作者: A. Wollenberg , S. Reitamo , G. Girolomoni , M. Lahfa , T. Ruzicka
DOI: 10.1111/J.1398-9995.2008.01683.X
关键词:
摘要: Background: Long-term treatment for atopic dermatitis (AD) using low dose, intermittent, topical anti-inflammatory agents may control acute disease and prevent relapses. This 12-month, European, multicentre, randomized study investigated whether the proactive use of 0.1% tacrolimus ointment applied twice weekly can keep AD in remission reduce incidence exacerbations (DE). Methods: During initial open-label period, 257 adults with daily (b.i.d.) up to 6 weeks affected areas. When an Investigator Global Assessment (IGA) score ≤2 was achieved, patient entered period (DCP) either (n = 116) or vehicle (n = 108) 12 months. Exacerbations were treated b.i.d. until IGA regained, then restarted. The primary endpoint number DEs during DCP that required a substantial therapeutic intervention. Results: Proactive application significantly reduced requiring intervention (median difference 2; P < 0.001; Wilcoxon rank sum test), percentage DE days difference: 15.2%; test) increased time first 142 vs 15 days; stratified log-rank test). adverse event profile similar two approaches. Conclusion: A effective most patients which prevented, delayed occurrence exacerbations.