Primary immune thrombocytopenia
Conditions
Interventions
the short-course group (Group A):Oral methylprednisolone for 2 weeks, the initial dosage is 0.8mg/kg/d, than reduces to 0.4mg/kg/d for 1 week, than to 0.2mg/kg/d for 1 week, than stop.
the long-course treatment group (Group B):Oral methylprednisolone for 1 month, the initial dosage is 0.8mg/kg/d,than reduces to 0.4mg/kg/d for 1 month, than to 0.1mg/kg/d for 2 week, than stop.
Sponsors
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years old, male or female; 2. Conform to the diagnostic criteria of ITP: (1) decreased platelet counts in many laboratory tests; (2) Without splenmegaly; (3) Elevated or normal number of megakaryocytes in the bone morrow examination with dysmaturity; (4) With exception of other secondary thrombocytopenic purpura; 3. newly diagnosed ITP (Within three months after the diagnosis); 4. Complete response after glucocorticoids therapy (PLT=100×10^9/L); 5. People who are willing to sign the informed consent voluntarily and follow the research program.
Exclusion criteria
Exclusion criteria: 1. Secondary thrombocytopenic purpura; 2. Initial treatment included high-dose methylprednisolone and high-dose dexamethasone; 3. Initial treatment for intravenous immunoglobulin, excluded the patients with glucocorticoid treatment invalid; 4. Pregnant and lactating women; 5. Patients who were allergy to adrenal cortical hormone; 6. Participated in another new drug clinical trials in 3 months; 7. Liver and kidney function was abnormal: defined as serum transaminase and bilirubin were equal or more than 1.5 times of the upper limit of normal value. Serum creatinine was over the upper limit of the normal value; 8. Hepatitis B surface antigen, Anti-HCVRPR HIV (I+II) positive; 9. Patients complicated other diseases who were not suitable for maintained glucocorticoid therapy, such as diabetes, high blood pressure, glaucoma, peptic ulcer, herpes zoster, pulmonary infectionand so on; 10. Patients with poor compliance; 11. Patients who can not take contraception during the trial; 12. Researchers believe that patients should not participate in the test of any other condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose platelet counts relative to the baseline* increase more than 2 times and reached more than 30*10^9/L and without bleeding symptom in each week.;Proportion of subjects whose platelet counts are >=100*10^9/L and without bleeding symptom in each week.;Proportion of subjects who have received emergency treatment to increase the platelet counts;Proportion of subjects whose platelet counts <50*10^9/L in each week;Platelet count; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation:incidence of adverse events, vital signs and laboratory values.; | — |
Countries
China
Contacts
Public ContactRENCHI YANG
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed