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一项关于皮质类固醇用于川崎病初始治疗的多中心前瞻性随机试验:临床病程及冠状动脉转归

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

作者信息

Inoue Yoshinari, Okada Yasunori, Shinohara Makoto, Kobayashi Tohru, Kobayashi Tomio, Tomomasa Takeshi, Takeuchi Kazuo, Morikawa Akihiro

机构信息

Department of Pediatrics and Developmental Medicine, Gunma University Graduate School of Medicine, 3-29-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.

出版信息

J Pediatr. 2006 Sep;149(3):336-341. doi: 10.1016/j.jpeds.2006.05.025.

DOI:10.1016/j.jpeds.2006.05.025
PMID:16939743
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.

摘要

目的

探讨皮质类固醇激素在川崎病(KD)初始治疗中的作用。

研究设计

2000年9月至2005年3月期间,我们将来自12家医院的178例KD患者随机分为静脉注射免疫球蛋白(IVIG)组(n = 88;连续2天,1 g/kg)或IVIG加皮质类固醇激素(IVIG + PSL)组(n = 90)。主要终点是1个月超声心动图评估前的冠状动脉异常(CAA)。次要终点包括发热持续时间、血清C反应蛋白(CRP)恢复正常的时间以及需要额外治疗的初始治疗失败情况。分析基于意向性治疗。

结果

两组的基线特征相似。IVIG + PSL组在1个月前发生CAA的患者少于IVIG组(2.2%对11.4%;P = 0.017)。IVIG + PSL组的发热持续时间较短(P < 0.001),CRP下降速度比IVIG组更快(P = 0.

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