Chemical and Drug Induced Liver Injury
Conditions
Keywords
Hepatotoxicity of Antituberculosis Therapy, DILI
Brief summary
Drug-induced liver injury (DILI) is a common side effect in antituberculosis therapy, which interuputs the treatment of TB and leads to a higher proportion of Multidrug-Resistence TB(MDR-TB).The study primalily aims to observe the proportion of DILI in antituberculosis therapy. Furthermore, the secondary objective is to study the proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy in the obersevational study.
Detailed description
Drug-induced liver injury (DILI) is a common side effect in antituberculosis therapy, which interuputs the treatment of TB and leads to a higher proportion of Multidrug-Resistence TB(MDR-TB).The study primalily aims to observe the proportion of DILI in antituberculosis therapy. Furthermore, the secondary objective is to study the proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy in the obersevational study.
Interventions
OTHERNone intervetion
None intervetion
Sponsors
Huashan Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 1\) Patients who are about to start anti-tuberculosis treatment 2) Male or female, age \> 18 years old 3) Voluntary signing of Subject Informed Consent Form
Exclusion criteria
\- 1)A history of taking anti-tuberculosis drugs within 6 months before the treatment; 2)Abnormal liver function before starting anti-tuberculosis treatment; 3)DILI at the time of enrollment. 4)Combined with malignant tumors (including hematological tumors), HIV infection, etc. 5\) According to the investigator's judgment, patients who cannot complete this study or who cannot comply with the requirements of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of DILI in antituberculosis therapy | 12 months(DILI occurs) or 24 months(None-DILI occur) after treatment initiation | The study primalily aims to observe the proportion of DILI in antituberculosis therapy,by monitoring and following up the liver function of the participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy | 12 months(DILI occurs) or 24 months(None-DILI occur) after treatment initiation | The study secondly aims to observe the proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy,by monitoring and following up the liver function, drug treatment of the participants. |
Contacts
Primary ContactWenhong Zhang
Backup ContactTaoping Weng
Outcome results
None listed