中华皮肤科杂志 ›› 2010, Vol. 43 ›› Issue (2): 138-139.

• 药物与临床 • 上一篇    下一篇

复方氟米松软膏治疗神经性皮炎的随机开放试验

陈连军1,马莉2,黄雯2,陈向东3,温海4,郑捷5,杨勤萍6,徐金华1,章伟7   

  1. 1. 复旦大学附属华山医院
    2. 复旦大学附属华山医院皮肤科
    3. 上海交通大学医学院附属第九人民医院皮肤科
    4. 上海第二军医大学长征医院皮肤科
    5. 上海交通大学医学院附属瑞金医院皮肤科
    6. 复旦大学附属华山医院皮肤科,复旦大学附属华山医院南汇分院
    7. 上海市皮肤病性病医院
  • 收稿日期:2009-06-09 修回日期:2009-08-03 出版日期:2010-02-15 发布日期:2012-03-30
  • 通讯作者: 陈连军 E-mail:lianjunchan@163.com
  • 作者简介:

Neurodermitis treated with compound flumetasone ointment: a randomized, open study

1,MA Li1,HUANG Wen1,CHEN Xiangdong2,WEN Hai3,Jie ZHENGYANG Qinping1,XU Jinhua1,ZHANG Wei3   

  • Received:2009-06-09 Revised:2009-08-03 Online:2010-02-15 Published:2012-03-30

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摘要：

 目的 评价复方氟米松软膏治疗慢性单纯性苔藓患者的临床疗效和安全性。方法 采用多中心、随机、开放、阳性药物平行对照的临床试验方法。5个研究中心共240例慢性单纯性苔藓患者随机分为试验组复方氟米松软膏和对照组复方卤米松乳膏，疗程3周，观察两组靶皮损在入选及治疗结束时症状和体征总积分，并记录整个试验过程中可能发生的不良事件。结果 治疗结束时，两组的有效性分析差别没有统计学意义(P=0.1788)。试验组与对照组痊愈率分别为45.30%及38.33%(P=0.2430)。试验组与对照组有效率分别为88.89%及85.83%(P = 0.4736)。复方氟米松组共发生2例不良反应，发生率为1.77%，均表现为用药局部瘙痒，未见其他严重不良反应。结论 复方氟米松软膏治疗慢性单纯性苔藓疗效确切，安全性好。

关键词: 氟米松

Abstract:

Objective To evaluate the clinical efficacy and safety of Compound Flumetasone Ointment for the patients with neurodermatitis. Methods A multi-center, randomized, open and parallel controlled clinical trial was performed in the present study. 240 patients with neurodermatitis from five centers were divided randomly into 2 groups: the experimental group with Compound Flumetasone Ointment and the control group with Sicorten Plus. The treatment course for both was 3 weeks. The efficacy was evaluated by the total symptom scores (TSS) before and at the end of the treatment. The side reactions were also recorded. Results At the end of the treatment, the difference of effective analysis between these two groups had no statistical significance (P=0.2626). The cure rate in the experimental and control group was 44.25% and 39.29%, respectively (P=0.4371). The total effective rate in the experimental and control group was 88.5% and 84.8%, respectively (P=0.4202). Cost-benefit analysis showed the average cost per unit of effectiveness of Compound Flumetasone Ointment was higher than that of Sicorten Plus, with statistical significance（P<0.0001）. 2 cases (1.77%) of side-effect were seen in the experimental group, both complaining of the local itching at the applying site. Conclusions Compound Flumetasone Ointment is effective and safe for the treatment of neurodermatitis, with higer cost performance ratio compared with Sicorten Plus.