中华皮肤科杂志 ›› 2022, Vol. 55 ›› Issue (4): 299-303.doi: 10.35541/cjd.20210734

• 论著 • 上一篇    下一篇

儿童中重度特应性皮炎首次皮下注射度普利尤单抗短期疗效和安全性分析

田晶    梁源    申春平    赵牧童    汪洋    王珊    焦磊    马琳   

  1. 国家儿童医学中心  首都医科大学附属北京儿童医院皮肤科，北京  100045
  • 收稿日期:2021-10-09 修回日期:2022-02-10 发布日期:2022-04-01
  • 通讯作者: 马琳 E-mail:bch_maleen@aliyun.com
  • 基金资助:
    国家自然科学基金（81673042）；北京市医院管理局儿科学科协同发展中心专项经费（XTZD20180502）

Analysis of short-term efficacy and safety of the first subcutaneous injection of dupilumab in the treatment of moderate-to-severe childhood atopic dermatitis

Tian Jing, Liang Yuan, Shen Chunping, Zhao Mutong, Wang Yang, Wang Shan, Jiao Lei, Ma Lin   

  1. Department of Dermatology, Beijing Children′s Hospital, Capital Medical University, National Center for Children′s Health, China, Beijing 100045, China
  • Received:2021-10-09 Revised:2022-02-10 Published:2022-04-01
  • Contact: Ma Lin E-mail:bch_maleen@aliyun.com
  • Supported by:
    National Natural Science Foundation of China （81673042）; The Special Fund of the Pediatric Medical Coordinated Development Center of Beijing Hospitals Authority （XTZD20180502）

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摘要： 【摘要】 目的 了解度普利尤单抗皮下注射治疗儿童中重度特应性皮炎（AD）的短期疗效及安全性。方法 采用回顾性研究设计，收集2021年3 - 8月于首都医科大学附属北京儿童医院皮肤科诊断为中重度AD且同时接受度普利尤单抗注射液皮下注射治疗的患儿临床资料，评估度普利尤单抗注射液首次皮下注射治疗前、治疗后4周患儿湿疹面积及严重程度指数（EASI）、峰值瘙痒数字评价量表（NRS）评分、AD积分指数（SCORAD）、皮肤病家庭生活质量指数（DFI）变化情况，同时收集首次注射至4周后首次访视时的不良事件。符合正态分布的定量指标采用配对t检验比较；不符合正态分布的定量指标则采用符号秩检验比较；采用Logistic回归方法分析病程、嗜酸性粒细胞计数、IgE、自身过敏性疾病史、家族成员过敏性疾病史这5种因素对度普利尤单抗治疗后EASI50的影响。结果 39例患儿纳入分析，其中男21例，女18例，2 ~ < 6岁21例，6 ~ < 18岁18例，年龄M（Q1，Q3）为65.0（53.0，111.0）个月。度普利尤单抗单次皮下注射后4周，18例（84.85%）EASI评分下降 ≥ 50%，13例（60.61%）下降 ≥ 75%，18例（75.76%）峰值NRS下降 ≥ 4分，20例（81.82%）下降 ≥ 3分；15例（68.75%）SCORAD评分下降 ≥ 50%，7例（18.75%）下降 ≥ 75%。所有患儿注射度普利尤单抗后至4周访视时，均未出现结膜炎、皮肤感染、注射部位反应等常见不良事件，亦无严重不良事件。Logistic回归分析显示，病程、嗜酸性粒细胞计数、IgE水平、自身合并过敏性疾病史、家族成员过敏性疾病史对EASI50的影响均无统计学意义（均P > 0.05）。结论 单次度普利尤单抗皮下注射可明显改善中重度AD患儿瘙痒症状、皮损严重程度，提高患儿家庭生活质量，短期安全性良好。

关键词: 特应性皮炎, 儿童, 度普利尤单抗, 单次剂量

Abstract: 【Abstract】 Objective To investigate short-term efficacy and safety of subcutaneous injection of dupilumab in the treatment of moderate-to-severe childhood atopic dermatitis （AD）. Methods A retrospective study was conducted on clinical data from children who were diagnosed with moderate-to-severe AD and subcutaneously injected with dupilumab in Department of Dermatology, Beijing Children′s Hospital, Capital Medical University from March 2021 to August 2021. Changes in the Eczema Area and Severity Index （EASI）, itch Numeric Rating Scale （NRS） score, SCORing Atopic Dermatitis （SCORAD）index, and Dermatology Family quality of life Index （DFI） were analyzed before and 4 weeks after the first subcutaneous injection of dupilumab. Adverse events were collected during the first injection to the first follow-up visit at week 4 after the start of treatment. Normally distributed measurement indices were compared by using paired t test, non-normally distributed measurement indices were compared by using signed rank test, and logistic regression analysis was used to evaluate the effects of disease duration, eosinophil counts, IgE levels, personal and family history of allergic diseases on EASI50 （≥ 50% decrease in the EASI score） after dupilumab treatment. Results A total of 39 children were enrolled in this study, including 21 males and 18 females. Twenty-one patients were aged 2 to < 6 years, 18 were aged 6 to < 18 years, and their median age （Q1, Q3） was 65.0（53.0, 111.0） months. Four weeks after the single-dose subcutaneous injection of dupilumab, 18 patients （84.85%） achieved ≥ 50% decrease in EASI score, 13 （60.61%） ≥ 75% decrease in EASI score; 18 （75.76%） experienced a decrease of ≥ 4 points in peak NRS, and 20 （81.82%） ≥ 3 points in peak NRS; the SCORAD score decreased by ≥ 50% in 15 （68.75%） patients, and by ≥ 75% in 7 （18.75%）. Neither common adverse events such as conjunctivitis, skin infections, injection site reactions, nor serious adverse events were observed in any of the children from the first injection to the first follow-up visit at week 4. Logistic regression analysis showed no significant effect of the disease duration, eosinophil counts, IgE levels, personal or family history of allergic diseases on EASI50 （all P > 0.05）. Conclusion A single-dose subcutaneous injection of dupilumab can markedly improve pruritus and severity of skin lesions in children with moderate-to-severe AD, and enhance the family quality of life, with favorable short-term safety.

Key words: Dermatitis atopic, Children, Dupilumab, Single dose