Chinese Journal of Pharmacovigilance ›› 2024, Vol. 21 ›› Issue (1): 20-24.
DOI: 10.19803/j.1672-8629.20230785

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Investigation of objectivity in the relationship between aristolochic acid and hepatocellular carcinoma

FANG Zhie1,2, LI Chengxian1,3, BAI Zhaofang1, ZHAO Xu1, WANG Jiabo4, XIAO Xiaohe1,*   

  1. 1China Military Institute of Chinese Materia, the Fifth Medical Centre, Chinese PLA General Hospital, Beijing 100039, China;
    2Department of Pharmacy, Chongqing Hospital of Traditional Chinese of Medicine, Chongqing 400021, China;
    3Beijing University of Traditional Chinese Medicine, Beijing 100102, China;
    4School of Traditional Chinese Medicine, Capital Medical University, Beijing 100069, China
  • Received:2023-12-15 Online:2024-01-15 Published:2024-01-18

Abstract: Objective To propose risk prevention and control strategies by sorting out Objective studies on hepatocellular carcinoma caused by aristolochic acid (AA). Methods The research progress of hepatocellular carcinoma caused by AA was briefly described. The scientific significance of the re-study of the correlation between AA and hepatocellular carcinoma was elucidated. The objectivity, authenticity, and systematic research content of the study on hepatocellular carcinoma caused by AA by our group were sorted out, and the prevention and control strategies of traditional Chinese medicines containing AA were proposed. Results and Conclusion The result clarified a lack of a correlation between AA and hepatocellular carcinoma. Risk prevention and control strategies for safe use of traditional Chinese medicines and preparations containing aristolochic acid were proposed including clarification of risk-benefit ratios, comprehensive analysis of pharmaceutical research data for regulatory decision-making; adoption of graded management measures for patients with different levels of risk; establishment of quality-control methods for safety and standards for limitations; and establishment of a new method for the scientific cognition and precise evaluation of the use of traditional Chinese medicines.

Key words: aristolochic acid, hepatocellular carcinoma, safety evaluation, risk prevention and control, quality control

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