Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: A randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle
Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: A randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle
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DOI：
10.1016/j.jaad.2008.02.008
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发表时间：
2008-06-01
影响因子：
13.8
通讯作者：
Hanifin, Jon M.
中科院分区：
文献类型：
--
作者：
Breneman, Debra;Fleischer, Alan B., Jr.;Hanifin, Jon M.
背景资料：局部钙调磷酸酶抑制剂的间歇给药预防稳定的AD患者的特应性皮炎（AD）疾病复发尚未评估。目的：我们试图评估每周3次使用他克莫司软膏预防AD疾病复发的长期疗效和安全性。在他克莫司软膏治疗长达16周后疾病消失的中重度AD成人和儿童患者以双盲方式随机分为3组，每周用他克莫司软膏（0.03%或0.1%）或载体治疗40周。主要终点是无复发治疗天数。共有125例患者随机接受他克莫司治疗，72例患者随机接受溶媒治疗。他克莫司组的平均无发作治疗天数为177天，溶媒组为134天（P =.003）。他克莫司组首次复发的中位时间为169天，赋形剂组为43天（P = 0.037）。局限性：临床上所有患者的可推广性可能有限，因为只有在稳定期对他克莫司软膏有反应的患者才被随机分配到试验的维持期。他克莫司软膏的维持治疗与无复发天数显著长于溶媒组相关，且首次疾病复发时间显著长于溶媒组。
Background: Intermittent dosing of a topical calcineurin inhibitor for preventing atopic dermatitis (AD) disease relapse in patients with stabilized AD has not been evaluated.Objective: We sought to evaluate the long-term efficacy and safety of 3-times-weekly use of tacrolimus ointment in preventing AD disease relapse.Methods: Adult and pediatric patients with moderate to severe AD who were clear of disease after up to 16 weeks of treatment with tacrolimus ointment were randomized in a double-blind fashion to 3-times-weekly treatment with either tacrolimus ointment (0.03% or 0.1%) or vehicle for 40 weeks. The primary end point was the number of flare-free treatment days.Results. A total of 125 patients were randomized to tacrolimus and 72 patients to vehicle. The mean number of flare-free treatment days was 177 for tacrolimus and 134 for vehicle (P =.003). Median time to first relapse was 169 days for tacrolimus and 43 for vehicle (P =.037).Limitations: Generalizability to all patients seen in clinic may be limited because only patients who responded to tacrolimus ointment in the stabilization phase were randomized into the maintenance phase of the trial.Conclusions. Maintenance therapy with tacrolimus ointment was associated with significantly more flare-free days compared with vehicle, and a significantly longer time until first disease relapse.