美国FDA批准OMRIX Biopharmaceuticals公司Evicel液状人纤维蛋白封闭剂[Liquid Fibrin Sealant (Human)]用于手术止血。本品是首个液状纤维蛋白封闭剂，是用于患者手术时采用常规手术止血技术无效时止血的辅助剂。 虽然纤维蛋白封闭剂在美国1999年就已上市，但其潜在作用仍有很大的开发空间。美国FDA此次批准Evicel用于手术时止血对其扩展市场具有重大意义。 本品是美国上市得唯一来源于全人血浆的液状纤维蛋白封闭剂。本品不含造成人体不良反应的抑肽酶，使用方便。Evicel以冻干液体销售，融化制备不需1分钟。配成的现用液体制剂置冰箱内可储存30日，这使本品具有显著的竞争性优点。 Evicel Fibrin Sealant Approved for Control of Surgical Bleeding Evicel™, a fibrin glue manufactured by OMRIX Biopharmaceuticals LTD, in Kiryat Ono, Israel, has received a new indication from the FDA for use for general hemostasis in surgery. The sealant, called Evicel, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications. “This approval provides a new option to help control bleeding during general surgery, when other approaches and techniques are ineffective or impractical,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research. Evicel contains fibrinogen and thrombin, two proteins involved in the production of fibrin. Fibrinogen and thrombin are found in human plasma, the liquid portion of blood. The plasma used to manufacture the product is collected from donors who have been screened and tested for blood-transmitted infections. The fibrinogen and thrombin also undergo a two-step process to further reduce the risk for the transmission of potentially contaminating bloodborne viruses. While the potential risk for infectious disease transmission is remote, it cannot be eliminated. A study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone, when the urinary bladder does not empty effectively, which can cause discomfort and infection. FDA approved Evicel’s predecessor (Crosseal) in 2003 for use during liver surgery. It became Evicel in May 2007 when FDA expanded the indication to include use during vascular surgery.