中华皮肤科杂志 ›› 2012, Vol. 45 ›› Issue (1): 47-49.

• 研究报道 • 上一篇    下一篇

积雪苷治疗35例鱼尾纹12周疗效观察

张洁尘1,陈祥生2,侯伟1,田蔚蔚1,陈解春3   

  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. 医科院皮研所
    3. 上海现代制药股份有限公司
  • 收稿日期:2011-01-27 修回日期:2011-09-18 出版日期:2012-01-15 发布日期:2011-12-31
  • 通讯作者: 侯伟 E-mail:houwei1964@hotmail.com

Centella triterpenes cream in the treatment of crow′s feet in 35 women: a randomized, double-blind vehicle-controlled 12-week study

  • Received:2011-01-27 Revised:2011-09-18 Online:2012-01-15 Published:2011-12-31

摘要:

目的 评估积雪苷治疗鱼尾纹的临床疗效及安全性。方法 采用12周随机、双盲、赋形剂自身对照试验,通过第0、4、8、12周研究者盲法评价皱纹程度、受试者盲法自评、仪器测量3个方面评价试验用药侧与对照侧鱼尾纹的改善情况。结果 完成试验的35名受试者的双侧鱼尾纹程度根据研究者盲法评估,在使用第4周,治疗组与对照组的皱纹变化有统计学意义(P < 0.05)。在第8、12周试验用药侧的皱纹程度的减轻优于对照侧,皱纹评分具有统计学意义(P < 0.05)。采用Visioscan VC98定量测量双侧鱼尾纹SEw值结果显示,试验用药侧随时间的变化SEw的值增大,即皱纹程度减轻,与对照侧相比,差异有统计学意义。受试者评估显示,双侧药物在使用过程中刺激性及粗皱纹的改善情况无差异,外眦部位肌肤纹理改善方面治疗侧优于对照侧(P < 0.05)。结论 积雪苷霜软膏每日3次局部外用改善鱼尾纹有一定疗效,无不良反应。

关键词: 自身对照试验

Abstract:

Objective To evaluate the efficacy and safety of centella triterpenes cream?誖for treating crow′s feet. Methods A double-blind, randomized, vehicle-controlled 12-week study was conducted. Centella triterpenes cream?誖was applied to the lateral canthus on one side (treatment side) and vehicle-control cream to the lateral canthus on the other side (control side) 3 times daily. Efficacy was evaluated based on an investigator-blinded assessment, subject self-blinded assessment and a quantitative analysis by Visioscan?誖VC98 at the baseline, 4, 8, 12 weeks after the beginning of treatment. Results Thirty-six volunteers were recruited and 35 subjects completed the 12-week trial. The investigator-blinded assessment showed a significant difference in the changes of wrinkle scores between the treatment side and control side after 4 weeks (P < 0.05), and the improvement of wrinkles was more obvious on the treatment side than on the control side at 8 and 12 weeks with a statistical difference in the wrinkle scores (both P < 0.05). Compared with the control side, a significant increase in SEw value, which suggested an improvement in wrinkles, was observed on the treatment side after the application of centella triterpenes cream?誖. Subjects′ assessments revealed no significant difference in the occurrence of irritation or the improvement of coarse wrinkles, whereas the treatment side was superior to the control side in the improvement of skin texture(P < 0.05) at the lateral canthus. Conclusion Centella triterpenes cream?誖thrice daily is effective for the improvement of crow′s feet with no obvious side effects.

Key words: randomized controlled trial