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克罗恩病患儿接受英夫利昔单抗治疗一年期间,IMPACT-III与儿童克罗恩病活动指数的自回归交叉滞后模型

Autoregressive cross-lagged models of IMPACT-III and Pediatric Crohn's Disease Activity Indexes during one year infliximab therapy in pediatric patients with Crohn's disease.

作者信息

Szabó Dolóresz, Kökönyei Gyöngyi, Arató András, Dezsőfi Antal, Molnár Kriszta, Müller Katalin Eszter, Lakatos Péter László, Papp Mária, Lovász Barbara D, Golovics Petra A, Cseh Aron, Veres Gábor

机构信息

1st Department of Pediatrics, Semmelweis University, Budapest, Hungary.

Institute of Psychology, Eötvös Loránd University, Budapest, Hungary.

出版信息

J Crohns Colitis. 2014 Aug;8(8):747-55. doi: 10.1016/j.crohns.2013.12.020. Epub 2014 Jan 14.

Abstract

BACKGROUND

Quality of life (QoL) is an important outcome measure in the evaluation of therapies for inflammatory bowel disease. The primary aim of this study was to determine the effect of one year infliximab treatment on QoL and clinical parameters in pediatric patients with Crohn's diseases (CD).

METHODS

Our prospective study involved 51 children with conventional therapy resistant, severe CD (mean age: 15.25years, range: 11-18years). Infliximab was given according to the protocol (5mg/kg, at weeks 0, 2, 6 and every 8weeks). During the infliximab courses QoL of patients was evaluated by IMPACT-III questionnaire at weeks 0, 6, 30 and 53. At the same time, the Pediatric Crohn's Disease Activity Index (PCDAI) score was calculated. Moreover, serum C-reactive protein (CRP), serum platelets and serum albumin were followed up. Auto-regressive, cross-lagged models were used to assess relation between QoL and the clinical parameters.

RESULTS

The initial IMPACT-III scores [median, percentile 25-75 (pc 25-75) at week 0: 115, 102.5-130.25] increased significantly (p<0.001) following infliximab therapy at week 54 (median: 141.5, 124.5-153.75). Clinical and laboratory parameters also improved significantly (p<0.001). Auto-regressive regression coefficients (β value) were significant between each variable over time. The strongest cross-lagged relations were observed between IMPACT-III and serum albumin, IMPACT-III and platelets. Reliability test of IMPACT-III revealed an excellent level of internal consistency (Cronbach's alpha=0.931).

CONCLUSION

Infliximab treatment has beneficial clinical effect which is confirmed by decrease of PCDAI and increase of IMPACT-III. Autoregressive regression analysis showed regression relation between IMPACT-III and PCDAI and laboratory parameters.

摘要

背景

生活质量(QoL)是评估炎症性肠病治疗效果的一项重要指标。本研究的主要目的是确定英夫利昔单抗治疗一年对克罗恩病(CD)患儿生活质量和临床参数的影响。

方法

我们的前瞻性研究纳入了51例对传统治疗耐药的重度CD患儿(平均年龄:15.25岁,范围:11 - 18岁)。英夫利昔单抗按照方案给药(5mg/kg,在第0、2、6周以及之后每8周一次)。在英夫利昔单抗治疗期间,于第0、6、30和53周通过IMPACT - III问卷评估患者的生活质量。同时,计算儿童克罗恩病活动指数(PCDAI)评分。此外,对血清C反应蛋白(CRP)、血清血小板和血清白蛋白进行随访。采用自回归、交叉滞后模型评估生活质量与临床参数之间的关系。

结果

在第54周英夫利昔单抗治疗后,初始IMPACT - III评分[第0周中位数,百分位数25 - 75(pc 25 - 75):115,102.5 - 130.25]显著升高(p<0.001)(中位数:141.5,124.5 - 153.75)。临床和实验室参数也显著改善(p<0.001)。随着时间推移,各变量之间的自回归回归系数(β值)具有显著性。在IMPACT - III与血清白蛋白、IMPACT - III与血小板之间观察到最强的交叉滞后关系。IMPACT - III的信度检验显示出极佳的内部一致性水平(克朗巴哈系数α = 0.931)。

结论

英夫利昔单抗治疗具有有益的临床效果,这通过PCDAI降低和IMPACT - III升高得到证实。自回归回归分析显示IMPACT - III与PCDAI以及实验室参数之间存在回归关系。

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