A multicenter prospective randomized trial of corticosteroids in primary therapy for Kawasaki disease: clinical course and coronary artery outcome.
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.
Inoue
Yoshinari
Y
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
Okada
Yasunori
Y
Shinohara
Makoto
M
Kobayashi
Tohru
T
Kobayashi
Tomio
T
Tomomasa
Takeshi
T
Takeuchi
Kazuo
K
Morikawa
Akihiro
A
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
D005938:Glucocorticoids; D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors; D011239:Prednisolone