基于区域监测数据的抗凝药物安全性评价:一项2020–2025年的回顾性研究

Safety Evaluation of Anticoagulants Based on Regional Surveillance Data: A Retrospective Study from 2020 to 2025

关键词:  抗凝药物  药品不良反应  药物安全性监测  回顾性研究

Key words:  anticoagulants  adverse drug reactions (ADR)  drug safety monitoring  retrospective study

摘要:

目的 分析潍坊市2020–2025年抗凝药物不良反应(ADR)的发生特征与分布规律,为临床安全用药提供参考。方法 采用回顾性研究方法,提取潍坊市药品不良反应监测中心2020年1月至2025年10月上报的四大类抗凝药物(肝素类药物、直接Xa因子抑制剂、维生素K拮抗剂、直接凝血酶抑制剂)ADR报告,对人口学特征、用药原因、ADR类型、累及系统及转归等进行统计分析。结果 共纳入684例ADR报告,肝素类药物的报告数量最多(513例,75.00%)。ADR主要集中在65岁以上老年患者(55.85%),女性略多于男性(55.56%)。严重ADR比例较高(48.54%),其中直接Xa因子抑制剂严重报告占比最高(58.42%)。出血为最常见ADR,直接Xa因子抑制剂出血相关ADR占比达55.46%,显著高于肝素类(23.92%)和维生素K拮抗剂(33.33%)。非出血性ADR存在类别差异,肝素类药物以皮肤及肝胆系统反应为主,直接Xa因子抑制剂常见胃肠道症状。结论 该地区抗凝药物ADR具有明显的药物类别差异和人群特征,反映出其不同的临床应用模式与安全性特征,为后续药物安全性评价与合理用药提供了重要数据支持。建议临床根据患者出血风险、年龄、肝肾功能及合并用药等情况个体化选择抗凝药物,加强对出血事件及特定药物非出血反应的监测,完善ADR报告体系,以提升抗凝治疗的安全性。

Abstract:

ABSTRACT: Objective?To analyze the characteristics and distribution patterns of adverse drug reactions (ADRs) associated with anticoagulants in Weifang City from 2020 to 2025, and to provide references for clinical medication safety. Methods?A retrospective study was conducted using ADR reports for four categories of anticoagulants (heparins, direct factor Xa inhibitors, vitamin K antagonists, and direct thrombin inhibitors) collected by the Weifang City ADR Monitoring Center from January 2020 to October 2025. Statistical analysis was performed on demographic characteristics, reasons for medication, ADR types, systems affected, and outcomes. Results?A total of 684 ADR reports were included. Heparins accounted for the highest number of reports (513 cases, 75.00%). ADRs were primarily concentrated in patients aged over 65 years (55.85%), with a slightly higher proportion in females (55.56%). The proportion of serious ADRs was high (48.54%), with direct factor Xa inhibitors having the highest percentage of serious reports (58.42%). Bleeding was the most common ADR. The proportion of bleeding-related ADRs for direct factor Xa inhibitors reached 55.46%, significantly higher than that for heparins (23.92%) and vitamin K antagonists (33.33%). Non-bleeding ADRs showed category-specific differences: skin and hepatobiliary system reactions were predominant for heparins, while gastrointestinal symptoms were common for direct factor Xa inhibitors. Conclusion ADRs associated with anticoagulants in this region exhibits distinct Inter-class variation and population characteristics, reflecting their different clinical application patterns and safety profiles. This study provides important data for subsequent drug safety evaluation and rational drug use. It is recommended that clinicians individualize the selection of anticoagulants based on the patient's bleeding risk, age, liver and kidney function, and concomitant medications, strengthen the monitoring of bleeding events and specific drug-related non-bleeding reactions, and improve the ADR reporting system to enhance the safety of anticoagulant therapy.