Prescrire Int. 2004 Dec;13(74):209-12.
(1) Symptomatic treatment of atopic dermatitis is initially based on simple measures and moisturising creams. Topical corticosteroids are reserved for treatment of inflammatory exacerbations. (2) After topical tacrolimus, marketing authorisation has been granted in France for a second topical immunosuppressant, pimecrolimus, as a short-term symptomatic treatment for atopic dermatitis in children from the age of two years, and intermittently for long-term prevention of new exacerbations. (3) Short-term treatment with pimecrolimus has been tested in three trials in children with mild to moderate dermatitis (against the excipient), in one adult trial against the excipient, and in one dose-finding study in adults that included a group treated with topical corticosteroids. (4) Longer term treatment periods of 6 to 12 months have been tested in two trials versus excipient in children, and two adult trials, one versus moderately active topical corticosteroids. (5) These trials show that pimecrolimus works better than the excipient, but not nearly as well as moderately active topical corticosteroids. Pimecrolimus has not been compared with topical corticosteroids in children, the age group most vulnerable to atopic dermatitis. (6) The commonest adverse effects observed in clinical trials were local and included a burning sensation at the site of application and skin infections. Systemic adverse effects (mainly infections) were most marked in infants. Long-term risks, especially the risk of skin cancer, have not been assessed. (7) In practice, the reference treatment for exacerbations of atopic dermatitis is a topical corticosteroid; in children, it seems best to begin with a weak preparation. There is no reason to use pimecrolimus, which is less active than topical corticosteroids and whose potential long-term adverse effects, especially in children, are unknown.
(1) 特应性皮炎的对症治疗最初基于简单措施和保湿霜。外用糖皮质激素留作炎症加重期的治疗用药。(2) 在外用他克莫司之后，法国已批准第二种外用免疫抑制剂吡美莫司作为两岁及以上儿童特应性皮炎的短期对症治疗药物，并间歇用于长期预防新的病情加重。(3) 吡美莫司的短期治疗已在三项针对轻度至中度皮炎儿童的试验（与赋形剂对照）、一项针对成人的与赋形剂对照的试验以及一项针对成人的剂量探索研究中进行了测试，该研究包括一组接受外用糖皮质激素治疗的患者。(4) 在两项针对儿童与赋形剂对照的试验以及两项针对成人的试验（一项与中度活性外用糖皮质激素对照）中测试了6至12个月的较长治疗期。(5) 这些试验表明，吡美莫司的疗效优于赋形剂，但远不如中度活性外用糖皮质激素。吡美莫司尚未在最易患特应性皮炎的儿童年龄组中与外用糖皮质激素进行比较。(6) 在临床试验中观察到的最常见不良反应是局部性的，包括用药部位的烧灼感和皮肤感染。全身不良反应（主要是感染）在婴儿中最为明显。长期风险，尤其是皮肤癌风险，尚未评估。(7) 在实践中，特应性皮炎病情加重的参考治疗方法是外用糖皮质激素；对于儿童，似乎最好从弱效制剂开始。没有理由使用吡美莫司，它的活性低于外用糖皮质激素，其潜在的长期不良反应，尤其是在儿童中，尚不清楚。
