中华皮肤科杂志 ›› 2012, Vol. 45 ›› Issue (10): 741-744.

• 研究报道 • 上一篇    下一篇

三乙醇胺乳膏治疗皮肤溃疡的多中心研究

布文博1,赵亮2,邓军3,陈晓栋4,张琬5,王焱2,吴敏智6,黄莉明7,王强2,吴信峰2,于浩7,方方2   

  1. 1. 中国医学科学院北京协和医学院皮肤病研究所
    2. 南京 中国医学科学院北京协和医学院皮肤病研究所
    3. 第三军医大学附属西南医院皮肤科
    4. 南通大学附属医院皮肤科
    5. 重庆 第三军医大学西南医院
    6. 苏州市第五人民医院
    7.
  • 收稿日期:2011-12-27 修回日期:2012-03-06 出版日期:2012-10-15 发布日期:2012-09-29
  • 通讯作者: 赵亮 E-mail:pfwkchina@yahoo.com.cn

Triethanolamine cream in the treatment of skin ulcer: a multicenter study

  • Received:2011-12-27 Revised:2012-03-06 Online:2012-10-15 Published:2012-09-29

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摘要：

目的 探讨三乙醇胺乳膏治疗皮肤溃疡的安全性和有效性。 方法 多中心、随机、单盲及阳性药平行对照研究。选取年龄为18 ～ 65岁皮肤溃疡的患者，按试验组和对照组2 ∶ 1分配，总共120例。试验组使用三乙醇胺乳膏，对照组使用重组牛碱性成纤维细胞生长因子凝胶。观察溃疡愈合率、上皮形成率、肉芽生成率等指标，观察期为4周。结果 随着治疗时间的延长，两组患者的病情均得到改善。治疗4周时，试验组80例，完成76例；对照组40例，完成38例。痊愈率：试验组为71.05%，对照组为34.21%，P = 0.0002；上皮形成率：试验组为66.25%，对照组为37.5%，P = 0.0035；肉芽生成率：试验组为85%，对照组为50%，P = 0.0001。两组患者均未发现与药物相关的不良事件。 结论 三乙醇胺乳膏在溃疡愈合率、上皮形成率、肉芽生成率等方面优于重组牛碱性成纤维细胞生长因子凝胶的对照组，是治疗皮肤溃疡一种较好的外用药物。

关键词: 关键词：皮肤 溃疡 三乙醇胺 重组牛碱性成纤维细胞生长因子

Abstract:

Objective To evaluate the efficacy and safety of triethanolamine cream in the treatment of skin ulcer. Methods A multicenter, single-blind, randomized, positive-control study was conducted. One-hundred and twenty patients aging 18－65 years with skin ulcer were randomly classified into the test and control group at a ratio of 2︰1 to be treated with triethanolamine cream and recombinant bovine basic fibroblast growth factor gel respectively for 4 weeks. The healing rate of ulcer, granulation tissue production rate and epithelialization rate were calculated. Results After the beginning of treatment, the condition of all patients was improved with time. In total, 76 out of 80 triethanolamine-treated patients and 38 out of 40 basic fibroblast growth factor gel-treated patients completed the 4-week trial. Significant differences were observed in the healing rate of ulcer, epithelialization rate and granulation tissue production rate between the test and control group （71.05% vs. 34.21%, P = 0.0002; 85% vs. 50%, P = 0.0001; 66.25% vs. 37.5%, P = 0.0035）. No adverse events occurred in any of the patients. Conclusions Triethanolamine cream seems superior to recombinant bovine basic fibroblast growth factor gel with regard to the healing rate of ulcer, epithelialization rate and granulation tissue production rate, and may be a promising drug for the treatment of skin ulcer.

Key words: Key words: skin, ulcer, triethanolamine, recombinant bovine basic fibroblast growth factor