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Volume 149, Issue 3, Pages 336-341.e1 (September 2006)


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

Yoshinari Inoue, MDCorresponding Author Informationemail address, Yasunori Okada, MD, Makoto Shinohara, MD, Tohru Kobayashi, MD, Tomio Kobayashi, MD, Takeshi Tomomasa, MD, Kazuo Takeuchi, MD, MPH, Akihiro Morikawa, MD, Gunma Kawasaki Disease Study Group

Received 24 September 2005; received in revised form 2 May 2006; accepted 16 May 2006.

Refers to article:
Revisiting steroids in the primary treatment of acute Kawasaki disease
Jane C. Burns
The Journal of Pediatrics
September 2006 (Vol. 149, Issue 3, Pages 291-292)
Full Text | Full-Text PDF (62 KB)
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

Department of Pediatrics and Developmental Medicine, Gunma University Graduate School of Medicine, Gunma, Japan; Department of Cardiology, Gunma Children’s Medical Center, Gunma, Japan; and Department of Health Care and Social Welfare, Takasaki University of Health and Welfare, Gunma, Japan.

Corresponding Author InformationReprint requests: Yoshinari Inoue, Department of Pediatrics and Developmental Medicine, Gunma University Graduate School of Medicine, 3-29-22, Showa-machi, Maebashi, Gunma 371-8511, Japan.

 A list of the members of the Gunma Kawasaki Disease Study Group is available at www.jpeds.com.

PII: S0022-3476(06)00463-X

doi:10.1016/j.jpeds.2006.05.025


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