Signal Mining on Adverse Drug Events of Cisplatin-and Carboplatin-Induced Thromboembolism
10.3870/j.issn.1004-0781.2025.09.011
- VernacularTitle:顺铂和卡铂致血栓栓塞的不良事件信号挖掘
- Author:
Qinfang ZHU
1
;
Yangyun ZHOU
;
Yonglong HAN
Author Information
1. 江西中医药大学药学院,南昌 330000;上海交通大学医学院附属第六人民医院药剂科,上海 200233
- Publication Type:Journal Article
- Keywords:
Cisplatin;
Carboplatin;
Thromboembolism;
Adverse drug reactions;
Signal mining
- From:
Herald of Medicine
2025;44(9):1440-1447
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore and evaluate the adverse drug events(ADE)signals of thromboembolic events induced by cisplatin and carboplatin,and to provide references for clinical safety and rational use of drugs.Methods The cisplatin-and carboplatin-related thromboembolic adverse events reports were collected from the U.S.FDA Adverse Event Reporting System(FAERS)database with the reporting time range from the first quarter of 2004 to the fourth quarter of 2023.Thromboembolic ADR signals were detected using the reporting odds ratio(ROR)method,the medicines and healthcare products regulatory agency(MHRA)method,and the Bayesian confidence propagation neural network(BCPNN)method at the SMQ level and preferred term(PT)level.Results A total of 1 959 cisplatin-related thromboembolism events and 2 524 carboplatin-related thromboembolism events were reported.In terms of gender composition,after excluding reports with unspecified gender,the ratio of male to female was 1.69∶1 for cisplatin and 0.65∶1 for carboplatin.For cisplatin,triple signals were generated at the"thromboembolic events"SMQ level as well as its sub-levels"venous thromboembolic events",and dual signals were generated at the"arterial thromboembolic events"sub-level.However,for carboplatin,dual signals were generated at the"thromboembolic events"SMQ level,and three signals were generated only at the"venous thromboembolic events"sub-level.The PT hierarchy analysis of thromboembolic events revealed that except for"thrombotic microangiopathy"produced single signal,signals generated by cisplatin were all triple signals,among which"aortic thrombosis"(ROR 95%CI lower limit=72.59,IC-2SD=5.93)exhibited the strongest signal intensity.Different from cisplatin,except for"acute myocardial infarction","ischemic stroke",and"cerebral infarction",which generated dual signals,"aortic thrombosis",which generated a single signal,all the other signals produced by carboplatin were triple signals.Additionally,"venous occlusive liver disease"(ROR 95%CI lower limit=11.58,IC-2SD=3.35)displayed the strongest signal intensity.Among various types of thromboembolic events,both cisplatin-and carboplatin-related"pulmonary embolism"and"deep vein thrombosis"were reported the highest number,ranking first and second,respectively.Conclusions In this study,cisplatin and carboplatin were proven to increase the risk of thromboembolic adverse events.Cisplatin was associated with potential risks of"venous thromboembolism"and"arterial thromboembolism",while carboplatin was associated with"venous thromboembolism".Therefore,attention should be paid to the above risks during clinical use.
