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一项双中心、双盲、随机试验,旨在测试一种新型治疗剂减少橘皮组织的耐受性和疗效。

A two-center, double-blinded, randomized trial testing the tolerability and efficacy of a novel therapeutic agent for cellulite reduction.

作者信息

Rao Jaggi, Gold Michael H, Goldman Mitchel P

机构信息

Dermatology/Cosmetic Laser Associates of La Jolla, Inc., La Jolla, California, USA.

出版信息

J Cosmet Dermatol. 2005 Jun;4(2):93-102. doi: 10.1111/j.1473-2165.2005.40208.x.

DOI:10.1111/j.1473-2165.2005.40208.x
PMID:17166206
Abstract

INTRODUCTION

Cellulite is the unsightly dimpling and nodularity found on the thighs and buttocks of many postadolescent women. Unfortunately, poor understanding of its pathophysiology coupled with very few scientifically based studies have left us with limited treatment options that are tolerable and effective.

PURPOSE

To review current concepts of the etiology and nature of cellulite and summarize available treatment options. To evaluate a novel, pathophysiologically based, topical agent for treatment.

MATERIALS AND METHODS

A total of 40 women with a moderate degree of cellulite (20 from each of the two research centers) entered a double-blinded, randomized trial where an anticellulite cream was applied on a nightly basis to the affected sites for four continuous weeks. Each subject was randomized to receive active cream on either the right or left leg, with the contralateral side serving as placebo control. Bioceramic-coated neoprene shorts were worn overnight to enhance penetration of the topical agents by occlusion. High-quality digital photography was taken before treatment and after 4 weeks, with tangential full-spectrum lighting. Five blinded, independent physician reviewers assessed the photographs for improvement. Subject questionnaires were completed to assess tolerability and efficacy.

RESULTS

Of the 34 subjects who completed the study, 62% (21/34) noticed an overall improvement in their cellulite, with 62% (13/21) reporting greater improvement in the thigh that received active product. All 34 subjects found the shorts and creams easy and pleasant to use. Overall, the average measured decrease in thigh circumference was 1.9 cm (range: 0.1-4.5) with active product, and 1.3 cm (range: 0.1-3.0) with placebo. Upon review of the pre- and poststudy photographs, dermatologist evaluators found thighs treated with active product showed greater improvement than thighs treated with placebo in 68% of subjects.

CONCLUSIONS

The active topical agent used in this study was found to be effective in reducing the appearance of cellulite. All subjects tolerated the formulation well with no adverse effects. The success of this research validates the pathophysiologic concepts used to formulate the topical compound. This study both increases our understanding of the nature of cellulite and establishes a tolerable, effective product to treat it.

摘要

引言

橘皮组织是许多青春期后女性大腿和臀部出现的难看的凹陷和结节。不幸的是,对其病理生理学的了解不足,加上基于科学的研究很少,使得我们可选择的可耐受且有效的治疗方法有限。

目的

回顾橘皮组织的病因和本质的当前概念,并总结可用的治疗选择。评估一种新型的、基于病理生理学的局部用药进行治疗。

材料和方法

共有40名中度橘皮组织女性(两个研究中心各20名)进入一项双盲、随机试验,每晚将一种抗橘皮组织乳膏涂抹于受影响部位,持续四周。每位受试者随机在右腿或左腿使用活性乳膏,对侧作为安慰剂对照。夜间穿着生物陶瓷涂层氯丁橡胶短裤,通过封闭作用增强局部用药的渗透。在治疗前和4周后,采用切线全光谱照明拍摄高质量数码照片。由五名不知情的独立医生评审员评估照片以判断改善情况。完成受试者问卷以评估耐受性和疗效。

结果

在完成研究的34名受试者中,62%(21/34)注意到其橘皮组织总体有所改善,其中62%(13/21)报告使用活性产品的大腿改善更大。所有34名受试者都觉得短裤和乳膏使用方便且令人愉悦。总体而言,使用活性产品时,大腿周长平均测量减少1.9厘米(范围:0.1 - 4.5厘米),使用安慰剂时为1.3厘米(范围:0.1 - 3.0厘米)。在查看研究前后的照片时,皮肤科医生评估员发现,68%的受试者中,使用活性产品治疗的大腿比使用安慰剂治疗的大腿改善更大。

结论

本研究中使用的活性局部用药被发现可有效减少橘皮组织的外观。所有受试者对该制剂耐受性良好,无不良反应。这项研究的成功验证了用于配制局部化合物的病理生理学概念。本研究既增进了我们对橘皮组织本质的理解,又确立了一种可耐受、有效的治疗产品。

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