title: High dose Intravenous Anti-D Immune Globulin is More Effective and Safe in Indian Paediatric Patients of Immune Thrombocytopenic Purpura.
abstract: BACKGROUND
  Immune Thrombocytopenia (ITP) is characterised by an autoimmune antibody-mediated destruction of platelets and impaired platelet production. Few controlled trials exist to guide management of patients with ITP in Indian scenario for which patients require an individualized approach. Anti-D (Rho (D) immune globulin) at a higher dose can prove to be a cost effective and safe alternative for Indian patients with ITP.
  
  
  OBJECTIVE
  To compare the safety and efficacy of higher dose (75μg/kg) intravenous Anti-D immune globulin against the standard dose of 50μg/kg for the management of ITP in Indian patients.
  
  
  METHODS
  One hundred and sixty four children with newly diagnosed ITP between 4-14 years were randomly selected for inclusion and were treated with 50μg/kg (standard dose) or 75μg /kg (higher dose) of Anti-D to compare the efficacy and safety of higher dose intravenous anti-D immune globulin. Efficacy of Anti-D was measured in terms of rate of response and median time to response for increase in platelet counts. Any adverse event was noted. A decrease in haemoglobin concentration suggested accompanying haemolysis.
  
  
  RESULTS
  Seventy one out of 84 patients treated with Anti-D at 75μg/kg produced complete response (85%) with median time of response being 2.5 days. On the contrary, 45 patients (70%) patients treated with 50μg/kg had complete response. However, there was no significant increase in haemolysis with higher dose. A significant correlation was found between dose and peak increase in platelet count measured at 7thday following administration. However, there was no relationship between the decrease in haemoglobin and the dose given, or between the increase in platelet count and fall in haemoglobin.
  
  
  CONCLUSIONS
  A 75μg/kg dose of Anti-D is more effective with acceptable side effect in comparison to 50μg dose for treatment of newly diagnosed Indian patients of ITP.
authors.affiliation: Associate Professor and In charge, Clinical Pharmacology Unit, Department of Pharmacology, SCB Medical College and Hospital , Cuttack, Odisha, India .
authors.forename: Trupti Rekha
authors.initials: TR
authors.lastname: Swain
authors.affiliation: Head, Department of Clinical Haematology, SCB Medical College , Cuttack, Odisha, India .
authors.forename: Rabindra Kumar
authors.initials: RK
authors.lastname: Jena
authors.affiliation: Assistant Professor, Department of Neurology, SCB Medical College , Cuttack, Odisha, India .
authors.forename: Kali Prasanna
authors.initials: KP
authors.lastname: Swain
keywords: Autoimmune; Children; Platelet count