The Application Evaluation Of Diagnosis Method Of HILI Based On Integrated Evidencechain-based Causality Identification Algorithm

Background: The coverings of herbals and their preparations causing live injuries have been more and more along with increasing usage of herbals, improvement of drugs monitoring system of side effects and the increasing awarness of consumers to safeguard their legal rights, which has received highlights widely at home and abroad. The primary problem of HILI is to build the clinical diagnosis methods. Various complexityies of HILI are in proportation to the diagnosis. Early on ,the research group has built the diagnosis strategies based on the iEC, but still need further to be assessed and applied in clinic.Objective: The assessment is based on the difference in the effects and diagnosis of iEC,SEOP and RUCAM scale. Exploring the retrospective and prospective application of iEC in clinic and screening the characteristic biomarkers in metabonomics. Method:Retrospective analysis in those three methods for patients with HILI who were admitted from January, 2010 to December, 2015 in 302 hospital of PLA .Compare the difference of diagnosis results among those three methods. Prospective analysis in those three methods for patients with HILI and DILI who were admitted from September, 2015 to June, 2016 in 302 hospital of PLA . Compare the difference of diagnosis results among those three methods and analyze the clinical features and treatment prognosis of HILI and DILI.Retrospective analysis of the clinical feature differences of TCM and western medicine related to ALF for patients with ALF who were admitted from January, 2010 to December,2015 in the 302 hospital of PLA . In adoption of the LC-MS technology to develop the metabonomic research between HILI and healthy persons and patients with HBV, AIH,PBC and seek the possible diagnosis specific biomakers. Results: the diagnosis rate of iEC is 42.8%, and the SEOP is 28.7% from the 390 cases. In terms of constituent radio of HILI/DILI, the diagnosis rate of iEC, RUCAM and SEOP is 10.4 %, 24.4 %, 7 %. On the top of five basic diseases caused HILI are gastrics(8 %), protrusion of intervertebral disc(5.3 % ), insomia (4.8% ) , alopecia (4.8% ), psoriasis (4.3% ) .78 patients(41.7%) in TCM decoction. On the top of five herbals are Polygonum multiflorum (n = 21 ), corydalis rhizoma( n = 10 ), Rhei radix et rhizoma( n = 9 ), bupleuri radix (n = 8 ), psoraleae fructus(n = 7) .64 patients (34.2 % ) in Chinese patent drugs related to 84 Chinese patent drugs.The clinical diagnosis rate of iEC is 47.6 % , SEOP 29.9 % , in terms of constituent radio of HILI/DILI, the diagnosis rate of iEC,RUCAM and SEOP is 23.2%,48.7%,14.6%.110 patients(58.8 % ) were healing and 30 patients (16.0 % ) envolved into chronic drug-produced liver injuries. 20 patients (15.5%) envolved intoliver cirrosis.3 patients(1.6 % )died.15 patients (8.0 % ) loss to follow up. Through the TCM sydrome differentiation for 187 patients with HILI, jaundice with damp-heat pathogen(44.4 % )is the most common and the next is Ganyupixu( 33.7 % ) and Ganshenyinxu( 15 % ). The clinical diagnosis rate of iEC is 65.7 % , and SEOP is 63.7 % . Among 96 patients with drug-produced DALF, the patients who are more elder caused by TCM (42±18vs.34±18 years, p = 0.04), compared to patients with DALF caused by western medicine have higher creatinine and usea nitrogen. (155.2±108.8vs,97.5±130.4umol/L , p = 0.047 ;9.1 1±7.67vs.4/26±5.03mmol/L, p = 0.02). Patients with ALF caused by TCM are prone to accompany with the abnormal renal function(OR,3.75;95 % CI, 1.330-10.577). There is no statistical difference in terms of the chronic fibrosis, death and liver transplation for patients with ALF caused by TCM and western medicine.(25vs33 % , 40.6vs38.1%,3.1vs7.1 %,p = 0.642)。96 patients with DALF,Hepatocellular pattern accounts for 58(60.4 %), Cholestatic pattern (16.7 % ) and Mixed pattern (22.9 % ) .Patients with HILI caused by Polygonum multiflorum and its preparations are in the average of 44, and female more. It is more common for breeding and colouring hair. And the incubation period is in the average of 55 days. The most common type of liver injury is Hepatocellular pattern,most of the patients can be healed. Minority of patients can envolve into the chronic drug-induced liver injury and liver cirrosis. Liver biopsy of 76 patients with HILI ,47.4 %with positive antoantibody in the peripheral blood and divided them into positive group and negative group in terms of autoantibody. There is no significant difference in terms of and, allergies, incubation period and biochemical indicator. But the patients with positive autoantibody are prone to envolve into chronic drug-produced liver injury the the nagative group(p < 0.05). Meanwhile, interface inflammation is clearly higher than nagative group(p<0.01). Conclusion: The diagnosis strategies and methods of HILI based on iEC is suitable for the diagnosis of HILI. Compared to the retrospective method, prospetive methods are better to display theadvantages of this method. And metabolomics can provide new mindset for the precausion, diagnosis and pathologic study of HILI.