Is It Necessary to Combine Glucocorticoid in Newly Diagnosed ITP Infant Under 1 Year-Old with Severe Thrombocytopenia When Based on Intravenous Immunoglobulin Treatment ?

Objective: Children with immune thrombocytopenia (ITP) are mostly self-limited, so they are usually observed closely and not need treatment in the clinical work. However, for children with platelet<10×10⁹/L or platelet <20×10⁹/L accompanied with obvious hemorrhagic tendency, intravenous immunoglobulin (IVIG) combined with glucocorticoids is commonly used on prevent severe bleeding. The purpose of this study is to investigate whether glucocorticoids are required at the same time in ITP children who need intravenous gamma globulin to rapidly increase platelet level. Method: 210 newly diagnosed ITP children with severe thrombocytopenia (platelet <20×10⁹/L with obvious bleeding tendency) were randomly assigned to the non-glucocorticoid group and glucocorticoid group. The former was treated with IVIG alone, while the latter was treated with a combination of IVIG and glucocorticoid. Then each group was further divided into the infant group (<1 year old) and the older children group (≥1 year old). Clinical index such as complete response rate, relapse rate, duration of therapy and glucocorticoid side effects were analyzed and compared in each group. Results: ①The complete response rate showed no statistically differences (P>0.05) among the non-glucocorticoid infant group (95.65%) and glucocorticoid infant group (92.50%), but significant differences in the older children groups with or without glucocorticoid (100% vs 92.31%, χ²=4.720, P=0.03). ②Regard the relapse rate, it was statistically lower in non-glucocorticoid infant group than in non-glucocorticoid older children group (10.41% vs 53.35%, χ²=21.685, P<0.001); in the glucocorticoid older children group than in the non-glucocorticoid older children group (21.05% vs 53.45%, χ²=12.888, P <0.001). No statistical significance was proved among glucocorticoid infant group and non-glucocorticoid infant group (12.5% vs 10.41%, P>0.05). ③After treatment for 72 h, There was no significant difference in the number of children with the platelet count >50×10⁹/L between glucocorticoid group and non-glucocorticoid group. ④There was a significant difference for the duration of therapy between the non-glucocorticoid group (4d) and glucocorticoid group (2 months)(Ζ=-7.430, P<0.001). ⑤32.5% patients of the glucocorticoid infant group suffered from infections, that was higher than in the non-glucocorticoid infant group(11.63%), and there was marked significance(χ²=7.031, P=0.008). The incidence of Cushing's syndrome in the infant glucocorticoid group (42.5%) was as the same as that in the older children glucocorticoid group (36.84%). No corticosteroid-related side effects were observed in all non-glucocorticoid groups. Conclusions: Intravenous immunoglobulin (IVIG) is accepted as an effective treatment for newly diagnosed infant ITP with platelet counts<20×10⁹/L, combination with glucocorticoid provided no significant benefit for the complete response and preventing relapse, on the contrary, may lead to high risk for infections and increasing glucocorticoid side-effects. IVIG combined with glucocorticoid can make significant clinical efficacy improvement in the older children group.

Key words: Immune thrombocytopenia; Intravenous immunoglobulin; glucocorticoid; Children; Relapse