Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.
Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Lancet. 2020 Mar 21;395(10228):962-972. doi: 10.1016/S0140-6736(19)32984-8. Epub 2020 Feb 19.
Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children.
We did a multicentre, pragmatic, parallel-group, randomised controlled trial in 12 hospitals and four primary care sites across the UK. Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma, diagnosed by a doctor). Term newborns with a family history of atopic disease were randomly assigned (1:1) to application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The randomisation schedule was created using computer-generated code (stratified by recruiting centre and number of first-degree relatives with atopic disease) and participants were assigned to groups using an internet-based randomisation system. The primary outcome was eczema at age 2 years (defined by UK working party criteria) with analysis as randomised regardless of adherence to allocation for participants with outcome data collected, and adjusting for stratification variables. This trial is registered with ISRCTN, ISRCTN21528841. Data collection for long-term follow-up is ongoing, but the trial is closed to recruitment.
1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group. Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data. At age 2 years, eczema was present in 139 (23%) of 598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0·95 [95% CI 0·78 to 1·16], p=0·61; adjusted risk difference -1·2% [-5·9 to 3·6]). Other eczema definitions supported the results of the primary analysis. Mean number of skin infections per child in year 1 was 0·23 (SD 0·68) in the emollient group versus 0·15 (0·46) in the control group; adjusted incidence rate ratio 1·55 (95% CI 1·15 to 2·09).
We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections. Our study shows that families with eczema, asthma, or allergic rhinitis should not use daily emollients to try and prevent eczema in their newborn.
National Institute for Health Research Health Technology Assessment.
皮肤屏障功能障碍先于湿疹发展。我们测试了在第一年中是否每天使用保湿剂可以预防高危儿童的湿疹。
我们在英国的 12 家医院和 4 个初级保健点进行了一项多中心、实用、平行组、随机对照试验。通过产前或产后服务向有患湿疹（即至少有一位一级亲属有父母报告的湿疹、过敏性鼻炎或哮喘，由医生诊断）高风险的足月婴儿（至少 37 周妊娠）招募家庭。有特应性疾病家族史的足月新生儿被随机分配（1:1）每天使用保湿剂（Diprobase 乳膏或 DoubleBase 凝胶）进行第一年的治疗，外加标准皮肤护理建议（保湿剂组）或仅接受标准皮肤护理建议（对照组）。随机分组方案使用计算机生成的代码（按招募中心和有特应性疾病的一级亲属数量分层）创建，参与者使用基于互联网的随机系统分配到各组。主要结局是 2 岁时的湿疹（根据英国工作组的标准定义），分析为随机分配，无论参与者的依从性如何，均对分配进行分析，并且对分层变量进行了调整。该试验在 ISRCTN 和 ISRCTN 注册，ISRCTN21528841。长期随访的数据收集仍在进行中，但该试验已停止招募。
2014 年 11 月 19 日至 2016 年 11 月 18 日期间，共有 1394 名新生儿被随机分配到研究组；693 名被分配到保湿剂组，701 名被分配到对照组。在有完整问卷数据的参与者中，保湿剂组在 3 个月时的依从率为 88%（532 例中的 466 例），6 个月时为 82%（519 例中的 427 例），12 个月时为 74%（506 例中的 375 例）。在有结局数据的 598 名婴儿中，有 139 名（23%）在 2 岁时患有湿疹，在 612 名对照组婴儿中有 150 名（25%）（调整后的相对风险 0.95[95%CI 0.78 至 1.16]，p=0.61；调整后的风险差异 -1.2%[-5.9 至 3.6]）。其他湿疹定义支持主要分析的结果。在第一年中，每例儿童的皮肤感染平均数在保湿剂组为 0.23（SD 0.68），在对照组为 0.15（0.46）；调整后的发病率比为 1.55（95%CI 1.15 至 2.09）。
我们没有发现每天在生命的第一年使用保湿剂可以预防高危儿童的湿疹的证据，并且有一些证据表明皮肤感染的风险增加。我们的研究表明，有湿疹、哮喘或过敏性鼻炎的家庭不应使用每日保湿剂来尝试预防其新生儿的湿疹。
英国国家卫生研究院健康技术评估。
