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一项关于羟基磷灰石钙微球与人源胶原蛋白用于矫正鼻唇沟的随机、双侧、前瞻性对比研究。

A randomized, bilateral, prospective comparison of calcium hydroxylapatite microspheres versus human-based collagen for the correction of nasolabial folds.

作者信息

Smith Stacy, Busso Mariano, McClaren Marla, Bass Lawrence S

机构信息

Therapeutics Clinical Research and UCSD Division of Dermatology, San Diego, California 92123, USA.

出版信息

Dermatol Surg. 2007 Dec;33 Suppl 2:S112-21; discussion S121. doi: 10.1111/j.1524-4725.2007.33350.x.

DOI:10.1111/j.1524-4725.2007.33350.x
PMID:18086048
Abstract

BACKGROUND

Current soft tissue fillers are a compromise between ease of use, duration of correction, reactivity, and cost. A product utilizing calcium hydroxylapatite (CaHA) is currently being used as a soft tissue filler.

OBJECTIVE

The objective was to compare the efficacy and safety of CaHA microspheres versus human-based collagen for the correction of nasolabial folds.

MATERIALS AND METHODS

Four centers enrolled 117 subjects with moderate to deep nasolabial folds. Subjects received CaHA on one side of the face and human collagen on the other. Up to two touch-ups were allowed. A blinded panel of experts evaluated subject photographs from initial and follow-up visits.

RESULTS

Seventy-nine percent of subjects had superior improvement on the CaHA side through 6 months (p<.0001). For optimal correction, significantly less volume and fewer injections were needed for CaHA than for collagen (p<.0001). Adverse event rates were comparable, with some increase in bruising and edema for CaHA-treated sides. Adverse event duration was similar for both groups and generally resolved within 14 to 21 days.

CONCLUSION

This CaHA-based product gives significantly longer-lasting correction of nasolabial folds compared to human collagen. Less total material and fewer injections are required. The adverse event profile of the product is similar to the collagen-based product.

摘要

背景

目前的软组织填充剂是在易用性、矫正持续时间、反应性和成本之间的一种折衷。一种使用羟基磷灰石(CaHA)的产品目前正被用作软组织填充剂。

目的

目的是比较CaHA微球与人源胶原蛋白矫正鼻唇沟的疗效和安全性。

材料与方法

四个中心招募了117名有中度至深度鼻唇沟的受试者。受试者一侧面部接受CaHA,另一侧接受人胶原蛋白。允许进行多达两次补打。一个盲法专家小组评估受试者初次和随访时的照片。

结果

79%的受试者在6个月内CaHA一侧改善更优(p<0.0001)。为达到最佳矫正效果,CaHA所需的总体积和注射次数明显少于胶原蛋白(p<0.0001)。不良事件发生率相当,CaHA治疗侧的瘀斑和水肿略有增加。两组不良事件持续时间相似,一般在14至21天内消退。

结论

与人类胶原蛋白相比,这种基于CaHA的产品对鼻唇沟的矫正效果显著更持久。所需的总材料更少,注射次数也更少。该产品的不良事件情况与基于胶原蛋白的产品相似。

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