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A preliminary study was carried out from 2000 through 2005, mostly in Gunma University's affiliated hospitals, to investigate the usefulness of initial combined therapy with immunoglobulin and prednisolone (a multicenter, randomized, open-label, controlled study). The results showed that initial co-administration of immunoglobulin and prednisolone (1) significantly decreased the frequency of coronary artery dilation during the course of the disease, (2) tended to reduce the incidence of coronary sequelae, (3) decreased the total dose of immunoglobulin administered by reducing the incidence of nonresponsiveness to initial treatment, and (5) quickly lowered fever and improved inflammatory response. If similar effects are obtained in the present clinical study, the following effects can be anticipated:
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