Warshaw Erin M, Paller Amy S, Fowler Joseph F, Zirwas Matthew J
Department of Dermatology, Minneapolis Veterans Affairs Medical Center, Minneapolis, Minnesota, USA.
Clin Ther. 2008 Feb;30(2):326-37. doi: 10.1016/j.clinthera.2008.01.022.
Psychostimulants remain the most-used medications for attention-deficit/hyperactivity disorder (ADHD). The methylphenidate transdermal system (MTS) is the first stimulant patch dosage formulation to be approved by the US Food and Drug Administration for the treatment of the symptoms of ADHD in children aged 6 to 12 years. The MTS patch is approved to be applied once daily to the hip and worn for 9 hours. While cutaneous reactions may occur with any formulation of medication, they are more likely with transdermal administration.
The purpose of this commentary was to describe the types of cutaneous reactions that have been reported with transdermal systems in general, review the cutaneous adverse events seen in clinical trials with the MTS specifically, and provide practical management suggestions for prevention and treatment of these potential cutaneous reactions.
In September 2007, a group of child psychiatrists, pediatricians, developmental pediatricians, and pediatric neurologists who treat ADHD and have had experience in their practices with MTS convened to discuss cutaneous reactions in relation to its use. Information collected from this meeting and from the clinical trials database of the sponsor was reviewed by a panel of 3 dermatologic clinical experts in contact dermatitis and 1 pediatric dermatologist. The panel's recommendations form the basis for this report.
Mild to moderate erythema is a common cutaneous effect with MTS use, and is generally not a cause for discontinuation if seen in isolation. Irritant contact dermatitis is relatively common and can be reduced and treated by alternating patch application sites, moisturizing, gentle skin care, and application of topical corticosteroids at the previous patch sites if needed. Allergic contact dermatitis (ACD) and allergic contact urticaria are rare when MTS is worn as directed in the prescribing information. MTS should be discontinued if ACD is suspected.
精神兴奋剂仍然是治疗注意力缺陷多动障碍(ADHD)最常用的药物。哌甲酯透皮系统(MTS)是首个获美国食品药品监督管理局批准用于治疗6至12岁儿童ADHD症状的刺激性贴片剂型。MTS贴片被批准每日一次贴于臀部,佩戴9小时。虽然任何药物剂型都可能发生皮肤反应,但经皮给药时更易出现。
本评论的目的是描述一般透皮系统报告的皮肤反应类型,具体回顾MTS临床试验中出现的皮肤不良事件,并提供预防和治疗这些潜在皮肤反应的实用管理建议。
2007年9月,一组治疗ADHD且在实践中使用过MTS的儿童精神科医生、儿科医生、发育儿科医生和儿科神经科医生召开会议,讨论与MTS使用相关的皮肤反应。由3名接触性皮炎皮肤科临床专家和1名儿科皮肤科医生组成的小组审查了从本次会议和申办者临床试验数据库收集的信息。小组的建议构成了本报告的基础。
使用MTS时,轻度至中度红斑是常见的皮肤效应,如果单独出现,通常不是停药的原因。刺激性接触性皮炎相对常见,可通过交替贴片应用部位、保湿、温和皮肤护理以及必要时在前一贴片部位应用外用皮质类固醇来减少和治疗。按照处方信息指导佩戴MTS时,过敏性接触性皮炎(ACD)和过敏性接触性荨麻疹很少见。如果怀疑有ACD,应停用MTS。