A multicenter, randomized, controlled trial of intravenous gamma globulin therapy in children with acute Kawasaki disease.

Acta Paediatr Jpn. 1994 Aug;36(4):347-54.

Morikawa Y, Ohashi Y, Harada K, Asai T, Okawa S, Nagashima M, Katoh T, Baba K, Furusho K, Okuni M, et al.

Department of Pediatrics, School of Medicine, Keio University, Tokyo, Japan.

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.

Publication Types:
  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

PMID: 7524263 [PubMed - indexed for MEDLINE]
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