Clinical trial NCT04302506: Correlative Cohort Study on the Clinical Features and Prognosis of Drug-induced Liver Injury
Official title: The Correlative Cohort Study on the Clinical Features and Prognosis of Drug-induced Liver Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug-induced Liver Injury
Keywords: Drug-induced liver injury
Chronic
regression analysis
ROC curve
Joint diagnosis
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University was admitted and a liver biopsy was performed from 2014.9 to 2019.9. The patients were clearly diagnosed with drug-induced liver injury. These patients also met the RUCAM score and were diagnosed as DILI.

Brief summary: This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.

Detailed description: This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.

Eligibility criteria: Inclusion Criteria:

* Have a clear history of taking drugs (Chinese herbal medicine and dietary supplements, NSAIDs, cardio-cerebrovascular drugs, anti-interference drugs, anti-tuberculosis drugs, hormone drugs and others);
* All patients were examined by liver biopsy Patients with clear diagnosis of drug-induced liver injury and clinical diagnosis of DILI who meet the RUCAM score.

Exclusion Criteria:

* Combined with various liver diseases, such as viral hepatitis (hepatitis A, B, C, D, E), alcoholic hepatitis, autoimmune hepatitis, metabolic hepatitis, non-alcoholic fatty liver disease;
* Combining other viral infections that may lose liver function, such as Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), and Human Immunodeficiency Virus (HIV);
* Mental illness;
* Evidence of liver tumors (liver cancer or alpha-fetoprotein\> 100 ng / ml).

Primary outcomes:
measure: The rate of chronicity
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hepatology Division 2, Beijing Ditan Hospital
state: Beijing
Study officials:
References: