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《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:

29卷

期数:

2023年02期

页码:

165-169

栏目:

临床医学

出版日期:

2023-03-20

文章信息/Info

Title:

Efficacy and safety study of dupilumab in the treatment of moderate-to-severe atopic dermatitis in children

文章编号:

1006-8147（2023）02-0165-05

作者:

许丽¹; 胡建¹; 石梦醒¹; 孙鑫雨¹; 王雪艳¹; 2; 刘长山¹; 2

1.天津医科大学第二医院儿科，天津300211;2.天津医科大学儿童呼吸及哮喘研究中心，天津300211

Author(s):

XU Li¹; HU Jian¹; SHI Meng-xing¹; SUN Xin-yu¹; WANG Xue-yan¹; 2; LIU Chang-shan¹; 2

1.Department of Pediatrics，The Second Hospital，Tianjin Medical University，Tianjin 300211，China;2.Tianjin Medical University Children′s Respiratory and Ashma Research Center，Tianjin 300211，China

关键词:

度普利尤单克隆抗体; 特应性皮炎; 过敏性共病; 儿童

Keywords:

dupilumab; atopic dermatitis; allergic comorbidity; child

分类号:

R725.9

DOI:

-

文献标志码:

A

摘要:

目的：探讨度普利尤单克隆抗体（单抗）治疗儿童中重度特应性皮炎（AD）的疗效与安全性。方法：采用回顾性分析的方法，纳入2021年4月—2022年10月在天津医科大学第二医院儿科哮喘和过敏专病门诊接受度普利尤单抗治疗16周的中重度AD患儿17例。比较治疗前后各项AD相关临床评估量表及过敏性共病临床指标、外周血嗜酸性粒细胞计数（EOS）、血清总IgE（T-IgE）水平的变化，评估治疗期间达到湿疹面积及严重程度指数从基线到16周降低≥50%（EASI50）和湿疹面积及严重程度指数从基线到16周降低≥90%（EASI90）的患儿比例及研究者整体评估（IGA）评分达到0或1（皮疹清除或几乎清除）的比例，观察治疗期间不良反应与不良事件的发生情况。结果：与基线相比，AD相关评估量表在度普利尤单抗首次注射后2周即出现显著下降（均P<0.01）；治疗8周后，达到EASI50、EASI90（及IGA评分达到0或1的患者比例即明显增加。度普利尤单抗治疗16周后，患者EOS水平总体较基线上升，5例患者血清T-IgE水平较基线下降，但差异无统计学意义。合并哮喘或过敏性鼻炎（AR）患儿的儿童哮喘控制测试／哮喘控制测试（C-ACT/ACT）、哮喘控制问卷（ACQ）、鼻炎视觉模拟（VAS）评分均得到显著改善，呼出气一氧化氮（FeNO）水平及吸入性糖皮质激素（ICS）剂量均较基线显著下降，第1秒用力呼气容积（FEV1）较基线上升（均P<0.05）。合并食物过敏患儿2例，既往食用过敏食物诱发AD皮疹及瘙痒加重的症状得到改善。治疗期间3例出现结膜炎。结论：度普利尤单抗治疗可以显著改善中重度AD儿童及其过敏性共病临床症状，降低FeNO水平及ICS剂量，改善肺功能，并可能降低血清T-IgE水平。治疗期间不良反应少，主要表现为轻中度结膜炎，安全性良好。

Abstract:

Objective：To investigate the efficacy and safety of Dupilumab in the treatment of moderate to severe atopic dermatitis（AD）in children. Methods：A retrospective analysis was used to include 17 children with moderate-to-severe AD who received dupilumab for 16 weeks at the pediatric asthma and allergy-specific clinic of the Second Hospital of Tianjin Medical University from April 2021 to October 2022. Changes in various AD-related clinical assessment scales and clinical indicators of allergic co-morbidity，peripheral blood eosinophil count（EOS），and total serum IgE（T-IgE）levels were compared before and after treatment.The proportion of children achieving EASI50 and EASI90（≥50% and≥90% reduction in eczema area and severity index from baseline to 16 weeks），and the proportion achieving an IGA（Investigator′s Overall Assessment）score of 0 or 1（rash clearance or almost clearance）during the treatment period was assessed.The adverse reactions and adverse events during treatment were observed. Results：Compared with baseline，the AD-related assessment scales showed a significant decrease 2 weeks after the first dupilumab injection（all P<0.01）；the proportion of patients achieving EASI50，EASI90 and IGA scores of 0 or 1 increased significantly immediately after 8 weeks of treatment. After 16 weeks of dupilumab treatment，the patients′EOS levels increased overall from baseline and serum T-IgE levels decreased from baseline in 5 patients，but the differences were not statistically significant. Children with combined asthma or allergic rhinitis（AR）had significant improvements in Childhood Asthma Control Test/ Asthma Control Test（C-ACT/ACT），Asthma Control Questionnaire（ACQ），visual analog scale（VAS）scores for rhinitis，exhaled nitric oxide（FeNO）levels and inhaled corticosteroids（ICS）dose decreased significantly from baseline，and the forced expiratory volume in the first second（FEV1）increased from baseline（all P<0.05）. Two children with combined food allergy had improvement of AD rash and itching aggravation induced by previous consumption of allergic food. Conjunctivitis developed in 3 cases during treatment.Conclusion：Dupilumab treatment can significantly improve the clinical symptoms of moderate and severe AD children and their allergic comorbidities，reduce the level of FeNO and ICS dose，improve lung function，and may reduce the level of serum T-IgE. During the treatment，there were few adverse reactions，mainly mild to moderate conjunctivitis，with good safety.

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相似文献/References:

[1]王俊霞,杨子微 综述,车雅敏 审校.特应性皮炎小鼠模型研究进展[J].天津医科大学学报,2017,23(04):383.
[2]毕田田,陈立新,王 莹,等.特异性免疫治疗对特应性皮炎模型小鼠细胞因子的调控[J].天津医科大学学报,2017,23(05):408.
　,,et al.Effect of specific immunotherapy on cytokines in atopic dermatitis mice model[J].Journal of Tianjin Medical University,2017,23(02):408.

备注/Memo

备注/Memo:

基金项目：：天津市科技计划项目（22KPHDRC00280）
作者简介：许丽（1997-），女，硕士在读，研究方向：儿童过敏性疾病；
通信作者：刘长山，E-mi chshliu@163.com。

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更新日期/Last Update: 2023-04-30