Chinese Journal of Pharmacovigilance ›› 2025, Vol. 22 ›› Issue (3): 271-275.
DOI: 10.19803/j.1672-8629.20240720

• Orginal Article • Previous Articles     Next Articles

Big Data Analysis of Liver Adverse Reactions Monitoring of Chinese and Western Medicines Based on Age Correction and Risk Warning for Dermatologic Drugs

LONG Minjuan1,2, ZHAO Xu, GUO Longxin2, CAI Yuhan3, LIN Li2, ZHU Shengkai2, LIU Wenlong1, SONG Haibo4#, XIAO Xiaohe1,2,*   

  1. 1School of Pharmacy, Hunan University of Chinese Medicine, Changsha Hunan 410208, China;
    2China Military Institute of Chinese Materia, the Fifth Medical Centre, Chinese PLA General Hospital, Beijing 100039, China;
    3The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine, Changsha Hunan 410208, China;
    4Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China
  • Received:2024-09-14 Online:2025-03-15 Published:2025-03-17

Abstract: Objective To explore the relationship between age and the risk of drug-induced liver injury (DILI), and to study the impact of age on the risk of adverse reactions induced by Chinese and Western medicines. Methods Reports about adverse drug reactions related to DILI were retrospectively analyzed, and the number of ADR reports was adjusted demographically based on the data of a census. The way in which the risk of DILI changed with age, the usage of categorized drugs and the characteristics of drugs of special varieties were analyzed. Results After age correction, the incidence of liver injury was found to increase with the age of users of traditional Chinese medicines and Western medicines in particular. Analysis by drug category showed that the risk of DILI increased with age, except for Western medicines used for the nervous system, traditional Chinese medicines and Western medicines for skin diseases. DILI due to traditional Chinese medicines for dermatologic diseases caused a larger number of serious adverse reactions than Western medicines. The underlying diseases of patients were mostly vitiligo, psoriasis and alopecia. Preparations involving Dictamni cortex, Polygonum multiflorum, Psoralea corylifolia were high-risk drugs. Conclusion The risk of DILI is positively correlated with age for most drugs. The risk posed by drugs for DILI and by traditional Chinese medicines for skin diseases deserves more attention so as to prevent the occurrence of serious adverse reactions.

Key words: Adverse Drug Reaction, Drug-Induced Liver Injury, Age, Skin Medicine, Risk Signal

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