Humans ; Liver Failure ; diagnosis ; therapy

Humans ; Liver Cirrhosis ; diagnosis ; etiology ; therapy

Autoimmune Diseases ; diagnosis ; therapy ; Humans ; Liver Diseases ; diagnosis ; therapy

Humans ; Liver Cirrhosis ; diagnosis ; therapy

Humans ; Liver Cirrhosis, Biliary ; diagnosis ; etiology ; therapy

China ; epidemiology ; Education, Medical, Continuing ; Hepatitis B ; epidemiology ; prevention & control ; Hepatitis B Vaccines ; immunology ; Humans ; Practice Guidelines as Topic ; Vaccination

Humans ; Liver Diseases

Angiotensin II Type 1 Receptor Blockers ; therapeutic use ; Antiviral Agents ; therapeutic use ; Biomarkers ; blood ; Biopsy ; Elasticity Imaging Techniques ; Humans ; Liver Cirrhosis ; diagnosis ; etiology ; therapy

Hepatic Stellate Cells ; Humans ; Liver Cirrhosis ; diagnosis ; metabolism ; Signal Transduction

OBJECTIVE:To excavate and evaluate the security alert signals of linezolid after marketing,and to provide refer-ence for rational drug use in clinic. METHODS:The reporting odds ratio(ROR)method was used to excavate the security alert signals from the adverse drug events(ADE)data in the OpenFDA platform of FDA during second quarter of 2004-2016. The low-er limit of 95%CI >1 was regarded as suggestive of ADE alert signal. RESULTS:A total of 6828534 reports were extracted, among which there were 7224 reports mainly induced by linezolid. Top 10 ADE reports were thrombocytopenia,drug interac-tion,thrombocytopenia,nausea,anaemia,serotonin syndrome,diarrhoea,pyrexia,drug ineffective,vomiting. After the detec-tion of top 200 ADE reports by ROR method,120 signals related to 18 system organ class(SOC)were identified. Top 5 ADE sig-nals in turn by SOC were medical examination,nervous system disorders,blood and lymphatic system disorders,metabolism and nutrition disorders,cardiac disorders. The high risk signals with clinical reference value included 42 cases of optic neuropathy (ROR=56.33),350 cases of serotonin syndrome(ROR=52.86),162 cases of lactic acidosis(ROR=18.30),31 cases of endo-carditis (ROR=15.38),566 cases of thrombocytopenia (ROR=14.29),122 cases of bone marrow failure (ROR=14.20),261 cases of panhematopenia (ROR=11.92),86 cases of disseminated intravascular coagulation (ROR=10.91),58 cases of toxic epidermal necrolysis(ROR=9.06),etc. As for ADE reports,male was slightly higher than female,and the patients in age group of ≥45 reported evidently more compared to younger age group. CONCLUSIONS:By detecting and evaluating alert signals of li-nezolid through OpenFDA platform,we could effectively lay the foundation for further research of pharmacovigilance.