| アブストラクト | We described ceftriaxone-induced CNS adverse events through the largest case series of Adverse Drug Reactions (ADRs) reports, from 1995 to 2017, using the French Pharmacovigilance Database. In total, 152 cases of serious CNS ADRs were analyzed; 112 patients were hospitalized or had a prolonged hospitalization (73.7%), 12 dead (7.9%) and 16 exhibited life-threatening ADRs (10.5%). The median age was 74.5 years, mainly women (55.3%), with a median creatinine clearance of 35 mL/min. Patients mainly exhibited convulsions, status epilepticus, myoclonia (n = 75, 49.3%), encephalopathy (n = 45, 29.6%), confused state (n = 34, 22.4%) and hallucinations (n = 16, 10.5%). The median time of onset was 4 days, and the median duration was 4.5 days. The mean daily dose was 1.7 g mainly through an intravenous route (n = 106, 69.7%), and three patients received doses above maximal dose of Summary of Product Characteristics. Ceftriaxone plasma concentrations were recorded for 19 patients (12.5%), and 8 were above the toxicity threshold. Electroencephalograms (EEG) performed for 32.9% of the patients (n = 50) were abnormal for 74% (n = 37). We described the world's biggest case series of ceftriaxone-induced serious CNS ADRs. Explorations (plasma concentrations, EEG) are contributive to confirm the ceftriaxone toxicity-induced. Clinicians may be cautious with the use of ceftriaxone, especially in the older age or renal impairment population. |
|---|
| 組織名 | Centre Regional de Pharmacovigilance, Service de Pharmacologie Clinique, APHM,;INSERM, Institut Neurosciences Systeme, UMR 1106, Aix Marseille Universite, 13005;Marseille, France.;Centre Regional de Pharmacovigilance et d'Information sur le Medicament;Centre-Val-de-Loire, Service de Pharmacosurveillance, Centre Hospitalier Regional;Universitaire de Tours, 37000 Tours, France.;Service de Pharmacologie Medicale et Clinique, Centre de Pharmacovigilance,;Pharmacoepidemiologie et d'Informations sur le Medicament, Centre Hospitalier;Universitaire, Faculte de Medecine, 31000 Toulouse, France.;Unite Clinique de Pharmacologie Psychiatrique, Faculte de Medecine, Centre;Hospitalier Universitaire, 31000 Toulouse, France.;Department of Anaesthesiology and Critical Care Medicine, University Hospital;Timone, Aix Marseille Universite, 13005 Marseille, France.;CNRS, INT, Institut Neurosci Timone, UMR 7289, Aix Marseille Universite, 13005;Laboratoire de Pharmacologie Clinique, Service de Pharmacologie Clinique, APHM, |
|---|
