运用信息成分方法分析伊布替尼的不良反应

doi:10.19803/j.1672-8629.20210683

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (11): 1228-1232.
DOI: 10.19803/j.1672-8629.20210683

运用信息成分方法分析伊布替尼的不良反应

郑轶, 郭晓晶, 许金芳, 郭志坚, 迟立杰, 陈晨鑫, 梁际洲, 韦连慧, 陈枭, 叶小飞^#, 贺佳^*

海军军医大学卫勤系军队卫生统计学教研室,上海 200433

收稿日期:2021-07-16 发布日期:2022-11-17
通讯作者: ^*贺佳,女,教授•博导,药物流行病学及新药评价。E-mail: hejia63@yeah.net;^#为共同通信作者。
作者简介:郑轶,男,硕士,药物流行病学。
基金资助:
国家自然科学基金（82073671）; 上海市自然科学基金（18ZR1449500）; 军队双重建设项目-03; 上海市卫计委优秀青年医学人才培养计划（2018YQ47）; 上海市公共卫生学科带头人（GWV-10.2-XD22）; 上海市公共卫生优青计划（GWV-10.2-YQ33）

Analysis of adverse reactions of ibrutinib with information component method

ZHENG Yi, GUO Xiaojing, XU Jinfang, GUO Zhijian, CHI Lijie, CHEN Chenxin, LIANG Jizhou, WEI Lianhui, CHEN Xiao, YE Xiaofei^#, HE Jia^*

Department of Health Statistics Military Medical Service, Naval Medical University, Shanghai 200433, China

Received:2021-07-16 Published:2022-11-17

摘要/Abstract

摘要： 目的全面系统地挖掘伊布替尼导致的药品不良反应（ADR）,为临床医生安全用药提供参考。方法运用信息成分（IC）方法,基于美国食品药品监督管理局(FDA)不良事件报告系统（FAERS）数据库对从建库至2021年6月1日中伊布替尼的ADR进行挖掘。结果 FAERS数据库种共有伊布替尼ADR报告20 120份,检测出阳性信号445个,包括Richter 综合征[IC的95%置信区间下限（IC₀₂₅）=5.67]和脑曲霉病（IC₀₂₅ =5.05） 2种IC₀₂₅>5的强信号ADR。房颤（n=982, IC₀₂₅=3.33, IC=3.44）, 疲乏(n=958, IC₀₂₅=0.36, IC=0.47),腹泻（n=931, IC₀₂₅=0.64, IC=0.75）是3种发生频数最高的ADR,其报告数均超过900份。结论伊布替尼在多个系统存在较为广泛的ADR,临床医生应充分关注其ADR,并及时采取相应措施保证患者的用药安全。

关键词: 伊布替尼, 药品不良反应, 不成比例分析方法, 美国食品药品监督管理局不良事件报告系统数据库

Abstract: Objective To comprehensively and systematically explore the possible adverse drug reactions (ADR) of ibrutinib, and provide references for clinicians’ safe medication. Methods The ADR signals of ibrutinib were mined on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database using Information Component (IC) method. Results A total of 20 120 ADR reports of ibrutinib were included in FAERS database from the construction of the library to Jun 1, 2021, and 446 positive signals were detected, including two strong ADR signals with IC₀₂₅>5, which were Richter syndrome (IC₀₂₅ =5.67) and cerebral aspergillosis (IC₀₂₅ =5.05). The top 3 ADR were atrial fibrillation (n=982, IC₀₂₅=3.33, IC=3.44), fatigue (n=958, IC₀₂₅=0.36, IC=0.47), diarrhea (n=931, IC₀₂₅=0.64, IC=0.75), the reports of which also exceed 900. Conclusion Ibrutinib has more widespread ADR in multiple systems. Clinicians should pay full attention to its ADR, and take corresponding measures in time to ensure the safety of patients’ medication.

Key words: Ibrutinib, adverse drug reaction, disproportionate analysis, FAERS database

中图分类号:

郑轶, 郭晓晶, 许金芳, 郭志坚, 迟立杰, 陈晨鑫, 梁际洲, 韦连慧, 陈枭, 叶小飞, 贺佳. 运用信息成分方法分析伊布替尼的不良反应[J]. 中国药物警戒, 2022, 19(11): 1228-1232.

ZHENG Yi, GUO Xiaojing, XU Jinfang, GUO Zhijian, CHI Lijie, CHEN Chenxin, LIANG Jizhou, WEI Lianhui, CHEN Xiao, YE Xiaofei, HE Jia. Analysis of adverse reactions of ibrutinib with information component method[J]. Chinese Journal of Pharmacovigilance, 2022, 19(11): 1228-1232.

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运用信息成分方法分析伊布替尼的不良反应

Analysis of adverse reactions of ibrutinib with information component method

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