Glucocorticoid combined with ulinastatin in treatment of Kawasaki disease in children: a non-randomized controlled clinical trial

Abstract:

Objective To investigate the clinical efficacy of glucocorticoid combined with ulinastatin in the treatment of Kawasaki disease (KD) in children. Methods A total of 104 children who were admitted and diagnosed with typical KD between January 2011 and December 2013 were assigned to ulinastatin group (methylprednisolone + ulinastatin; n=46) and intravenous immunoglobulin (IVIG) group (n=58) according to the severity of KD and the willingness of their parents. Observations for the two groups were performed to compare the changes in coronary artery diameter before and at 1 week, 3 months, and 6 months after treatment, fever clearance time, retreatment condition, changes in white blood cells (WBC), platelets (PLT), hemoglobin (HB), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) at 1 week and 3 weeks after treatment, and total in-hospital cost. Results There was no significant difference in the coronary artery diameter between the two groups before or at 1 week, 3 months or 6 months after treatment (P> 0.05). All the patients (100%) in the ulinastatin group vs 83% in the IVIG group had a normal body temperature after 48 hours of treatment (P< 0.01). Two patients (4%) in the ulinastatin group and 10 patients (17%) in the IVIG group received retreatment. Significant differences were observed in ESR, WBC, and HB between them (P< 0.01). The total in-hospital cost in the ulinastatin group was significantly lower than that in the IVIG group (P< 0.01). Conclusions For children with KD, methylprednisolone combined with ulinastatin does not increase the risk of coronary artery aneurysm, decreases in-hospital costs, is superior in controlling laboratory markers and shortening the duration of fever during the acute phase compared with the IVIG therapy.