PDF(Pubmed)
Abstract：
UNASSIGNED: Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life.
UNASSIGNED: 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.
UNASSIGNED: A United Kingdom, multicentre, pragmatic, two-arm, parallel-group randomised controlled prevention trial with follow-up to 5 years.
UNASSIGNED: Twelve secondary and four primary care centres.
UNASSIGNED: Healthy infants (at least 37 weeks\' gestation) at high risk of developing eczema, screened and consented during the third trimester or post delivery.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: To pool similar studies in an individual patient data meta-analysis.
UNASSIGNED: This trial is registered as ISRCTN21528841.
UNASSIGNED: 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.
Eczema is a troublesome itchy skin condition affecting 1 in 5 children and 1 in 10 UK adults. There is no cure and affected children are more likely to develop food allergies. We wanted to see if we could prevent eczema by protecting the skin of babies at higher risk of developing eczema (with an immediate relative with eczema, asthma or hay fever) with moisturisers used to treat dry skin. Previous research suggested that protecting the skin barrier might also prevent food allergy. One thousand three hundred and ninety-four families took part in a study; half of them were asked to apply moisturiser every day to their newborn baby for the first year and half to look after their baby’s skin in the normal way. At the age of 2 years, we did not see any difference in how common eczema was between the two groups: 23% had eczema in the moisturiser group and 25% in the normal care group. It did not matter how we defined eczema – whether examined by a researcher or parent report. We did not find any differences in related conditions like asthma or hay fever either. We found that children using moisturisers had seen their doctor slightly more often for mild skin infections. There was a hint that food allergy might have been increased in the moisturiser group, but there was not enough data to be sure. We followed up the children to age 5 years, but we still did not find any benefits from using moisturisers in early life. Since this study, other similar research has been done using newer types of moisturisers, but their results are the same. This study shows that using daily moisturisers on healthy babies with a high risk of eczema does not prevent eczema. It is one less thing for busy families to worry about.
UNASSIGNED: 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.
UNASSIGNED: A United Kingdom, multicentre, pragmatic, two-arm, parallel-group randomised controlled prevention trial with follow-up to 5 years.
UNASSIGNED: Twelve secondary and four primary care centres.
UNASSIGNED: Healthy infants (at least 37 weeks\' gestation) at high risk of developing eczema, screened and consented during the third trimester or post delivery.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: To pool similar studies in an individual patient data meta-analysis.
UNASSIGNED: This trial is registered as ISRCTN21528841.
UNASSIGNED: 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.
Eczema is a troublesome itchy skin condition affecting 1 in 5 children and 1 in 10 UK adults. There is no cure and affected children are more likely to develop food allergies. We wanted to see if we could prevent eczema by protecting the skin of babies at higher risk of developing eczema (with an immediate relative with eczema, asthma or hay fever) with moisturisers used to treat dry skin. Previous research suggested that protecting the skin barrier might also prevent food allergy. One thousand three hundred and ninety-four families took part in a study; half of them were asked to apply moisturiser every day to their newborn baby for the first year and half to look after their baby’s skin in the normal way. At the age of 2 years, we did not see any difference in how common eczema was between the two groups: 23% had eczema in the moisturiser group and 25% in the normal care group. It did not matter how we defined eczema – whether examined by a researcher or parent report. We did not find any differences in related conditions like asthma or hay fever either. We found that children using moisturisers had seen their doctor slightly more often for mild skin infections. There was a hint that food allergy might have been increased in the moisturiser group, but there was not enough data to be sure. We followed up the children to age 5 years, but we still did not find any benefits from using moisturisers in early life. Since this study, other similar research has been done using newer types of moisturisers, but their results are the same. This study shows that using daily moisturisers on healthy babies with a high risk of eczema does not prevent eczema. It is one less thing for busy families to worry about.
