Analysis Of Clinical Characteristics And TCM Syndrome Types Of Immune-mediated Drug-induced Liver Injury

Objective:To retrospectively analyze the clinical characteristics of patients with immune-mediated drug-induced liver injury(IM-DILI)and the distribution of TCM evidence patterns,and to explore the differences in the pathogenesis,severity and recovery time of immune-related drug-induced liver injury and non-immune-mediated drug-induced liver injury,in order to provide a reference for clinical research on the mechanisms and characteristics of immune involvement in drug-induced liver injury.The clinical characteristics of patients with immune-mediated drug-induced liver injury(IM-DILI)and the distribution of TCM evidence patterns were retrospectively analysed to explore the differences in the pathogenesis,severity and recovery time of immune-related drug-induced liver injury and non-immune-mediated drug-induced liver injury.This study will provide a reference for clinical research on the mechanisms and characteristics of immune involvement in drug-related liver injury.Methods:1.Retrospective analysis of all patients considered for diagnosis of DILI who attended the outpatient clinic or were admitted to the the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from January 2015 to November 2021 was performed in a total of 271 cases,of which 94 were ANA-positive patients and 177 were ANA-negative patients in the control group.In this study,the general conditions(including gender,age,comorbid diseases,etc.),liver function(including ALT,AST,GGT,ALP,TBIL),immune indexes(including ANA,Ig G,Ig M),medication status(including specific drugs or types of drugs causing liver injury),prognosis(including the time required for cure or improvement,chronicity)and other information,and compare the clinical characteristics and whether there is any difference in prognosis between the two groups by statistical analysis.2.A total of 94 patients with IM-DILI who attended the outpatient clinic or were admitted to the Department of Hepatobiliary Medicine of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from January 2015 to November 2021 were retrospectively analyzed.According to the clinical symptoms and tongue pulse,the patients were divided into five syndromes of liver depression and spleen deficiency,damp-heat jaundice,qi stagnation and blood stasis,cold dampness and blood stasis,liver-kidney Yin deficiency by referring to the 2016 Edition of Guidelines for the clinical management of herb-induced liver injury.The general situation,laboratory indicators and prognosis of patients were collected,and the distribution characteristics of TCM syndromes of IM-DILI patients were summarized through statistical analysis.Results:1.By comparing the general conditions between the two groups,there was no significant difference between ANA-positive and ANA-negative patients in terms of gender and age(P>0.05),which was comparable.In terms of drugs causing DILI,there was a significant difference between the two groups(p<0.05),with the ANA-positive group being dominated by herbal medicines and the ANA-negative group having the most western medicines.The statistical results showed that there was no significant difference in the type of liver injury between the ANA-positive and ANA-negative groups(p>0.05).In terms of immune indices,Ig G and Ig M in ANA-positive group were significantly higher than those in ANA-negative group,and there was a significant difference between the two groups(p<0.05).In terms of severity,the proportion of grade 3 patients in ANA-positive group was significantly higher than that in ANA-negative group,suggesting that there was a significant difference in the severity of liver injury between the two groups(p<0.05).A comparative analysis of the improvement time between the two groups showed that the median improvement time in the ANA-positive group was significantly longer than that in the ANA-negative group,and there was a significant difference between the two groups(p<0.05).Comparing the chronic of patients in the two groups,statistics showed that the proportion of chronic in ANA-positive patients was significantly higher than that in ANA-negative patients,and there was a significant difference between the two groups(p<0.05).2.The 94 ANA-positive patients were divided into syndrome differentiation,including38 cases of liver depression and spleen deficiency(40.4%),33 cases of damp-heat jaundice(35.1%),10 cases of qi stagnation and blood stasis(10.6%),5 cases of cold dampness and blood stasis(5.3%),8 cases of liver-kidney Yin deficiency(8.5%).There was no significant difference in gender and age among the five types of patients(P > 0.05),and they were comparable.In terms of the type of liver injury,there was a significant difference between liver depression and spleen deficiency syndrome and damp-heat jaundice syndrome(P < 0.005),which was mainly manifested in that the patients with damp-heat jaundice syndrome with liver cell injury were significantly more than those with liver depression and spleen deficiency syndrome.In terms of disease severity,damp heat jaundice syndrome and liver depression and spleen deficiency,qi stagnation and blood stasis,cold dampness and blood stasis,liver-kidney Yin deficiency syndrome were significant differences(P < 0.005),with liver depression and spleen deficiency,qi stagnation and blood stasis,cold dampness and blood stasis and liver-kidney Yin deficiency syndrome all being dominated by patients with mild liver injury,while damp-heat jaundice had the highest number of patients with moderate to severe liver injury.Conclusions:1.IM-DILI is usually caused by taking Chinese herbal medicines and their products,often accompanied by elevated Ig G and Ig M,and the degree of liver injury is more severe,takes longer to heal or improve,and has a higher rate of chronicity than ordinary DILI.2.Among IM-DILI patients,liver depression and spleen deficiency,qi stagnation and blood stasis,cold dampness and blood stasis,liver-kidney Yin deficiency syndrome are mainly mild liver injury patients,while damp-heat jaundice is most prevalent in patients with moderate to severe liver injury,suggesting that patients with damp-heat jaundice are more likely to have severe cases.