Long‐term treatment with cetirizine of infants with atopic dermatitis: A multi‐country, double‐blind, randomized, placebo‐controlled trial (the ETAC™trial) over 18 months

作者：Thomas Ludwig Diepgen · 发表于：Pediatric Allergy and Immunology · 年份：2002 · DOI：10.1034/j.1399-3038.2002.01047.x · 被引用次数：188 · 研究领域：Dermatology and Skin Diseases、Allergic Rhinitis and Sensitization、Asthma and respiratory diseases

H1-receptor antagonists are considered central to the treatment of atopic dermatitis (AD)-associated pruritus and are widely used in the treatment of AD despite a lack of double-blind, randomized clinical trials. In this study we analyzed the effects of the long-term use of cetirizine on the severity, natural history, and treatment of AD. In the prospective, multi-country, double-blind, randomized, placebo-controlled Early Treatment of the Atopic Child (ETAC) study, 817 infants (12-24 months of age) who suffered from AD at study entry and with a history of atopic disease in a parent or sibling were treated for 18 months with either cetirizine (0.25 mg/kg) or placebo twice daily. All concomitant medications for the treatment of AD were allowed but had to be recorded by the investigator in the case report form; the concomitant use of H1-antihistamines was discouraged. The primary end-point for efficacy was the onset of asthma. Secondary parameters of efficacy, however, were the consumption of concomitant medications for AD (topical and systemic treatment) and the severity of symptoms related to AD, which was rated with the AD scale, SCORAD. The severity of AD, as measured by SCORAD, decreased significantly (p < 0.001) over the study period (18 months) in both groups. Other oral H1-antihistamines were significantly more often used in the placebo group than in the cetirizine group (24.9% vs. 18.6%, p = 0.03). The number of infants who developed urticaria during the study period w...