Koo John Y M, Fleischer Alan B, Abramovits William, Pariser David M, McCall Calvin O, Horn Thomas D, Gottlieb Alice B, Jaracz Eileen, Rico M Joyce
University of California-San Francisco Psoriasis and Skin Treatment Center, San Francisco, California, USA.
J Am Acad Dermatol. 2005 Aug;53(2 Suppl 2):S195-205. doi: 10.1016/j.jaad.2005.04.063.
We sought to evaluate the safety and efficacy of tacrolimus ointment in a large cohort of adult and pediatric patients with atopic dermatitis (AD).
A cohort of 3964 adult and 3959 pediatric patients with AD were enrolled in this open-label noncomparative study. Patients applied tacrolimus 0.03% or 0.1% ointment twice daily to the affected areas. Efficacy and safety assessments included percentage of body surface area affected and incidence of adverse events, respectively.
A total of 7923 patients were evaluated; 95.5% had severe or moderate AD at baseline. There was a 52% decrease from baseline in the mean percentage of body surface area affected at month 1 and a 91% decrease at month 18. Two of the most common adverse events, skin burning and pruritus, were generally mild, transient in nature, and decreased in prevalence as AD improved. Severity and frequency of other common adverse events were consistent with expected rates in the general population.
Tacrolimus ointment monotherapy in almost 8000 pediatric and adult patients led to continuous improvement in AD and revealed no change in the safety profile reported in previous clinical trials.
我们试图评估他克莫司软膏在一大群成人和儿童特应性皮炎（AD）患者中的安全性和有效性。
本开放标签非对照研究纳入了3964例成人和3959例儿童AD患者。患者每天两次在患处涂抹0.03%或0.1%的他克莫司软膏。疗效和安全性评估分别包括受影响的体表面积百分比和不良事件的发生率。
共评估了7923例患者；95.5%的患者在基线时患有重度或中度AD。在第1个月时，受影响的体表面积平均百分比较基线下降了52%，在第18个月时下降了91%。两种最常见的不良事件，皮肤烧灼感和瘙痒，通常为轻度，具有一过性，并且随着AD的改善患病率降低。其他常见不良事件的严重程度和发生率与一般人群的预期发生率一致。
近8000例儿科和成人患者使用他克莫司软膏单药治疗导致AD持续改善，并且未发现先前临床试验报告的安全性概况有变化。
