Dataset Information

HIGH DOSE PULSE DEXAMETHASONE THERAPY IN CHRONIC IDIOPATHIC THROMBOCYTOPENIC PURPURA.

ABSTRACT: We studied the response to pulse high dose dexamethasone (DXM) in 12 consecutive patients of symptomatic chronic idiopathic thrombocytopenic purpura (ITP) who had not responded to the standard forms of therapy. All patients had been exhibited to two or more cycles of prednisolone. Besides this 5 patients had also been given danazol and 4 patients had undergone splenectomy. Six cycles of dexamethasone (40 mg per day for 4 sequential days every 4 weeks) were successfully given in all 12 patients. At the end of the sixth cycle there were 7 (58%) complete responders (CR) [platelet count (PLT)100 × 109 /L], 1 partial responder (PR) [PLT-50-100 × 109/L] and 4 non responders (NR) [PLT < 50 × 107L]. Follow up at 1 year showed 4 (33.3%) patients each in CR, PR and NR group. Side effects noted were increased appetite in 8 (66.6%) patients, hyperalertness in 6 (50%) patients, abdominal discomfort in 5 (41.6%) patients and nausea with vomiting in 2 (16.6%) patients. We were not able to identify any chemical or laboratory prognostic parameter which would allow prediction of a successful outcome of this treatment.

SUBMITTER: Nair V

PROVIDER: S-EPMC5531573 | biostudies-other | 1998 Jul

REPOSITORIES: biostudies-other

ACCESS DATA

Similar Datasets

Project description:Background and objectivesThis multicentre, open-label study investigated the safety and efficacy of Gammaplex, a 5% Intravenous Immunoglobulin (IVIg), in patients with idiopathic (immune) thrombocytopenic purpura (ITP).Materials and methodsPatients were between the ages of 6 and 70 years; had ITP for at least six months and had a platelet count ≤ 20 × 10(9)/L. Eligible patients were dosed with 1 g/kg of Gammaplex on two consecutive days, followed by assessment of safety and efficacy on Days 3, 5, 9, 14, 21, 32 and 90. Response was defined as the increase in platelet count to a threshold of ≥ 50 × 10(9)/L on or before Day 9 after the first dose of Gammaplex.ResultsAll 35 patients received at least one infusion of Gammaplex. Twenty-nine (83%) patients responded to Gammaplex, similar to the historical control, with a 95% lower one-sided confidence interval of 68.9%. Median duration of response was 10.0 days, with an overall reduction in bleeding episodes. Gammaplex provided supranormal concentrations of total IgG; mean peak concentration (Cmax) of 45.3 g/L (4.53 g/dL), with a mean half-life of 28.5 days. Fifteen patients reported 63 Adverse Drug Reactions (ADRs); the most common were headache (10 patients), vomiting (6 patients) and pyrexia (5 patients). Five of these ADRs were considered serious, one patient had three concurrent Serious Adverse Events (SAEs); these were vomiting, dehydration and headache. Two other patients each had one SAE (headache). There were no unexpected Adverse Events (AEs) or thromboembolic episodes and no significant changes in vital signs, biochemical, haematological and virology results.ConclusionGammaplex achieved a very high concentration of serum IgG but was well-tolerated and effective in the treatment of ITP with a similar degree of efficacy to the pre-determined historical control group and the pre-set statistical criteria.Trial registrationClinicalTrials.gov NCT00504075 Clinical Trials Registry India 000016.

Dataset Information

HIGH DOSE PULSE DEXAMETHASONE THERAPY IN CHRONIC IDIOPATHIC THROMBOCYTOPENIC PURPURA.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets