- A randomized
trial of 53 patients compared intravenous immune globulin G (IVIG),
oral prednisone, and placebo in the treatment of acute ITP.1
- Nineteen patients
received IVIG at 1 gm/kg daily for two days, 18 received prednisone
at a dose of 4 mg/kg (tapered over 21 days), and 16 received no therapy.
Baseline clinical characteristics were similar for all three groups.
The administration of drugs was not blinded.
- Prior to randomization,
subjects were stratified by severity of hemostatic defect. Inclusion
criteria included: age over 6 months and under 18 years; platelet count
less than 20,000; a bone marrow aspirate consistent with ITP; and no
evidence of chronic ITP.
- Primary outcomes
for the study were: number of days with a platelet count under 20,000
and the number of days required to reach a platelet count over 50,000.
Secondary outcomes were the occurrence of any adverse effect of therapy.
- Median duration
of severe thrombocytopenia after treatment was 1 day for IVIG (p<0.001)
and 2 days for prednisone (p<0.01) compared to 4 days for no therapy.
Results between the two treatment groups were not significantly different.
- The median time
to reach a platelet count above 50,000 was 2 days for those in the IVIG
group (statistically different than both prednisone and no therapy)
percent of those treated with IVIG had some combination of nausea, vomiting,
headache, and fever. The most common adverse reaction to prednisone
was weight gain.