中华皮肤科杂志 ›› 2005, Vol. 38 ›› Issue (7): 406-409.

• 论著 • 上一篇    下一篇

他克莫司软膏治疗成人特应性皮炎疗效和安全性研究

刘玲玲1, 窦侠1, 闻卫兢1, 郑志忠3, 王宝玺2, 林麟4, 曾凡钦5, 顾军6, 朱学骏1   

  1. 1. 北京大学第一医院皮肤性病科 100034;
    2. 中国医学科学院、中国协和医科大学北京协和医院皮肤性病科;
    3. 复旦大学附属华山医院皮肤性病科;
    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皮肤性病科;
    6. 上海长海医院皮肤性病科
  • 收稿日期:2004-11-09 发布日期:2005-07-15

Efficacy and Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis in Adults

LIU Ling-ling1, DOU Xia1, WEN Wei-jing1, ZHENG Zhi-zhong3, WANG Bao-xi2, LIN Lin4, ZENG Fan-qin5, GU Jun6, ZHU Xue-jun1   

  1. Department of Dermatology, First Hospital, Peking University, Beijing 100034, China
  • Received:2004-11-09 Published:2005-07-15

PDF

318

赞

摘要： 目的 评价0.1%和0.03%他克莫司软膏治疗成人中、重度特应性皮炎的疗效和安全性。方法 采用多中心、随机双盲、赋形剂平行对照的临床研究,受试者每日2次外搽0.1%或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周各访视1次,进行疗效和安全性评价。结果 6个中心共有211例中、重度特应性皮炎患者纳入疗效分析。治疗结束时,0.1%和0.03%他克莫司软膏组治疗有效率分别为88.4%和77.8%,均明显高于赋形剂组的30.0%(P<0.001)。治疗后第1、2、3周,0.1%和0.03%他克莫司软膏组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、患者对瘙痒自我评分均明显优于赋形剂组,且多于治疗后第1周始即明显改善(P=0.002-P<0.001),0.1%他克莫司软膏组疗效优于0.03%他克莫司软膏组。0.1%和0.03%他克莫司软膏组药物相关性不良反应发生率分别为47.3%和40.0%,均高于赋形剂组的28.2%,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 0.1%和0.03%他克莫司软膏对治疗成人特应性皮炎具有良好的疗效和安全性。

关键词: 皮炎,特应性, 他克莫司, 随机对照试验

Abstract: Objective To observe the clinical efficacy and safety of 0.1% and 0.03% tacrolimus ointment in patients aged 18 to 65 years with atopic dermatitis (AD).Methods Treatment was given twice daily to all affected areas for 3 weeks in a multicentre,randomized,double blind,parallel,and vehicle-controlled study.Follow-up visits were scheduled on day 1 (baseline),and 1,2 and 3 weeks post-treatment.The therapeutic effect and safety were evaluated.Results A total of 211 adults with moderate to severe AD in 6 study centres were enrolled in the efficacy evaluation.The efficacy rates were 88.4%,77.8% and 30.0% in patients treated with 0.1%,0.03% tacrolimus ointment,and the vehicle,respectively (P<0.001).Statistically significant differences were observed between tacrolimus treatment and the vehicle control group according to the modified Eczema Area and Severity Index score,the percentage of Body Surface Area (BSA%) affected,the total scores for individual signs and pruritus symptoms,physician's global evaluation of clinical response,and patient's assessment of pruritus.Significantly greater clinical improvement was achieved in both 0.1% and 0.03% tacrolimus ointment groups than that in the vehicle group for all efficacy parameters as early as in week 1 (except BSA% affected in the second week) and maintained throughout the study period (P=0.002-P<0.001).Treatment with 0.1% tacrolimus ointment was more effective than 0.03% tracrolimus ointment for most of the parameters.Transient skin burning,itching and stinging were the most common adverse events on the drug application site.Skin burning was the only sign,which occurred more often in tacrolimus treatment groups than that in the vehicle group.There were no significant changes of laboratry parameters between different treatment groups before and after treatment.Conclusion Treatment with 0.1% and 0.03% tacrolimus ointment is safe and effective in adult patients with moderate to severe AD.

Key words: Dermatitis,atopic, Tacrolimus, Randomized controlled trials