积雪苷霜软膏治疗黄褐斑随机\双盲\自身对照试验研究(1)
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[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。
[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
[中图分类号]R758.4+2 [文献标识码]A [文章编号]1008-6455(2011)05-0792-03
Randomized, double-blind and own-controlled study on the effects of Centella triterpenes cream for melasma
HOU Wei, ZHANG Jie-chen，TIAN Wei-wei，Zhang Huai-liang, CHEN Jie-chun
(Institute of Dermatology，Chinese Academy of Medical Sciences&Peking Union Medical College，Nanjing 210042，China)
Abstract: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.ConclusionThe study demonstrates that topical Centella triterpenes creamR is safe, tolerable, and clinically more efficacious than placebo in treating melasma.
Key words:asiaticoside；Centella triterpenes cream;melasma; efficacy; randomized controlled trial
积雪草是一种广泛分布于中国、印度、非洲及一些欧洲国家的植物，被用于治疗多种疾病已有数百年的历史[1]。积雪苷是积雪草提取物，目前被广泛用于伤口愈合、烧伤、瘢痕、硬皮病等。研究报道[2]积雪草甙对蘑菇酪氨酸酶活性有抑制作用，且呈剂量依赖性。在UVB照射攻击豚鼠的同时用积雪苷霜软膏进行治疗性给药，结果显示积雪苷霜软膏能减少黑素细胞数，并使色素沉着区颜色变淡、面积变小，证明其有治疗黑素沉积的作用[3]。为了评价其对面部常见色素性疾病 —黄褐斑是否有治疗作用，我们进行了用积雪苷霜软膏R治疗黄褐斑12周(随机、双盲、对照)的临床试验，现将结果报道如下。
1对象和方法
1.1 研究对象：黄褐斑女性36例，年龄20～60岁,室内工作者。入选标准：①20～60岁有黄褐斑的女性；②自愿参加，知情同意(签知情同意书)；③能按要求使用产品并完成随访者。排除标准：①孕妇或哺乳期妇女；②有较重的系统疾病；③面部皮肤有瘢痕、萎缩、鲜红斑痣等其他皮损而影响试验结果的判定者；④近1月内有日晒伤影响评估者；⑤体质高度敏感者；⑥参加其他的临床试验研究者；⑦正在服用其他药物可能干扰或影响黄褐斑疗效判定者 ......
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