Clark R A
Department of Dermatology, SUNY at Stony Brook, Stony Brook, New York 11795-8165, USA.
Expert Opin Investig Drugs. 2000 Oct;9(10):2371-92. doi: 10.1517/13543784.9.10.2371.
Fibrin sealants have recently been approved for clinical use in the US by the FDA and have been available for clinical use in Europe for years. The indication for use in the US is haemostasis. Nevertheless, both commercial and non-commercial fibrin sealant preparations are also for wound healing and for prevention of abdominal adhesions in the US and Europe. To the non-cognoscenti of fibrin sealants, their use to promote wound repair and to prevent abdominal adhesions appears contradictory since an agent that promotes connective tissue repair might be expected to promote abdominal adhesion rather than prevent them. In this systematic survey of the animal and clinical data evidence is presented that supports both off-label uses. However there is much inconsistency in the data secondary to the use of various fibrin sealant preparations, different animal models and clinical situations and different application techniques. It is clear from this survey that standard preparation and application of fibrin sealant for a particular surgical setting are needed to resolve the many apparent discrepancies in the literature. A corollary to this is the likelihood that different fibrin sealant preparations may be preferred for different clinical situations.
纤维蛋白密封剂最近已获美国食品药品监督管理局(FDA)批准在美国临床使用,并且在欧洲可供临床使用已有数年。在美国,其使用指征是止血。然而,在美国和欧洲,商业和非商业纤维蛋白密封剂制剂也用于伤口愈合和预防腹腔粘连。对于不了解纤维蛋白密封剂的人来说,其用于促进伤口修复和预防腹腔粘连似乎相互矛盾,因为一种促进结缔组织修复的制剂可能会促进而不是预防腹腔粘连。在这项对动物和临床数据的系统调查中,提供了支持这两种非标签用途的证据。然而,由于使用了各种纤维蛋白密封剂制剂、不同的动物模型和临床情况以及不同的应用技术,数据存在很多不一致之处。从这项调查中可以清楚地看出,需要针对特定手术环境对纤维蛋白密封剂进行标准制备和应用,以解决文献中许多明显的差异。由此推断,不同的临床情况可能更倾向于使用不同的纤维蛋白密封剂制剂。