他克莫司软膏治疗儿童特应性皮炎疗效和安全性研究  

Efficacy and Safety of TacroUmus Ointment for the Treatment of Atopic Dermatitis in Chinese Children

作　　者：刘玲玲[1] 窦侠[1] 谢志强[1] 王娣[1] 郑志忠[2] 魏明辉[2] 余碧娥[2] 王宝玺[3] 马东来[3] 林麟[4] 弓娟琴[4] 曾凡钦[5] 郭庆[5] 朱学骏[1] 

机构地区：[1]北京大学第一医院,100034 [2]复旦大学华山医院 [3]中国医学科学院中国协和医科大学北京协和医院 [4]中国医学科学院中国协和医科大学皮肤病研究所 [5]中山大学附属第二医院

出　　处：《中华皮肤科杂志》2005年第10期608-611,共4页Chinese Journal of Dermatology

摘　　要：目的评价0．03％他克莫司软膏治疗儿童中、重度特应性皮炎的疗效和安全性。方法采用多中心．随机、双肓、赋形剂平行对照的临床研究,受试者每日2次外搽0.03％他克莫司软膏或赋形剂,疗程3周,于治疗前及治疗后第1、2、3周各随访1次,进行疗效和安全性评价。结果 5个中心共有139例中、重度儿童特应性皮炎患者纳入疗效分析。治疗结束时,0.03％他克莫司软膏组治疗有效率为84.6％,明显高于赋形剂组的29.0％(P<0．001)。其他疗效评估指标包括湿疹面积与严重度指数、皮损受累面积百分比、症状/体征总评分、研究者对治疗临床反应总评、患者／监护人对瘙痒自我评分。在治疗后第1、2、3周0.03％他克莫司软膏组明显优于赋形剂组,且均于治疗后第1周始即明显改善(P=0.002～P<0．001)。0.03％他克莫司软膏组药物相关不良反应发生率为32.9％,赋形剂组为37.7％,主要表现为皮肤灼热、瘙痒／瘙痒加重或刺痛等局部刺激反应。结论 0.03％他克莫司软膏对治疗儿童特应性皮炎具有良好的疗效和安全性。Objective To evaluate the efficacy and safety of 0.03% tacrolimus ointment for the treatment of atopie dermatitis （AD） in Chinese chihtren. Methods A total of 139 children, 2 to17 years of age, with moderate to severe AD from 5 study centres were enrolled in this muhicentre, randomized, double-blind, vehicle-controlled, parallel group study. Treatment with 0.03% taerolimus ointment or vehicle was applied twice daily to the affected areas for 3 weeks. Visits were scheduled on day 1 （base line, before treatment） and 1, 2, 3 weeks after the treatment. The main therapeutic parameter was the efficacy rate at the end of the treatment. Results The efficacy rates were 84.6% and 29.0% for tacrolimus group and vehicle group, respectively （P 〈 0.001 ）. Statistically significant differem：es were observed between the two groups in the modified Eczema Area and Severity Index score, the percentage of body surface area （BSA%） affected, the total scores of signs and symptoms, physician＇s global evaluation of clinical response and guardian＇s or patient＇s self assessment of pruritus. Improvements in efficacy parameters, which were greater （P = 0.002 or P 〈 0.001） in tacrolimus group than thnse in vehicle group, occurred within 1 week after the treatment and continued thereafter. There was no significant difference in adverse events between tacrolimus group and vehicle group. Transient skin burning, itching and stinging at application sites were the most common adverse events, Conclusions Tacrolimus ointment （0.03%） is safe and effective for the treatment of moderate to severe AD in Chinese children.

关 键 词：皮炎 特应性 儿童 他觅莫司 随机对照试验 他克莫司软膏 特应性皮炎 安全性研究 疗效分析 治疗后 

分 类 号：R758.2[医药卫生—皮肤病学与性病学]