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一项比较他克莫司与氢化可的松治疗儿童特应性皮炎的随机对照试验:关于γ-干扰素诱导蛋白和生长相关癌基因-α的新观点

A randomized controlled trial comparing tacrolimus versus hydrocortisone for the treatment of atopic dermatitis in children: new perspectives on interferon gamma-induced protein and growth-related oncogene-α.

作者信息

Binsaleh Ammena Y, Bahaa Mostafa M, Elmasry Thanaa A, Elberri Eman I, Kotkata Fedaa A, El-Khateeb Eman, Kamal Marwa, El-Samongy Marwa Ahmed, Hamouda Amir O, Alghamdi Amira M, Alrubia Sarah, Salahuddin Muhammed M, Eltantawy Nashwa

机构信息

Department of Pharmacy Practice, College of Pharmacy, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.

Pharmacy Practice Department, Faculty of Pharmacy, Horus University, New Damietta, Egypt.

出版信息

Front Med (Lausanne). 2024 Jul 24;11:1399305. doi: 10.3389/fmed.2024.1399305. eCollection 2024.

Abstract

INTRODUCTION

Atopic dermatitis (AD) is a type of chronic inflammatory disorder that affects children.

AIM

To investigate whether hydrocortisone or tacrolimus could be more effective for treating AD in children.

PATIENTS AND METHODS

This clinical randomized investigation included 100 children with AD who met the eligibility criteria. AD patients were recruited from Tanta University's Dermatology Department and divided into two groups ( = 50)., For four months, group 1 (the hydrocortisone group) received topical hydrocortisone cream. Group 2 received topical tacrolimus for four months. A dermatologist evaluated the patients at the start and four months after the treatment had been initiated to measure serum concentrations of neutrophil chemoattractant growth-related oncogene-α (GRO-α), interferon gamma induced protein 10 (IP-10), tumor necrosis factor alpha (TNF-α), vascular adhesion molecule 1 (VCAM-1), intercellular adhesion molecule 1 (ICAM-1). All patients were examined using the modified Eczema Area and Severity Index (mEASI) score.

RESULTS

Tacrolimus group showed a significant reduction in serum levels of all measured biomarkers ( < 0.05) when compared to its baseline and when compared to the hydrocortisone group. Both groups displayed a significant decline in mEASI score in comparison with their baseline values ( < 0.05).

CONCLUSION

In children with AD, tacrolimus reduces inflammatory biomarkers better than hydrocortisone, suggesting its potential as a more effective treatment option.

CLINICAL TRIAL REGISTRATION

https://clinicaltrials.gov, identifier NCT05607901.

摘要

引言

特应性皮炎(AD)是一种影响儿童的慢性炎症性疾病。

目的

研究氢化可的松或他克莫司对治疗儿童AD是否更有效。

患者和方法

这项临床随机研究纳入了100名符合入选标准的AD患儿。AD患者从坦塔大学皮肤科招募并分为两组(每组n = 50)。在四个月的时间里,第1组(氢化可的松组)接受外用氢化可的松乳膏治疗。第2组接受外用他克莫司治疗四个月。一名皮肤科医生在治疗开始时和开始治疗四个月后对患者进行评估,以测量中性粒细胞趋化因子生长相关癌基因-α(GRO-α)、干扰素γ诱导蛋白10(IP-10)、肿瘤坏死因子-α(TNF-α)、血管黏附分子1(VCAM-1)、细胞间黏附分子1(ICAM-1)的血清浓度。所有患者均使用改良的湿疹面积和严重程度指数(mEASI)评分进行检查。

结果

与基线水平相比以及与氢化可的松组相比,他克莫司组所有测量的生物标志物血清水平均显著降低(P < 0.05)。与各自的基线值相比,两组的mEASI评分均显著下降(P < 0.05)。

结论

在AD患儿中,他克莫司比氢化可的松更能降低炎症生物标志物水平,表明其作为一种更有效治疗选择的潜力。

临床试验注册

https://clinicaltrials.gov,标识符NCT05607901。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c41/11303293/91e0129f5f81/fmed-11-1399305-g002.jpg

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