Exploring new risk signals and susceptibility factors of traditional Chinese medicine-induced hepatotoxicity based on big data from adverse reaction monitoring
Objective To explore the method of discovering signals of hepatotoxicity risk in traditional Chinese medicine(TCM)based on national adverse reaction monitoring big data,preliminarily screen risky varieties,and analyze the susceptible factors of liver damage based on the"Trielement Injury Hypothesis"theory.Methods Retrospective analysis of adverse drug reaction(ADR)reports related to TCM-induced drug-induced liver injury(DILI)collected between 2012 and 2016.Identify suspicious TCM varieties and predict the susceptible factors for liver damage in these varieties.Results A total of 1 901 ADR reports(1 719 patients)of TCM-induced DILI were collected,and 237 suspicious TCM varieties were newly discovered.Traditional Chinese medicine used for anti-tumor purposes had the highest incidence of DILI.The oral route of administration accounted for the largest proportion(71.70%),with a median latency period of 13.00 days,and the majority of cases had a latency period of 0 to 7 days(34.46%).Analysis based on the"Trielement Injury Hypothesis"theory revealed that the TCM varieties suspected of causing DILI were related to the body's state,the drugs themselves,and the medication environment.Conclusion Discovery of a series of TCM risk signals requires further confirmation of the risk and analysis of the causal mechanisms.
traditional Chinese medicineadverse drug reactionsTrielement Injury Hypothesisliver injuryanti-tumorrisk signals
维普
万方数据
