Fibrin sealant: current and potential clinical applications.
Fibrin sealant: current and potential clinical applications.
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纤维蛋白密封剂：当前和潜在的临床应用。
DOI：
10.1097/00001721-199611000-00001
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发表时间：
1996
期刊：
影响因子：
--
通讯作者：
B. Alving
中科院分区：
文献类型：
--
作者：
Mark R. Jackson;M. Macphee;W. Drohan;B. Alving
很少有关于纤维蛋白密封胶临床疗效的良好对照研究，其定义是挽救生命或减少输血需求。评估纤维蛋白密封剂在创伤情况下，如肝撕裂，一直是困难的。直到最近，纤维蛋白密封胶才被美国制造商积极推广为一种有商业价值的替代品，以取代目前使用的相对便宜的粗牛凝血酶和低温沉淀。监管机构和制造商意识到，在美国，患者接受的是一种次优形式的纤维蛋白胶，因为冷沉淀没有病毒灭活，并且纤维蛋白原浓度可变。此外，牛凝血酶不受因子V含量或任何其他杂质的调节。在过去的一年中，监管机构与制造商和临床医生一起，开始定义商业化制备的纤维蛋白密封胶疗效的临床有效终点。这些可能包括与安慰剂或被认为是“标准护理”的药物相比，止血的改善。因此，监管机构可能愿意考虑在动物身上进行证明疗效的研究，以及替代终点，例如需要拔牙的严重血友病患者降低因子浓缩物需求。随着纤维蛋白密封胶以液体形式和潜在的绷带形式出现，它也可能成为影响内皮功能的重组因子的必要基质。
There are few well-controlled studies of the clinical efficacy of fibrin sealant, defined by lives saved or reduced need for blood transfusions. Evaluation of fibrin sealant in trauma situations, e.g. liver laceration, has been difficult to perform. Only recently has fibrin sealant been actively promoted by US manufacturers as a commercially valuable alternative to the relatively inexpensive crude bovine thrombin and cryoprecipitate that are in current use. Regulatory agencies and manufacturers are aware that patients in the USA are receiving a suboptimal form of fibrin glue since cryoprecipitate is not virally inactivated and has a variable fibrinogen concentration. In addition, bovine thrombin is not regulated with respect to factor V content or any other impurities. During the past year regulatory agencies, together with manufacturers and clinicians, have begun to define clinically valid endpoints for efficacy of a commercially prepared fibrin sealant. These may include improvement in hemostasis compared with a placebo or agents considered to be 'standard of care'. Thus, the regulatory agencies may be willing to consider studies in animals that demonstrate efficacy as well as surrogate endpoints, such as reduced factor concentrate requirements in patients with severe hemophilia requiring dental extraction. As fibrin sealant becomes available in a liquid and potentially in a bandage form, it may also become an essential matrix for recombinant factors that can affect endothelial function.