Alomar A, Berth-Jones J, Bos J D, Giannetti A, Reitamo S, Ruzicka T, Stalder J-F, Thestrup-Pedersen K
Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Spain.
Br J Dermatol. 2004 Dec;151 Suppl 70 Dec 2004:3-27. doi: 10.1111/j.1365-2133.2004.06269.x.
For more than five decades, topical corticosteroids and emollients have been the mainstay of therapy for atopic dermatitis. However, the potential for side-effects limits the clinical utility of corticosteroids in providing long-term disease control. With a unique mode of action that differs from that of corticosteroids, the steroid-free topical calcineurin inhibitors (TCIs), tacrolimus ointment and pimecrolimus cream, provide skin-selective treatment that targets key factors involved in the pathogenesis of this chronic disease. An extensive series of clinical trials involving more than 16,000 patients with predominantly moderate to severe atopic dermatitis in tacrolimus studies and over 2000 patients with primarily mild to moderate disease in pimecrolimus studies has shown that both TCIs provide effective and well-tolerated treatment for atopic dermatitis. Randomized controlled trials have demonstrated that tacrolimus is superior to conventional hydrocortisone-based regimens and does not cause skin atrophy or other steroidal side-effects. Both tacrolimus and pimecrolimus prevent disease flares and provide progressive and sustained disease improvement with long-term therapy. These and other clinical benefits of TCIs are discussed, together with the safety profiles of tacrolimus and pimecrolimus and their use in clinical practice. In addition, this review summarizes findings from the many trials carried out with these agents and outlines how TCIs can provide long-term treatment and control of a chronic skin disease that may persist for years.
五十多年来,局部用皮质类固醇和润肤剂一直是特应性皮炎治疗的主要手段。然而,副作用的可能性限制了皮质类固醇在提供长期疾病控制方面的临床应用。无类固醇局部钙调神经磷酸酶抑制剂(TCIs)他克莫司软膏和吡美莫司乳膏具有与皮质类固醇不同的独特作用方式,提供针对这种慢性疾病发病机制中关键因素的皮肤选择性治疗。一系列广泛的临床试验涉及他克莫司研究中超过16000例主要为中度至重度特应性皮炎患者以及吡美莫司研究中超过2000例主要为轻度至中度疾病患者,结果表明两种TCIs均为特应性皮炎提供了有效且耐受性良好的治疗。随机对照试验表明,他克莫司优于传统的基于氢化可的松的治疗方案,且不会引起皮肤萎缩或其他类固醇副作用。他克莫司和吡美莫司均可预防疾病发作,并通过长期治疗使疾病逐步且持续改善。本文将讨论TCIs的这些及其他临床益处,以及他克莫司和吡美莫司的安全性概况及其在临床实践中的应用。此外,本综述总结了使用这些药物进行的众多试验的结果,并概述了TCIs如何提供对可能持续数年的慢性皮肤病的长期治疗和控制。