Lemperle Gottfried, Morhenn Vera, Charrier Ulrich
Division of Plastic Surgery, University of California, San Diego, CA, USA.
Aesthetic Plast Surg. 2003 Sep-Oct;27(5):354-66; discussion 367. doi: 10.1007/s00266-003-3022-1. Epub 2003 Dec 4.
An increasing number of soft tissue filler substances have been introduced to the beauty market outside the U.S. which lack experimental and clinical data in support of their claim. Ten commercially available filler substances were examined for biocompatibility and durability: 0.1 cc of each substance was injected deep intradermally into the volar forearm of one of the authors and observed for clinical reaction and permanence. At 1, 3, 6, and 9 months the test sites were excised, histologically examined, and graded according to foreign body reactions classification. Collagen (Zyplast) was phagocytosed at 6 months and hyaluronic acid (Restylane) at 9 months. PMMA microspheres (Artecoll) had encapsulated with connective tissue, macrophages, and sporadic giant cells. Silicone oil (PMS 350) was clinically inconspicuous but dissipated into the tissue, causing a chronic foreign body reaction. Polylactic acid microspheres (New-Fill) induced a mild inflammatory response and had disappeared clinically at 4 months. Dextran microspheres (Reviderm intra) induced a pronounced foreign body reaction and had disappeared at 6 months. Polymethylacrylate particles (Dermalive) induced the lowest cellular reaction but had disappeared clinically at 6 months. Polyacrylamide (Aquamid) was well tolerated and remained palpable to a lessening degree over the entire testing period. Histologically, it dissipated more slowly and was kept in place through fine fibrous capsules. Polyvinylhydroxide microspheres suspended in acrylamide (Evolution) were well tolerated, slowly diminishing over 9 months. Calcium hydroxylapatite microspheres (Radiance FN) induced almost no foreign body reaction but were absorbed by the skin at 12 months. Host defense mechanisms react differently to the various filler materials, but all substances-resorbable or nonresorbable-appeared to be clinically and histologically safe, although all exhibit undesirable side effects. Since the mechanism of late inflammation or granuloma formation is still unknown, early histological findings are not useful in predicting possible late reactions to filler substances.
越来越多的软组织填充物质被引入美国以外的美容市场，这些产品缺乏实验和临床数据来支持其宣称的效果。对十种市售填充物质进行了生物相容性和持久性检测：将每种物质0.1立方厘米皮内深层注射到其中一位作者的掌侧前臂，观察临床反应和持久性。在1、3、6和9个月时，切除测试部位，进行组织学检查，并根据异物反应分类进行分级。胶原蛋白（Zyplast）在6个月时被吞噬，透明质酸（Restylane）在9个月时被吞噬。聚甲基丙烯酸甲酯微球（Artecoll）被结缔组织、巨噬细胞和散在的巨细胞包裹。硅油（PMS 350）在临床上不明显，但扩散到组织中，引起慢性异物反应。聚乳酸微球（New-Fill）引发轻度炎症反应，在4个月时临床消失。葡聚糖微球（Reviderm intra）引发明显的异物反应，在6个月时消失。聚甲基丙烯酸甲酯颗粒（Dermalive）引发的细胞反应最低，但在6个月时临床消失。聚丙烯酰胺（Aquamid）耐受性良好，在整个测试期间触感逐渐减轻。组织学上，它消散得更慢，并通过细纤维囊固定在原位。悬浮在丙烯酰胺中的聚乙烯醇微球（Evolution）耐受性良好，在9个月内缓慢减少。羟基磷灰石钙微球（Radiance FN）几乎不引发异物反应，但在12个月时被皮肤吸收。宿主防御机制对各种填充材料的反应不同，但所有物质——可吸收或不可吸收的——在临床和组织学上似乎都是安全的，尽管都表现出不良副作用。由于晚期炎症或肉芽肿形成的机制仍然未知，早期组织学发现对于预测填充物质可能的晚期反应并无用处。
