基于openFDA对利伐沙班及阿哌沙班药品不良反应的比较

doi:10.19803/j.1672-8629.2021.08.18

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (8): 780-783.
DOI: 10.19803/j.1672-8629.2021.08.18

基于openFDA对利伐沙班及阿哌沙班药品不良反应的比较

凌涛^1,2, 徐瑞娟¹, 葛卫红^1,*

¹南京大学医学院附属鼓楼医院药学部,江苏南京 210008;
²中国药科大学基础医学与临床药学学院,江苏南京 210009

收稿日期:2019-12-30 出版日期:2021-08-15 发布日期:2021-08-17
通讯作者: ^*葛卫红,女,主任药师,医院药学。E-mail：6221230@sina.com
作者简介:凌涛,女,在读硕士,初级药师,临床药学·医院药学。
基金资助:
南京药学会—常州四药医院药学科研基金（2016YX001）

Comparison Analysis of Adverse Drug Reactions of Rivaroxaban and Apixaban Based on OpenFDA

LING Tao^1,2, XU Ruijuan¹, GE Weihong^1,*

¹Department of Pharmacy, Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing Jiangsu 210008, China;
²School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing Jiangsu 210009, China

Received:2019-12-30 Online:2021-08-15 Published:2021-08-17

摘要/Abstract

摘要： 目的利用美国食品药品管理局公共数据开放项目（openFDA）检索口服抗凝药物利伐沙班及阿哌沙班的药品不良反应（ADR）报告,对比分析两药的ADR相关情况,为医院药品品种引进和临床合理用药提供参考依据。方法使用openFDA数据库中ADR端点的交互式图表板块访问API,检索openFDA数据库中2004年1月1日~2019年8月12日间提交的利伐沙班、阿哌沙班的ADR报告,对相关数据进行提取分析。结果利伐沙班及阿哌沙班的ADR报告数目分别为6 766份、10 513份,主要由医生上报,ADR集中发生于美国,且发生人群集中分布于（65~82）岁,两药都可用于深静脉血栓和肺栓塞的预防和治疗等,主要ADR为出血。结论基于openFDA大数据库能对两药的ADR相关信息进行分析,为有效开展药学监护、及时处理ADR提供参考,但数据质量存在一定的缺陷,有待进一步完善。

关键词: 利伐沙班, 阿哌沙班, openFDA, 药品不良反应

Abstract: Objective To search for reports of adverse reactions caused by oral anticoagulant drugs-rivaroxaban and apixaban by using openFDA, and compare the adverse reactions of the two drugs in order to provide reference for clinical rational drug use. Methods Reports of adverse reactions caused by rivaroxaban and apixaban that were submitted between January 1, 2004 and August 12, 2019 to the openFDA database were searched for using the interactive chart section access API for Adverse Drug Reaction Endpoints. Relevant data and charts were retrieved and analyzed. Results There were 6 676 and 10 513 ADR reports of rivaroxaban and apixaban respectively, which were mostly reported by doctors. The adverse reactions occurred in the United States, and the affected population ranged from 65 to 82 years old. Rivaroxaban and apixaban could be used for the prevention and treatment of deep vein thrombosis and pulmonary embolism, but the main adverse reaction was bleeding. Conclusion Based on the openFDA large databases, the ADR related information of the two drugs can be analyzed, which provides data for effective drug monitoring and immediate treatment of adverse reactions, but the data has some flaws and needs to be improved.

Key words: rivaroxaban, apixaban, openFDA, adverse drug reactions

中图分类号:

R994.1

凌涛, 徐瑞娟, 葛卫红. 基于openFDA对利伐沙班及阿哌沙班药品不良反应的比较[J]. 中国药物警戒, 2021, 18(8): 780-783.

LING Tao, XU Ruijuan, GE Weihong. Comparison Analysis of Adverse Drug Reactions of Rivaroxaban and Apixaban Based on OpenFDA[J]. Chinese Journal of Pharmacovigilance, 2021, 18(8): 780-783.

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基于openFDA对利伐沙班及阿哌沙班药品不良反应的比较

Comparison Analysis of Adverse Drug Reactions of Rivaroxaban and Apixaban Based on OpenFDA

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