Primary immune thrombocytopenia
Conditions
Interventions
Experiment Group:Subcutaneous injection of ropivacaine is administered weekly. The initial dose is 1 µg/kg. For those with a higher risk of bleeding, the starting dose can be 3 µg/kg. The maximum dosa
Sponsors
Huai'an First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-75 years old, gender not restricted; 2. Before enrollment, the clinical diagnosis of primary immune thrombocytopenia was no more than 3 months ago, and the platelet count within 48 hours before the first administration of the study drug was less than 30×10^9/L; 3. Prednisone treatment at 1mg/kg/d (maximum dose 80mg/d) for 4-6 weeks was ineffective or two rounds of high-dose dexamethasone 40mg/d × 4 days were ineffective; 4. No previous treatment with splenectomy or other drugs other than glucocorticoids for ITP; 5. Prothrombin time does not exceed the normal range by ±3 seconds, and activated partial thromboplastin time does not exceed the normal range by ±10 seconds; apart from ITP, there is no history of other coagulation disorders; 6. Understand the research procedures and voluntarily sign the informed consent form in person; 7. Within the two weeks before enrollment, no ITP-related treatment was received or within two weeks of receiving ITP treatment with a stable dose (only receiving glucocorticoids, Leukocin, amino peptide, caffeic acid tablets, and clearly formulated Chinese patent medicines).
Exclusion criteria
Exclusion criteria: 1. Myelodysplastic syndrome, immune disorders such as systemic lupus erythematosus, early aplastic anemia, atypical aplastic anemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura and other secondary thrombocytopenias caused by various reasons; 2. The patient has experienced any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), or clinical symptoms and medical history suggest thrombophilia; 3. Within 3 months before screening, the patient has suffered from heart disease, including congestive heart failure of NYHA grade III/IV, arrhythmias requiring drug treatment or myocardial infarction, or known arrhythmias that increase the risk of thrombotic events (such as atrial fibrillation), or the corrected QT interval (QTc) is prolonged (QTc > 450 milliseconds, or for patients with bundle branch block, QTc > 480 milliseconds); 4. Within 3 months before screening, the patient has participated in other clinical trials; 5. Within 2 weeks before screening, the patient has continuously used drugs that affect platelet function (including but not limited to aspirin, aspirin-containing complexes, clopidogrel, salicylates, and/or non-steroidal anti-inflammatory drugs NSAIDs) or anticoagulant treatment for more than 3 days; 6. The bone marrow biopsy results during the screening period suggest bone marrow fibrosis MF >= 2 (European expert consensus bone marrow fibrosis scoring criteria Thieleja 2005), or the bone marrow biopsy indicates the presence of other primary diseases that can cause thrombocytopenia except ITP; 7. During the screening period, the patient has HIV infection or positive hepatitis C antibody (if the hepatitis B surface antigen is positive, or the hepatitis B surface antigen is negative but the hepatitis B core antibody is positive, HBV-DNA testing is required, if it indicates viral replication, the patient should be excluded); 8. During the screening period, the alanine aminotransferase (ALT), aspartate aminotransferase (AST) are more than 1.5 times the upper limit of the normal value, total bilirubin, serum creatinine are more than 1.2 times the upper limit of the normal value; 9. History of liver cirrhosis or portal hypertension; 10. History of malignant tumor or accompanied by malignant tumor; 11. Pregnant or lactating women; 12. Patients with potential fertility who do not wish to use effective contraceptive measures throughout the trial period and 14 days after the end of the trial (or prematurely terminate the trial); 13. The investigator considers that there are any other conditions that may prevent the subject from completing this study or bring obvious risks to the subject; 14. Common subcutaneous injection sites are prone to infection and have no alternative drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete reaction rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficiency;Response time to treatment; | — |
Countries
China
Contacts
Public ContactChunling Wang
Huai'an First People's Hospital
Outcome results
None listed