中华皮肤科杂志 ›› 2013, Vol. 46 ›› Issue (1): 49-51.

• 研究报道 • 上一篇    下一篇

0.03％他克莫司软膏治疗中重度特应性皮炎患儿疗效和安全性观察

梁源1,张霞2,燕丽2,韦祝3,汤建萍3,郭一峰4,姚志荣5,马琳2   

  1. 1. 首都医科大学附属北京儿童医院;国家儿童医学中心
    2. 首都医科大学附属北京儿童医院
    3. 长沙市湖南省儿童医院皮肤性病科
    4. 上海交通大学医学院附属新华医院
    5. 上海交通大学医学院新华医院皮肤科
  • 收稿日期:2012-03-02 修回日期:2012-09-05 出版日期:2013-01-15 发布日期:2013-01-01
  • 通讯作者: 马琳 E-mail:bch_maleen@aliyun.com

Efficacy and safety of tacrolimus 0.03% ointment for the treatment of 2-year-old patients with moderate to severe atopic dermatitis

  • Received:2012-03-02 Revised:2012-09-05 Online:2013-01-15 Published:2013-01-01

PDF

34

赞

摘要： 目的 探讨0.03%他克莫司软膏治疗中重度特应性皮炎（AD）患儿的安全性与疗效。方法 多中心、开放的方法对59例2岁中、重度AD患儿给予0.03%他克莫司软膏治疗3周。分别在基线和治疗后1、2、3周分析AD症状/体征与面积总体改善率、湿疹面积和严重度指数（EASI）评分、受累体表面积百分数（BSA%）、医生的总体评估（PGE），评价患儿生活质量改善情况以及用药安全性，同时应用视觉模拟尺（VAS）对瘙痒程度进行评估。结果 治疗3周后，AD症状/体征与面积总体改善率达到65.85%，EASI评分仅为4.18，BSA%仅为16.41%。疗程结束时，治疗成功率高达85.10%，其中有2.13%的患儿达到痊愈，且所有患者AD均有改善，无恶化现象。通过VAS对患者瘙痒程度进行评估，显示治疗3周后评分下降为3.21。AD患儿在使用0.03%他克莫司软膏治疗后，儿童皮肤病学生活质量指数有明显下降，由基线时7.06逐渐降为治疗结束时2.91。安全性评估中药物不良反应主要为用药局部一过性烧灼感等不适，未见与他克莫司软膏相关的严重不良事件发生。结论 0.03%他克莫司软膏治疗2岁中、重度特应性皮炎患儿安全、有效。

关键词: 皮炎，特应性, 他克莫司

Abstract: LIANG Yuan*, ZHANG Xia, YAN Li, WEI Zhu, TANG Jian-ping, GUO Yi-feng, YAO Zhi-rong, MA Lin. *Department of Dermatology, Beijing Children′s Hospital, Capital Medical University, Beijing 100045, China Corresponding author: MA Lin, Email: bch_maleen@yahoo.cn 【Abstract】 Objective To evaluate the efficacy and safety of tacrolimus 0.03% ointment for the treatment of 2-year-old patients with moderate to severe AD. Methods An open-labeled, non-comparative, multi-center study was carried out, which included 59 2-year-old children with moderate to severe AD. All the patients were given topical tacrolimus 0.03% ointment twice daily for 3 weeks. The evaluation of patients was scheduled at the baseline, 1, 2, and 3 weeks after the start of treatment. Clinical outcome parameters included the total response rate, eczema area and severity index score （EASI score）, the percentage of body surface area （BSA%） affected, physician′s global evaluation （PGE）, children′s dermatology life quality index （CDLQI）, visual analog scale （VAS） pruritus score. Safety was assessed based on adverse events reported by patients or observed by the physicians. Results At the end of the treatment, the total response rate was 65.85% with an EASI score of 4.18, and BSA% of 16.41%. Of these patients, 85.10% achieved a satisfactory outcome, 2.13% achieved a complete cure, and all achieved an improvement, with no exacerbation observed. The 3-week treatment also resulted in a significant decrease in VAS pruritus score （from 6.80 to 3.21） and CDLQI （from 7.06 to 2.91）. Side effects mainly manifested as temporary burning sensation at the application site, and no severe adverse events associated with tacrolimus were observed. Conclusion Tacrolimus 0.03% ointment seems safe and effective for the treatment of 2-year-old patients with moderate to severe AD.

Key words: Dermatitis, Atopic, Tacrolimus