摘要：
■过敏性湿疹是儿童时期常见的与哮喘有关的皮肤问题，食物过敏和过敏性鼻炎会损害生活质量。
■确定建议父母在第一年每天涂抹润肤剂是否可以预防高危儿童的湿疹和/或其他特应性疾病。
■英国，多中心,务实,双臂，平行组随机对照预防试验，随访5年。
■12个二级保健中心和4个初级保健中心。
■健康婴儿（妊娠至少37周）发展为湿疹的高风险，在妊娠晚期或分娩后进行筛查并同意。
■婴儿在出生后21天内随机(1:1)使用润肤剂(DoublebaseGel®;DermalLaboratoriesLtd,希钦,UK或DiprobaseCream®）第一年每天对全身（不包括头皮），加上标准护肤建议（润肤组）或仅标准护肤建议（对照组）。家庭并没有对分配视而不见。
■主要结果是在2岁的最后一年诊断出湿疹，根据英国工作组对Hanifin和Rajka诊断标准的细化定义，由对分配视而不见的研究护士评估。2岁以下的次要结局包括其他湿疹定义，湿疹的发病时间和严重程度，过敏性鼻炎,喘息,过敏性致敏，食物过敏,安全性（皮肤感染和滑脱）和成本效益。
■在2014年11月至2016年11月之间随机分配了一千三百九十四个新生儿；693个润肤剂和701个对照。润肤剂组中的依从性为88%(466/532)，在3、6和12个月时分别为82%(427/519)和74%(375/506)。在2年,湿疹在润肤剂组中出现139/598（23％），在对照组中出现150/612（25％）（调整后相对风险0.95，95％置信区间0.78至1.16；p=0.61，调整后风险差异-1.2％，95%置信区间-5.9%至3.6%)。其他湿疹定义支持主要分析。食物过敏（牛奶，鸡蛋,花生）在润肤剂组中的比例为41/547（7.5％），对照组为29/568（5.1％）（调整后的相对风险为1.47，95％置信区间为0.93至2.33）。润肤剂组中每个孩子第一年的平均皮肤感染次数为0.23（标准偏差0.68），对照组为0.15（标准偏差0.46）；调整后的发生率比为1.55，95％置信区间为1.15至2.09。2年湿疹风险降低的每百分比调整增量成本为5337英镑（未调整7281英镑）。通过父母问卷调查，在5岁以下的随访期间，两组在湿疹或其他特应性疾病方面没有差异。
■使用两种类型的润肤剂,其可以具有不同的效果。开始使用润肤剂的中位时间为出生后11天。对照组出现一些污染(<20%)。参与的家庭被揭盲，并报告了一些结果。
■我们没有发现任何证据表明，在生命的第一年中，每天使用润肤剂可以预防高危儿童的湿疹。使用润肤剂与皮肤感染的风险更高以及食物过敏的可能增加有关。在这种情况下，润肤剂的使用不太可能被认为具有成本效益。
■在个体患者数据荟萃分析中汇集类似的研究。
■本试验注册为ISRCTN21528841。
■该奖项由美国国家卫生与护理研究所（NIHR）卫生技术评估计划（NIHR奖参考：12/67/12）资助，并在《卫生技术评估》中全文发布。28号29.有关更多奖项信息，请参阅NIHR资助和奖励网站。
湿疹是一种麻烦的皮肤瘙痒状况，影响1/5的儿童和1/10的英国成年人。没有治愈方法，受影响的儿童更容易发生食物过敏。我们想看看我们是否可以通过保护患湿疹风险较高的婴儿的皮肤来预防湿疹（与湿疹的直系亲属，哮喘或花粉症）用保湿剂治疗皮肤干燥。先前的研究表明，保护皮肤屏障也可以防止食物过敏。一千三百九十四个家庭参加了一项研究；他们中的一半被要求在第一年半的时间里每天给他们的新生婴儿涂保湿霜，以正常的方式照顾他们婴儿的皮肤。在2岁的时候，我们没有发现两组湿疹的常见程度有任何差异:保湿霜组23%有湿疹,正常护理组25%有湿疹.我们如何定义湿疹并不重要-无论是由研究人员还是家长报告检查。我们也没有发现哮喘或花粉热等相关疾病的任何差异。我们发现，使用保湿霜的儿童因轻度皮肤感染而经常去看医生。有迹象表明，保湿霜组的食物过敏可能有所增加，但没有足够的数据来确定。我们跟踪孩子到5岁，但是我们仍然没有发现在早期生活中使用保湿霜的任何好处。由于这项研究,其他类似的研究已经使用新型的保湿霜，但是他们的结果是一样的。这项研究表明，对湿疹高风险的健康婴儿使用日常保湿剂并不能预防湿疹。忙碌的家庭少了一件事。
