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J Pediatr. 2006 Sep;149(3):336-341.

A multicenter prospective randomized trial of corticosteroids in primary therapy for Kawasaki disease: clinical course and coronary artery outcome.

Author information

1
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

Abstract

OBJECTIVE:

To investigate the role of corticosteroids in the initial treatment of Kawasaki disease (KD).

STUDY DESIGN:

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.

PMID:
16939743
DOI:
10.1016/j.jpeds.2006.05.025
[Indexed for MEDLINE]

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