Tripodi S, Di Rienzo Businco A, Panetta V, Pingitore G, Volterrani A, Frediani T, Pelosi S, Miceli Sopo S
Pediatric Allergology Unit, S. Pertini Hospital, Rome, Italy.
J Investig Allergol Clin Immunol. 2009;19(3):204-9.
Atopic dermatitis is a common disease in children. It is usually treated with topical steroids and/or calcineurin inhibitors in association with emollients but topical antioxidants have been recently introduced as a therapeutic option for children. The aim of this study was to evaluate the efficacy and tolerability of furfuryl palmitate, a new antioxidant molecule, in a multicenter, randomized, double-blind, vehicle-controlled study.
Children with atopic dermatitis were randomized into 2 groups treated for 2 weeks. One group of children (n = 60) was treated with a basic emollient cream and the other (n = 57) was treated with the same cream enriched with furfuryl palmitate.
In both groups, there was a significant reduction (P < .001) in atopic dermatitis-measured using the SCORAD index-after 14 days. The reduction in the per-protocol analysis was higher for the basic cream. Treatment success was defined as a reduction of 20% or more in the SCORAD index from baseline to day 14. Patients who used treatment not permitted by the protocol were also considered treatment failures. The intention-to-treat analysis showed 70% positive results for the basic treatment and 29% for the treatment containing furfuryl palmitate (P < .0001) with a number needed to treat of 2.4 (95% confidence interval, 1.6-4.6). The emollient cream without furfuryl palmitate was observed to be more efficacious by pediatricians and parents, and no differences were reported between the 2 products in terms of tolerability.
Both products proved to be efficacious in treating atopic dermatitis in children, but the emollient cream not containing furfuryl palmitate showed better clinical efficacy.
特应性皮炎是儿童常见疾病。通常采用外用类固醇和/或钙调神经磷酸酶抑制剂联合润肤剂进行治疗，但最近外用抗氧化剂已被引入作为儿童的一种治疗选择。本研究旨在通过一项多中心、随机、双盲、赋形剂对照研究，评估新型抗氧化分子棕榈酸糠酯的疗效和耐受性。
将患有特应性皮炎的儿童随机分为两组，治疗2周。一组儿童（n = 60）使用基础润肤霜治疗，另一组（n = 57）使用添加了棕榈酸糠酯的相同乳膏治疗。
两组在14天后，使用SCORAD指数测量的特应性皮炎均有显著改善（P <.001）。在符合方案分析中，基础乳膏的改善程度更高。治疗成功定义为SCORAD指数从基线到第14天降低20%或更多。使用未按方案允许治疗的患者也被视为治疗失败。意向性分析显示，基础治疗的阳性结果为70%，含棕榈酸糠酯治疗的阳性结果为29%（P <.0001），治疗所需人数为2.4（95%置信区间，1.6 - 4.6）。儿科医生和家长观察到不含棕榈酸糠酯的润肤霜更有效，且两种产品在耐受性方面无差异。
两种产品在治疗儿童特应性皮炎方面均被证明有效，但不含棕榈酸糠酯的润肤霜显示出更好的临床疗效。