■确定建议父母在第一年每天涂抹润肤剂是否可以预防高危儿童的湿疹和/或其他特应性疾病。
■英国，多中心,务实,双臂，平行组随机对照预防试验，随访5年。
■12个二级保健中心和4个初级保健中心。
■健康婴儿（妊娠至少37周）发展为湿疹的高风险，在妊娠晚期或分娩后进行筛查并同意。
■婴儿在出生后21天内随机(1:1)使用润肤剂(DoublebaseGel®;DermalLaboratoriesLtd,希钦,UK或DiprobaseCream®）第一年每天对全身（不包括头皮），加上标准护肤建议（润肤组）或仅标准护肤建议（对照组）。家庭并没有对分配视而不见。
■主要结果是在2岁的最后一年诊断出湿疹，根据英国工作组对Hanifin和Rajka诊断标准的细化定义，由对分配视而不见的研究护士评估。2岁以下的次要结局包括其他湿疹定义，湿疹的发病时间和严重程度，过敏性鼻炎,喘息,过敏性致敏，食物过敏,安全性（皮肤感染和滑脱）和成本效益。
■在2014年11月至2016年11月之间随机分配了一千三百九十四个新生儿；693个润肤剂和701个对照。润肤剂组中的依从性为88%(466/532)，在3、6和12个月时分别为82%(427/519)和74%(375/506)。在2年,湿疹在润肤剂组中出现139/598（23％），在对照组中出现150/612（25％）（调整后相对风险0.95，95％置信区间0.78至1.16；p=0.61，调整后风险差异-1.2％，95%置信区间-5.9%至3.6%)。其他湿疹定义支持主要分析。食物过敏（牛奶，鸡蛋,花生）在润肤剂组中的比例为41/547（7.5％），对照组为29/568（5.1％）（调整后的相对风险为1.47，95％置信区间为0.93至2.33）。润肤剂组中每个孩子第一年的平均皮肤感染次数为0.23（标准偏差0.68），对照组为0.15（标准偏差0.46）；调整后的发生率比为1.55，95％置信区间为1.15至2.09。2年湿疹风险降低的每百分比调整增量成本为5337英镑（未调整7281英镑）。通过父母问卷调查，在5岁以下的随访期间，两组在湿疹或其他特应性疾病方面没有差异。
■使用两种类型的润肤剂,其可以具有不同的效果。开始使用润肤剂的中位时间为出生后11天。对照组出现一些污染(<20%)。参与的家庭被揭盲，并报告了一些结果。
■我们没有发现任何证据表明，在生命的第一年中，每天使用润肤剂可以预防高危儿童的湿疹。使用润肤剂与皮肤感染的风险更高以及食物过敏的可能增加有关。在这种情况下，润肤剂的使用不太可能被认为具有成本效益。
■在个体患者数据荟萃分析中汇集类似的研究。
■本试验注册为ISRCTN21528841。
■该奖项由美国国家卫生与护理研究所（NIHR）卫生技术评估计划（NIHR奖参考：12/67/12）资助，并在《卫生技术评估》中全文发布。28号29.有关更多奖项信息，请参阅NIHR资助和奖励网站。
湿疹是一种麻烦的皮肤瘙痒状况，影响1/5的儿童和1/10的英国成年人。没有治愈方法，受影响的儿童更容易发生食物过敏。我们想看看我们是否可以通过保护患湿疹风险较高的婴儿的皮肤来预防湿疹（与湿疹的直系亲属，哮喘或花粉症）用保湿剂治疗皮肤干燥。先前的研究表明，保护皮肤屏障也可以防止食物过敏。一千三百九十四个家庭参加了一项研究；他们中的一半被要求在第一年半的时间里每天给他们的新生婴儿涂保湿霜，以正常的方式照顾他们婴儿的皮肤。在2岁的时候，我们没有发现两组湿疹的常见程度有任何差异:保湿霜组23%有湿疹,正常护理组25%有湿疹.我们如何定义湿疹并不重要-无论是由研究人员还是家长报告检查。我们也没有发现哮喘或花粉热等相关疾病的任何差异。我们发现，使用保湿霜的儿童因轻度皮肤感染而经常去看医生。有迹象表明，保湿霜组的食物过敏可能有所增加，但没有足够的数据来确定。我们跟踪孩子到5岁，但是我们仍然没有发现在早期生活中使用保湿霜的任何好处。由于这项研究,其他类似的研究已经使用新型的保湿霜，但是他们的结果是一样的。这项研究表明，对湿疹高风险的健康婴儿使用日常保湿剂并不能预防湿疹。忙碌的家庭少了一件事。
