Real-world Study Of Large Samples Of Drug-induced Liver Injury Based On Automatic Monitoring System

OBJECTIVES:The automatic monitoring system was used to obtain real-world morbidity,drug distribution and risk factors in the hospitalized population of drug-induced liver injury(DILI),compared the case characteristics of severe patients and general patients,DILI patients and the database Liver Tox differences in medications provide a reference for clinically safe and rational medication.METHODS:(1)Based on the spontaneous report data in the PLA’s ADR database,screening with "Liver and biliary disorders" as the search term,including DILI patients with RUCAM ≥ 6 points,and retrospectively analyzing the epidemiological information of the target patients.(2)Used ADE-ASAS-Ⅱto retrieve the inpatients from January to March 2019 for pre-experiment and explore the setting of system conditions.(3)Used the i SAEC standard combined with the RUCAM scale to screen the electronic medical data of hospitalized patients in 2019.According to Hy’s Law,positive patients were divided into severe and general groups,and the differences between the two groups in gender,age,hospitalization time,and mortality rate were compared and analyzed.(4)Conduct a matched case-control study,and logistic regression was used to verify risk factors.RESULTS:(1)Among 2,838 reports of "Liver and biliary disorders",279 were drug-induced liver injury with RUCAM score ≥6.The top 3 drug categories were anti-infective agents,cardiovascular system agents,and antineoplastic agents.The average incubation period was 27.52 days.(2)The distribution of DILI types of different drugs was different.Carbapenem drugs were more prone to cholestatic DILI,while other β-lactams,synthetic antibacterial drugs,antitumor drugs and traditional Chinese medicines were mainly hepatocellular injury.(3)In 2019,there were 201,299 hospitalized patients,156,570 patients with complete indicators,499 DILI-positive cases,and the incidence rate was 0.32%.The top three drugs were anti-infective agents,antineoplastic agents,and non-steroidal anti-inflammatory drugs;cefoperazone,voriconazole and meropenem were the top three varieties in order of frequency.There were 114 cases of severe patients in compliance with Hy’s law.Compared with general DILI patients,severe patients were older(P=0.005),had a longer hospital stay(P=0.026),and had a higher mortality rate.Automatic monitoring saves 95.82% of the manual screening time of medical records.(4)Patients with hyperlipidaemia(AOR: 1.884),pre-existing liver disease(AOR: 1.827),cardiovascular disease(AOR: 1.465),and surgical history(AOR: 1.312)were statistically significant in logistic regression,which are risk factors for DILI.CONCLUSIONS:This research was the first domestic DILI large-sample,information-based,real-world research based on hospitalized populations.The automatic monitoring was efficient and fast,data traceability was good,and the results were accurate and reliable.(1)In spontaneous reports,DILI was characterized by a long incubation period,more men than women,and a wide distribution of drugs involved;ADR report data with detailed information could meet the evaluation criteria of the RUCAM scale.(2)Hy’s law could predict the development of ADR in advance and could be used in post-market research and risk monitoring plans for drugs.During treatment,attention should be paid to changes in patient-related indicators.(3)The incidence of DILI among hospitalized patients was occasional,and the information of Liver Tox could assist in the diagnosis of DILI.It is recommended to focus on the liver function of patients with hyperlipidemia,heart disease,hepatobiliary disease,and history of surgery.(4)ADE-ASAS-Ⅱ was used for the screening of target patients under the full-drug condition,which greatly reduces the time of manual screening.With this system,large sample real-world study could be carried out efficiently and conveniently.