| Objective: To investigate the population characteristics and drug characteristics of psoriasis related drugs in liver injury.Re-evaluate the cases of psoriasis related drugs liver injury,and verify their objective authenticity from the perspective of clinical diagnosis;In order to provide a reference for the study of liver injury of psoriasis drugs,the evaluation of liver injury of dixian skin preparation Keyin pills was carried out.Research methods: Part I: For national adverse drug reaction monitoring data from 2012 to 2016 cases of psoriasis with liver damage in the analysis by the world health organization,uppsala monitoring adverse reactions in the center of the causal relation method to evaluate cases,and by the method of retrospective investigation to crowd into the clinical data of the characteristic and the analysis of characteristics of drugs PartⅡ: Retrospective analysis was made on 114 cases of dermatological drug-related liver injury in the Fifth Medical Center of PLA General Hospital from 2008 to 2017,which met the diagnostic criteria of "Guidelines for the Diagnosis and Treatment of Drug-induced Liver Injury" and "Guidelines for Clinical Diagnosis and Treatment of Chinese Herbal Medicine-related Liver Injury".All cases were re-evaluated with the integrated evidence chain.Finally,statistical methods were used to analyze the relevant information in cases.Part Ⅲ: Method based on evidence chain of national adverse drug reaction database of CNKI literatures and the liver specialized subject hospital,silver pill related liver injury clinical cases of retrieval and evaluation,analyzing cases of liver damage category,and USES the immune stress animal model validation whether grams of silver pill can cause liver damage,and analyze the main risk factors of drug-induced liver injury Results:(1)Clinical characteristics of psoriasis-related Drug Liver Injury Based on ADR Surveillance DataA total of 155 cases of psoria-related drug liver injury were included in the national surveillance data of adverse drug reactions from 2012 to 2016 after causal evaluation,and the number of male and female patients was higher(101 vs 54).The age span of liver injury was from 11 to 80 years old,and the age of liver injury was mainly from 41 to 60 years old(accounting for 42.58% of all cases).However,the median time of liver injury in traditional Chinese medicine was longer than that in western medicine(16 vs 10.5).Among the 35 cases of combined use of tripterygium wilfordii capsules and tripterygium wilfordii tablets,awea capsules and methotrexate were the most used in 81 cases of western medicine,and tripterygium wilfordii capsules and methotrexate were the most used in 39 cases of traditional Chinese medicine.(2)Re-evaluation of psoriasis-related drugs for liver injury based on Integrative Evidence ChainThe liver injury of 48 patients with psoriasis related drugs in the fifth medical center of PLA general hospital from 2008 to 2017 was reevaluated.The results showed that 72.92% of the patients reached the level of suspected diagnosis and 27.08% reached the level of clinical diagnosis.Liver injury cases 22.92% of the western medicine of traditional Chinese medicines by 64.58% and 12.50% respectively on the number of women with traditional Chinese medicine and western medicine combined with more number of male patients(28 vs 20),liver injury caused by age span is 23 ~ 80 years,mainly in the onset age 41 ~ 60 years old(54.17% of all cases).lead to liver damage in psoriasis drugs,western medicine is given priority to with avi A capsule and methotrexate,traditional Chinese medicine(TCM)is given priority to with Tripterygium wilfordii polyglycoside、 keyin pill、 xiaoyin granule 、compound qingdai capsule(3)Clinical cases and experimental evaluation of liver injury related to anti-psoriasis Keyin.To national adverse drug reaction database of CNKI literatures and the liver specialized subject hospital,silver pill related liver injury cases for retrieval and evaluation,selected for a possible causal relationship and above levels of the cases,a total of 23 cases,among them alone grams of silver pill and causality for certain cases in 11 cases,accounting for 47.83%,the latency period of the liver damage caused by silver pill span of 1 ~ 90 days,the cumulative dose span of 20 ~ 1800 grams,individual differences,not seen liver damage with dosage and course of dependencies.Further based on the early stage of the team building of immune mediated the diathesis of liver damage in the rat model of stress,confirmed the grams of silver pellets in model rats dose dependent on immunological stress to cause acute liver damage,single drug poisoning dose(14 g/kg)for clinical equivalent dose of 6.7 times,and liver function and biochemical indicators of normal rats and the histopathological had no significant effect experiments show that the cortex dictamni in grams of silver pill party is the main ingredients of diathesis to liver damage,the other three herbs have neither liver damage effect,also do not have compatibility attenuated Research conclusions: Through case analysis,it was found that psoriasis medication can indeed cause liver injury,especially the preparation of dittany skin.Experiments found grams of silver pellets in immunological stress state can cause acute liver injury,cortex dictamni in party is main ingredients to diathesis liver damage as a result,after taking drug treatment for psoriasis,should be timely and multiple monitor liver function as soon as possible,and should be wary of taking preparations containing cortex dictamni in patients with immune stress can cause the risk of liver damage. |