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儿童急性重症溃疡性结肠炎的皮质类固醇给药:一项倾向评分分析

Corticosteroid Dosing in Pediatric Acute Severe Ulcerative Colitis: A Propensity Score Analysis.

作者信息

Choshen Sapir, Finnamore Helen, Auth Marcus K H, Bdolah-Abram Tali, Shteyer Eyal, Mack David, Hyams Jeffrey, Leleiko Neal, Griffiths Anne, Turner Dan

机构信息

*The Juliet Keidan Institute of Pediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center†The Hebrew University of Jerusalem, Jerusalem, Israel‡Alder Hey Children's NHS Foundation Trust, Liverpool, UK§Children's Hospital of Eastern Ontario IBD Centre and Department of Pediatrics, University of Ottawa, Ottawa, Canada||Connecticut Children's Medical Center, Hartford, CT¶Hasbro Chidren's Hospital/Rhode Island Hospital, Alpert School of Medicine at Brown University, Providence#SickKids Hospital, University of Toronto, Toronto, Canada.

出版信息

J Pediatr Gastroenterol Nutr. 2016 Jul;63(1):58-64. doi: 10.1097/MPG.0000000000001079.

Abstract

OBJECTIVES

We aimed to explore the optimal dosing of intravenous-corticosteroids (IVCS) using a robust statistical method on the largest pediatric cohort of acute severe colitis to date.

METHODS

Two hundred eighty-three children treated with IVCS for ulcerative colitis were included and studied for 1 year (46% boys, age 12.1 ± 3.9 years, disease duration 2 (interquartile range [IQR] 0-14) months, baseline Pediatric Ulcerative Colitis Activity Index 69 ± 13 points). Confounding by indication was addressed by matching high- and low-IVCS dose patients according to the propensity score method, using 3 cutoffs (1 mg · kg · methylprednisolone to 40 mg · day, 1.25 mg · kg to 50 mg · day and 2 mg · kg to 80 mg · day).

RESULTS

The median IVCS dose in the entire cohort was 1.0 mg · kg · day (IQR 0.8-1.4) and 44 mg · kg · day (32-60). Ninety-four of 283 children were matched in the low-dose cutoff (1 mg · kg · day), 218 of 283 were matched in the middle cutoff (1.25 mg · kg · day), and 86/283 in the high dose cutoff (2 mg · kg · day). No differences were found in 25 pretreatment baseline variables in the three cutoffs, implying successful matching. There were no statistical differences in the outcomes of the two lower cutoffs (including need for salvage therapy during admission and by 1 years, admission duration, and day-5 Pediatric Ulcerative Colitis Activity Index<35 points; all P > 0.05). In the high cutoff, the higher doses were somewhat better but this benefit reversed in a sensitivity analysis excluding one center. High doses were not associated with better outcome also in a propensity score-weighted regression model on the entire cohort.

CONCLUSIONS

Our data support present guidelines that doses of IVCS >1 to 1.5 mg · kg · day (maximum 40-60 mg · kg · day) are not justified in acute severe colitis.

摘要

目的

我们旨在运用一种稳健的统计方法,在迄今为止最大的急性重症结肠炎儿科队列中探索静脉注射皮质类固醇(IVCS)的最佳剂量。

方法

纳入283例接受IVCS治疗的溃疡性结肠炎患儿,并进行为期1年的研究(46%为男孩,年龄12.1±3.9岁,病程2(四分位间距[IQR]0 - 14)个月,基线儿童溃疡性结肠炎活动指数为69±13分)。通过倾向评分法,采用3个截断值(1mg·kg·甲基泼尼松龙至40mg/天、1.25mg·kg至50mg/天和2mg·kg至80mg/天)对高剂量和低剂量IVCS患者进行匹配,以解决指征性混杂问题。

结果

整个队列中IVCS的中位剂量为1.0mg·kg/天(IQR 0.8 - 1.4)和44mg/天(32 - 60)。283例患儿中有94例在低剂量截断值(1mg·kg/天)下匹配,283例中有218例在中等截断值(1.25mg·kg/天)下匹配,283例中有86例在高剂量截断值(2mg·kg/天)下匹配。在三个截断值中,25个治疗前基线变量未发现差异,这意味着匹配成功。两个较低截断值的结果无统计学差异(包括入院期间及1年时的挽救治疗需求、住院时间和第5天儿童溃疡性结肠炎活动指数<35分;所有P>0.05)。在高截断值中,较高剂量在某种程度上更好,但在排除一个中心的敏感性分析中这种益处逆转。在整个队列的倾向评分加权回归模型中,高剂量也与更好的结局无关。

结论

我们的数据支持当前的指南,即急性重症结肠炎中IVCS剂量>1至1.5mg·kg/天(最大40 - 60mg/天)是不合理的。

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