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一项关于使用注射用聚左旋乳酸治疗中度至重度痤疮或水痘瘢痕的单中心、开放标签研究。

A single-center, open-label study on the use of injectable poly-L-lactic acid for the treatment of moderate to severe scarring from acne or varicella.

作者信息

Beer Kenneth

机构信息

Palm Beach Esthetic Center, West Palm Beach, Florida 33401-2717, USA.

出版信息

Dermatol Surg. 2007 Dec;33 Suppl 2:S159-67. doi: 10.1111/j.1524-4725.2007.33356.x.

Abstract

BACKGROUND AND OBJECTIVE

Acne scars may negatively impact quality of life. The purpose of this study was to collect preliminary data on the efficacy and safety of injectable poly-L-lactic acid (PLLA, Sculptra, Dermik Laboratories) for the treatment of acne scars.

METHODS

Twenty subjects aged 42.4+/-10.7 years (10 men, 10 women) with facial scars resulting from moderate to severe acne or varicella participated in this single-center, open-label prospective study. The primary end point was the resolution of the acne or varicella scars. Secondary end points were the physician and subject assessments of scar improvement. PLLA reconstituted with 5 mL of sterile water was injected serially at or near the sites of the acne scars without topical anesthesia.

RESULTS

Investigator-assessed reductions in acne scar size and severity were significant (p<.0001) during the course of seven treatments. Subject-rated reduction in scar severity was also significant (p=.0078). Subject satisfaction with treatment trended toward an increase with each treatment session and approached significance (p=.0899). Adverse events were limited to depression (n=1) not related to the treatment.

CONCLUSION

Injectable PLLA as used in this investigation appears to correct the types of acne scars treated in this study without serious adverse effects.

摘要

背景与目的

痤疮瘢痕可能对生活质量产生负面影响。本研究的目的是收集关于注射用聚左旋乳酸(PLLA,塑然雅,德美公司)治疗痤疮瘢痕的疗效和安全性的初步数据。

方法

20名年龄在42.4±10.7岁(10名男性,10名女性)、有中度至重度痤疮或水痘所致面部瘢痕的受试者参与了这项单中心、开放标签的前瞻性研究。主要终点是痤疮或水痘瘢痕的消退。次要终点是医生和受试者对瘢痕改善情况的评估。用5毫升无菌水复溶的PLLA在不进行局部麻醉的情况下,在痤疮瘢痕部位或其附近进行连续注射。

结果

在七次治疗过程中,研究者评估的痤疮瘢痕大小和严重程度的降低具有显著性(p<0.0001)。受试者评定的瘢痕严重程度降低也具有显著性(p=0.0078)。受试者对治疗的满意度随着每次治疗疗程呈上升趋势,接近显著性水平(p=0.0899)。不良事件仅限于1例与治疗无关的抑郁。

结论

本研究中使用的注射用PLLA似乎能改善本研究中所治疗的痤疮瘢痕类型,且无严重不良反应。

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