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一项为期 1 年的成人中重度特应性皮炎患者使用 0.1%他克莫司软膏与皮质类固醇治疗方案的随机、双盲、对照试验。

One-year treatment with 0.1% tacrolimus ointment versus a corticosteroid regimen in adults with moderate to severe atopic dermatitis: A randomized, double-blind, comparative trial.

机构信息

Skin and Allergy Hospital, Department of Dermatology, Helsinki University Central Hospital, Finland.

出版信息

Acta Derm Venereol. 2010 Mar;90(2):170-4. doi: 10.2340/00015555-0803.

DOI:10.2340/00015555-0803
PMID:20169301
Abstract

A one-year, randomized, double-blind study was conducted in 80 patients with atopic dermatitis treated with tacrolimus ointment or a corticosteroid regimen (hydrocortisone acetate 1% ointment for head and neck, hydrocortisone butyrate 0.1% ointment for trunk and limbs) to compare efficacy and safety, and effects on Th2-reactivity. The study was completed by 36/40 patients in the tacrolimus group, and 31/40 patients in the corticosteroid group. In both groups affected body surface area, eczema area and severity index, and transepidermal water loss decreased at months 6 and 12. Tacrolimus was superior for all efficacy scores at month 6, and in the head and neck area at month 12. Recall antigen reactivity increased at month 12 in both groups. Adverse events were reported by 40/40 patients in the tacrolimus, and by 34/40 patients in the corticosteroid group. Long-term treatment with topical tacrolimus or a corticosteroid regimen improves atopic dermatitis and recall antigen reactivity, suggesting an improvement in the Th1/Th2-balance.

摘要

一项为期一年、随机、双盲的研究在 80 例特应性皮炎患者中进行,这些患者分别接受他克莫司软膏或皮质类固醇治疗方案(醋酸氢化可的松 1%软膏用于头颈部,丁酸氢化可的松 0.1%软膏用于躯干和四肢),以比较疗效和安全性,以及对 Th2 反应的影响。该研究由他克莫司组的 40 例患者中的 36 例和皮质类固醇组的 40 例患者中的 31 例完成。在两组中,受影响的体表面积、湿疹面积和严重程度指数以及经表皮水分流失在第 6 个月和第 12 个月均减少。在第 6 个月时,他克莫司在所有疗效评分上均优于所有评分,在第 12 个月时在头颈部区域也是如此。在第 12 个月时,两组的回忆抗原反应性均增加。他克莫司组的 40 例患者和皮质类固醇组的 34 例患者均报告了不良反应。长期局部使用他克莫司或皮质类固醇治疗方案可改善特应性皮炎和回忆抗原反应性,表明 Th1/Th2 平衡得到改善。

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