Department of Pediatrics, Division of Pediatric Allergy & Immunology, Ann & Robert H. Lurie Children's Hospital, Chicago, IL, United States of America.
Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.
J Pediatr Nurs. 2019 Jul-Aug;47:36-43. doi: 10.1016/j.pedn.2019.03.018. Epub 2019 Apr 23.
To determine the safety and efficacy of topical corticosteroid versus vehicle/moisturizer in children under 2 years old (<2 y).
A systematic review and meta-analysis searching PubMed MEDLINE, Embase, Web of Science, Cochrane Database of Controlled Trials, Cochrane Database of Systematic Reviews, DARE, NHS Economic Evaluation, CINAHL, GREAT, and Clinicaltrials.gov. We selected randomized controlled trials (RCTs) comparing topical corticosteroids to vehicle/moisturizer and included children <2 y. Two authors extracted data.
Only one study limited analyses to children <2 y, so our review included participants older than 2 years. Twelve RCTs were included with 2224 participants. Ten studies were industry-sponsored.
The proportion of responders to topical corticosteroid across studies was 0.65 (95% CI, 0.54-0.74), as compared to vehicle/moisturizer 0.32 (95% confidence interval (CI), 0.20-0.48). The proportion of adverse events were similar between groups (topical steroids 0.17 (95% CI, 0.08-0.33) vs. vehicle/moisturizer 0.12 (CI 0.02-0.42)). High heterogeneity in treatment response occurred across studies that could not be explained by potential moderators. Mild adrenal suppression occurred in 4 of 157 measured participants (3%) receiving topical corticosteroids. Limitations include the few RCTs on this topic, the inclusion of participants >2 y and outcome measures and reporting methods rarely met CONSORT guidelines.
Topical corticosteroids trended to being more effective and equally safe to vehicle/moisturizers, but generalizability is limited given the dearth of well-designed studies focused on children <2 y. Adverse events from vehicle/moisturizer may be greater than topical corticosteroid due to under treatment.
Further work is needed in this age group.
确定 2 岁以下儿童(<2 岁)使用局部皮质类固醇与载体/保湿剂的安全性和疗效。
系统检索 PubMed MEDLINE、Embase、Web of Science、Cochrane 对照试验数据库、Cochrane 系统评价数据库、DARE、NHS 经济评估、CINAHL、GREAT 和 Clinicaltrials.gov 中的随机对照试验(RCT)。我们选择了将局部皮质类固醇与载体/保湿剂进行比较的 RCT,并纳入了<2 岁的儿童。两位作者提取了数据。
只有一项研究将分析仅限于<2 岁的儿童,因此我们的综述纳入了年龄大于 2 岁的参与者。12 项 RCT 纳入 2224 名参与者。10 项研究由工业界赞助。
与载体/保湿剂相比,各研究中局部皮质类固醇的应答者比例为 0.65(95%置信区间,0.54-0.74),而 0.32(95%置信区间,0.20-0.48)。两组之间不良反应的比例相似(局部类固醇 0.17(95%置信区间,0.08-0.33)与载体/保湿剂 0.12(CI 0.02-0.42))。研究之间的治疗反应存在高度异质性,无法用潜在的调节剂来解释。在接受局部皮质类固醇治疗的 157 名测量参与者中,有 4 名(3%)出现轻度肾上腺抑制。局限性包括关于这个主题的 RCT 很少,纳入了>2 岁的参与者,并且结局指标和报告方法很少符合 CONSORT 指南。
局部皮质类固醇在疗效上有趋势更有效,与载体/保湿剂同样安全,但鉴于缺乏针对<2 岁儿童的精心设计研究,其普遍性有限。由于治疗不足,载体/保湿剂的不良反应可能大于局部皮质类固醇。
在这个年龄组还需要进一步的工作。