中华皮肤科杂志 ›› 2011, Vol. 44 ›› Issue (12): 838-841.

• 论著 • 上一篇    下一篇

青鹏软膏治疗湿疹的随机、双盲、对照多中心临床观察

唐慧1,杨勤萍2,骆丹3,孙秋宁4,郭在培5,李东宁6,席丽艳7,徐金华8   

  1. 1. 上海复旦大学附属华山医院皮肤科
    2. 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
    3. 南京市南京医科大学附属第一医院皮肤科
    4. 北京协和医院皮肤科
    5. 成都四川大学华西医院皮肤科
    6. 锦州辽宁医学院附属第一医院皮肤科
    7. 中山大学孙逸仙纪念医院皮肤科
    8. 上海市复旦大学附属华山医院皮肤科
  • 收稿日期:2011-08-17 修回日期:2011-09-19 出版日期:2011-12-15 发布日期:2011-12-02
  • 通讯作者: 徐金华 E-mail:xjhhuashan@yahoo.com.cn
  • 基金资助:

    “重大新药创制”科技重大专项项目

Qingpeng ointment in the treatment of eczema: a multi-center, randomized, double-blind, placebo-controlled study

  • Received:2011-08-17 Revised:2011-09-19 Online:2011-12-15 Published:2011-12-02

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摘要：

目的 评价青鹏软膏治疗湿疹的疗效和安全性。方法 采用随机、双盲、安慰剂对照的多中心临床试验，试验组和对照组病例数比为2：1。6个研究中心共入选湿疹患者246例，纳入疗效分析共228例，其中试验组 154例，对照组74例。试验组外用青鹏软膏，对照组外用安慰剂，均为每天2次，疗程为3周。在基线、治疗后第1、2、3周分别对瘙痒、红斑、丘疹、丘疱疹或水疱、鳞屑或结痂、浸润或苔藓样变的积分进行评价并记录不良事件。结果 用药第3周时，试验组和对照组的有效率分别为85.71%和41.89%，痊愈率分别为31.82%和12.16%，两组差异均有统计学意义（Z = 47.16、12.30，P值均 < 0.01）。试验组和对照组不良事件发生率分别为2.48%和2.56%，差异无统计学意义（χ2 = 0，P > 0.05）。结论 青鹏软膏治疗轻中度湿疹时疗效显著，起效快，安全性较高。

关键词: 青鹏软膏

Abstract:

Objective To evaluate the efficacy and safety of Qingpeng ointment in the treatment of eczema. Methods A multi-center, randomized, double-blind and placebo-controlled clinical trial was conducted. A total of 246 patients with eczema were randomly assigned with a ratio of 2∶1 to the treatment group and control group to topically apply Qingpeng ointment and placebo respectively twice daily for 3 weeks． Total symptom scores were calculated for the patients at the baseline, on week 1, 2 and 3 during the treatment according to the individual scores for pruritus, lesions including erythema, papules, papulovesicles or vesicles, desquamation, crusting, infiltration and lichenification. The occurrence of adverse events was recorded. Results Totally, 228 patients completed the trial, including 154 patients in the treatment group and 74 patients in the control group. After 3 weeks of treatment, a statistical difference was observed in the response rate （85.71% vs. 41.89%, Z = 47.16, P < 0.01） and cure rate（31.82% vs. 12.16%, Z = 12.30, P < 0.01） between the treatment and control group. There was no significant difference in the incidence of adverse events between the two groups （2.48% vs. 2.56%, ?字2 = 0，P > 0.05）. Conclusion Qingpeng ointment displays a promising efficacy for the treatment of mild to moderate eczema with a rapid onset and high safety.

Key words: eczema

中图分类号: 

  • R758.23