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度普利尤单抗治疗中度至重度特应性皮炎的疗效和安全性临床观察

[Clinical observation on the efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis].

作者信息

Li C Y, Chen S, Qian W L, Yang L, Zheng Q, Chen A J, Chen J, Huang K, Fang S, Wang P, Hu L, Liu X R, Zhao X Q, Tan N, Cai T

机构信息

Department of Dermatology, the First Affiliated Hospital of Chongqing Medical University,Chongqing 400042, China.

出版信息

Zhonghua Yu Fang Yi Xue Za Zhi. 2023 Oct 6;57(10):1590-1595. doi: 10.3760/cma.j.cn112150-20221103-01063.

Abstract

To investigate the clinical efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis (AD) in China. A small sample self-controlled study before and after treatment was conducted to retrospective analysis patients with moderate to severe AD treated with dupilumab in the department of dermatology of the First Affiliated Hospital of Chongqing Medical University from July 2020 to March 2022. Dupilumab 600 mg was injected subcutaneously at week 0, and then 300 mg was injected subcutaneously every 2 weeks. The condition was evaluated by SCORAD(severity scoring of atopic dermatitis), NRS(numerical rating scale), DLQI(dermatology life quality index) and POEM(patient-oriented eczema measure). The improvement of SCORAD, NRS, DLQI and POEM was analyzed by paired test and non-parametric paired Wilcoxon. The results showed that a total of 67 patients with moderate to severe AD received dupilumab treatment, of which 41 patients (the course of treatment was more than 6 weeks) had reduced the severity of skin lesions, improved quality of life and reduced pruritus. A total of 23 patients completed 16 weeks of treatment. At 4, 8, 12 and 16 weeks, SCORAD, NRS, DLQI and POEM decreased compared with the baseline, and the differences were statistically significant. SCORAD (50.13±15.19) at baseline, SCORAD (36.08±11.96)(=6.049,<0.001) at week 4,SCORAD (28.04±11.10)(=10.471,<0.001) at week 8, SCORAD (22.93±9.72)(=12.428,<0.001) at week 12, SCORAD (16.84±7.82)(=14.609,<0.001) at week 16, NRS 7(6,8) at baseline, NRS 4(3,5)(3.861,<0.001) at week 4, NRS 2(1,4)(4.088,<0.001) at week 8, NRS 1(0,2)(4.206,<0.001) at week 12, NRS 2(0,2)(4.222,<0.001) at week 16, DLQI (13.83±5.71) at baseline, DLQI (8.00±4.02)(=6.325,<0.001) at week 4, DLQI (5.61±3.50)(=8.060,<0.001) at week 8, DLQI (3.96±1.99)(=8.717,<0.001) at week 12, DLQI (2.70±1.89)(=10.355,<0.001) at week 16, POEM (18.04±6.41) at baseline, POEM (9.70±4.70)(=7.031,<0.001) at week 4, POEM (7.74±3.48)(=8.806,<0.001) at week 8, POEM (6.35±3.33)(=10.474,<0.001) at week 12, POEM (4.26±2.51)(=11.996,<0.001) at week 16. In the 16th week, 100%(23 patients), 91.3%(21 patients), 34.8%(8 patients) and 8.7%(2 patients) of 23 patients reached SCORAD30, SCORAD50, SCORAD70, and SCORAD90 statuses, respectively. There were 82.6%(19 patients), 95.7%(22 patients) and 95.7%(22 patients) of 23 patients with NRS, DLQI and POEM improved by≥4 points compared with baseline. Twelve patients with AD who continued to receive dupilumab after 16 weeks showed further improvement in skin lesions. The adverse events were conjunctivitis and injection site reaction. In conclusion, dupilumab is an effective and safe treatment for moderate and severe AD. However, the longer-term efficacy and safety require further studies involving larger sample sizes and a longer follow-up time.

摘要

探讨度普利尤单抗治疗中国中度至重度特应性皮炎(AD)的临床疗效及安全性。采用治疗前后小样本自身对照研究,对2020年7月至2022年3月在重庆医科大学附属第一医院皮肤科接受度普利尤单抗治疗的中度至重度AD患者进行回顾性分析。第0周皮下注射度普利尤单抗600mg,之后每2周皮下注射300mg。采用特应性皮炎严重程度评分(SCORAD)、数字评定量表(NRS)、皮肤病生活质量指数(DLQI)和患者导向性湿疹评估量表(POEM)进行病情评估。采用配对t检验和非参数配对Wilcoxon检验分析SCORAD、NRS、DLQI和POEM的改善情况。结果显示,共有67例中度至重度AD患者接受度普利尤单抗治疗,其中41例(治疗疗程超过6周)皮肤病变严重程度减轻,生活质量改善,瘙痒减轻。共有23例患者完成16周治疗。在第4、8、12和16周时,SCORAD、NRS、DLQI和POEM较基线水平下降,差异有统计学意义。基线时SCORAD为(50.13±15.19),第4周时SCORAD为(36.08±11.96)(t=6.049,P<0.001),第8周时SCORAD为(28.04±11.10)(t=10.471,P<0.001),第12周时SCORAD为(22.93±9.72)(t=12.428,P<0.001),第16周时SCORAD为(16.84±7.82)(t=

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