Analysis of adverse events of polatuzumab vedotin and fam-trastuzumab deruxtecan-nxki based on OpenFDA database
10.13699/j.cnki.1001-6821.2024.06.025
- VernacularTitle:基于openFDA的维泊妥珠单抗和德曲妥珠单抗不良事件分析
- Author:
Mao LIN
1
;
Guan-Min ZHANG
;
Gui-Sen YIN
;
Cai-Se LING
;
Hong-Tao XIAO
;
Yan-Hua ZHANG
Author Information
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
- Keywords:
polatuzumab vedotin;
fam-trastuzumab deruxtecan-nxki;
adverse drug event;
proportional reporting ratio method;
reporting ratio method;
data mining
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(6):904-908
- CountryChina
- Language:Chinese
-
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.
