手术后第一天就开始使用华法林治疗的368名患者, 采用交叉设计方案, 对患者进行随机分组, 以国际标准化比值 (INR) 反映抗栓治疗结果详情。两组患者住院期间分别接受两种不同规格 (中国2.5 mg, 美国3 mg) 华法林抗凝治疗, 对其抗凝结果进行统计学分析, 以评价预测INR治疗范围的因素。患者的平均年龄为(48.23±12.96)岁。2.5 mg组患者INR在治疗范围的比例低于3 mg组 (35.17%, 47.72%), 两者具有显著性差异 (P = 0.032<0.05)。研究显示INR目标范围1.8-2.2和2.0-2.5之间有显著关联, 统计学分析显示各自P值为0.031和0.025。两组患者在治疗期间有显著性差异。大部分患者都需要终生治疗 (P = 0.035)。统计学研究表明, 规格3.0 mg华法林较2.5 mg华法林更优。在不同治疗期间应尽可能简化治疗方案。

关键词: 抗凝, 中国患者, 剂量, 国际标准化比值, 低剂量华法林治疗方案

Abstract:

Oral anticoagulation therapy with warfarin is used to prevent and treat venous and arterial thrombosis and embolism. Its narrow therapeutic index should be monitored carefully in order to reach the desired outcomes. The complexity of the pharmacokinetic and pharmacodynamics profile of warfarin makes it a challenge to use during treatment. Its manufacturing characteristics play a key role in its dosage. The aim of this study is to examine and evaluate the effect of two different warfarin regimens in Chinese patients. A cross-sectional study design was adopted. Medical records of all patients (n = 368) who received warfarin therapy in cardio-thoracic surgery wards between Sep. 2008 and Dec. 2009 were reviewed. Details of antithrombotic results of international normalized ratio (INR) monitoring were obtained. Statistical analysis was performed to assess factors predictive of INR therapeutic range at patients’ discharge time according to different warfarin regimens (2.5 mg in China and 3.0 mg in USA). The patients’ mean age was (48.23±12.96) years. The percentage of patients within the INR therapeutic range in the group treated with 2.5 mg warfarin (35.17%) was much lower than that in group treated with 3.0 mg warfarin (47.72%). Therefore, a significance difference was observed (P = 0.032<0.05). In this study, statistical values have shown that most of the patients were related to medical case requesting INR target range of 1.8-2.2 and 2.0-2.5, respectively. There was a statistically significant difference between the two groups. The study showed that the 2.5 mg-warfarin regimen was less suitable than the 3.0 mg-warfarin regimen. Medication regimen should be simplified as much as possible, especially during different treatment period.

Key words: Anticoagulation, Chinese patients, Dose, INR, Low warfarin regimen

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Supporting: *Corresponding author. Tel: 86-13913853314; Fax: 86-25-57717275