A prospective, single-center, randomized, controlled clinical study of all-trans retinoin acid plus prednisone versus prednisone in the treatment of naive/treatment-naive ITP

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: treatment arm:Regular dose of prednisone acetate tablets 1mg/kg/d (gradually reduced after PLT >= 100 X10^9/L) + ATRA 10 mg bid;control arm:Conventional dose of prednisone acetate tablets 1mg/kg/d (gradually reduced after PLT >= 100 X10^9/L); CONDITION: Primary immune thrombocytopenia PRIMARY OUTCOME: Time when platelets begin to rise in both groups (time to onset of action); SECONDARY OUTCOME: 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; 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 X10^9/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 X10^9/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.
Epistemonikos ID: 59af696799d59aaea6866980f266230245000cf3
First added on: Feb 20, 2024