RANDOMIZED TRIAL COMPARING INTRAVENOUS IMMUNOGLOBULIN WITH METHYLPREDNISOLONE PULSE THERAPY IN ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA

Forty-three children with newly diagnosed idiopathic thrombocytopenic purpura (ITP), platelet count (PC) below 20 x 10(9)l(-1), and either c ontinued bleeding or failure to show a spontaneous rise in the PC afte r a 3 day observation period were randomized to treatment with either intravenous immunoglobulin (IVIG) infusions 1 gkg(-1) (n = 23) or intr avenous methylprednisolone pulse therapy (MPPT) 30 mg kg(-1) (n = 20) on two consecutive days. After 72 h, IVIG had induced greater platelet responses (mean PC 188 x 10(9) versus 77 x 10(9)l(-1), 2p <0.001) and raised the PC to a haemostatically safe level above 50 x 10(9)l(-1) m ore frequently (91 versus 50%, one-sided exact p = 0.003). Children re sponding poorly were then given the alternative treatment in addition. After 6 days, a normal PC of over 150 x 10(9) l(-1) had been obtained more frequently in the group given first-line IVIG (70 versus 50%, p= 0.16). The relapse rates during 6 months of follow-up were not signifi cantly different (26 versus 40%, p=0.26). Cross-over treatment in 11 c hildren with relapse confirmed the superior response to IVIG. The trea tment given was restricted to the two initial infusions more often in the IVIG group (70 versus 35%, p=0.05). These results indicate that IV IG may be preferable to MPPT as the initial treatment for ITP.