类人胶原蛋白修复敷料联合度普利尤单抗治疗中重度特应性皮炎患儿的效果

doi:10.3760/cma.j.cn441417-20240723-04031

摘要/Abstract

摘要：

目的　探讨类人胶原蛋白修复敷料联合度普利尤单抗治疗中重度特应性皮炎患儿的效果。方法　选取2021年2月至2023年8月西北妇女儿童医院收治的116例中重度特应性皮炎患儿进行随机对照试验。采用抽签法将其分为对照组和试验组，各58例。对照组男29例，女29例，年龄（5.78±2.34）岁。试验组男29例，女29例，年龄（5.82±2.28）岁。对照组度普利尤单抗治疗，试验组类人胶原蛋白修复敷料联合度普利尤单抗治疗。比较两组疗效、症状改善状况（皮肤干燥、皮肤瘙痒、皮损）、皮肤屏障状况［皮脂含量、含水量、经表皮水份丢失（transepidermal water loss，TEWL）］、特应性皮炎量表（Scoring Atopic Dermatitis，SCORAD）评分、研究者整体（Investigator's Global Assessment，IGA）评分、湿疹面积及严重度指数（Eczema Area and Severity Index，EASI）评分、生活质量［儿童皮肤病生活质量指数（Children's Dermatology Life Quality Index，CDLQI）、婴儿皮炎生活质量指数（Infant Dermatitis Quality of Life Index，IDQOL）］。采用t检验、χ²检验进行统计分析。结果　试验组总有效率高于对照组［96.55%（56/58）比81.03%（47/58）］，差异有统计学意义（χ²=7.017，P=0.008）。试验组皮肤干燥、皮肤瘙痒、皮损改善时间均短于对照组［（5.56±1.77）d比（7.06±2.16）d、（10.56±2.73）d比（12.09±2.16）d、（7.58±2.06）d比（10.73±2.27）d］，差异均有统计学意义（t=4.091、3.347、7.826，均P<0.05）。治疗后，试验组皮脂含量、含水量均高于对照组［（84.22±12.24）μg/cm²比（65.47±10.31）μg/cm²、（46.35±8.17）%比（37.40±7.75）%］，TEWL低于对照组［（15.87±2.14）g/（h·cm²）比（19.76±2.94）g/（h·cm²）］，差异均有统计学意义（t=8.923、6.053、8.147，均P<0.05）。治疗后，试验组SCORAD、IGA、EASI评分均低于对照组［（18.52±7.98）分比（23.12±8.49）分、（1.53±0.74）分比（2.02±0.61）分、（5.75±0.94）分比（7.92±1.26）分］，差异均有统计学意义（t=3.007、3.891、10.513，均P<0.05）。治疗后，试验组CDLQI、IDQOL评分均低于对照组［（3.92±0.53）分比（9.19±1.31）分、（4.68±0.37）分比（8.83±1.26）分］，差异均有统计学意义（t=28.401、24.067，均P<0.05）。结论　类人胶原蛋白修复敷料联合度普利尤单抗治疗中重度特应性皮炎患儿能改善其皮肤症状和皮肤屏障功能，降低相关评分，并提高患儿生活质量。

关键词:

特应性皮炎, 类人胶原蛋白修复敷料, 度普利尤单抗, 效果

Abstract:

