Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Galter Health Sciences Library, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Br J Clin Pharmacol. 2023 Jul;89(7):2039-2065. doi: 10.1111/bcp.15751. Epub 2023 May 9.
New topical agents have been developed for the treatment of atopic dermatitis (AD) in recent years. This systematic review is intended to synthesize the clinical trial literature and concisely report the updated safety and adverse effects of topical medications used to treat atopic dermatitis in children.
A systematic search of Cochrane Library, Embase, PubMed and ClinicalTrials.gov from inception to March 2022 was conducted for trials of topical medications used to treat AD in patients <18 years (PROSPERO #CRD42022315355). Included records were limited to English-language publications and studies of ≥3 weeks duration. Phase 1 studies and those that lacked separate paediatric safety reporting were excluded.
A total of 5005 records were screened; 75 records met inclusion criteria with 15 845 paediatric patients treated with tacrolimus, 12 851 treated with pimecrolimus, 3539 with topical corticosteroid (TCS), 700 with crisaborole and 202 with delgocitinib. Safety data was well reported in tacrolimus trials with the most frequently reported adverse events being burning sensation, pruritus and cutaneous infections. Two longitudinal cohort studies were included, one for tacrolimus and one for pimecrolimus, which found no significant increased risk of malignancy with topical calcineurin inhibitor (TCI) use in children. Skin atrophy was identified as an adverse event in TCS trials, which other medications did not. Systemic adverse events for the medications were largely common childhood ailments.
Data discussed here support the use of steroid-sparing medications (tacrolimus, pimecrolimus, crisaborole, delgocitinib) as safe options with minimal adverse events for managing paediatric AD, although a larger number of TCI studies reported burning and pruritus compared to TCS studies. TCS was the only medication class associated with reports of skin atrophy in this review. The tolerability of these adverse events should be considered when treating young children. This review was limited to English-language publications and the variable safety reporting of trial investigators. Many newer medications were not included due to pooled adult and paediatric safety data that did not meet inclusion criteria.
近年来，针对特应性皮炎（AD）的治疗已经开发出了一些新的局部治疗药物。本系统综述旨在综合临床试验文献，简明报告治疗儿童 AD 的局部药物的最新安全性和不良作用。
系统检索 Cochrane Library、Embase、PubMed 和 ClinicalTrials.gov 从建库至 2022 年 3 月的关于用于治疗 AD 的局部药物的临床试验，纳入患者年龄＜18 岁的研究（PROSPERO#CRD42022315355）。纳入的研究仅限于英文出版物和疗程≥3 周的研究。排除了 I 期研究和缺乏单独儿科安全性报告的研究。
共筛选出 5005 条记录，75 条记录符合纳入标准，共纳入 15845 例接受他克莫司治疗的儿科患者、12851 例接受吡美莫司治疗的患者、3539 例接受局部皮质类固醇（TCS）治疗的患者、700 例接受克立硼罗治疗的患者和 202 例接受度鲁特韦治疗的患者。他克莫司试验中安全性数据报告良好，最常报告的不良事件为烧灼感、瘙痒和皮肤感染。纳入了 2 项纵向队列研究，一项是针对他克莫司的，另一项是针对吡美莫司的，均未发现儿童使用局部钙调磷酸酶抑制剂（TCI）治疗的恶性肿瘤风险显著增加。TCS 试验中发现了药物不良反应皮肤萎缩，而其他药物没有。这些药物的全身不良事件主要是儿童常见的疾病。
本文讨论的数据支持将类固醇节约药物（他克莫司、吡美莫司、克立硼罗、度鲁特韦）作为安全选择，用于管理儿童 AD，不良事件最小，尽管与 TCS 研究相比，TCI 研究报告的烧灼感和瘙痒更多。在本综述中，TCS 是唯一与皮肤萎缩报告相关的药物类别。在治疗幼儿时应考虑这些不良事件的耐受性。本综述仅限于英文出版物和试验研究者的可变安全性报告。由于汇总了不符合纳入标准的成人和儿童安全性数据，许多较新的药物未被包括在内。
