Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Department of Dermatology, Preventive Medicine and Medical Social Sciences, Northwestern University Feinberg School of Medicine, 676 N. Saint Clair St, Suite 1600, Chicago, IL, 60611, USA.
Am J Clin Dermatol. 2018 Feb;19(1):15-22. doi: 10.1007/s40257-017-0299-4.
Numerous diagnostic criteria for atopic dermatitis are used in clinical trials, which may limit comparison of results.
We sought to determine the most commonly used atopic dermatitis diagnostic criteria in randomized controlled trials internationally.
We performed a systematic review of randomized controlled trials with a pharmacological intervention from 2007 to 2016. Cochrane Library, EMBASE, GREAT, LILACS, MEDLINE, and Scopus were searched. Two authors independently performed the study selection and data extraction.
Two hundred and twelve randomized controlled trials met inclusion/exclusion criteria. Overall, ten different diagnostic criteria were used. The Hanifin and Rajka criteria were most commonly used (41.0%), followed by the UK refinement of the Hanifin and Rajka criteria (9.0%), Japanese Dermatological Association criteria (4.2%), and American Academy of Dermatology criteria (3.8%). No diagnostic criteria were specified in 37.3% of randomized controlled trials. The Hanifin and Rajka criteria were the most commonly used atopic dermatitis diagnostic criteria in clinical trials of topical and systemic interventions, across all years between 2007 and 2016, in pediatric and adult populations, in most countries and regions internationally.
The results highlight the lack of uniformity and documentation of atopic dermatitis diagnostic criteria in randomized controlled trials for atopic dermatitis. We recommend harmonizing the diagnostic criteria for atopic dermatitis in future randomized controlled trials.
在临床试验中，有许多特应性皮炎的诊断标准被使用，这可能会限制结果的比较。
我们旨在确定国际上在随机对照试验中最常使用的特应性皮炎诊断标准。
我们对 2007 年至 2016 年间具有药物干预的随机对照试验进行了系统回顾。检索了 Cochrane Library、EMBASE、GREAT、LILACS、MEDLINE 和 Scopus。两位作者独立进行了研究选择和数据提取。
212 项随机对照试验符合纳入/排除标准。总体而言，使用了十种不同的诊断标准。Hanifin 和 Rajka 标准最常用（41.0%），其次是 Hanifin 和 Rajka 标准的英国修订版（9.0%）、日本皮肤病学会标准（4.2%）和美国皮肤病学会标准（3.8%）。37.3%的随机对照试验未指定诊断标准。在 2007 年至 2016 年期间，特应性皮炎的局部和系统干预的临床试验中，Hanifin 和 Rajka 标准是最常使用的特应性皮炎诊断标准，无论在儿科还是成人人群中，无论在哪个国家或地区，均如此。
结果强调了特应性皮炎随机对照试验中特应性皮炎诊断标准缺乏统一性和记录。我们建议在未来的随机对照试验中协调特应性皮炎的诊断标准。
