Immune Thrombocytopenia (ITP)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. In line with the newly diagnosed ITP diagnosis, bone marrow aspiration results were not used as the key evaluation criteria, and patients with decreased megakaryocyte number could be included, but other secondary causes of thrombocytopenia should be excluded; 2. Without hormone therapy, patients who did not respond to rhTPO or IVIG therapy could be included, but a 30-day washout period was required; 3. Platelet count =2); 4. Did not participate in other clinical studies; 5. Aged >12 and <=60 years; 6. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Any clinically relevant abnormalities (other than ITP) or any other medical condition or condition found during screening that the investigator deems the subject unfit for study participation; 2. With a history of platelet aggregation, platelet count cannot be measured reliably; 3. Patients with any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism) and >= 2 of the following risk factors: hormone replacement therapy, smoking, diabetes, hypercholesterolemia, hypertension medications, cancer, genetic thromboembolism (e.g., coagulation factor V Leiden, antiphospholipid syndrome, etc.); 4. Heart disease (Class II/III/IV of the modified ROSS scale for Pediatric Heart Failure) should not be included; Arrhythmias at risk of thrombosis (such as atrial fibrillation), pulmonary hypertension, or uncontrolled hypertension (>180/100 mmHg); 5. Any clinical history of hepatitis C infection or chronic hepatitis B infection; Or any evidence of active hepatitis at the time of subject screening; 6. Patients who are allergic to therapeutic drug ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood routine;immune globulin;lymphocyte subsets;cytokines;health-related quality of life score;liver and kidney function;efficacy;bleeding score; | — |
Countries
China
Contacts
Zhejiang Provincial Hospital of Traditional Chinese Medicine