Abstract:
OBJECTIVE To investigate incidences of liver injury and pancreatitis induced by tigecycline in hospitalized patients.
METHODS Retrospectively automatic monitoring method and active monitor and assessment system on adverse drug events(ADE) of medical institution were implemented for 499 inpatients who received tigecycline in hospital information system(HIS) from Mar. 2012 to Mar. 2017. The suspected cases of drug induced liver injury and acute pancreatitis warned by system were manually reviewed.
RESULTS The actual screening cases of drug induced liver injury (DILI) and pancreatitis (DIP) of 499 patients were 487 cases (97.60%) and 424 cases(84.97%). After the manual re-evaluation, there were 8 actual positive cases of drug induced liver injury and the incidence was 1.60%. No pancreatitis induced by tigecycline was found. The mean age of 8 patients with drug induced liver injury was (69.75±20.49) years old, and the mean occurrence time was (5.25±4.06) days after medication. Mild and severe liver injury were both 4 cases. There were 3 cases of hepatocellular damage (37.50%) and 5 case of cholestasis (62.50%) respectively. Totally 3 cases were cured, 2 cases were improved, and 3 cases were continued after drug withdrawal and symptomatic treatment.
CONCLUSION The incidence of liver injury induced by tigecycline is common in 499 cases of hospitalized patients which is higher than that in instruction. In consideration of limited number of cases and no pancreatitis case is found, which needs aubsequent monitoring samples. Using special software to implement automatic monitoring can efficiently and quickly obtain high-quality real world drug risk data, and assist timely identification and avoid the risk of medication in clinic.