Immune thrombocytopenia (ITP) Haematological Disorders
Conditions
Interventions
34 children with primary persistent ITP were enrolled in the ITP group, whereas 30 age- and sex-matched healthy children undergoing physical examinations during the same period served as control group
Sponsors
First Affiliated Hospital of Xinxiang Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ITP group: 1. Patients meeting the diagnostic criteria for primary persistent ITP as outlined in the Chinese Guidelines for the Diagnosis and Treatment of Childhood Primary Immune Thrombocytopenia (2019 Edition), defined as a disease duration exceeding 3 months and a platelet count below 100 × 10?/L 2. Age =14 years at the time of enrolment 3. No prior treatment with glucocorticoids, intravenous immunoglobulin (IVIG) or immunosuppressive agents within 1 month before initiating study treatment 4. Availability of complete clinical data for analysis. Control group: The control group comprised healthy children undergoing physical examinations during the same period, matched by age and sex to the ITP group. The inclusion criteria were as follows: 1. Age difference within 1 year compared with ITP participants 2. Gender distribution matching that of the ITP group (male-to-female ratio: approximately 1.6:1) 3. Participants had no infections, vaccinations or intake of folic acid, vitamin B12 or vitamin B6 within 4 weeks prior to enrolment
Exclusion criteria
Exclusion criteria: 1. Presence of severe infections, haematologic malignancies or substantial hepatic or renal dysfunction 2. History of vaccination or blood transfusion within 4 weeks prior to enrolment 3. Secondary thrombocytopenia, including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, drug-induced thrombocytopenia or Evans syndrome 4. Known or suspected primary immunodeficiency 5. History of haematopoietic stem cell transplantation 6. Refusal of informed consent by legal guardians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune cell population (Th17 cell level, Treg cells, Breg cells) quantitatively analyzed and measured using BD FACSDx Flex TM flow cytometry at baseline and 3 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| BD FACSDx FlexTM flow cytometry was used to analyze the proportion of Th17 / Treg and the proportion of Breg cells in CD19 / B lymphocytes at baseline and 3 months before and after treatment | — |
Countries
China
Contacts
Public ContactPeiling Li
Outcome results
None listed