从出生开始涂润肤剂预防高危儿童湿疹:BEEP RCT。

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Health technology assessment Pub Date : 2024-07-01 DOI:10.3310/RHDN9613
Lucy E Bradshaw, Laura A Wyatt, Sara J Brown, Rachel H Haines, Alan A Montgomery, Michael R Perkin, Tracey H Sach, Sandra Lawton, Carsten Flohr, Matthew J Ridd, Joanne R Chalmers, Joanne Brooks, Richard Swinden, Eleanor J Mitchell, Stella Tarr, Nicola Jay, Kim S Thomas, Hilary Allen, Michael J Cork, Maeve M Kelleher, Eric L Simpson, Stella T Lartey, Susan Davies-Jones, Robert J Boyle, Hywel C Williams
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引用次数: 0

摘要

背景:特应性湿疹是一种常见的儿童皮肤问题,与哮喘、食物过敏和过敏性鼻炎有关,会影响生活质量:目的:确定建议家长在婴儿出生后第一年每天使用润肤剂是否能预防高危儿童的湿疹和/或其他特应性疾病:设计:英国一项多中心、务实、双臂、平行组随机对照预防试验,随访 5 年:地点:12 个二级医疗中心和 4 个初级医疗中心:健康婴儿(妊娠至少 37 周),有患湿疹的高风险,在怀孕三个月或产后接受筛查并同意接受治疗:在婴儿出生后 21 天内随机分配(1:1)婴儿在第一年内每天全身(不包括头皮)涂抹润肤剂(Doublebase Gel®;Dermal Laboratories Ltd,Hitchin,UK 或 Diprobase Cream®),同时提供标准皮肤护理建议(润肤剂组)或仅提供标准皮肤护理建议(对照组)。主要结果指标:主要结果:主要结果是根据英国工作小组对Hanifin和Rajka诊断标准的改进,在2岁时的最后一年诊断出湿疹,由研究护士在分配盲法下进行评估。2岁前的次要结果包括其他湿疹定义、湿疹发病时间和严重程度、过敏性鼻炎、喘息、过敏致敏、食物过敏、安全性(皮肤感染和滑脱)以及成本效益:2014年11月至2016年11月期间,随机抽取了1394名新生儿,其中润肤剂693名,对照组701名。在3、6和12个月时,润肤剂组的坚持率分别为88%(466/532)、82%(427/519)和74%(375/506)。2 年后,润肤剂组 139/598 人(23%)出现湿疹,对照组 150/612 人(25%)出现湿疹(调整后相对风险为 0.95,95% 置信区间为 0.78 至 1.16;P = 0.61,调整后风险差异为-1.2%,95% 置信区间为-5.9% 至 3.6%)。其他湿疹定义支持主要分析。润肤剂组 41/547 例(7.5%)患儿对食物(牛奶、鸡蛋、花生)过敏,对照组 29/568 例(5.1%)患儿对食物(牛奶、鸡蛋、花生)过敏(调整后相对风险为 1.47,95% 置信区间为 0.93 至 2.33)。润肤剂组每名儿童第一年的平均皮肤感染次数为 0.23 次(标准差为 0.68 次),对照组为 0.15 次(标准差为 0.46 次);调整后发病率比为 1.55,95% 置信区间为 1.15 至 2.09。2年后,湿疹风险每降低一个百分点的调整后增量成本为5337英镑(未调整为7281英镑)。通过家长调查问卷随访至5岁时,未发现各组在湿疹或其他特应性疾病方面存在差异:使用了两种润肤剂,可能会产生不同的效果。开始使用润肤剂的中位时间为出生后 11 天。对照组中出现了一些污染(< 20%)。参与研究的家庭未被屏蔽,并报告了一些结果:我们没有发现任何证据表明,高危儿童在出生后第一年每天使用润肤剂可以预防湿疹。使用润肤剂与较高的皮肤感染风险和可能增加的食物过敏有关。在这种情况下,使用润肤剂不太可能具有成本效益:未来研究:将类似的研究集中起来,进行个体患者数据荟萃分析:该试验的注册号为 ISRCTN21528841:该奖项由美国国家健康与护理研究所(NIHR)健康技术评估项目资助(NIHR奖项编号:12/67/12),全文发表于《健康技术评估》(Health Technology Assessment)第28卷第29期。更多奖项信息请参阅 NIHR Funding and Awards 网站。
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Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT.

Background: Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life.

Objectives: To determine whether advising parents to apply daily emollients in the first year can prevent eczema and/or other atopic diseases in high-risk children.

Design: A United Kingdom, multicentre, pragmatic, two-arm, parallel-group randomised controlled prevention trial with follow-up to 5 years.

Setting: Twelve secondary and four primary care centres.

Participants: Healthy infants (at least 37 weeks' gestation) at high risk of developing eczema, screened and consented during the third trimester or post delivery.

Interventions: Infants were randomised (1 : 1) within 21 days of birth to apply emollient (Doublebase Gel®; Dermal Laboratories Ltd, Hitchin, UK or Diprobase Cream®) daily to the whole body (excluding scalp) for the first year, plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). Families were not blinded to allocation.

Main outcome measures: Primary outcome was eczema diagnosis in the last year at age 2 years, as defined by the UK Working Party refinement of the Hanifin and Rajka diagnostic criteria, assessed by research nurses blinded to allocation. Secondary outcomes up to age 2 years included other eczema definitions, time to onset and severity of eczema, allergic rhinitis, wheezing, allergic sensitisation, food allergy, safety (skin infections and slippages) and cost-effectiveness.

Results: One thousand three hundred and ninety-four newborns were randomised between November 2014 and November 2016; 693 emollient and 701 control. Adherence in the emollient group was 88% (466/532), 82% (427/519) and 74% (375/506) at 3, 6 and 12 months. At 2 years, eczema was present in 139/598 (23%) in the emollient group and 150/612 (25%) in controls (adjusted relative risk 0.95, 95% confidence interval 0.78 to 1.16; p = 0.61 and adjusted risk difference -1.2%, 95% confidence interval -5.9% to 3.6%). Other eczema definitions supported the primary analysis. Food allergy (milk, egg, peanut) was present in 41/547 (7.5%) in the emollient group versus 29/568 (5.1%) in controls (adjusted relative risk 1.47, 95% confidence interval 0.93 to 2.33). Mean number of skin infections per child in the first year was 0.23 (standard deviation 0.68) in the emollient group versus 0.15 (standard deviation 0.46) in controls; adjusted incidence rate ratio 1.55, 95% confidence interval 1.15 to 2.09. The adjusted incremental cost per percentage decrease in risk of eczema at 2 years was £5337 (£7281 unadjusted). No difference between the groups in eczema or other atopic diseases was observed during follow-up to age 5 years via parental questionnaires.

Limitations: Two emollient types were used which could have had different effects. The median time for starting emollients was 11 days after birth. Some contamination occurred in the control group (< 20%). Participating families were unblinded and reported on some outcomes.

Conclusions: We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children. Emollient use was associated with a higher risk of skin infections and a possible increase in food allergy. Emollient use is unlikely to be considered cost-effective in this context.

Future research: To pool similar studies in an individual patient data meta-analysis.

Trial registration: This trial is registered as ISRCTN21528841.

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/67/12) and is published in full in Health Technology Assessment; Vol. 28, No. 29. See the NIHR Funding and Awards website for further award information.

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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
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