Safety evaluation of edaravone in clinical application / 中华神经科杂志

ABSTRACT

Objective To analyze the adverse drug reactions(ADRs)of edaravone in treatment of patients with acute cerebral infarction(ACI)by reviewing Chinese medical literature and to evaluate safety of edaravone treatment in ACI.Methods Publications from Pubmed and Chinese Biomedical Literature Datababe(CBMdisc)were reviewed and the ADR of edaravone was analyzed among the published 8645 cases.Literatures about randomed-control clinical trails(RCTs)on security of edaravone for treating ACI Was analyzed by meta-analysis.Results Abnormal hepatic function,especially mild elevation of aminotransferase,renal dysfunction and skin rash induced by edaravone were tIle most common ADRs.Among 8645 patients,ADRs were reported in 283(3.27 % ).The meta-analysis in RCTs showed that between the group treated with a combination of edaravone and routine and the group treated with routine treatment only,there was no significant difference in the occurrence rate of ADRs(OR=1.18,95 % CI0.70-2.00,P=0.536),elevation of aminotransferase(OR=1.23,95 % CI 0.57-2.68,P=0.595)or renal dysfunction including albuminutia,increased level of serum ereatinine and nitrogen(OR=1.65.95 % CI0.57- 4.79.P=0.353).Conclusion Edaravone has a low ADRs OCCurrence rate and iS safely used in cerebral infarction treatment.