Dexamethasone Versus Prednisone For Newly Diagnosed Adult Primary Immune Thrombocytopenia Patients:a Prospective,Randomized, Controlled, Multicenter, Clinical Study

Background:The acronym ITP stands for primary immune thrombocytopenia (formerly idiopathic thrombocytopenic purpura), an acquired autoimmune disorder characterised by transient or persistent decrease of the platelet count and, depending upon the degree of thrombocytopenia, increased risk of bleeding. Manifestations of ITP can be localised haemorrhaging in skin or mucousmembranes that are usuallyof little to no clinical consequence (petechiae, purpura, ecchymoses,epistaxis);more rarely, ITP can be associated with severe bleeding events such as intracranial haemorrhage (ICH). However, most ITP patients are asymptomatic in the presence of platelet counts greater than50x109/L.And it is the most common clinical hemorrhagic disease. According to the International consensus report, corticosteroid therapy is still the first-line treatment of ITP, including routine-dose prednisone (PSL) and high-dose dexamethasone (HDD). Prednisone is the standard initialtreatment for adult patients with ITP who require treatment. According to previous reports, an initial responsewas achieved in2/3of patients by this approachwith PSL, whereas the long-term remission rate was10～25%. High-dose dexamethasone (HDD) has beenshown to be an effective initial treatment for immunethrombocytopenia (ITP), but it is not clear whether HDDoffers any advantages over conventional-dose prednisone(PSL).Objective:To compare the efficacy and safety between High-Dose Dexamethasoneand Conventional-Dose Prednisone Therapy for adult Primarylmmune Thrombocytopenia.Methods:We enrolled newly diagnosed patients who conform to the standard set while not conform to the exclusion criteria. All the patients were randomly divided into two groups: PSL group and HDD group. Patients in PSL group received PSL therapy (daily administration of1mg/kg prednisone for4weeks) and then given HDD treatment (40mg/day for four consecutive days) if no response; patients in HDD group received HDD treatment and then given it again if no response. All the subjects had being observed in the hospital and then followed up for1year.Results:The initial effective rates of PSL group and HDD group were75.8%and85.2%respectively (P>0.05). The long-term remission rates (after following up1year) of PSL group and HDD group were40%and73.9%. Adverse reactions in PSL group were more serious and frequently than HDD group.Conclusion:High-Dose Dexamethasonetherapy was considered to be superior to Conventional-Dose Prednisone therapy in the efficacy and safety, in view of its higher long-term remission rate and better safety.