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［摘 要］ 目的
评价他克莫司软膏治疗儿童特应性皮炎（AD）的疗效与安全性。
方法
采用随机、双盲、赋形剂对照临床研究方法，将36例儿童AD患者随机分为两组，按1∶1比例分别接受0.03%他克莫司软膏或赋形剂治疗，观察治疗第1，2和3周的临床疗效和不良反应。
结果
0.03%他克莫司软膏组有效率为83.3%（15/18），明显高于赋形剂组的27.8%（5/18），差异非常显著（P<0.001）；总体疗效比较，他克莫司软膏组亦优于赋形剂组（P=0.002）；治疗后第1，2，3周患者的主要症状/体征指标平均值均明显低于赋形剂组，组间差异显著(P<0.01～P<0.05)，治疗后患者的生活质量亦明显改善。药物相关不良反应主要表现为一过性局部刺激，组间比较差异无显著性（P>0.05）。两组患者均未出现严重不良反应。
结论
0.03%他克莫司软膏治疗儿童特应性皮炎安全有效。
［关键词］
特应性皮炎，儿童；他克莫司软膏；临床研究
［中图分类号］
R 758.23
［文献标识码］
A
［文章编号］
1001-7089(2005)01-0021-03
Clinical Trial of Tacrolimus Ointment for Treatment of Atopic Dermatitis
in Children
GONG Juanqin,LIN Lin,YANG Xueyuan，et
al
(Institute of Dermatology, Peking Union Medical College & Chinese
Academy of Medical Science,Nanjing 210042，China)
Abstract: Objective
To evaluate the efficacy and safety of 0.03%
tacrolimus ointment for the treatment of moderate to severe atopic
dermatitis in children patients.
Methods A randomized,doubleblind,vehiclecontrolled
study with 3 weeks' followup was performed. A
total of 36 patients were enrolled according the ages. They were
randomized divided into two groups, which were treated with 0.03%
tacrolimus ointment or vehicle respectively twice daily. Efficacy and
safety were evaluated at baseline, and after weeks 1, 2 and 3.
Results At the end of treatment, the rates
of efficacy were 83.3%（15/18）and
27.8%（5/18）respectively
in tacrolimus ointmenttreated and vehicletreated
group, the difference was statistically significant(P<0.001). Tacrolimus
ointmenttreated patients showed significantly
greater improvement than vehicletreated
patients for all other efficacy parameters evaluated after weeks 1,2 and
3 (P<0.01～P<0.05)). The significant benefits in
terms of quality of life with atopic dermatitis were obtained after
treatment. The rates of adverse events were higher in tacrolimus groups
than in vehicle group, there were no statistic differences (P>0.05).
Skin itching and burning on the application site was a common but
temporary side effect. No significant adverse events were observed in
two groups.
Conclusion Tacrolimus ointment is a safe
and effective therapy for the treatment of children patients with atopic
dermatitis.
Key words： Atopic
dermatitis,Children;Tacrolimus ointment;Clinical trial
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