度普利尤单抗治疗结节性痒疹疗效与安全性的多中心回顾性分析  

Efficacy and safety of dupilumab in the treatment of prurigo nodularis: a multicenter retrospective analysis

作　　者：夏曼琪 邵蕾 黄琼霄 田歆 梁毅敏 黄婷 梁景耀 刘玉梅 Xia Manqi;Shao Lei;Huang Qiongxiao;Tian Xin;Liang Yimin;Huang Ting;Liang Jingyao;Liu Yumei(Institute of Dermatology,Guangzhou Medical University,Department of Dermatology,Guangzhou Institute of Dermatology,Guangzhou 510095,China)

机构地区：[1]广州医科大学皮肤病研究所广州市皮肤病医院皮肤科,广州510095

出　　处：《中华皮肤科杂志》2024年第8期679-684,共6页Chinese Journal of Dermatology

基　　金：广州市科技计划项目(2023A03J0473、2023A03J0468)。

摘　　要：目的分析真实世界度普利尤单抗治疗结节性痒疹(PN)的临床疗效与安全性。方法回顾性分析2021年6月至2022年10月中国2型炎症皮肤病均质化诊疗项目数据库中应用度普利尤单抗皮下注射治疗≥12周的PN患者的临床资料。纳入收集患者的人口学资料并分析治疗前后瘙痒数字评价量表(NRS)、PN研究者总体评分(IGA PN-S)、皮肤病生活质量指数(DLQI)和医院焦虑抑郁量表(HADS)的评分变化。治疗前后评分差异及疗效的比较采用Wilcoxon符号秩和检验、配对t检验或卡方检验。结果纳入66例PN患者,男42例,女24例,年龄8~89(44.12±24.17)岁。36例有特应性疾病史;27例有特应性家族史。66例治疗12周时与基线时比较NRS评分[3.00(2.00,4.25)比7.00(5.00,8.00)]、IGA PN-S评分[2.00(2.00,3.00)比3.00(3.00,4.00)]、DLQI指数[5.00(1.75,8.25)比12.00(7.75,20.25)]均降低(均P<0.001);39例继续规律用药治疗并随访至16周时瘙痒NRS、IGA PN-S评分较12周时进一步降低(均P<0.05)。有无特应性疾病史患者之间12周NRS改善≥4分比例、IGA 0/1比例差异无统计学意义(均P>0.05)。治疗前32例合并轻至重度焦虑和/或抑郁,治疗12周时,28例合并焦虑(HADS-A>7分)的HADS-A评分和20例合并抑郁(HADS-D>7分)的HADS-D评分与基线比较均降低,差异均有统计学意义(均P<0.001);18例(56.52%)焦虑抑郁缓解(HADS-A和HADS-D均<7分)。66例中包含13例未成年患者,男7例,女6例,年龄8~17(13.77±3.09)岁,治疗12周时,瘙痒NRS、IGA PN-S和DLQI评分与基线比较均显著改善(均P<0.05);其中8例继续治疗至16周,IGA PN-S较12周时进一步下降(P<0.05),瘙痒NRS和DLQI评分与12周时差异无统计学意义(均P>0.05)。7例成年患者出现不良反应,包括眼部瘙痒、局部注射反应及注射当日全身红斑瘙痒,未成年患者均未报告不良反应。结论真实世界中度普利尤单抗可以显著缓解PN的瘙痒、皮肤病变和焦虑抑郁症状,显著提高生活质量,安全Objective To evaluate the efficacy and safety of dupilumab in the treatment of prurigo nodularis(PN)in the real world.Methods PN patients who were subcutaneously injected with dupilumab for over 12 weeks were collected from the China TypeⅡInflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project Database from June 2021 to October 2022.Their clinical data were retrospectively analyzed,which included demographic data,and changes in pruritus numeric rating scale(NRS),investigator global assessment for PN-Stage(IGA PN-S),dermatology life quality index(DLQI)and hospital anxiety and depression scale(HADS)scores before and after treatment.Differences in scores before and after treatment,as well as in efficacy between patients with and without a history of atopic diseases,were analyzed using Wilcoxon signed-rank test,paired t-test or chi-square test.Results A total of 66 PN patients were collected,including 42 males and 24 females,and they were aged 8 to 89(44.12±24.17)years.Thirty-six patients had a history of atopic diseases,and 27 had a family history of atopic diseases.After 12-week treatment with dupilumab,the pruritus NRS,IGA PN-S and DLQI scores in the 66 patients significantly decreased from the baseline scores(7.00[5.00,8.00],3.00[3.00,4.00],12.00[7.75,20.25],respectively)to 3.00[2.00,4.25],2.00[2.00,3.00],5.00[1.75,8.25],respectively(all P<0.001).Among the 66 patients,39 continued the regular treatment with dupilumab after 12 weeks and were followed up to 16 weeks;their pruritus NRS and IGA PN-S scores at week 16 further decreased compared with those at week 12(both P<0.05).There were no significant differences in the proportion of patients showing an improvement of≥4 points in the NRS score or the proportion of patients achieving IGA 0/1 at week 12 between the patients with history of atopic diseases and those without(both P>0.05).Before treatment,32 PN patients were accompanied by mild to severe anxiety and/or depression;after 12-week treatment,the HADS-A scores in the

关 键 词：痒疹 结节性痒疹 度普利尤单抗 治疗结果 焦虑 抑郁 真实世界研究 

分 类 号：R758.3[医药卫生—皮肤病学与性病学]