Division of Plastic Surgery, University of California, San Diego, 200 West Arbor Drive, San Diego, CA 92103, USA.
Aesthetic Plast Surg. 2010 Jun;34(3):264-72. doi: 10.1007/s00266-009-9413-1. Epub 2009 Sep 29.
After more than 25 years of research and development, in October 2006 ArteFill became the first and only permanent injectable wrinkle filler to receive FDA approval. ArteFill is a third-generation polymeric microsphere-based filler, following its predecessor Artecoll, which was marketed outside the United States between 1994 and 2006. ArteFill is approved for the correction of nasolabial folds and has been used in over 15,000 patients since its U.S. market introduction in February 2007. No serious side effects have been reported to date according to the FDA's MAUDE reporting database. ArteFill consists of polymethylmethacrylate (PMMA) microspheres (20% by volume), 30-50 microm in diameter, suspended in 3.5% bovine collagen solution (80% by volume) and 0.3% lidocaine. The collagen carrier is absorbed within 1 month after injection and completely replaced by the patient's own connective tissue within 3 months. Each cc of ArteFill contains approximately six million microspheres and histological studies have shown that long-term wrinkle correction consists of 80% of the patient's own connective tissue and 20% microspheres. The standard injection technique is subdermal tunneling that delivers a strand of ArteFill at the dermal-subdermal junction. This strand beneath a wrinkle or fold acts like a support structure that protects against further wrinkling and allows the diminished thickness of the dermis to recover to its original thickness.
经过 25 年多的研究和开发，2006 年 10 月，ArteFill 成为第一个也是唯一一个获得 FDA 批准的永久性可注射皱纹填充剂。ArteFill 是一种第三代基于聚合物微球的填充剂，继其前身 Artecoll 之后，Artecoll 于 1994 年至 2006 年在美国以外的市场销售。ArteFill 被批准用于矫正鼻唇沟，自 2007 年 2 月在美国市场推出以来，已在超过 15000 名患者中使用。根据 FDA 的 MAUDE 报告数据库，迄今为止尚未报告严重的副作用。ArteFill 由聚甲基丙烯酸甲酯（PMMA）微球（体积的 20%）组成，直径为 30-50 微米，悬浮在 3.5%牛胶原蛋白溶液（体积的 80%）和 0.3%利多卡因中。胶原载体在注射后 1 个月内被吸收，在 3 个月内被患者自身的结缔组织完全取代。每 cc 的 ArteFill 含有大约六百万个微球，组织学研究表明，长期皱纹矫正由 80%的患者自身结缔组织和 20%的微球组成。标准的注射技术是皮下隧道注射，将一条 ArteFill 输送到真皮-皮下交界处。这条皱纹或褶皱下的线就像一个支撑结构，防止进一步的皱纹，并允许变薄的真皮恢复到原来的厚度。
