Perälä Miia, Ahola Maria, Mikkola Tytti, Pelkonen Anna S, Remitz Anita, Mäkelä Mika J
University of Helsinki and Helsinki University Hospital, Skin and Allergy Hospital, Helsinki, Finland.
Acta Paediatr. 2020 Mar;109(3):550-556. doi: 10.1111/apa.15001. Epub 2019 Oct 7.
We collected evidence and safety data for topical tacrolimus in small children with atopic dermatitis (AD) and compared the usage with topical corticosteroid.
This was an interim analysis of 75 patients (55% female) at 1 year of an ongoing 3-year randomised open-label comparative follow-up study of topical tacrolimus vs corticosteroid treatment. One- to three-year-old children with moderate-to-severe eczema referred to the Skin and Allergy Hospital in Helsinki, Finland, were enrolled.
Efficacy parameters, the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), transepidermal water loss (TEWL), eczema area, serum total immunoglobulin E (IgE) and the blood eosinophil count, showed improvement in both groups during the study. However, patients with signs of early sensitisation at baseline (elevated serum total IgE, elevated eosinophil count, positive prick tests or specific IgEs to aero or food allergens) had statistically significantly lower TEWL at the eczema site and a smaller eczema area at 12 months in the tacrolimus group. No severe adverse effects were seen during the treatment.
Children with AD and signs of early sensitisation appeared to benefit more from early tacrolimus than corticosteroid treatment. Small children may need stronger but nevertheless safe ointment options when treating moderate-to-severe AD.
我们收集了外用他克莫司治疗小儿特应性皮炎(AD)的证据和安全性数据,并与外用糖皮质激素的使用情况进行比较。
这是一项正在进行的为期3年的外用他克莫司与糖皮质激素治疗随机开放标签对照随访研究中1年时对75例患者(55%为女性)的中期分析。纳入了芬兰赫尔辛基皮肤与过敏医院转诊的1至3岁中重度湿疹患儿。
在研究期间,两组的疗效参数,即湿疹面积和严重程度指数(EASI)、研究者整体评估(IGA)、经表皮水分流失(TEWL)、湿疹面积、血清总免疫球蛋白E(IgE)和血液嗜酸性粒细胞计数均有改善。然而,在基线时有早期致敏迹象(血清总IgE升高、嗜酸性粒细胞计数升高、点刺试验阳性或对空气或食物过敏原的特异性IgE阳性)的患者,他克莫司组在12个月时湿疹部位的TEWL在统计学上显著较低,湿疹面积较小。治疗期间未观察到严重不良反应。
患有AD且有早期致敏迹象的儿童似乎从早期使用他克莫司比使用糖皮质激素治疗中获益更多。在治疗中重度AD时,小儿可能需要更强效但仍安全的软膏选择。