Objective　To explore the effect of human-like collagen repair dressings combined with dupilumab for children with moderate to severe atopic dermatitis. Methods　One hundred and sixteen children with moderate to severe atopic dermatitis treated at Northwest Women's and Children's Hospital from February 2021 to August 2023 were selected for the randomized controlled trial, and were divided into a control group and an experimental group by lottery, with 58 cases in each group. There were 29 males and 29 females in the control group; they were (5.78±2.34) years old. There were 29 males and 29 females in the experimental group; they were (5.82±2.28) years old. The control group were treated with dupilumab, while the experimental group with human-like collagen repair dressings and dupilumab. The treatment efficacies, symptom improvement (skin dryness, itching, and skin lesions), skin barrier function [sebum content, moisture content, and transepidermal water loss (TEWL)], scores of Scoring Atopic Dermatitis (SCORAD), scores of Investigator's Global Assessment (IGA), scores of Eczema Area and Severity Index (EASI), and quality of life [Children's Dermatology Life Quality Index (CDLQI) and Infant Dermatitis Quality of Life Index (IDQOL)] were compared between the two groups using t and χ² tests. Results　The overall treatment efficacy in the experimental group was higher than that in the control group [96.55% (56/58) vs. 81.03% (47/58)], with a statistical difference (χ²=7.017; P=0.008). The improvement times for skin dryness, itchiness, and lesions in the experimental group were shorter than those in the control group [(5.56±1.77) d vs. (7.06±2.16) d, (10.56±2.73) d vs. (12.09±2.16) d, and (7.58±2.06) d vs. (10.73±2.27) d], with statistical differences (t=4.091, 3.347, and 7.826; all P<0.05).After the treatment, the sebum content, hydration level, and TEWL in the experimental group were better than those in the control group [(84.22±12.24) μg/cm² vs. (65.47±10.31) μg/cm², (46.35±8.17)% vs. (37.40±7.75)%, (15.87±2.14) g/(h·cm²) vs. (19.76±2.94) g/(h·cm²)], with statistical differences (t=8.923, 6.053, and 8.147; all P<0.05). After the treatment, the scores of SCORAD, IGA, EASI, CDLQI, and IDQOL in the experimental group were lower than those in the control group (18.52±7.98 vs. 23.12±8.49, 1.53±0.74 vs. 2.02±0.61, 5.75±0.94 vs. 7.92±1.26, 3.92±0.53 vs. 9.19±1.31, and 4.68±0.37 vs. 8.83±1.26), with statistical differences (t=3.007, 3.891, 10.513, 28.401, and 24.067; all P<0.05). Conclusion　Human-like collagen repair dressings combined with dupilumab for children with moderate to severe atopic dermatitis can improve their skin symptoms, barrier function, and life quality, and reduce relevant scores.

Key words:

Atopic dermatitis, Human-like collagen repair dressings, Dupilumab, Effect

杨丽娟马芳.

类人胶原蛋白修复敷料联合度普利尤单抗治疗中重度特应性皮炎患儿的效果 [J]. 国际医药卫生导报, 2025, 31(4): 684-688.

Yang Lijuan, Ma Fang.

Human-like collagen repair dressings combined with dupilumab for children with moderate to severe atopic dermatitis [J]. International Medicine and Health Guidance News, 2025, 31(4): 684-688.

