Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (11): 1020-1024.
DOI: 10.19803/j.1672-8629.2021.11.05

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Clinical Characteristics and Rationality of Drug Usage in Antibiotic Agents Related Liver Injury

LI Jiayi1,2, GE Feilin1, CAO Junling1,3#, ZHOU Xiaochun1, GAO Yunjuan2, MU Guangdi2, ZHAO Xu2, CAO Boya1, GUO Yuming2,*   

  1. 1College of Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, China;
    2Department of Liver Disease, the Fifth Medical Center of Chinese PLA General Hospital Beijing 100039, China;
    3Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100071, China
  • Received:2021-04-23 Published:2021-11-18

Abstract: Objectiv eTo investigate the potential risk signals of liver injury in order to provide data for rational use of antibiotic agents. Methods ADR reports on liver injury related to antibiotic agents and collected between January 1, 2012 and December 31, 2016 were retrospectively analyzed to find the main clinical characteristics and ways in which these drugs were used. The reporting odds ratio (ROR) method was used to analyze the risk stratification. Results There were 2 938 ADR reports and male patients outnumbered female ones (1.83∶1) in our study. The median age of these patients was 53. The largest proportion (25.73%) of these patients was 45-60 years old. Moreover, the top five antibiotic agents were lactams, cephalosporins, quinolones, antifungals and macrolactones. The highest ROR in children aged 0 to 14 versus the entire population was observed for erythromycin (ROR, 11.19; 95% CI: 4.33~28.92) and mezlocillin (ROR, 5.07; 95% CI: 1.43~18.04) in penicillins and macrolides agents. The highest ROR in patients aged 45 to 59 was observed for ceftazidime (ROR, 1.80; 95% CI: 1.07~3.04) in cephalosporins. The highest ROR in patients aged 60 to 74 was observed for piperacillin-sulbactam (ROR, 1.64; 95% CI: 1.069~2.53) in lactams. Conclusion Antibiotic agents related liver injury is more common in elder patients. However, the risk of liver injury caused by different categories of antibiotics varies in different age groups. The risk difference in clinical use of drugs should be fully assessed for the sake of safety.

Key words: antibiotic agents, liver injury, risk signal, drug safety, adverse drug reaction

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