Study of the Atopic March: Development of Atopic Comorbidities.
Study of the Atopic March: Development of Atopic Comorbidities.
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特应性游行的研究：特应性合并症的发展。
DOI：
10.1111/pde.12867
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发表时间：
2016
影响因子：
1.5
通讯作者：
Paller,AmyS
中科院分区：
文献类型：
--
作者：
Schneider,Lynda;Hanifin,Jon;Boguniewicz,Mark;Eichenfield,LawrenceF;Spergel,JonathanM;Dakovic,Rada;Paller,AmyS
背景特应性皮炎（AD）通常是特应性皮炎发展的第一步，导致哮喘或过敏性鼻炎的发生。本研究的目的是确定是否与吡美莫司早期干预限制特应性游行在婴儿AD和评估其疗效和safety.MethodsThis是一个为期3年的双盲研究中，患者随机吡美莫司或车辆，然后开放标签吡美莫司计划进一步3年。如果研究药物治疗3天未导致改善，则允许使用补救外用皮质类固醇;研究者在第14周前决定是否使用补救药物，此后由护理人员决定。疗效评估包括无病天数，兴奋面积和严重程度指数，和体表面积affected. Results 3至18个月的婴儿与最近发作的AD（≤3个月），观察了平均2.8年（N= 1,091）。研究结束时，吡美莫司治疗组和安慰剂治疗组发生哮喘（10.7%）或其他过敏性疾病（过敏性鼻炎，22.4%;食物过敏，15.9%;过敏性结膜炎，14.1%;一种或多种特应性合并症，37.0%）的AD患者百分比无显著差异。在基线时AD严重程度较高的婴儿中，过敏性鼻炎、食物过敏和患有一种或多种特应性合并症（但不是哮喘或过敏性结膜炎）的发生率显著更高。在第14周，吡美莫司治疗AD的有效性显著高于溶媒。不良事件的发生率是similar.ConclusionsThis纵向观察AD的婴儿提供证据的特应性游行。吡美莫司治疗轻中度AD婴儿安全有效。
BackgroundAtopic dermatitis (AD) is often the first step in the atopic march leading to the development of asthma or allergic rhinitis. The goal of this study was to determine whether early intervention with pimecrolimus limits the atopic march in infants with AD and to evaluate its efficacy and safety.MethodsThis was a 3‐year double‐blind study in which patients were randomized to pimecrolimus or vehicle and then open‐label pimecrolimus for a planned further 3 years. Rescue topical corticosteroid was permitted if 3 days of study medication led to no improvement; investigators made decisions on rescue medication until week 14 and caregivers thereafter. Efficacy assessments included disease‐free days, Eczema Area and Severity Index, and body surface area affected.ResultsInfants ages 3 to 18 months with recent‐onset AD (≤3 months) were observed for a mean of 2.8 years (N= 1,091). No significant differences between pimecrolimus‐ and placebo‐treated groups were found in the percentage of patients with AD who developed asthma (10.7%) or other allergic conditions (allergic rhinitis, 22.4%; food allergy, 15.9%; allergic conjunctivitis, 14.1%; one or more atopic comorbidities, 37.0%) by study end. Allergic rhinitis, food allergy, and having one or more atopic comorbidities (but not asthma or allergic conjunctivitis alone) developed significantly more often in infants with greater AD severity at baseline. Pimecrolimus was significantly more effective than vehicle for AD treatment at week 14. Adverse event incidences were similar.ConclusionsThis longitudinal observation of infants with AD provides evidence of the atopic march. Pimecrolimus was safe and effective in infants with mild to moderate AD.