Drug-induced Liver Injury
Conditions
Keywords
glucocorticosteroid
Brief summary
The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury.
Interventions
DRUGhepatoprotectant
Participants received hepatoprotectants (i.v.gtt.) for 7 days.
DRUGGlucocorticoids+hepatoprotectant
Participants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days.
Sponsors
Li Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of DILI 2. RUCAM score≥6 and with liver histology 3. Meet any of the following conditions: 1. TBIL ≥ 10 fold ULN ; 2. TBIL ≥ 5 fold ULN and serum AST or ALT ≥ 20 fold ULN
Exclusion criteria
1. An chronic onset (≥6 months) 2. Other liver diseases, such as autoimmune liver diseases, viral hepatitis, etc 3. with contraindications of glucocorticoid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients that AST or ALT decline 25% at day 4 | Change from Baseline ALT and AST at day4 | AST or ALT decline 25% at day 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients that AST or ALT decline 50% at day 8 | Change from Baseline ALT and AST at day8 | AST or ALT decline 25% at day 8 |
| the time needed when TBIL decline 50% | up to 2 weeks | TBIL decline 50%; time |
| incidence of side effects | up to 2 years | infection，uncontrolled hypertension or hyperglycemia |
| relapse rate in 12 months after drug withdrawal | 12 months after drug withdrawal | relapse rate |
| mortality in 12 months after drug withdrawal | 12 months after drug withdrawal | mortality |
Countries
China
Outcome results
None listed