Evaluation of Artecoll Polymethylmethacrylate Implant for Soft‐Tissue Augmentation: Biocompatibility and Chemical Characterization
Evaluation of Artecoll Polymethylmethacrylate Implant for Soft‐Tissue Augmentation: Biocompatibility and Chemical Characterization
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Artecoll 聚甲基丙烯酸甲酯软组织增强植入物的评估：生物相容性和化学表征
DOI：
10.1097/00006534-199711000-00014
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发表时间：
1997
影响因子：
3.6
通讯作者：
F. Delustro
中科院分区：
文献类型：
--
作者：
Marcee McClelland;B. Egbert;V. Hanko;R. Berg;F. Delustro
&NA;Artecoll聚甲基丙烯酸甲酯植入物（Artecoll）是悬浮在3.5%去端胶原中的聚甲基丙烯酸甲酯珠粒的组合，设计用于软组织填充应用。评价了Artecoll的生物相容性和免疫原性，以评估该产品用于真皮的安全性。为了表征胶原成分，进行化学分析，包括胰蛋白酶敏感性、差示扫描量热法和胃蛋白酶含量。还对聚甲基丙烯酸甲酯珠粒进行粒度分析。在致敏和非致敏豚鼠皮内模型中测定了该材料引发免疫应答的能力。在这些研究中，24只豚鼠皮内注射Artecoll或Zyderm（一种用于软组织填充的牛胶原蛋白产品）。在注射后3、7和28天，对每种材料的6个部位进行评价。在致敏模型中，将60只豚鼠分为5组，每组接受致敏剂量（与弗氏佐剂结合）的Zyderm、Artecoll或非致敏剂量的相同材料。第五组作为非治疗对照组。动物致敏后，皮内注射各种抗原进行攻击，以评估迟发型超敏反应。化学表征表明聚甲基丙烯酸甲酯珠粒大小不同，包括许多小于35微米的珠粒，以及广泛变性和不纯胶原的载体。体内评价表明，Artecoll在豚鼠中引起免疫应答，包括迟发型超敏反应和抗体反应。组织学评估表明颗粒吞噬作用和经皮消除。用Artecoll免疫后，还发现豚鼠对胃蛋白酶（胶原载体中的一种杂质）过敏。将该材料的生物相容性与牛真皮胶原（Zyderm胶原植入物）进行了比较，后者被广泛使用并被认为具有生物相容性。该评价结果表明，Artecoll聚甲基丙烯酸甲酯植入物有可能在人体中引发免疫应答，聚甲基丙烯酸甲酯珠粒易被吞噬和消除。（Plast。重建100：1466，1997）。
&NA; Artecoll polymethylmethacrylate implant (Artecoll) is a combination of polymethylmethacrylate beads suspended in 3.5% atelocollagen and has been designed for use in soft‐tissue augmentation applications. The biocompatibility and immunogenicity of Artecoll were evaluated to assess the safety of this product for use in the dermis. To characterize the collagen component, chemical analysis was performed including trypsin sensitivity, differential scanning calorimetry, and pepsin content. Particle size analysis was also performed on the polymethylmethacrylate beads. The ability of this material to elicit an immunologic response was measured in a sensitized and nonsensitized guinea pig intradermal model. In these studies, 24 guinea pigs were injected intradermally with either Artecoll or Zyderm, a bovine collagen product for softtissue augmentation. Six sites were evaluated for each material at 3, 7, and 28 days after injection. In the sensitized model, 60 guinea pigs were divided into five groups, and each group received a sensitizing dose (in conjunction with Freund's adjuvant) of Zyderm, Artecoll, or a nonsensitizing dose of the same materials. The fifth group served as a nontreatment control. After the animals were sensitized, they were challenged with intradermal injections of various antigens to evaluate delayed type hypersensitivity reactions. Chemical characterization indicated polymethylmethacrylate beads of varying sizes, including many less than 35 microns, and a vehicle of extensively denatured and impure collagen. In vivo evaluations indicated that Artecoll elicited an immune response in guinea pigs, including delayed type hypersensitivity and antibody reactions. Histological assessment demonstrated particle phagocytosis and transepidermal elimination. Following immunization with Artecoll, guinea pigs were also found to be sensitized to pepsin, an impurity found in the collagen carrier. The biocompatibility of this material was compared with that of bovine dermal collagen (Zyderm collagen implant), which is widely used and accepted as biocompatible. The results of this evaluation indicate that Artecoll polymethylmethacrylate implant has the potential to elicit an immune response in humans, and polymethylmethacrylate beads are susceptible to phagocytosis and elimination. (Plast. Reconstr. Surg. 100: 1466, 1997.)