By Yael Waknine
Medscape Medical News

April 6, 2010 — The US Food and Drug Administration (FDA) has approved the first absorbable fibrin sealant patch for use in cardiovascular surgery (TachoSil, Nycomed Austria GmbH) to prevent mild and moderate bleeding from small blood vessels when standard surgical techniques are ineffective or impractical.

The ready-to-use biodegradable product consists of a sponge made from equine tendons and coated with a dry layer of the human coagulation factors fibrinogen and thrombin. When applied to a wound, the patch mimics the final steps of the natural blood clotting process, creating a hemostatic fibrin clot within 3 to 5 minutes that dissolves within 4 to 6 months.

FDA's action was based on data from a study (n = 119) showing that use of the fibrin sealant patch was significantly more effective than standard hemostatic fleece for achieving hemostasis in cardiovascular surgery patients with persistent hemorrhage (74.6% vs 33.3%).

"This approval provides an additional tool for surgeons to help control mild and moderate bleeding from blood vessels during cardiovascular surgery when standard surgical techniques are ineffective or impractical," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research, in an agency news release.

Although adverse events reported in the study did not differ significantly between treatment groups, allergic type hypersensitivity reactions may occur if the fibrin sealant patch is applied repeatedly or used in patients with known hypersensitivity to its components. Thromboembolic complications are also possible with intravascular application.

Because the fibrin sealant patch is derived from human and equine products, the potential for transmission of infective agents cannot be totally excluded despite screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps to inactivate/remove viruses.

作者:Yael Waknine


  【24drs.com】2010 — 美國食品藥物管理局(FDA)核准第一個可吸收之纖維素封劑貼片(商品名TachoSil,Nycomed Austria GmbH公司)用於心血管手術,以預防標準手術技術無效或無法使用時的輕微到中度出血。
  FDA的核准是根據一篇有119名研究對象的研究資料,該研究顯示,持續出血之心血管手術病患使用纖維素封劑貼片,比標準止血織物更有效達到止血(74.6% vs 33.3%)。
  FDA生物製劑評估與研究中心行動主任Karen Midthun醫師在該局的新聞稿中表示,這個核准提供一個新工具給外科醫師,當進行心血管手術而標準手術技術無效或無法使用時,可幫助控制輕微到中度的血管出血。











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