Signal mining and analysis of nervous system adverse events induced by polymyxin B and polymyxin E based on FAERS database

GAO Hongzhu; LIU Yue; JIN Shanzi; XU Fengping; ZOU Dongna

doi:10.13506/j.cnki.jpr.2025.08.016

Abstract：Objective To provide a reference basis for the rational clinical use of polymyxin B(PMB)and polymyxin E(PME).Methods Based on the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)data from the first quarter of 2004 to the third quarter of 2024,data mining was conducted using Reporting Odds Ratios(ROR),Medicines and Healthcare products Regulatory Agency(MHRA),and Bayesian Confidence Propagation Neural Network(BCPNN).Results 24 and 91 patients with nervous system adverse events(AE)related to PMB and PME,respectively.Most reports came from the US(70.83％for PMB,30.77％for PME),with physicians and pharmacists as the main reporters.Most patients were relatively young(median age 32 for PMB and 48 for PME).In patients under 44 years of age,the constituent ratio of AE associated with PMB is higher than that with PME.PMB had a higher constituent ratio than PME in patients with cystic fibrosis and exacerbated lung disease(35.84％VS 5.49％).PMB posed a greater constituent ratio of nervous system AE than PME(ROR[95％CI],1.58[1.13,2.20];PRR[95％CI],1.51[1.13,2.01];x2,7.46;IC[IC-2SD],0.59[0.09]).PMB was associated with a higher constituent ratio of peripheral nervous system issues,while PME had a higher constituent ratio related to the neuromuscular tube.In addition,PMB and PME show different neurological AE at different drug doses.Conclusion PMB and PME-related nervous system AE risks differ in age,indication,type,and drug dose.In clinical practice,attention should be paid to the use of neurotoxic protective agents,improve vigilance and other countermeasures to ensure the safety of patients.