局部外用新型色甘酸钠(Altoderm)洗剂治疗2～12岁儿童异位性皮炎的有效性和可接受性的双盲、随机、安慰剂对照试验研究

作     者：Stainer R. MatthewsS. Arshad S.H. A.M.Edwards 罗素菊 冯义国 

作者机构：David Hide Asthma Allerg. Res. Ctr.St. Mary' s Hospital Newport Isle of Wight PO30 5TG United Kingdom 

出 版 物：《世界核心医学期刊文摘（皮肤病学分册）》 (Digest of the World Core Medical JOurnals:Dermatology)

年 卷 期：2005年第1卷第7期

页      面：11-12页

学科分类：1002[医学-临床医学] 100206[医学-皮肤病与性病学] 10[医学] 

主　　题：儿童异位性皮炎 Altoderm 色甘酸钠 安慰剂对照 可接受性 试验研究 类固醇激素 患儿父母 润滑药 皮肤情况 

摘      要：Background: Atopic dermatitis (AD) is a common inflammatory allergic disease of children. The primary anti-inflammatory therapy is topical steroids. An effective treatment without the topical and systemic adverse effects of corticosteroids would be useful. Topical formulations of sodium cromoglicate have been researched in the past, but without consistent results. We report a trial of a new aqueous skin lotion of sodium cromoglicate (Altoderm) in children with AD. Objectives: To compare the efficacy, safety and acceptability of Altoderm lotion with a placebo control in the treatment of AD in children. Methods: A double- blind, controlled study in which children aged 212 years with AD were randomized to 12 weeks of treatment withalotioncontaining4% sodiumcromoglicate(Altoderm)or the lotion base. To be included subjects had to have a SCORAD score of ≥ 25 and ≤ 60 at both of two clinic visits 14 days apart. Subjects continued using existing treatment which included emollients and topical steroids. The primary outcome was the change in the SCORAD score. The two groups were compared for the change in the SCORAD score from the second baseline visit to the visit after 12 weeks of treatment using an analysis of variance. Secondary outcome measures included parents’ assessment of symptoms, usage of topical steroids recorded on daily diary cards, and final opinions of treatment by parent and clinician. Parents were asked about adverse effects at each clinic visit and the responses recorded. Results: Fifty- eight children were randomized to Altoderm and 56 to placebo and all were included in the intention- totreat analysis. The mean ± SD SCORAD scores at baseline were 41.0 ± 9.0 (Altoderm) and 40.4 ± 8.73 (placebo). These scores were reduced after 12 weeks by 13.2 (36% ) with Altoderm and by 7.6 (20% ) with placebo. The difference of 5.6 (95% confidence interval 1.0- 10.3) is statistically significant (P=0.018). Diary card symptoms improved with both treatments but the improve