积雪苷霜软膏治疗黄褐斑随机、双盲、自身对照试验研究  

Randomized,double-blind and own-controlled study on the effects of Centella triterpenes cream for melasma

作　　者：侯伟[1] 张洁尘[1] 田蔚蔚[1] 张怀亮[1] 陈解春[2] 

机构地区：[1]中国医学科学院北京协和医学院皮肤病研究所,江苏南京210042 [2]上海现代制药股份有限公司,上海200040

出　　处：《中国美容医学》2011年第5期792-795,共4页Chinese Journal of Aesthetic Medicine

基　　金：上海市科技创新行动计划2010年度中药现代化专项资助(项目编号:10DZ197030)

摘　　要：目的:评估积雪苷霜软膏R治疗黄褐斑的临床疗效及安全性。方法:采用12周随机、双盲、自身对照试验,受试者左右两侧面部黄褐斑区域随机使用积雪苷霜软膏R与不含积雪草总苷成分的安慰剂,观察色斑改善程度。通过第0周、第4周、第8周、第12周研究者盲法评价黄褐斑面积及严重程度指数(MASI)、受试者盲法自评、仪器测量三个方面评价比较用药侧与安慰剂侧黄褐斑的改善情况。结果:共纳入符合要求的研究对象36例全部按期完成,在试验结束揭盲后统计,受试者的治疗侧MASI指数下降45%,结合受试者对疗效的自我评估、颜色定量测量及拍照,治疗侧疗效明显优于安慰剂侧。结论:本研究结果显示积雪苷霜软膏R治疗黄褐斑皮肤耐受性良好,临床疗效明显优于安慰剂。Objective To evaluate the efficacy of a Centella triterpenes creamR in treating women with melasma.Methods A double-blind,randomized,own-controlled 12 weeks split-face study was conducted.Centella triterpenes creamR was applied twice daily to half face and vehicle-control cream was applied to the other side.Efficacy was based on an investigator-blinded assessment,subject self-blinded assessment,and ChromameterRquantitative analysis at week 0,4,8 and 12.Results Thirty-six volunteer were recruited and all of them completed a 12-week trial.By the end of the study,MASI score decreased 45% on the treated side.Significant improvement was observed on treatment side,according to the Investigator＇s Global Assessment,volunteers self assessment,color measurement and photograph.Conclusion The study demonstrates that topical Centella triterpenes creamR is safe,tolerable,and clinically more efficacious than placebo in treating melasma.

关 键 词：积雪草苷 积雪草苷霜软膏 黄褐斑 功效评价 随机对照试验 

分 类 号：R758.42[医药卫生—皮肤病学与性病学]