A multicenter, randomized, controlled trial of intravenous gamma globulin therapy in children with acute Kawasaki disease.
We studied the effect of intravenous, polyethyleneglycol-treated, human immunoglobulin, administered at 200 mg/kg per day (group A: n = 147; male 86, female 61; age < 1 year, 50) or 400 mg/kg per day (group B: n = 152; male 87, female 65; age < 1 year, 52) for five consecutive days and compared it with freeze-dried, sulfonated human immunoglobulin [group C: n = 152; male 87, female 65; age < 1 year, 51), administered at 200 mg/kg per day for five consecutive days, on the prevention of coronary artery abnormalities in Kawasaki disease. Echocardiograms were interpreted blindly and independently. Proportions of 87.1%, 95.4%, and 82.3% in groups A, B, and C, respectively, had no coronary artery abnormalities. The confidence limits of difference between the proportions of groups A and C, groups B and C, and groups B and A were -4.4% and 10.4%, 7.8% and 15.9%, and 4.0% and 10.8%, respectively. Duration of fever and serum immunoglobulin G (IgG) levels were correlated with the prevalence of coronary artery abnormalities. We concluded that intravenous, polyethyleneglycol-treated, human immunoglobulin and freeze-dried, sulfonated human immunoglobulin had clinically equivalent effects on coronary artery abnormalities, and that five daily doses of 400 mg/kg of intravenous, polyethyleneglycol-treated, human immunoglobulin is more effective than that of 200 mg/kg gamma globulin.
Morikawa
Y
Y
Department of Pediatrics, School of Medicine, Keio University, Tokyo, Japan.
Ohashi
Y
Y
Harada
K
K
Asai
T
T
Okawa
S
S
Nagashima
M
M
Katoh
T
T
Baba
K
K
Furusho
K
K
Okuni
M
M
D000208:Acute Disease; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007275:Injections, Intravenous; D008297:Male; D009080:Mucocutaneous Lymph Node Syndrome / Q000628:therapy*; D005719:gamma-Globulins / Q000008:administration & dosage*
D005719:gamma-Globulins