[Clinical trial of SM-4300 in the pediatric field]

SM-4300, a newly developed human immunoglobulin for intravenous use, was administered to 6 patients in the pediatric field. Two cases out of 3 cases with immunodeficiency syndrome were studied in terms of absorption and excretion of SM-4300 and all of them were observed effect of preventive bacterial infection. Three cases were administered combination therapy with SM-4300 and antibiotics. Two cases were pneumonia and 1 case was pleurisy. The following results were obtained. Two cases with immunodeficiency syndrome were observed serum levels of immuno gammaglobulin before and after administration of SM-4300. At 2-3 hours after the administration of SM-4300, the serum levels got to peak and the half-lives were 22.1 days and 22.6 days, respectively. The half-lives of SM-4300 were similar to plasmin or polyethylene glycol treated and sulfonated human immunoglobulin. The clinical effects of substitution therapy against 3 patients with immunodeficiency syndrome were observed. Through the administration of SM-4300 every 18 to 21 days for 6 months, 1 case was doing well. One case with chronic bronchitis and otitis media was hanging in the balance as well as she has been administered other immunoglobulin preparations. The last case didn't control the serum levels of immunoglobulin because he did not visit a hospital until incidence of infectious disease.