中华皮肤科杂志 ›› 2005, Vol. 38 ›› Issue (10): 608-611.

• 论著 • 上一篇    下一篇

他克莫司软膏治疗儿童特应性皮炎疗效和安全性研究

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   

  1. 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. 中山大学附属第二医院
  • 收稿日期:2005-03-15 发布日期:2005-10-15

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

LIU Ling-ling1, DOU Xia1, XIE Zhi-qimg1, WANG Di1, ZHENG Zhi-zhong2, WEI Ming-hui2, YU Bi-e2, WANG Bao-xi3, MA Dong-lai3, LIN Lin4, GONG Juan-qin4, ZENG Fan-qin5, GUO Qing5, ZHU Xue-jun1   

  1. Department of Dermatology, Peking University First Hospital, Beijing 100034, China
  • Received:2005-03-15 Published:2005-10-15

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。

关键词: 皮炎, 特应性, 儿童, 他克莫司, 随机对照试验

Abstract: Objective To evaluate the efficacy and safety of 0.03% tacrolimus ointment for the treatment of atopic dermatitis (AD) in Chinese children. Methods A total of 139 children, 2 to17 years of age, with moderate to severe AD from 5 study centres were enrolled in this multicentre, randomized, double-blind, vehicle-controlled, parallel group study. Treatment with 0.03% tacrolimus 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 differences 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 those 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.

Key words: Dermatitis, atopic, Children, Taerolimus, Randomized controlled trials