中华皮肤科杂志 ›› 2025, Vol. 58 ›› Issue (10): 964-969.doi: 10.35541/cjd.20250164

• 研究报道 • 上一篇    下一篇

度普利尤单抗治疗儿童结节性痒疹的临床疗效及影响因素分析

万慧颖1    苏佳2    钟玲3    赵蓓1    周夕湲1   

  1. 1四川省医学科学院  四川省人民医院（电子科技大学附属医院）皮肤病性病研究所，成都  610072；2成都中医药大学医学与生命科学学院，成都  611137；3电子科技大学医学院  四川省人民医院皮肤科，成都  610054 
  • 收稿日期:2025-03-31 修回日期:2025-08-07 发布日期:2025-09-30
  • 通讯作者: 周夕湲 E-mail:zhouxiyuan@med.uestc.edu.cn

Clinical efficacy of dupilumab in the treatment of prurigo nodularis in children and analysis of its influencing factors

Wan Huiying1, Su Jia2, Zhong Ling3, Zhao Bei1, Zhou Xiyuan1   

  1. 1Institute of Dermatology and Venereology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu 610072, China; 2School of Medicine and Life Sciences, Chengdu University of Traditional Chinese Medicine, Chengdu 611137, China; 3Department of Dermatology, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610054, China
  • Received:2025-03-31 Revised:2025-08-07 Published:2025-09-30
  • Contact: Zhou Xiyuan E-mail:zhouxiyuan@med.uestc.edu.cn

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摘要： 【摘要】 目的 评估度普利尤单抗治疗儿童结节性痒疹（PN）的疗效及安全性，分析疗效的影响因素。方法 回顾性分析2022年12月至2025年1月在四川省人民医院皮肤性病研究所接受度普利尤单抗治疗的26例儿童PN患者的临床资料。主要疗效指标为治疗8周时研究者整体评估-活动度评分（IGA PN-A）和分级评分（IGA PN-S）达0/1分的比例；次要疗效指标包括瘙痒数字评价量表（NRS）下降 ≥ 4分的比例及实验室指标变化。治疗前后比较采用配对t检验或Wilcoxon符号秩和检验，采用广义估计方程评估湿疹面积与严重程度（EASI）评分随治疗时间的变化，采用单因素logistic回归分析计算比值比（OR）及95%置信区间（CI），分析疗效的影响因素。结果 PN患儿26例，男14例（53.8%），女12例（46.2%），年龄［M（Q1，Q3）］为4.50（3.00，9.25）岁，病程1.00（0.48，2.25）年。24例（92.3%）合并特应性疾病，其中17例合并过敏性鼻炎，15例合并特应性皮炎（AD）。治疗8周时，IGA PN-A从基线（x ± s）（3.27 ± 0.53）分降至（1.31 ± 0.84）分（t = 10.44，P < 0.001），16例（61.5%）达0/1分；IGA PN-S从基线（3.15 ± 0.46）分降至（1.73 ± 0.78）分（t = 10.33，P < 0.001），10例（38.5%）达0/1分；瘙痒NRS评分从基线5.00（5.00， 6.00）分下降至2.00（1.00， 3.00）分（Z = -3.82，P < 0.001），10例（38.5%）达NRS下降 ≥ 4分。40周时，7例持续治疗的患儿症状均完全缓解。单因素logistic回归分析显示，头面部受累（OR = 7.000，95% CI：1.200 ~ 40.829）及病程 < 1年（OR = 7.000，95% CI：1.200 ~ 40.829）疗效更佳，基线IGA评分为4分者疗效较差（OR = 0.114，95% CI：0.017 ~ 0.742）。治疗期间2例出现结膜炎和局部感染，未中断治疗；所有患儿均未出现严重不良事件。结论 度普利尤单抗可快速、持续改善儿童PN症状，安全性良好。头面部受累、病程较短及基线病情较轻者疗效更优。

关键词: 痒疹, 结节性痒疹, 度普利尤单抗, 儿童, 治疗结果, 影响因素

Abstract: 【Abstract】 Objective To evaluate the clinical efficacy and safety of dupilumab in the treatment of pediatric prurigo nodularis （PN）, and to explore factors associated with the treatment response. Methods A retrospective analysis was conducted on clinical data from 26 children with PN who received dupilumab treatment at the Institute of Dermatology and Venereology, Sichuan Provincial People's Hospital between December 2022 and January 2025. Primary efficacy endpoints were the proportion of patients achieving investigator's global assessment-activity （IGA PN-A） and stage （IGA PN-S） scores of 0/1 at week 8; secondary efficacy endpoints included the proportion of patients achieving a ≥ 4-point reduction in the pruritus numerical rating scale （NRS） and changes in laboratory parameters. Paired t tests or Wilcoxon signed-rank tests were used for pre- and post-treatment comparisons; generalized estimating equation models were applied to evaluate changes in eczema area and severity index （EASI） scores over time; univariate logistic regression analysis was performed to calculate odds ratios （ORs） and 95% confidence intervals （CIs） to analyze factors influencing efficacy. Results Among the 26 children with PN, 14 （53.8%） were males and 12 （46.2%） were females, with ages （M［Q1, Q3］） of 4.50 （3.00, 9.25） years and disease duration of 1.00 （0.48, 2.25） years. Twenty-four （92.3%） patients had comorbid atopic diseases, including 17 with allergic rhinitis and 15 with atopic dermatitis （AD）. At week 8, IGA PN-A scores decreased from 3.27 ± 0.53 points at baseline to 1.31 ± 0.84 points （t = 10.44, P < 0.001）, with 16 （61.5%） patients achieving IGA PN-A 0/1; IGA PN-S scores decreased from 3.15 ± 0.46 points at baseline to 1.73 ± 0.78 points （t = 10.33, P < 0.001）, with 10 （38.5%） patients achieving IGA PN-S 0/1; pruritus NRS scores decreased from 5.00 （5.00, 6.00） points at baseline to 2.00 （1.00, 3.00） points （Z = -3.82, P < 0.001）, with 10 （38.5%） patients achieving a ≥ 4-point reduction in NRS scores. At week 40, 7 patients who continued treatment achieved complete remission. Univariate logistic regression showed that head/face involvement （OR = 7.000, 95% CI: 1.200–40.829） and disease duration of < 1 year （OR = 7.000, 95% CI: 1.200–40.829） were associated with better treatment response, while baseline IGA scores of 4 points predicted poorer outcomes （OR = 0.114, 95% CI: 0.017–0.742）. During treatment, conjunctivitis and local infection occurred in 2 cases without discontinuation, and no serious adverse events occurred in any of the cases. Conclusions Dupilumab demonstrated rapid and sustained efficacy in pediatric PN with a favorable safety profile. Head/face involvement, shorter disease duration, and lower baseline severity were associated with better treatment response.

Key words: Prurigo, Prurigo nodularis, Dupilumab, Child, Treatment outcome, Influencing factor

引用本文

万慧颖 苏佳 钟玲 赵蓓 周夕湲. 度普利尤单抗治疗儿童结节性痒疹的临床疗效及影响因素分析[J]. 中华皮肤科杂志, 2025,58(10):964-969. doi:10.35541/cjd.20250164

Wan Huiying, Su Jia, Zhong Ling, Zhao Bei, Zhou Xiyuan. Clinical efficacy of dupilumab in the treatment of prurigo nodularis in children and analysis of its influencing factors[J]. Chinese Journal of Dermatology, 2025, 58(10): 964-969.doi:10.35541/cjd.20250164