title: A multicenter prospective randomized trial of corticosteroids in primary therapy for Kawasaki disease: clinical course and coronary artery outcome.
abstract: OBJECTIVE
  To investigate the role of corticosteroids in the initial treatment of Kawasaki disease (KD).
  
  
  METHODS
  Between September 2000 and March 2005, we randomly assigned 178 KD patients from 12 hospitals to either an intravenous immunoglobulin (IVIG) group (n = 88; 1 g/kg for 2 consecutive days) or an IVIG plus corticosteroid (IVIG+PSL) group (n = 90). The primary endpoint was coronary artery abnormality (CAA) before a 1-month echocardiographic assessment. Secondary endpoints included duration of fever, time to normalization of serum C-reactive protein (CRP), and initial treatment failure requiring additional therapy. Analyses were based on intention to treat.
  
  
  RESULTS
  Baseline characteristics of groups were similar. Fewer IVIG+PSL patients than IVIG patients had a CAA before 1 month (2.2% vs 11.4%; P = .017). The duration of fever was shorter (P < .001) and CRP decreased more rapidly in the IVIG+PSL group than in the IVIG group (P = .001). Moreover, initial treatment failure was less frequent (5.6% vs 18.2%; P = .010) in the IVIG+PSL group. All patients assigned to the IVIG+PSL group completed treatment without major side effects.
  
  
  CONCLUSIONS
  A combination of corticosteroids and IVIG improved clinical course and coronary artery outcome without causing untoward effects in children with acute KD.
authors.affiliation: Department of Pediatrics and Developmental Medicine, Gunma University Graduate School of Medicine, 3-29-22 Showa-machi, Maebashi, Gunma 371-8511, Japan. yinoue@showa.gunma-u.ac.jp
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Inoue
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Okada
authors.forename: Makoto
authors.initials: M
authors.lastname: Shinohara
authors.forename: Tohru
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Tomio
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tomomasa
authors.forename: Kazuo
authors.initials: K
authors.lastname: Takeuchi
authors.forename: Akihiro
authors.initials: A
authors.lastname: Morikawa
mesh_terms: D002648:Child; D002675:Child, Preschool; D003323:Coronary Aneurysm / Q000139:chemically induced / Q000000981:diagnostic imaging / Q000517:prevention & control*; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage*; D007155:Immunologic Factors / Q000008:administration & dosage*; D007223:Infant; D008297:Male; D009080:Mucocutaneous Lymph Node Syndrome / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D005938:Glucocorticoids; D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors; D011239:Prednisolone