A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis.

摘要: Summary Background  Atopic dermatis (AD) is a chronic disease that often requires long-term treatment. Topical corticosteroids are the usual therapy for patients with AD, but prolonged usage can result in skin atrophy and other side-effects. Objectives  In randomized, double-blind, comparative study, to compare efficacy safety of 6-month treatment period 0·1% tacrolimus ointment vs. corticosteroid regimen adults moderate severe AD. Methods  Treatment was applied twice daily maximum 6 months. Patients group (n = 487) all affected areas over whole body. The treated (n = 485) hydrocortisone butyrate on trunk extremities 1% acetate face neck. study primary endpoint response rate, i.e. proportion at least 60% improvement modified Eczema Area Severity Index (mEASI) between baseline month 3. Results  By month 3, more responded (72·6% 52·3% group, P < 0·001). also showed greater mEASI, EASI, body surface area physician patient assessments global response. applying experienced burning (52·4% 13·8% group; most patients, mild severity decreased rapidly after first week There no increase incidence infections or malignancies time either group. Conclusions  Long-term significantly efficacious than AD.