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A real world study of polyene phosphatidylcholine injection for the prevention and treatment of DILI in patients with malignant hematological diseases

A real world study of polyene phosphatidylcholine injection for the prevention and treatment of DILI in patients with malignant hematological diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120300
Enrollment
Unknown
Registered
2026-03-11
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-Induced Liver Injury (DILI)

Interventions

Observation group:N/A

Sponsors

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Over 18 years old, gender not limited; 2. Confirmed by histology or cytology as malignant hematological diseases (including but not limited to acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma); 3. Patients who have received at least one cycle of chemotherapy regimens with a clear risk of hepatotoxicity; 4. Receive treatment with polyene phosphatidylcholine injection or prevent liver injury; 5. Liver injury treatment drugs are used in combination, and drugs containing the following are used in combination with polyene phosphatidylcholine injection. The combined use of drugs includes one or both of magnesium isoglycyrrhizinate injection, glutathione injection, adenosylmethionine succinate injection/tablet, ursodeoxycholic acid oral preparation, and bicyclol alcohol tablets. In addition, those who have not used other liver-protecting drugs; 6. Those who have at least one record of liver function test within 7 days before and after the application of liver injury treatment drugs.

Exclusion criteria

Exclusion criteria: 1. Patients with significantly missing main research data, including age, gender, liver function indicators (ALT/AST/TBIL) before and after treatment, and important information related to disease diagnosis and treatment; 2. For active viral hepatitis, autoimmune liver disease, alcoholic or non-alcoholic fatty liver disease, etc., identify other major causes of liver damage; 3. Those who have used drugs with therapeutic effects on liver damage one week before treatment; 4. Other researchers determine that it affects the evaluation of therapeutic effect.

Design outcomes

Primary

MeasureTime frame
The ALT treatment effectiveness rate 7 days after starting polyunsaturated phosphatidylcholine application (defined as the proportion with ALT reduction >50% and return to normal);

Secondary

MeasureTime frame
aspartic transaminase(AST);TBIL;alkaline phosphatase(ALP);glutamyltranspeptidase(GGT);ncidence of liver injury;

Countries

China

Contacts

Public ContactErlie Jiang

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

jiangerlie@ihcams.ac.cn+86 22 2390 9180

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026