度普利尤单抗治疗中重度特应性皮炎儿童有效性及安全性研究

Efficacy and Safety Study of Dupilumab in Children with Moderate to Severe Atopic Dermatitis

摘要: 目的：探讨度普利尤单抗(Dupilumab)治疗中重度特应性皮炎(Atopic Dermatitis, AD)儿童患者的有效性及安全性。方法：本研究采用单中心前瞻性设计，纳入77例中重度AD儿童，均接受12周Dupilumab治疗。通过特应性皮炎评分(Scoring Atopic Dermatitis, SCORAD)、瘙痒症数值评定量表(Pruritus Numerical Rating Scale, P-NRS)、皮肤病生活质量指数(Dermatology Life Quality Index, DLQI)、患者湿疹自我监测(Patient-Oriented Eczema Measure, POEM)对病情进行评估。采用非参数秩检验分析治疗前后SCORAD、NRS、DLQI、POEM及过敏原血清总免疫球蛋白E (Total Immunoglobulin E, tIgE)及血常规等实验室指标。结果：本研究共纳入了77例完成12周Dupilumab治疗及随访的中重度AD儿童。与基线相比，第12周治疗后SCORAD、P-NRS、DLQI、POEM各量表评分较基线均显著下降(P < 0.001)。血清tIgE水平较基线降低具有统计学意义(903 kU/L vs. 395 kU/L, P < 0.001)。在安全性方面，10例(13.0%)儿童报告了治疗相关的不良事件，主要为眼部瘙痒(4例，5.2%)和结膜炎(2例，2.6%)，均未导致停药。结论：Dupilumab治疗中重度AD儿童疗效显著且安全性良好，能有效改善临床症状并降低血清tIgE水平，为临床治疗提供了重要的参考依据，有助于指导临床医生合理选择治疗方案。

Abstract: Objective: To investigate the efficacy and safety of Dupilumab in the treatment of children with moderate to severe atopic dermatitis (AD). Method: This study adopted a single-center prospective design, enrolling 77 children with moderate-to-severe atopic dermatitis (AD) who received 12 weeks of Dupilumab treatment. Disease severity was evaluated using Scoring Atopic Dermatitis (SCORAD), Pruritus Numerical Rating Scale (P-NRS), Dermatology Life Quality Index (DLQI), and Patient-oriented Eczema Measure (POEM). Nonparametric rank tests were used to analyze pre- and post-treatment differences in SCORAD, P-NRS, DLQI, POEM scores, as well as laboratory indices including Total Immunoglobulin E (tIgE) in allergen-specific serum and blood routine parameters. Results: This study included 77 children with moderate-to-severe atopic dermatitis (AD) who completed 12 weeks of dupilumab treatment and follow-up. Compared with baseline, scores on the SCORAD, P-NRS, DLQI, and POEM scales significantly decreased at week 12 (all P < 0.001). Serum total IgE (tIgE) levels showed a statistically significant reduction from baseline (903 kU/L vs. 395 kU/L, P < 0.001). In terms of safety, 10 patients (13.0%) reported treatment-related adverse events, primarily ocular pruritus (4 cases, 5.2%) and conjunctivitis (2 cases, 2.6%), none of which led to treatment discontinuation. Conclusions: Dupilumab shows significant efficacy and good safety in the treatment of children with moderate to severe AD. It can effectively improve clinical symptoms and reduce serum tIgE levels, providing an important reference for clinical treatment and helping clinicians rationally select treatment options.