Boguniewicz M, Fiedler V C, Raimer S, Lawrence I D, Leung D Y, Hanifin J M
National Jewish Medical and Research Center and the Department of Pediatrics, University of Colorado Health Sciences Center, Denver, USA.
J Allergy Clin Immunol. 1998 Oct;102(4 Pt 1):637-44. doi: 10.1016/s0091-6749(98)70281-7.
A topical formulation of tacrolimus, an immunosuppressant currently marketed for the prevention of rejection after solid organ transplant, is a potential therapeutic agent for atopic dermatitis.
We sought to determine the safety and efficacy of tacrolimus ointment in pediatric patients with moderate-to-severe atopic dermatitis.
In this double-blind, vehicle-controlled multicenter trial, children ages 7 to 16 years were treated with twice daily application of tacrolimus ointment at 1 of 3 concentrations (0.03% [n = 43], 0.1% [n = 49], or 0.3% [n = 44]) or vehicle (n = 44) for up to 22 days, with a 2-week follow-up period.
The Physician's Global Evaluation of clinical response showed that 69% (95% confidence interval: 53-82) of patients in the 0.03% tacrolimus ointment group, 67% (95% confidence interval: 52-81) in the 0.1% tacrolimus ointment group, and 70% (95% confidence interval: 54-83) in the 0.3% tacrolimus ointment group, compared with 38% (95% confidence interval: 24-54) in the vehicle group, had a marked to excellent (> or =75%) improvement or clearing of their atopic dermatitis (P =.005, .007, and .004, respectively for the 3 tacrolimus groups compared with the vehicle group). The mean percent improvement for a modified Eczema Area and Severity Index at end of treatment for each of the 3 tacrolimus groups (0.03%, 72%; 0.1%, 77%: and 0.3%, 81%) was significantly better than that of the vehicle group (26%; P <.001). The median percent reduction in pruritus was significantly greater for tacrolimus-treated patients (74% to 89%) than for vehicle-treated patients (51%, P = .027). No serious systemic adverse events were noted, and systemic absorption was minimal.
Tacrolimus ointment appears to be safe and effective in children with atopic dermatitis.
他克莫司的一种局部用制剂，是一种目前用于预防实体器官移植后排斥反应的免疫抑制剂，是特应性皮炎的一种潜在治疗药物。
我们试图确定他克莫司软膏在中重度特应性皮炎儿科患者中的安全性和有效性。
在这项双盲、赋形剂对照的多中心试验中，7至16岁的儿童每日两次外用三种浓度（0.03%[n = 43]、0.1%[n = 49]或0.3%[n = 44]）之一的他克莫司软膏或赋形剂（n = 44），持续22天，并进行为期2周的随访。
医生对临床反应的整体评估显示，0.03%他克莫司软膏组69%（95%置信区间：53 - 82）的患者、0.1%他克莫司软膏组67%（95%置信区间：52 - 81）的患者和0.3%他克莫司软膏组70%（95%置信区间：54 - 83）的患者，相比赋形剂组38%（95%置信区间：24 - 54）的患者，特应性皮炎有显著至极佳（≥75%）改善或消退（与赋形剂组相比，三种他克莫司组的P值分别为0.005、0.007和0.004）。三种他克莫司组（0.03%，72%；0.1%，77%；0.3%，81%）治疗结束时改良湿疹面积和严重程度指数的平均改善百分比显著优于赋形剂组（26%；P <0.001）。他克莫司治疗患者瘙痒程度的中位数降低百分比（74%至89%）显著大于赋形剂治疗患者（51%，P = 0.027）。未观察到严重的全身性不良事件，全身吸收极少。
他克莫司软膏在患有特应性皮炎的儿童中似乎是安全有效的。
