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 improvement was greater in the Altoderm- treat
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 improvement was greater in the Altoderm- treated
