Spotnitz W D, Mintz P D, Avery N, Bithell T C, Kaul S, Nolan S P
Am Surg. 1987 Aug;53(8):460-2.
European surgeons have used fibrin glue extensively during thoracic, cardiovascular, and general surgical operations. Until now, however, it has been available only as a commercial preparation made from pooled human plasma, and it has not been approved by the U.S. Food and Drug Administration for use in the United States because of a high associated risk of hepatitis and acquired immune deficiency syndrome. Methods of obtaining fibrinogen, an essential component of fibrin glue, from cryoprecipitate or fresh frozen plasma have been published recently. However, the cryoprecipitate method results in relatively low concentrations of fibrinogen, which can reduce glue effectiveness. The fresh frozen plasma method is more expensive and does not meet the standards of the American Association of Blood Banks for the "closed" system required for safe handling and management of blood component products. Both the cryoprecipitate and the fresh frozen plasma methods result in waste of unstable clotting factors. These factors are necessary to replace human plasma clotting deficiencies but are not necessary for the production of fibrin glue. The authors have developed an efficient, high-concentration blood bank method for producing and maintaining a local supply of a safer and less expensive but equally effective material derived from stored human plasma. This material is produced using approved blood bank techniques for a "closed" system in blood component production, thus reducing the risks of contamination and infection, and its fibrinogen concentration is higher than that of standard cryoprecipitate. The cost of 1 unit of this fibrin glue is comparable to that for 1 unit of cryoprecipitate and less than that for 1 unit of fresh frozen plasma.(ABSTRACT TRUNCATED AT 250 WORDS)
欧洲外科医生在胸科、心血管和普通外科手术中广泛使用纤维蛋白胶。然而,到目前为止,它仅作为一种由混合人血浆制成的商业制剂提供,并且由于与肝炎和获得性免疫缺陷综合征相关的高风险,尚未获得美国食品药品监督管理局批准在美国使用。最近已发表了从冷沉淀或新鲜冷冻血浆中获取纤维蛋白原(纤维蛋白胶的一种必需成分)的方法。然而,冷沉淀法产生的纤维蛋白原浓度相对较低,这可能会降低胶水的有效性。新鲜冷冻血浆法成本更高,并且不符合美国血库协会对血液成分产品安全处理和管理所需“封闭”系统的标准。冷沉淀法和新鲜冷冻血浆法都会导致不稳定凝血因子的浪费。这些因子对于替代人体血浆凝血缺陷是必要的,但对于纤维蛋白胶的生产并非必要。作者开发了一种高效、高浓度的血库方法,用于生产和维持当地供应一种更安全、成本更低但同样有效的源自储存人血浆的材料。这种材料是使用血液成分生产中“封闭”系统的批准血库技术生产的,从而降低了污染和感染风险,并且其纤维蛋白原浓度高于标准冷沉淀。这种纤维蛋白胶1单位的成本与1单位冷沉淀相当,且低于1单位新鲜冷冻血浆。(摘要截短为250字)