Primary immune thrombocytopenia
Conditions
Interventions
treatment arm:Regular dose of prednisone acetate tablets 1mg/kg/d (gradually reduced after PLT >= 100 x 10^9/L) + ATRA 10 mg bid
control arm:Conventional dose of prednisone acetate tablets 1mg/kg/d (gradually reduced after PLT >= 100 x 10^9/L)
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~75 years old, male or female; 2. For patients with ITP who are naive/treatment-naive, the diagnostic criteria comply with the Chinese Guidelines for the Diagnosis and Treatment of Primary Immune Thrombocytopenia in Adults (2020 Edition); or for patients with a previous diagnosis of ITP but firstly receive treatment; 3. The patient's platelet count is < 30 x 10^9/L twice in a row (not on the same day), and at least one of the following conditions is met at the same time: (1) Platelet count is < 10 x 10^9/L twice in a row (not on the same day); (2) Accompanied by obvious bleeding tendency; 4. Patients receive treatment voluntarily and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation; 2. Those with a history of thrombosis; 3. Severe abnormal heart, lung, liver and kidney function; 4. Severe or uncontrollable infections; 5. HCV, HBV, HIV carrier or patient; 6. With a history of mental illness; 7. With contraindications to the use of hormones and retinoic acid; 8. Any other situation in which the investigators consider it inappropriate for the patient to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time when platelets begin to rise in both groups (time to onset of action); | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency and total number of platelet transfusions in both groups;The efficacy on day 7, day 14, day 28, month 2 and month 3 of patients in both groups after enrollment;Safety of the regimen in both groups;The total cost of study medication, length of hospital stay, bed fee, and related adverse effects treatment cost in both groups; | — |
Countries
China
Contacts
Public ContactXu Peipei
Nanjing Drum Tower Hospital
Outcome results
None listed