度普利尤单抗与沙利度胺治疗成人难治性结节性痒疹的疗效及安全性比较
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篇名: 度普利尤单抗与沙利度胺治疗成人难治性结节性痒疹的疗效及安全性比较
TITLE: Efficacy and safety comparison of dupilumab versus thalidomide in the treatment of refractory prurigo nodularis in adults
摘要: 目的 比较度普利尤单抗与沙利度胺治疗成人难治性结节性痒疹(PN)的疗效及安全性。方法回顾性分析2021年5月至2024年6月武汉市第一医院收治的123例成人难治性PN患者的临床资料,将其中接受度普利尤单抗治疗的设为观察组(63例),接受沙利度胺治疗的设为对照组(60例)。比较两组患者治疗前后的临床疗效指标[研究者整体评估(IGA)法评分、瘙痒数字评分量表(P-NRS)评分、患者湿疹自我检查评分量表(POEM)评分及皮肤病生活质量指数(DLQI)评分]、过敏性指标[外周血中嗜酸性粒细胞(EOS)计数和血清总免疫球蛋白E(IgE)水平]、心理健康[医院焦虑抑郁量表(HADS)]评分及治疗期间的不良反应发生情况。结果治疗前,两组患者上述各项临床疗效指标、过敏性指标和心理健康评分比较,差异均无统计学意义(P>0.05)。两组患者治疗后4、8、12及16周的IGA评分(对照组治疗后4周除外)、IGA活动度评分(对照组治疗后4周除外)、P-NRS评分、POEM评分、DLQI评分(对照组治疗后4周除外)、血清EOS计数及总IgE水平均较治疗前显著下降(P<0.05),治疗后12及16周的HADS-焦虑分量表及HADS-抑郁分量表评分均较治疗前显著下降(P<0.05),且观察组均显著低于对照组(P<0.05)。观察组总不良反应发生率为12.70%,显著低于对照组的28.33%(P<0.05)。结论度普利尤单抗治疗成人难治性PN在改善皮损程度、缓解瘙痒、减少外周血EOS计数、降低血清总IgE水平、改善生活质量及心理状态方面均显著优于沙利度胺,且安全性良好。
ABSTRACT: OBJECTIVE To compare the efficacy and safety of dupilumab versus thalidomide in the treatment of refractory prurigo nodularis (PN) in adults. METHODS A retrospective analysis was conducted on the clinical data of 123 adult patients with refractory PN admitted to Wuhan First Hospital from May 2021 to June 2024. Among them, 63 patients who received dupilumab comprised the observation group and 60 patients who received thalidomide comprised the control group. Clinical efficacy indicators [Investigator Global Assessment (IGA) score, Pruritus Numerical Rating Scale (P-NRS) score, Patient-Oriented Eczema Measure (POEM) score, and Dermatology Life Quality Index (DLQI) score], allergic biomarkers [eosinophil (EOS) count in peripheral blood and serum total immunoglobulin E (IgE) level], psychological scores [Hospital Anxiety and Depression Scale (HADS)] before and after treatment, as well as the occurrence of adverse drug reaction during treatment, were compared between the two groups. RESULTS Before treatment, there were no statistically significant differences between the two groups in above clinical efficacy indicators, allergic biomarkers, or psychological scores (P>0.05). At 4, 8, 12 and 16 weeks after treatment, both groups showed significant decreases in IGA score (except for the control group 4 weeks after treatment), IGA activity score (except for the control group 4 weeks after treatment), P-NRS score, POEM score, DLQI score (except for the control group 4 weeks after treatment), serum EOS count, and serum total IgE level compared with baseline (P<0.05); at 12 and 16 weeks after treatment, scores on both the HADS-anxiety subscale and HADS-depression subscale were also significantly lower than baseline in both groups (P<0.05); the observation group was significantly lower than the control group (P<0.05). The overall incidence of adverse events was 12.70% in the observation group, which was significantly lower than 28.33% in the control group (P<0.05). CONCLUSIONS Dupilumab treatment in adults with refractory PN demonstrates superior efficacy compared with thalidomide in improving skin lesions, relieving pruritus, reducing peripheral EOS counts and serum total IgE, and improving quality of life and psychological status, while showing a more favorable safety profile.
期刊: 2025年第36卷第21期
作者: 张建波;胡磊;黄鹤归;刘杨从;王晓仙
AUTHORS: ZHANG Jianbo,HU Lei,HUANG Hegui,LIU Yangcong,WANG Xiaoxian
关键字: 结节性痒疹;度普利尤单抗;沙利度胺;皮损;瘙痒;生活质量;心理健康;疗效;安全性
KEYWORDS: prurigo nodularis; dupilumab; thalidomide;
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