Reitamo S, Harper J, Bos J D, Cambazard F, Bruijnzeel-Koomen C, Valk P, Smith C, Moss C, Dobozy A, Palatsi R
Department of Dermatology, Helsinki University Central Hospital, Helsinki, Finland.
Br J Dermatol. 2004 Mar;150(3):554-62. doi: 10.1046/j.1365-2133.2004.05782.x.
Topical corticosteroids are the usual treatment for atopic dermatitis (AD) in children but can have side-effects.
This study compared the efficacy and safety of 0.03% tacrolimus ointment applied once or twice daily over a 3-week period with the twice daily application of 1% hydrocortisone acetate (HA) ointment in children with moderate to severe AD.
Patients applied ointment daily to all affected body surface areas. The primary study endpoint was the percentage change in the modified Eczema Area and Severity Index (mEASI) between baseline and treatment end.
Six hundred and twenty-four patients, aged 2-15 years, applied 0.03% tacrolimus ointment once daily (n = 207), twice daily (n = 210) or 1% HA twice daily (n = 207). By the end of treatment, application of 0.03% tacrolimus ointment both once or twice daily resulted in significantly greater median percentage decreases in mEASI (66.7% and 76.7%, respectively) compared with 1% HA (47.6%; P < 0.001). Furthermore, the median percentage decrease in mEASI was significantly greater for patients applying 0.03% tacrolimus twice daily compared with once daily (P = 0.007). Patients with severe AD benefited especially from twice daily application of 0.03% tacrolimus ointment compared with once daily application (P = 0.001). Transient mild to moderate skin burning occurred significantly more often in the 0.03% tacrolimus groups (P = 0.028) but resolved in most cases within 3-4 days. Laboratory parameters showed no clinically relevant changes.
0.03% tacrolimus ointment applied once or twice daily is significantly more efficacious than 1% HA in treating moderate-severe AD in children. Twice daily application of 0.03% tacrolimus ointment results in the greatest improvement in mEASI, and is especially effective in patients with severe baseline disease.
外用糖皮质激素是儿童特应性皮炎（AD）的常用治疗方法，但可能有副作用。
本研究比较了0.03%他克莫司软膏每日一次或两次、连续3周的疗效和安全性，以及1%醋酸氢化可的松（HA）软膏每日两次在中重度AD儿童中的应用情况。
患者每天在所有受影响的体表区域涂抹软膏。主要研究终点是基线至治疗结束时改良湿疹面积和严重程度指数（mEASI）的变化百分比。
624名年龄在2至15岁之间的患者，分别每日一次（n = 207）、每日两次（n = 210）涂抹0.03%他克莫司软膏，或每日两次（n = 207）涂抹1% HA软膏。治疗结束时，与1% HA（47.6%）相比，每日一次或两次涂抹0.03%他克莫司软膏导致mEASI的中位数下降百分比显著更大（分别为66.7%和76.7%；P < 0.001）。此外，与每日一次相比，每日两次涂抹0.03%他克莫司软膏的患者mEASI的中位数下降百分比显著更大（P = 0.007）。与每日一次应用相比，重度AD患者尤其受益于每日两次涂抹0.03%他克莫司软膏（P = 0.001）。0.03%他克莫司组中短暂的轻度至中度皮肤烧灼感明显更常见（P = 0.028），但大多数情况下在3 - 4天内消退。实验室参数未显示出临床相关变化。
每日一次或两次涂抹0.03%他克莫司软膏在治疗儿童中重度AD方面比1% HA显著更有效。每日两次涂抹0.03%他克莫司软膏导致mEASI改善最大，并且对基线疾病严重的患者特别有效。
