FDA批准Xarelto用于降低髋、膝关节置换后的血凝风险

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FDA NEWS RELEASE

FDA新闻发布

For Immediate Release:July 5, 2011

及时发布：2011-07-05
Media Inquiries:Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

媒体咨询处：Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

消费者咨询处： 888-INFO-FDA

FDA approves Xarelto to reduce risk of blood clots after hip, knee replacements

FDA批准Xarelto用于降低髋、膝关节置换后的血凝风险。

On July 1, the U.S. Food and Drug Administration approved Xarelto (rivaroxaban) to reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee or hip replacement surgery.

于7月1日，FDA批准了Xarelto (rivaroxaban) 用于降低深静脉血栓（DVT）和肺栓塞（PE）以及髋、膝关节置换后的血凝风险。

Xarelto is a pill taken once daily. Those undergoing a knee replacement should take the medication for 12 days and patients undergoing a hip replacement procedure should take Xarelto for 35 days.

Xarelto 每日一次给药。膝关节置换的患者应给药12天，髋关节置换的应给药35天。

The safety and effectiveness of Xarelto was evaluated in patients undergoing hip replacement surgery and patients undergoing knee replacement surgery. Clinical studies were designed to identify occurrence of venous thromboembolic events (VTE), DVT, PE or death in patients treated. Treatment with Xarelto was compared to treatment with enoxaparin, a drug that prevents DVTs or blood clotting.

Xarelto已对经髋关节和膝关节手术后患者进行安全性和有效性的评价。临床试验设计为确认治疗的患者发生静脉血栓栓塞（VTE）、DVT、PE或者死亡。Xarelto进行治疗时，与一种仿制DVTs或凝血的药物依诺肝素进行对比。

“Xarelto represents a new oral treatment option to help prevent blood clotting in patients receiving a hip or knee replacement,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. Xarelto was reviewed by the Division of Hematology Products within the Office of Oncology Drug Products.

“Xarelto是一种新型的口服治疗凝血药物，是接受髋或膝关节置换的患者防止凝血发生的新选择。”FDA药物评价研究中心肿瘤药物办公室的负责人Richard Pazdur, M.D.如是说。Xarelto是在血液药品部的肿瘤药物办公室进行审查的。

More than 6,000 patients undergoing hip or knee replacement surgery received Xarelto in clinical studies. Among patients undergoing knee replacement surgery, 9.7 percent of those treated with Xarelto had VTE compared with 18.8 percent of patients who received enoxaparin. In a study involving hip replacement surgery, 1.1 percent of patients who received Xarelto had VTE compared with 3.9 percent of those who received enoxaparin. In another study of hip replacement patients, 2.0 percent of those treated with Xarelto had VTE compared with 8.4 percent of those who received enoxaparin.

行经髋或膝关节置换手术的6 000多患者接受Xarelto进行临床试验。在行经膝关节置换术的患者中，用Xarelto治疗的患者有9.7%出现VTE，而用依诺肝素为18.8%。在一项髋关节置换术研究中，接受Xarelto治疗的患者有1.1%出现VTE，而用依诺肝素为3.9%。再另一项髋关节置换术研究中，接受Xarelto治疗的患者有2.0%出现VTE，而用依诺肝素为8.4%。

The most common side effect observed in patients treated with Xarelto was bleeding.

接受Xarelto治疗的患者最常见的不良反应为出血。

Other FDA approved drugs to prevent blood clotting include Lovenox (enoxaparin), generic versions of enoxaparin, Arixtra (fondaparinux), Fragmin (dalteparin) for hip replacement surgery only, Coumadin (warfarin) and heparin.

FDA批准的用于质量凝血的其他药物有Lovenox (依诺肝素)、通用名类的依诺肝素、Arixtra (磺达肝癸钠)、Fragmin (达肝素钠) 仅用于髋关节置换术、Coumadin (华法林) 和肝素。

Xarelto is marketed in the U.S. by Raritan, N.J.- based Janssen Pharmaceuticals, Inc., a member of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Xarelto由Raritan, N.J.- based Janssen Pharmaceuticals, Inc.公司上市销售，是Janssen Pharmaceutical Companies of Johnson & Johnson.的一个成员公司。

For more information:

更多信息：

FDA: Office of Oncology Drug Products1

FDA：肿瘤药物办公室

FDA: Approved Drugs: Questions and Answers2

FDA：批准药物：答疑

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA是美国卫生与公共服务部内设的一个机构，通过确保人和兽用药、人用疫苗和其他生物制品以及医疗器械的安全性、有效性，从而保障公众健康。该机构也负责国内食品供应、化妆品、食品补充剂、电子辐射产品和规范的烟草制品的安全。