中国临床药理学杂志2024，Vol.40Issue(6)：904-908,5.DOI:10.13699/j.cnki.1001-6821.2024.06.025
基于openFDA的维泊妥珠单抗和德曲妥珠单抗不良事件分析
Analysis of adverse events of polatuzumab vedotin and fam-trastuzumab deruxtecan-nxki based on OpenFDA database
林茂 1张关敏 2尹桂森 3凌彩色 4肖洪涛 1张艳华2
作者信息
- 1. 四川省肿瘤临床医学研究中心·四川省肿瘤医院研究所·四川省癌症防治中心·电子科技大学 附属肿瘤医院 药学部,四川 成都 610041
- 2. 北京大学肿瘤医院、北京市肿瘤防治研究所药剂科·恶性肿瘤发病机制及转化研究教育部重点实验室,北京 100142
- 3. 烟台市中医医院药学部,山东烟台 264000
- 4. 右江民族医学院附属医院药学部,广西壮族自治区百色 533000
- 折叠
摘要
Abstract
Objective To mine and analyze the adverse event data of polatuzumab vedotin(Pola)and fam-trastuzumab deruxtecan-nxki(T-Dxd),so as to provide reference for clinical medication safety.Methods The adverse events reported from January 1,2004 to June 7,2023 were extracted based on openFDA database.The suspicious risk signals were screened by the Open Vigil 2.1 data platform and ranked by signal strength and frequency of occurrence;then ADEs were classified by reference to the MedDRA 26.0.Results A total of 7 164 and 22 870 ADE reports related to Pola and T-Dxd were obtained,and 104 and 95 suspicious ADE signals were detected,respectively.According to the signal intensity,cytomegalovirus enterocolitis(ROR=416.94)for Pola and interstitial lung disease[reporting odds ratio(ROR)=82.55]for T-Dxd ranked first,both of which were recorded in the drug instructions.According to the frequency of occurrence,the two drugs were most frequently associated with death(n=111)and nausea(n=285),respectively.The risk of Pola was associated with 12 systems/organs,of which 26 risk signals were not documented in the drug instruction,and the risk of T-Dxd was associated with 13 systems/organs,of which 18 risk signals were not documented in the drug instruction.Conclusion By tapping the ADE after real-world administration of Pola and T-Dxd,physicians are prompted to pay attention to the risk of adverse reactions in clinical use and actively take preventive and therapeutic measures to ensure the safety of patients'medication.关键词
维泊妥珠单抗/德曲妥珠单抗/药品不良事件/比例报告比值法/报告比值比法/数据挖掘Key words
polatuzumab vedotin/fam-trastuzumab deruxtecan-nxki/adverse drug event/proportional reporting ratio method/reporting ratio method/data mining分类
医药卫生引用本文复制引用
林茂,张关敏,尹桂森,凌彩色,肖洪涛,张艳华..基于openFDA的维泊妥珠单抗和德曲妥珠单抗不良事件分析[J].中国临床药理学杂志,2024,40(6):904-908,5.
