中国药物警戒 ›› 2018, Vol. 15 ›› Issue (12): 705-708.

• 基础与临床研究 •    下一篇

非瓣膜病心房颤动患者服用达比加群酯合理性、安全性和依从性评价

杨玉辉, 罗助荣, 郑卫星, 黄明方, 林毅, 曹小织, 章文莉   

  1. 中国人民解放军福州总医院 福建医科大学福州总医院临床医学院 福建中医药大学福州总医院临床医学院 心血管内科,福建 福州 350000
  • 收稿日期:2019-01-18 修回日期:2019-01-18 出版日期:2018-12-20 发布日期:2019-01-18
  • 作者简介:杨玉辉,男,博士,主治医师,副教授,心律失常的临床和基础研究。
  • 基金资助:
    福建省自然科学基金（2015J01484）：Anti-M2-R对心房颤动消融术后复发的预测意义及其机制初步研究

Assessment of Rationality, Safety and Adherence of Dabigatran in Patients with Nonvalvular Atrial Fibrillation

YANG Yuhui, LUO Zhurong, ZHENG Weixing, HUANG Mingfang, LIN Yi, CAO Xiaozhi, ZHANG Wenli   

  1. Department of Cardiology, Fuzhou General Hospital of People's Liberation Army; Fuzhou General Hospital of Fujian Medical University; Fuzhou General Hospital of Fujian Traditional Chinese Medical University, Fujian Fuzhou 350000, China
  • Received:2019-01-18 Revised:2019-01-18 Online:2018-12-20 Published:2019-01-18

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摘要： 目的 了解非瓣膜病心房颤动患者服用达比加群酯的合理性、安全性和依从性,为临床更好使用达比加群酯提供研究基础。方法 选取2016年1月~ 2018年1月在我院心内科诊断为非瓣膜病心房颤动并服用达比加群酯的患者,进行病例回顾性调查,结合电话随访方式,评价其达比加群酯应用的合理性、安全性和依从性。结果 共109例患者入组本研究。平均年龄68.26±10.82岁,平均CHA2DS2-VASc评分为3.21±1.30,平均HAS-BLED评分为1.38±1.02。CHA2DS2-VASc评分0分的低危患者9例（8.26%）,其中3例无抗凝治疗指征。服用110 mg剂型患者91例（83.49%）,服用150 mg剂型患者18例（16.51%）,其中5例服用150 mg患者选用剂型不合理。漏服13人次,4人服用频次错误。13例（11.93%）患者发生不良反应。进行药物转换的34例患者中41.18%未监测INR或INR未达合理估值。16例（14.68%）患者长期合并应用胺碘酮治疗,其中7例患者未规律随访。停药患者11例（10.09%）,其中自行停药7例（6.42%）。15.60%患者未规律随访,43.12%患者未规律复检尿潜血。结论 本研究中达比加群酯有着比较好的安全性及依从性,但仍有一定比例的不良反应,部分患者对其风险认识不足,不能规律随访和检测。应遵照指南,加强教育,进一步提高达比加群酯用药的安全性和依从性。

关键词: 非瓣膜病心房颤动, 达比加群酯, 合理性, 安全性, 依从性

Abstract: Objective To analyze the rationality of dabigatran application in the patients with nonvalvular atrial fibrillation(NVAF), as well as the safety and adherence, so as to better guide clinical therapy and obtain foundation for further research． Methods A retrospective research was conducted on patients with NVAF who were given dabigatran from January 2016 to January 2018． The rationality, safety and adherence of dabigatran application were evaluated by retrospective cases analysis and telephone follow-up method． Results A total of 109 patients (average age 68.26±10.82, average CHA2DS2-VASc score 3.21±1.30, average HAS-BLED score 1.38±1.02)were enrolled． 9 patients had a CHA2DS2-VASc score=0, 3 of them had no indication of anticoagulant therapy. 91 patients were given dabigatran of 110 mg. 18 patients were given dabigatran of 150 mg and 5 of their dosage were unsuitable. 4 patients had wrong frequency of dosage. 13 patients had adverse reactions. 34 patients changed their anticoagulant and 41.18% of them had unreasonable international normalized ratio (INR). 16 patients were given amiodarone at the same time and 7 of them had no regular follow-up. 11 patients stopped taking pills and 7 of them had no doctors' instructions. 15.60% of the patients had no regular follow-up. 43.12% of the patients didn't test their urine occult blood regularly. Conclusion Dabigatran has good safety and adherence with some adverse reactions. Part of the patients paid inadequate attention to the risk and had no regular follow-up. Medication education according to guidelines is necessary to improve the safety and adherence of dabigatran application.

Key words: nonvalvular atrial fibrillation, dabigatran, rationality, safety, adherence

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