ABSTRACT
Idiosyncratic drug-induced liver injury(IDILI)is an adverse drug reaction that occurs only in a minority of the population. IDILI also has many characteristics such as unpredictable and low morbidity, its occurrence has often not been clearly correlated with the dose, route, or duration of drug administration. Several studies have shown that IDILI is a synergistic effect which was caused by body diathesis, environment and drugs. In addition, evidence also suggests that most IDILIs are mediated by immunity. Chemical medicines-related IDILIs have been extensively studied, and a variety of immunological mechanism hypotheses have also emerged to explain the pathogenesis and characteristics of chemical medicines-related IDILIs. However, the traditional Chinese medicine(TCM)-related IDILI has always been neglected due to the complexity and specificity of TCM. In recent years, TCM-related IDILI has been gradually confirmed by researchers, and formed a new hypothesis, a immunological stress-mediated tri-elements synergetic mechanism hypothesis, which can reveal the pathogenesis and clinical characteristics of TCM-related IDILI. This paper is prepared to summarize the immunological mechanism hypotheses of chemical medicine-related IDILI and TCM-related IDILI to provide a scientific basis for guiding IDILI research and establishing its clinical risk prevention and control measures.
ABSTRACT
In recent years, the report of adverse reaction of traditional Chinese medicine(TCM), especially the traditional non-toxic TCM-induced liver injury problems have been repeatedly arising, causing serious concerns about the safety of TCM from the public, and meanwhile there is a huge controversy about the objectivity of traditional non-toxic TCM-induced liver injury as well. How to scientifically acknowledge the side effects of traditional non-toxic TCM has become one of the most challenging and difficult international problems in this field. Previous studies may only focus on the search for toxic substances and toxic mechanisms from the perspective of drugs, so there is little attention and research on the factors that it may be caused by patients' bodies, especially the immune-mediated idiosyncratic drug induced liver injury. This paper carries on the analysis to the TCM-induced liver injury from the angles of objective identification and evaluation problems, elaborates the relationship between the immune and drug-induced liver injury, taking the traditional non-toxic TCM Polygonum Multiflorum as an example to analyze the objective authenticity and mechanism of immune-mediated idiosyncratic drug induced liver injury, on which basis the immunological stress "Three Factors Causing toxicity" mechanism hypothesis of idiosyncratic TCM-induced liver injury has been frist put forward. This hypothesis also provides a theoretical basis for the objective identification and evaluation of traditional non-toxic TCM-induced liver injury, innovate and develop a new evaluation model and method of TCM's safety, which has a significant value for revealing the objectivity of TCM-induced liver injury.