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光滑凝胶型透明质酸真皮填充剂与交联牛胶原蛋白的比较:一项多中心、双盲、随机、受试者自身对照研究。

Comparison of smooth-gel hyaluronic acid dermal fillers with cross-linked bovine collagen: a multicenter, double-masked, randomized, within-subject study.

作者信息

Baumann Leslie S, Shamban Ava T, Lupo Mary P, Monheit Gary D, Thomas Jane A, Murphy Diane K, Walker Patricia S

机构信息

University of Miami Cosmetic Center, Miami, Florida 33140, USA.

出版信息

Dermatol Surg. 2007 Dec;33 Suppl 2:S128-35. doi: 10.1111/j.1524-4725.2007.33352.x.

Abstract

BACKGROUND

A new family of next-generation non-animal hyaluronic acid (HA) dermal fillers was approved by the FDA in June 2006. Compared with other HA fillers available in the United States at the time of writing, these new fillers have a higher concentration of HA, higher concentration of cross-linked HA, and a smooth consistency--which should promote long-lasting corrections and a smooth, natural look and feel postinjection.

OBJECTIVE

The objective was to compare the effectiveness and safety of these smooth-gel HA dermal fillers with bovine collagen for nasolabial fold (NLF) correction.

METHODS AND MATERIALS

A total of 439 subjects with moderate or severe NLFs received one of three types of smooth-gel HA dermal filler (in one NLF) and cross-linked bovine collagen (in the other NLF) and were evaluated for <or=24 weeks.

RESULTS

All three HA dermal fillers achieved considerably longer-lasting clinical correction than bovine collagen; 81% to 90% of HA dermal filler-treated NLFs maintained a clinically significant improvement from baseline for >or=6 months. Up to 88% of subjects preferred the HA dermal fillers over bovine collagen. All fillers were similarly well tolerated.

CONCLUSION

The smooth-gel HA dermal fillers offer longer-lasting correction than bovine collagen-which may lessen the frequency that repeat treatments are needed. Also, they were preferred by the vast majority of subjects-which should promote patient satisfaction.

摘要

背景

2006年6月,美国食品药品监督管理局(FDA)批准了新一代非动物源透明质酸(HA)真皮填充剂系列产品。与撰写本文时美国市场上的其他HA填充剂相比,这些新型填充剂具有更高的HA浓度、更高的交联HA浓度以及光滑的质地,这有望实现持久的矫正效果,并在注射后呈现出光滑、自然的外观和触感。

目的

比较这些光滑凝胶型HA真皮填充剂与牛胶原蛋白用于矫正鼻唇沟(NLF)的有效性和安全性。

方法和材料

共有439例中重度鼻唇沟患者,一侧鼻唇沟接受三种类型的光滑凝胶型HA真皮填充剂中的一种治疗,另一侧接受交联牛胶原蛋白治疗,并进行了为期≤24周的评估。

结果

所有三种HA真皮填充剂实现的临床矫正效果比牛胶原蛋白持久得多;81%至90%接受HA真皮填充剂治疗的鼻唇沟在≥6个月的时间里,与基线相比保持了具有临床意义的改善。高达88%的受试者更喜欢HA真皮填充剂而非牛胶原蛋白。所有填充剂的耐受性相似。

结论

光滑凝胶型HA真皮填充剂比牛胶原蛋白提供更持久的矫正效果,这可能会减少重复治疗的频率。此外,绝大多数受试者更喜欢使用它们,这应该会提高患者满意度。

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