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The Treatment of Kawasaki Syndrome with Intravenous Gamma Globulin

List of authors.
  • Jane W. Newburger, M.D., M.P.H.,
  • Masato Takahashi, M.D.,
  • Jane C. Burns, M.D.,
  • Alexa S. Beiser, Ph.D.,
  • Kyung Ja Chung, M.D.,
  • C. Elise Duffy, M.D.,
  • Mary P. Glode, M.D.,
  • Wilbert H. Mason, M.D.,
  • Venudhar Reddy, M.D.,
  • Stephen P. Sanders, M.D.,
  • Stanford T. Shulman, M.D.,
  • James W. Wiggins, M.D.,
  • Raquel V. Hicks, M.D.,
  • David R. Fulton, M.D.,
  • Alan B. Lewis, M.D.,
  • Donald Y.M. Leung, M.D., Ph.D.,
  • Theodore Colton, Sc.D.,
  • Fred S. Rosen, M.D.,
  • and Marian E. Melish, M.D.

Abstract

We compared the efficacy of intravenous gamma globulin plus aspirin with that of aspirin alone in reducing the frequency of coronary-artery abnormalities in children with acute Kawasaki syndrome in a multicenter, randomized trial. Children randomly assigned to the gamma globulin group received intravenous gamma globulin, 400 mg per kilogram of body weight per day, for four consecutive days; both treatment groups received aspirin, 100 mg per kilogram per day, through the 14th day of illness, then 3 to 5 mg per kilogram per day. Two-dimensional echocardiograms were interpreted blindly and independently by two or more readers. Two weeks after enrollment, coronary-artery abnormalities were present in 18 of 78 children (23 percent) in the aspirin group, as compared with 6 of 75 (8 percent) in the gamma globulin group (P = 0.01). Seven weeks after enrollment, abnormalities were present in 14 of 79 children (18 percent) in the aspirin group and in 3 of 79 (4 percent) in the gamma globulin group (P = 0.005). No child had serious adverse effects from receiving gamma globulin.

We conclude that high-dose intravenous gamma globulin is safe and effective in reducing the prevalence of coronary-artery abnormalities when administered early in the course of Kawasaki syndrome. (N Engl J Med 1986; 315:341–7.)

Funding and Disclosures

Supported by grants (HL 34545, RR 2172, RR 69, and RR 827} from the National Institutes of Health.

We are indebted to the members of the Safety and Policy Monitoring Committee: Mary Jane Jesse, M.D. (chairperson), Kathryn B. Davis, PH.D., Samuel W. Greenhouse, PH.D., Charles G. Hollingsworth, Dr.P.H., Martha Lepow, M.D., Laurence McCullough, PH.D., Richard D. Rowe, M.D., and Roberta G. Williams, M.D.; to Immuno AG (Austria) for the supply of gamma globulin; to Osamu Inoue, M.D., and Michael S. Schafier, M.D., for assistance in blind echocardiogram interpretations; to Harvey R. Meyerson for computer programming; to Yuki L. Takahashi for clerical assistance in blind echocardiogram-reading sessions; and to Laureen A. Russell, Janet L. Norton, Catherine L. Brosius, R.N., M.S., Donna Ching, M.P.H., and Julie P. Buck for coordination of the project and management of the data.

Author Affiliations

From the Departments of Pediatrics and Cardiology, Children's Hospital and Harvard Medical School, Boston; the Department of Pediatrics, Children's Memorial Hospital and Northwestern University School of Medicine, Chicago; Children's Hospital, the University of Colorado Health Sciences Center, and the University of Colorado School of Medicine, Denver; Children's Hospital of Los Angeles and the University of Southern California School of Medicine; Children's Hospital, the University of California, San Diego, Medical Center, and the University of California, San Diego, School of Medicine; Tufts–New England Medical Center and Tufts University School of Medicine, Boston; Kapiolani–Children's Medical Center and John A. Burns School of Medicine, Honolulu; and the Epidemiology and Biostatistics Section, Boston University School of Public Health. Address reprint requests to Dr. Newburger at the Department of Cardiology, Children's Hospital, 300 Longwood Ave., Boston, MA 02115.

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