Signal Mining of Bevacizumab-Related Adverse Drug Events Based on FAERS
Objective To promote the clinical safe use of bevacizumab.Methods The adverse drug event(ADE)reports with bevacizumab as the primary suspected drug from January 1,2014 to May 1,2023 were obtained by the FDA Adverse Event Reporting System(FAERS).The data mining was performed by the OpenVigil 2.1 online tool.The ADE signals were tested by the reporting odds ratio(ROR)and Bayesian confidence propagation neural network(BCPNN)methods,and they were classified and analyzed based on the preferred term(PT)and system organ classification(SOC)in the Medical Dictionary for Regulatory Activities(MedDRA)25.1.Results A total of 60 675 ADE reports with bevacizumab as the primary suspected drug were obtained,involving 60 675 patients,mainly from North America(48.78% )and Asia(29.00% );in serious ADE reports,the death reports were the most(14 358 cases,23.66% ).A total of 605 PT signals were involved in 20 127 ADE reports(20 127 patients),which could be classified into 21 SOCs;the top three SOCs with more signals were gastrointestinal diseases(89 signals),benign,malignant and unknown tumors(including cystic and polypoid tumors,68 signals),and eye organ diseases(66 signals);the top three SOCs with more cases of ADEs were systemic diseases and various reactions at the administration site(3 059 cases),blood and lymphatic system diseases(2 813 cases),vascular and lymphatic vessel diseases(2 235 cases).The top five PTs with more cases of ADE reports were disease progression(1 279 cases),hypertension(1 072 cases),anemia(585 cases),bone marrow suppression(583 cases),proteinuria(569 cases).Conclusion During the medication,clinical physicians should not only pay attention to the common ADEs induced by bevacizumab,but also focus on the serious ADEs such as hypertension,proteinuria,bone marrow suppression,bleeding,gastrointestinal perforation,and interstitial pneumonia.
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