A Real World Study of Polyene Phosphatidylcholine Injection for the Prevention and Treatment of DILI in Patients With Malignant Hematological Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: polyene phosphatidylcholine.
- Who it may be relevant to
- Registry conditions: Drug-Induced Liver Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a retrospective, multicenter real-world observational study. Its main goal is to find out if Polyene Phosphatidylcholine Injection works to treat drug-induced liver injury (DILI) in adults with hematologic malignancies, and to check if the drug is safe. It also aims to answer these key questions: Does Polyene Phosphatidylcholine Injection help prevent DILI in people with hematologic malignancies? How effective and safe are different combinations of Polyene Phosphatidylcholine Injection with other liver-protective drugs for DILI? Which DILI treatment plan offers better value for money? Who can take part? Participants must meet all these criteria: 18 years or older (no gender restriction) Diagnosed with a hematologic malignancy (such as leukemia, lymphoma, or multiple myeloma) Received at least one cycle of chemotherapy that may harm the liver Used Polyene Phosphatidylcholine Injection to treat or prevent DILI (alone or with one/two specific liver-protective drugs: Magnesium Isoglycyrrhizinate Injection, Glutathione Injection, Ademetionine 1,4-Butanedisulfonate Injection/Tablets, Ursodeoxycholic Acid Oral Formulation, or Bicyclol Tablets) Had liver function tests within 7 days before starting treatment and at least once after starting treatment What will the study involve? Researchers will look back at medical records of eligible participants treated on or before November 30, 2025. They will collect and analyze: Participants' basic information (age, gender) and disease details Details about Polyene Phosphatidylcholine Injection use (dose, frequency, duration) Liver function test results (including alanine aminotransferase \[ALT, a liver enzyme that rises when the liver is injured\], aspartate aminotransferase \[AST\], total bilirubin \[TBIL\], and other related indicators) at different time points (3 days, 7 days, 14 days, 21 days, 30 days, 60 days) after starting treatment Any unwanted health issues (adverse events, AEs) during treatment and how they were managed Costs related to treatment (drug fees, test fees, AE management fees) What are the key things researchers will measure? Main measure: How well ALT levels improve 7 days after starting Polyene Phosphatidylcholine Injection (defined as ALT dropping by more than 50% or returning to normal) Secondary measures: Improvement in liver function indicators at other time points (3 days, 14 days, 21 days, 30 days, 60 days) How well the drug prevents DILI (how often DILI occurs and how severe it is) Differences in effectiveness and safety between different drug combinations Which treatment plan is more cost-effective
Interventions
- Drug polyene phosphatidylcholine
The clinical visit data of patients with malignant hematological diseases who used polyene phosphatidylcholine injection for the prevention or treatment of drug-induced liver injury were retrospectively collected
Primary outcome measures
- The effective rate of ALT treatment 7 days after the initiation of polyene phosphatidylcholine [Time frame: From enrollment to the end of treatment at 7 days]
Eligibility criteria
Inclusion criteria
- Over 18 years old, gender not limited;
- 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);
- Patients who have received at least one cycle of chemotherapy regimens with a clear risk of hepatotoxicity;
- Receive treatment with polyene phosphatidylcholine injection or prevent liver injury;
- 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;
- 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
- 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;
- For active viral hepatitis, autoimmune liver disease, alcoholic or non-alcoholic fatty liver disease, etc., identify other major causes of liver damage;
- Those who have used drugs with therapeutic effects on liver damage one week before treatment; Other researchers determine those who affect the evaluation of therapeutic effects.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07476885 · QT2025012