The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of All-Trans Retinoic Acid (ATRA) combining with High-dose Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.
The investigators are undertaking a parallel group, randomised controlled trial of 80 primary ITP adult patients from Qilu Hospital of Shandong University in China. One part of the participants are randomly selected to receive All-Trans Retinoic Acid(10mg tablet by mouth every 8 hours a day for 12 consecutive weeks, combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, the others are selected to receive high-dose of dexamethasone treatment (given orally at a dose of 40 mg daily for 4 days). Patients were monitored every 1 to 3 days at the first two weeks and every 1 to 4 weeks afterwards for platelet counts, and were monitored every 1 month for transaminitis and other side effects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
patients in ATRA\&High dose-DEX group take All-Trans Retinoic Acid(orally,10mg every 8 hours a day for 12 consecutive weeks) in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days).
Patients in High dose-DEX treatment group take dexamethasone( orally , 40mg daily for 4 days),patients in ATRA\&High dose-DEX group take All-Trans Retinoic Acid(orally,10mg every 8 hours a day for 12 consecutive weeks) in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days).
Qilu Hospital, Shandong University
Jinan, Shandong, China
Platelet count
The outcome should be classified into one of the following descriptions accordingly : 1. CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10\^9/L. 2. R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia. 3. NR.No response (NR) was defined as platelet count \< 30 × 10\^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart. 4. Relapse.A relapse was defined as platelet count falls below 30×10\^9/L or bleeding accrues after achieving R or CR.
Time frame: up to six months per subject
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