Department of Dermatology & Cutaneous Surgery, University of Miami Miller School of Medicine, 1600 NW 10th Ave., RMSB, Room 2023-A, Miami, Florida, 33136, USA.
Acta Derm Venereol. 2010;90(1):58-64. doi: 10.2340/00015555-0748.
Adult and pediatric patients (n = 347) with atopic dermatitis enrolled in three multicenter, randomized, 6-week studies who had previously used steroids were analyzed to examine the null hypothesis that improvement in atopic dermatitis initiated after prior treatment with steroids eliminates any subsequent treatment differences between tacrolimus ointment and pimecrolimus cream. Of these patients, 171 were randomized to tacrolimus ointment and 176 to pimecrolimus cream. Based on improvement in the Eczema Area and Severity Index at the end of study, tacrolimus ointment was significantly more effective than pimecrolimus cream (p = 0.0002). Tacrolimus ointment was also significantly more effective than pimecrolimus cream at the end of study in all secondary end-points. Overall, the frequency of adverse events was comparable between treatment groups (24.0% for tacrolimus ointment vs. 25.6% for pimecrolimus cream). Tacrolimus ointment is more effective, with a similar safety profile, compared with pimecrolimus cream in patients with atopic dermatitis previously treated with topical corticosteroids.
在三项多中心、随机、6 周研究中，纳入了 347 名患有特应性皮炎的成年和儿科患者（n=347），这些患者之前曾使用过皮质类固醇，分析该研究旨在检验假设，即先前使用皮质类固醇治疗后特应性皮炎的改善消除了他克莫司软膏和吡美莫司乳膏之间任何后续治疗差异。在这些患者中，171 名患者被随机分配至他克莫司软膏组，176 名患者被分配至吡美莫司乳膏组。根据研究结束时湿疹面积和严重程度指数（Eczema Area and Severity Index，EASI）的改善情况，他克莫司软膏显著优于吡美莫司乳膏（p=0.0002）。在所有次要终点方面，他克莫司软膏在研究结束时也显著优于吡美莫司乳膏。总体而言，治疗组之间不良反应的频率相当（他克莫司软膏组为 24.0%，吡美莫司乳膏组为 25.6%）。与吡美莫司乳膏相比，他克莫司软膏在治疗先前接受过局部皮质类固醇治疗的特应性皮炎患者方面更有效，且安全性相当。