参考文献

[1] 杨亚敏,曹源,门月华,等. 度普利尤单抗治疗获得性反应性穿通性胶原病合并特应性皮炎1例[J]. 解放军医学院学报,2023,44(8):942-944,封3. DOI: 10.12435/j.issn.2095- 5227. 2023.059.
[2] 林颖,蔡坚雄,刘颖瑶,等. 培土清心法小儿推拿治疗婴幼儿特应性皮炎的理论与实践[J]. 中医药导报,2023,29(7):122-124,160. DOI: 10.13862/j.cn43-1446/r.2023.07.024.
[3] 沈祺彦,朱越,何子莹,等. 序贯外用地奈德乳膏与克立硼罗软膏治疗轻中度特应性皮炎的疗效和安全性[J]. 中国临床医学,2023,30(1):111-115. DOI:10.12025/j.issn.1008- 6358.2023.20221704.
[4] 田敏,熊炜,肖玉凤,等. 他克莫司联合度普利尤单抗治疗中、重度特应性皮炎的临床研究[J]. 中国现代医学杂志,2024,34(4):72-77. DOI: 10.3969/j.issn.1005-8982.2024.04.011.
[5] 许丽,胡建,石梦醒,等. 度普利尤单克隆抗体治疗儿童中重度特应性皮炎的疗效与安全性研究[J]. 天津医科大学学报,2023,29(2):165-169.
[6] 中华医学会皮肤性病学分会儿童皮肤病学组. 中国儿童特应性皮炎诊疗共识(2017版)[J]. 中华皮肤科杂志,2017,50(11):784-789. DOI: 10.3760/cma.j.issn.0412-4030. 2017.11.002.
[7] 中华医学会皮肤性病学分会免疫学组,特应性皮炎协作研究中心. 中国特应性皮炎诊疗指南(2020版)[J]. 中华皮肤科杂志,2020,53(2):81-88. DOI: 10.35541/cjd.20191000.
[8] 钟昕,刘朝圣,谭素芳,等. 养阴解毒外洗方联合他克莫司软膏治疗儿童中重度特应性皮炎脾虚湿蕴证临床研究[J]. 中国中医药信息杂志,2021,28(10):121-126. DOI:10.19879/j.cnki.1005-5304.202103170.
[9] 房祥芳,黄钰洁,李岩峰,等. 特应性皮炎的靶向治疗新进展[J]. 国际医药卫生导报,2023,29(24):3546-3550. DOI: 10.3760/cma.j.issn.1007-1245.2023.24.005.
[10] 姚超,马倩. 除湿止痒软膏联合0.03%他克莫司乳膏治疗儿童特应性皮炎的临床研究[J]. 中国中西医结合皮肤性病学杂志,2023,22(4):352-354. DOI: 10.3969/j.issn.1672- 0709. 2023.04.017.
[11] 董琦然,张虹亚. 老鹳草软膏联合丁酸氢化可的松乳膏序贯疗法治疗儿童期特应性皮炎临床观察[J]. 安徽中医药大学学报,2022,41(5):22-26. DOI: 10.3969/j.issn.2095-7246. 2022.05.007.
[12] 陈信春,张亚男,陈志伟,等. 健脾除湿食疗法治疗儿童特应性皮炎的疗效观察及对皮肤屏障生理指标、IL-31的影响[J]. 中国中医药科技,2021,28(5):699-701.
[13] 石永言. 外用他克莫司或皮质类固醇均可安全有效地治疗中重度特应性皮炎患儿[J]. 国际儿科学杂志,2020,47(3):222. DOI: 10.3760/cma.j.issn.1673-4408.2020.03.104.
[14] 邓维,苏伟,李倩,等. 度普利尤单抗治疗以泛发结节性痒疹为主要表现的儿童中重度特应性皮炎疗效分析[J]. 中国皮肤性病学杂志, 2023, 37(3): 308-313. DOI: 10.13735/j.cjdv.1001-7089.202206127.
[15] 张雪珥,叶晟桢,郑派,等. 楂曲消风散治疗儿童特应性皮炎湿热蕴结证的临床疗效及其对皮损处皮肤菌群的影响[J]. 中医杂志,2024,65(8):810-820. DOI: 10.13288/j.11-2166/r.2024.08.008.
[16] 李佳琪,王蕊,韩倩倩,等. 软组织修复医用材料及产品的研究进展[J]. 中国医疗器械杂志,2023,47(4):415-423. DOI: 10.3969/j.issn.1671-7104.2023.04.012.
[17] 纪倩,马梦瑶,柳恒青,等. 促创面修复胶原蛋白敷料的研究进展[J]. 中华创伤杂志, 2020, 36(3): 283-288. DOI: 10.3760/cma.j.issn.1001-8050.2020.03.018.
[18] Hosseini-Ashrafi M, Clayton TH, Herring M, et al. Real-world outcomes of children treated with dupilumab for moderate-to-severe atopic dermatitis: a single-centre retrospective observational UK study [J]. Clin Exp Dermatol, 2024, 49(6): 578-583. DOI: 10.1093/ced/llae013.
[19] 郑敏玲,罗海敏,冯俊慧,等. 人体肘窝部皮肤菌群培养方法的建立及其在特应性皮炎疾病辅助诊断中的应用探索[J]. 国际医药卫生导报, 2022, 28(17): 2400-2405. DOI: 10.3760/cma.j.issn.1007-1245.2022.17.007.
[20] Napolitano M, Fabbrocini G, Neri I, et al. Dupilumab treatment in children aged 6-11 years with atopic dermatitis: a multicentre, real-life study [J]. Paediatr Drugs, 2022, 24(6): 671-678. DOI: 10.1007/s40272-022-00531-0.
[21] Paller AS, Simpson EL, Siegfried EC, et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial [J]. Lancet, 2022, 400(10356): 908-919. DOI: 10.1016/S0140-6736(22)01539-2.
[22] Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial [J]. JAMA Dermatol, 2020, 156(1):44-56. DOI: 10.1001/jamadermatol.2019.3336.
[23] 韩玉慧,刘长山,李宜凡,等. 度普利尤单抗治疗儿童重度特应性皮炎疗效分析[J]. 中华实用儿科临床杂志,2022,37(18):1423-1425. DOI: 10.3760/cma.j.cn101070- 20211125-01395.
[24] 申春平,刘晓雁,王榴慧,等. 类人胶原蛋白修复敷料辅助治疗儿童特应性皮炎的临床研究[J]. 实用皮肤病学杂志,2023,16(4):193-196, 205. DOI: 10.11786/sypfbxzz.1674- 1293. 20230401.
[25] 田晶,梁源,申春平,等. 儿童中重度特应性皮炎首次皮下注射度普利尤单抗短期疗效和安全性分析[J]. 中华皮肤科杂志,2022,55(4):299-303. DOI: 10.35541/cjd.20210734.