Risk Signal Mining of Three New Oral Anticoagulants Based on FDA Adverse Event Reporting System Database.

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作者: 吕淑贤崔学艳梁笑笑李羚韩毅黄欣

作者单位: ² 山东省医药卫生临床药学重点实验室,济南 25001 ¹ 山东第一医科大学第一附属医院/ 山东省千佛山医院临床药学,济南 25001 ³ 山东中医药大学药学院,济南 25035

刊名: Evaluation & Analysis of Drug-Use in Hospitals of China

年份: 2023

卷号: Vol.23 No.8

页码: 1016-1024

ISSN: 1672-2124

摘要: OBJECTIVE: To mine the risk signals of three new oral anticoagulants such as dabigatran etexilate, rivaroxaban and apixaban based on big data sample analysis, so as to provide reference for rational clinical drug use. METHODS: Based on the FDA Adverse Event Reporting System database, OpenVigil 2. 1 platform was used to extract reports from the 1st quarter of 2004 to the 3rd quarter of 2021. Reporting odds ratio and proportional reporting ratio were used for signal mining. The risk signals wer...更多; OBJECTIVE: To mine the risk signals of three new oral anticoagulants such as dabigatran etexilate, rivaroxaban and apixaban based on big data sample analysis, so as to provide reference for rational clinical drug use. METHODS: Based on the FDA Adverse Event Reporting System database, OpenVigil 2. 1 platform was used to extract reports from the 1st quarter of 2004 to the 3rd quarter of 2021. Reporting odds ratio and proportional reporting ratio were used for signal mining. The risk signals were described and classified according to the preferred terms and systematic organ classification in the MedDRA . RESULTS: A total of 54 932, 112 642, and 108 850 adverse drug event reports were retrieved for dabigatran etexilate, rivaroxaban and apixaban, respectively. Adverse drug reactions with the first number of cases of dabigatran etexilate, rivaroxaban and apixaban were respectively gastrointestinal haemorrhage , gastrointestinal haemorrhage , and haemorrhage . Adverse drug reactions with the first signal intensity were gastric occult blood positive , haemorrhagic arteriovenous malformation , and spinal subarachnoid haemorrhage . Meanwhile, rivaroxaban may lead to acute kidney injury , apixaban may lead to renal impairment and hypoacusis and auditory disorder , which were not mentioned in the drug instructions and should be taken into account. The overall incidence of bleeding risk for the three new oral anticoagulants was rivaroxaban > dabigatran etexilate > apixaban. CONCLUSIONS: Dabigatran etexilate, rivaroxaban and apixaban need to be used with a focus on bleeding risk, and new risk signals for rivaroxaban and apixaban need to be followed.收起

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