中国药物警戒 ›› 2025, Vol. 22 ›› Issue (9): 1024-1028.
DOI: 10.19803/j.1672-8629.20250163

• 安全与合理用药 • 上一篇    下一篇

222例口服凝血因子Xa抑制剂不良反应报告分析

郑金凤1, 吴佳妮1, 林京玉2, 杨雪卿3,*   

  1. 1中国中医科学院望京医院药学部,北京 100102;
    2北京市药品不良反应监测中心,北京 101117;
    3中国中医科学院望京医院心血管内科,北京 100102
  • 收稿日期:2025-03-19 发布日期:2025-09-22
  • 通讯作者: * 杨雪卿,女,博士,副主任医师,中西医结合心血管疾病。E-mail: tyyxq1986@163.com
  • 作者简介:郑金凤,女,硕士,副主任药师,临床药学。
  • 基金资助:
    中国中医科学院望京医院自主选题（WJYY-ZZXT-2023-18）; 北京市中医管理局北京市第三批中药骨干人才培养项目（京中医科字 [2021]161号）

222 Adverse Reaction Reports of Factor Xa Inhibitors

ZHENG Jinfeng1, WU Jiani1, LIN Jingyu2, YANG Xueqing3,*   

  1. 1Department of Pharmacy, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing 100102, China;
    2Beijing Center for ADR Monitoring, Beijing 101117, China;
    3Department of Cardiology, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing 100102, China
  • Received:2025-03-19 Published:2025-09-22

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摘要： 目的 分析北京地区口服凝血因子Xa抑制剂不良反应（ADR）报告及其发生特点,为临床合理使用提供参考。方法 收集2019年1月1日至2024年6月30日北京市药品不良反应监测中心收集的口服凝血因子Xa抑制剂（利伐沙班、艾多沙班、阿哌沙班）ADR报告,对ADR报告的性别、年龄、ADR累及系统-器官及临床表现、ADR处置及转归情况、严重ADR等信息进行分析。结果 共收集利伐沙班ADR报告199例,艾多沙班ADR报告23例,无阿哌沙班的ADR相关报告。利伐沙班、艾多沙班ADR报告男女比例分别为1.05∶1、1∶1;平均年龄均在70岁以上;严重ADR比例分别为6.14%、16.00%。利伐沙班ADR主要累及血管、出血及凝血疾病,胃肠疾病,尿路疾病等,其中全身各部位出血相关ADR占58.77%。艾多沙班ADR主要累及胃肠疾病,血管、出血及凝血疾病,呼吸系统疾病等,其中全身各部位出血ADR占76.00%。结论 口服凝血因子Xa抑制剂出血是其最主要ADR,对高出血风险的患者应加强监护,同时说明书未载明的ADR（利伐沙班致紫癜、白细胞减少症、紫绀、高尿酸血症,艾多沙班致腹泻）需要临床关注和进一步研究。

关键词: 口服, 凝血因子Xa抑制剂, 利伐沙班, 艾多沙班, 血管, 出血, 凝血, 药品不良反应

Abstract: Objective To analyze the reports of adverse drug reactions (ADR) caused by factor Xa inhibitors in Beijing, find out about the characteristics of ADR associated with these drugs, and provide references for rational clinical use. Methods ADR reports of factor Xa inhibitors (rivaroxaban, edoxaban and apixaban) collected by Beijing Center for ADR Monitoring from January 2019 to June 2024 were retrieved. The gender and age of patients, organs and systems involved, clinical manifestations, management and outcomes of ADR, and severe cases of the ADR were statistically analyzed. Results A total of 199 ADR reports concerning rivaroxaban and 23 concerning edoxaban were collected, with no ADR reports related to apixaban. The male-to-female ratio was 1.05∶1 for rivaroxaban and 1∶1 for edoxaban based on these ADR. The age of these patients averaged over 70 years. The proportion of severe ADR was 6.14% for rivaroxaban, compared with 16.00% for edoxaban. The ADR of rivaroxaban involved blood vessels, bleeding and coagulation disorders, gastrointestinal disorders and urinary disorders, with bleeding-related adverse reactions accounting for 58.77% of the cases. The ADR of edoxaban included gastrointestinal disorders, blood vessel disorders, bleeding and coagulation disorders and respiratory system disorders, with bleeding-related adverse reactions making up 76.00% of the reported cases. Conclusion Bleeding is the most significant ADR caused by factor Xa inhibitors. Patients at high risk of bleeding should be closely monitored. Meanwhile, ADR not explicitly stated in drug inserts require more attention and research.

Key words: Oral, Factor Xa Inhibitors, Rivaroxaban, Edoxaban, Vascular, Bleeding, Coagulation Disorders, Drug Adverse Reactions

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