中华皮肤科杂志 ›› 2011, Vol. 44 ›› Issue (4): 241-243.

• 论著 • 上一篇    下一篇

国产复方倍他米松注射液局部注射治疗神经性皮炎的多中心对照临床研究

宗文凯1,崔盘根1,陈志强1,王宝玺1,李红春2,顾军3,陈洁4,温海5,顾菊林6,于浩7,娄冬华7   

  1. 1. 南京 中国医学科学院北京协和医学院皮肤病研究所
    2. 中国医学科学院北京协和医院
    3. 上海第二军医大学附属长海医院皮肤科
    4. 上海中医药大学附属岳阳中西医结合医院
    5. 上海第二军医大学长征医院皮肤科
    6. 上海市凤阳路415号第二军医大学长征医院
    7.
  • 收稿日期:2010-07-07 修回日期:2010-12-17 出版日期:2011-04-15 发布日期:2011-04-01
  • 通讯作者: 顾军 E-mail:gujun79@163.com

China-made compound betamethasone injection for the treatment of lichen simplex chronicus:　a multi-center, randomized, parallel controlled clinical study

  • Received:2010-07-07 Revised:2010-12-17 Online:2011-04-15 Published:2011-04-01
  • Contact: GU Jun E-mail:gujun79@163.com

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摘要：

目的 评价国产复方倍他米松注射液局部单次注射治疗神经性皮炎的安全性和疗效。方法 采用多中心、随机盲法、阳性药物平行对照的临床研究。受试者分别接受国产和进口复方倍他米松注射液治疗。在治疗前（D0）、治疗中（D14）及治疗后（D28）分别对各观察指标进行评估记录。结果 共入组病例144例，完成试验139例，其中对照组68例，试验组71例。疗后4周FAS分析显示，对照组有效率为86.11％，试验组为86.11％（χ2 = 0.00，P > 0.05）。痊愈率对照组为59.72％，试验组为54.17％（χ2 = 0.45，P > 0.05）。治疗结束时无严重不良事件出现，仅对照组有1例发生轻度皮肤萎缩，经随访自行好转，两组不良反应发生率差异无统计学意义（P > 0.05）。结论 国产复方倍他米松注射液治疗神经性皮炎安全有效。

关键词: 得宝松

Abstract:

Objective To evaluate the safety and efficacy of single and local use of a China-made compound betamethasone in the treatment of lichen simplex chronicus. Methods A multi-center, randomized, parallel controlled study was conducted. Patients with lichen simplex chronicus were divided into test and control groups to receive a single dose of intralesional compound betamethasone injection made in China or Schering-Plough Labo N.V. Belgium. Patients were visited for the evaluation of efficacy and safety of the China-made injection at the beginning of the treatment （D0）, on week 2 （D14） and 4 （D28） after the initiation of treatment. Results A total of 144 patients were enrolled, among which, 68 in the control group and 71 in the test group completed the trial. FAS analysis on week 4 revealed that the response rate and healing rate were 86.11% and 59.72% in the control group, respectively, 86.11% and 54.17% in the test group, respectively （χ2 = 0.00, 0.45, respectively, both P > 0.05）. There was no severe adverse event in either group after the treatment, and only mild atrophoderma occurred in one patient in the control group, which was improved spontaneously within several weeks of follow-up. There was no statistically significant difference in the occurrence of side reactions between the two groups （P > 0.05）. Conclusion The China-made compound betamethasone injection is effective and safe for the treatment of lichen simplex chronicus.

Key words: diprospan