Reitamo Sakari, Rustin Malcolm, Ruzicka Thomas, Cambazard Frédéric, Kalimo Kirsti, Friedmann Peter S, Schoepf Erwin, Lahfa Mourad, Diepgen Thomas L, Judodihardjo Harryono, Wollenberg Andreas, Berth-Jones John, Bieber Thomas
Department of Dermatology, Hospital for Skin and Allergic Diseases, University of Helsinki, Helsinki, Finland.
J Allergy Clin Immunol. 2002 Mar;109(3):547-55. doi: 10.1067/mai.2002.121832.
Vehicle-controlled studies have demonstrated the efficacy and safety of tacrolimus ointment for patients with atopic dermatitis.
This study was undertaken to compare 0.03% and 0.1% tacrolimus ointment with 0.1% hydrocortisone-17-butyrate ointment, a midpotent to potent topical corticosteroid, in the treatment of adult patients with moderate-to-severe atopic dermatitis.
Patients applied ointment twice daily to all affected areas for 3 weeks in this multicenter, randomized, double-blind, parallel-group study. The primary endpoint was the modified eczema area and severity index (mEASI) mean area under the curve as a percentage of baseline.
Five hundred seventy patients were randomized and received treatment. Discontinuations included 22 of 193 patients from the 0.03% tacrolimus group, 22 of 191 patients from the 0.1% tacrolimus group, and 17 of 186 patients from the hydrocortisone butyrate group. The median mEASI mean area under the curve as a percentage of baseline was 47.0%, 36.5%, and 36.1% for patients who received 0.03% tacrolimus, 0.1% tacrolimus, and 0.1% hydrocortisone butyrate, respectively. There was no statistically significant difference between 0.1% tacrolimus and 0.1% hydrocortisone butyrate; however, the lower improvement in mEASI for 0.03% tacrolimus was statistically significant when compared with 0.1% tacrolimus (P <.001) or hydrocortisone butyrate (P =.002). Skin burning and pruritus at the application site showed a higher incidence in the tacrolimus treatment groups than in the hydrocortisone butyrate group (P <.05). Laboratory parameters showed no treatment differences and no marked changes over time.
The efficacy of 0.1% tacrolimus ointment was similar to that of 0.1% hydrocortisone butyrate ointment and was lower for 0.03% tacrolimus ointment. No serious safety concerns were identified.
车辆对照研究已证明他克莫司软膏对特应性皮炎患者的有效性和安全性。
本研究旨在比较0.03%和0.1%他克莫司软膏与0.1%丁酸氢化可的松软膏（一种中效至强效的外用皮质类固醇）在治疗中度至重度特应性皮炎成年患者中的效果。
在这项多中心、随机、双盲、平行组研究中，患者每天两次将软膏涂抹于所有受影响区域，持续3周。主要终点是改良湿疹面积和严重程度指数（mEASI）曲线下平均面积相对于基线的百分比。
570名患者被随机分组并接受治疗。停药情况包括0.03%他克莫司组193名患者中的22名，0.1%他克莫司组191名患者中的22名，以及丁酸氢化可的松组186名患者中的17名。接受0.03%他克莫司、0.1%他克莫司和0.1%丁酸氢化可的松的患者，其mEASI曲线下平均面积相对于基线的百分比中位数分别为47.0%、36.5%和36.1%。0.1%他克莫司与0.1%丁酸氢化可的松之间无统计学显著差异；然而，与0.1%他克莫司（P <.001）或丁酸氢化可的松（P =.002）相比，0.03%他克莫司的mEASI改善程度较低具有统计学显著性。他克莫司治疗组在用药部位的皮肤烧灼感和瘙痒发生率高于丁酸氢化可的松组（P <.05）。实验室参数未显示治疗差异，且随时间无明显变化。
0.1%他克莫司软膏的疗效与0.1%丁酸氢化可的松软膏相似，0.03%他克莫司软膏的疗效较低。未发现严重的安全问题。
