Primary Immune Thrombocytopenia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient signed the informed consent, and the subject fully understood and complied with the requirements of the study protocol and was willing to complete the study as planned. 2. Aged >= 18, male or female. 3. Multiple laboratory tests showed thrombocytopenia; 4. The spleen is not enlarged or only mildly enlarged; 5. The number of megakaryocytes in bone marrow examination was increased or normal, with mature disorders; 6. Glucocorticoid-dependent patients: prednisone of > 5mg/d (or equivalent of other glucocorticoids) is required continuously, or glucocorticoids are required frequently to maintain platelet >= 30 x 10^9/L or to avoid bleeding. 7. Patients with ITP with platelet count 30 x 10^9/L and bleeding symptoms.
Exclusion criteria
Exclusion criteria: 1. Patients with secondary thrombocytopenia; 2. Pregnant and nursing women; 3. Have a history of allergy to adrenocorticosteroids; 4. Have participated in clinical trials of other new drugs within 3 months; 5. Abnormal liver and kidney functions;Defined as serum transaminase and bilirubin >= 1.5 times the upper limit of normal. Creatinine exceeding the upper limit of normal; 6. Antibody of second liver surface antigen, hepatitis c, HIV antibody (I + II), syphilis antibody positive; 7. Patients with diabetes, hypertension, glaucoma, gastrointestinal ulcer, herpes zoster, pulmonary infection and other conditions that are not suitable for glucocorticoid maintenance therapy; 8. Patients with poor compliance; 9. Those who cannot take contraceptive measures during the experiment; 10. Any other circumstances in which the investigator considers the patient unfit to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| platelate counts; | — |
Secondary
| Measure | Time frame |
|---|---|
| liver function; | — |
Countries
China
Contacts
Department of Hematology, the Second Affiliated Hospital of Kunming Medical University