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【商业翻译】医师报约稿：FDA Approves Expanded Use
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http://www.dxy.cn/bbs/post/view?bid=116&id=8600034&sty=1&tpg=1&age=0
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FDA Approves Expanded Use for Surgical Sealant
FDA Approves Expanded Use for Surgical Sealant
The U.S. Food and Drug Administration (FDA) today approved Evicel Fibrin Sealant, a liquid product that when applied topically helps control oozing from small blood vessels during surgical procedures.
"Evicel provides an effective means to stop oozing from small vessels during vascular surgery when suturing, compression or other standard techniques are not effective or practical," said Jesse Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.
This product is derived from pooled human plasma and consists of a fibrinogen concentrate and thrombin, two substances used to promote clotting. Both substances go through a two-stage process to reduce the risk of viral transmission in manufacturing, however, the potential risk for the transmission of blood-borne viruses cannot be totally eliminated.
In a pivotal study of 147 patients, the effectiveness of Evicel was compared with the standard bleeding control technique of applying pressure to a plastic covering (graft) placed over the open blood vessel. Eighty-three percent of those who received Evicel stopped bleeding within four minutes, compared with 39.7 percent in the control group.
Adverse events, such as anemia and graft site infection, were generally mild and occurred at about the same frequencies in the Evicel-treated group and the control group.
FDA originally licensed the predecessor of Evicel (Crosseal) in 2003 for use during liver surgery. Evicel is manufactured by OMRIX biopharmaceuticals LTD, Kiryat Ono, Israel. 本人认领此文. 如在24小时内未能提交译文, 其他战友自由认领. FDA Approves Expanded Use for Surgical Sealant
FDA批准推广使用外科密封剂
The U.S. Food and Drug Administration (FDA) today approved Evicel Fibrin Sealant, a liquid product that when applied topically helps control oozing from small blood vessels during surgical procedures.
美国食品与药品管理局 (FDA)今日批准了Evicel（商名品；通用名：Hexobarbital [海索比妥]）纤蛋白粘合剂，它是一种液态产品，局部应用以便控制术中小血管渗血。
"Evicel provides an effective means to stop oozing from small vessels during vascular surgery when suturing, compression or other standard techniques are not effective or practical,"
said Jesse Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. “当缝合、压迫或其它标准技术无效或不可行时，Evicel为阻止血管外科手术期间细小血管的渗血提供了一种有效方法，”FDA生物制品评价与研究中心主任Jesse Goodman医学博士兼公共卫生学硕士（M.P.H.）称。
This product is derived from pooled human plasma and consists of a fibrinogen concentrate and thrombin, two substances used to promote clotting. Both substances go through a two-stage process to reduce the risk of viral transmission in manufacturing, however, the potential risk for the transmission of blood-borne viruses cannot be totally eliminated.
该产品源自混合的人血浆，并由两种用于促进凝血的物质——浓缩的纤维蛋白原和凝血酶组成。这两种物质都通过了旨在减少生产过程病毒传播风险的两期程序，然而，血源性病毒传播的潜在风险不能被彻底消除。
In a pivotal study of 147 patients, the effectiveness of Evicel was compared with the standard bleeding control technique of applying pressure to a plastic covering (graft) placed over the open blood vessel. Eighty-three percent of those who received Evicel stopped bleeding within four minutes, compared with 39.7 percent in the control group.
在一项涉及147名患者的关键研究中，研究人员比较了Evicel纤蛋白粘合剂与标准控制出血技术即压迫置于开放性血管的塑性覆膜（移植物？）的有效性。使用了Evicel粘合剂患者的4分钟止血率高达83％，而对照组则为39.7％。
Adverse events, such as anemia and graft site infection, were generally mild and occurred at about the same frequencies in the Evicel-treated group and the control group.
其副作用如贫血及移植部位感染通常较轻，在治疗组和对照组中发生率大致相同。
FDA originally licensed the predecessor of Evicel (Crosseal) in 2003 for use during liver surgery. Evicel is manufactured by OMRIX biopharmaceuticals LTD, Kiryat Ono, Israel.
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作者:admin@医学,生命科学 2011-05-06 05:11
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