Reitamo S, Ortonne J P, Sand C, Cambazard F, Bieber T, Fölster-Holst R, Vena G, Bos J D, Fabbri P, Groenhoej Larsen C
Department of Dermatology, Helsinki University Central Hospital, Helsinki SF-00250, Finland.
Br J Dermatol. 2005 Jun;152(6):1282-9. doi: 10.1111/j.1365-2133.2005.06592.x.
Atopic dermatis (AD) is a chronic disease that often requires long-term treatment. Topical corticosteroids are the usual therapy for patients with AD, but prolonged usage can result in skin atrophy and other side-effects.
In a randomized, double-blind, comparative study, to compare the efficacy and safety of a 6-month treatment period with 0.1% tacrolimus ointment vs. a corticosteroid ointment regimen in adults with moderate to severe AD.
Treatment was applied twice daily for a maximum of 6 months. Patients in the tacrolimus treatment group (n = 487) applied 0.1% tacrolimus ointment to all affected areas over the whole body. The patients treated with the corticosteroid regimen (n = 485) applied 0.1% hydrocortisone butyrate ointment to affected areas on the trunk and extremities and 1% hydrocortisone acetate ointment to affected areas on the face and neck. The study primary endpoint was the response rate, i.e. the proportion of patients with at least 60% improvement in the modified Eczema Area and Severity Index (mEASI) between baseline and month 3.
By month 3, more patients in the 0.1% tacrolimus group responded to treatment (72.6% vs. 52.3% in the corticosteroid group, P < 0.001). The patients treated with 0.1% tacrolimus also showed greater improvement in mEASI, EASI, affected body surface area and physician and patient assessments of global response. Patients applying 0.1% tacrolimus ointment experienced more skin burning (52.4% vs. 13.8% in the corticosteroid group; P < 0.001). In most patients, skin burning was mild to moderate in severity and decreased rapidly after the first week of treatment. There was no increase in the incidence of infections or malignancies over time in either treatment group.
Long-term treatment with 0.1% tacrolimus ointment is significantly more efficacious than a corticosteroid ointment regimen in adults with moderate to severe AD.
特应性皮炎（AD）是一种常需长期治疗的慢性疾病。外用糖皮质激素是AD患者的常用治疗方法，但长期使用可能导致皮肤萎缩及其他副作用。
在一项随机、双盲、对照研究中，比较0.1%他克莫司软膏与糖皮质激素软膏方案对中度至重度AD成人患者进行6个月治疗的疗效和安全性。
每天用药两次，最长治疗6个月。他克莫司治疗组（n = 487）的患者将0.1%他克莫司软膏涂抹于全身所有受累部位。接受糖皮质激素方案治疗的患者（n = 485）将0.1%丁酸氢化可的松软膏涂抹于躯干和四肢的受累部位，将1%醋酸氢化可的松软膏涂抹于面部和颈部的受累部位。研究的主要终点是缓解率，即基线至第3个月时改良湿疹面积和严重程度指数（mEASI）改善至少60%的患者比例。
到第3个月时，0.1%他克莫司组有更多患者对治疗有反应（72.6% vs. 糖皮质激素组的52.3%，P < 0.001）。接受0.1%他克莫司治疗的患者在mEASI、EASI、受累体表面积以及医生和患者对整体反应的评估方面也有更大改善。使用0.1%他克莫司软膏的患者出现更多皮肤烧灼感（52.4% vs. 糖皮质激素组的13.8%；P < 0.001）。在大多数患者中，皮肤烧灼感的严重程度为轻度至中度，且在治疗第一周后迅速减轻。两个治疗组随时间推移感染或恶性肿瘤的发生率均未增加。
对于中度至重度AD成人患者，0.1%他克莫司软膏长期治疗的疗效显著优于糖皮质激素软膏方案。
