DeLustro F, Dasch J, Keefe J, Ellingsworth L
Collagen Corporation, Palo Alto, California 94303.
Clin Orthop Relat Res. 1990 Nov(260):263-79.
Whereas xenogeneic collagen has provided a safe and effective biomaterial for numerous medical applications, there are few instances in which data permit the correlation of the immunologic profile of well-defined devices with their clinical sequelae. A major exception is the use of injectable bovine dermal collagen for soft-tissue contour correction. The low incidence of hypersensitivity has been studied in the context of clinical efficacy and safety with several devices. The findings indicate that such immunity usually results in the manifestation of local symptoms of dermal inflammation at sites of treatment that resolve as the implant is resorbed by the host. In contrast, more immunogenic hemostatic agents may elicit a more frequent or vigorous immune response that is not clinically visible or relevant in that application. Recent experiences with collagen-based devices for the repair and regeneration of bone have also demonstrated that the presence of immunity to their collagenous or non-collagenous components does not necessarily predict adverse clinical sequelae. Indeed, numerous specific data indicate that this immunity can exist as an epiphenomenon with no effect on osteogenesis. To get a true composite picture of biocompatibility, significant steps must be taken to characterize biomaterials properly and to ensure that immunologic, clinical, histologic, and other pertinent laboratory data are viewed in relation to one another and not in isolation.
虽然异种胶原蛋白已为众多医学应用提供了一种安全有效的生物材料，但很少有实例能让明确界定的器械的免疫学特征与其临床后遗症相互关联。一个主要的例外是可注射牛真皮胶原蛋白用于软组织轮廓矫正。已经在几种器械的临床疗效和安全性背景下研究了低过敏发生率。研究结果表明，这种免疫反应通常会在治疗部位表现为皮肤炎症的局部症状，随着植入物被宿主吸收，这些症状会逐渐消失。相比之下，免疫原性更强的止血剂可能会引发更频繁或更强烈的免疫反应，而在该应用中这种反应在临床上并不明显或无关紧要。最近使用基于胶原蛋白的器械进行骨修复和再生的经验也表明，对其胶原或非胶原成分产生免疫反应并不一定预示着不良临床后遗症。事实上，大量具体数据表明，这种免疫反应可能只是一种附带现象，对骨生成没有影响。为了全面了解生物相容性，必须采取重大措施对生物材料进行恰当表征，并确保将免疫学、临床、组织学和其他相关实验室数据相互关联起来看待，而不是孤立地看待。
