2007年11月5日星期一
Study Shows Plasma Derived Human Thrombin Equivalent To Bovine Thrombin In Achieving Hemostasis In Surgery
Study Shows Plasma Derived Human Thrombin Equivalent To Bovine Thrombin In Achieving Hemostasis In SurgeryA randomized study comparing treatment with plasma-derived human thrombin and thrombin derived from bovine sources shows that human thrombin is as effective as bovine thrombin in achieving hemostasis in patients at three-, six- and 10-minute intervals. The study of 305 patients with mild or moderate bleeding during elective cardiovascular, neurological or general surgical procedures also showed that human thrombin was less likely to result in an immune response in patients as compared to bovine thrombin. Study results were presented Friday at the Society for the Advancement of Blood Management meeting in Los Angeles. The study was supported by ETHICON, Inc.In the study, the proportion of patients achieving hemostasis at 10 minutes (primary outcome) was 97.4% following treatment with human thrombin and also following treatment with bovine-derived thrombin. The percentages of patients achieving hemostasis at six minutes and three minutes were also equivalent. There were no statistically significant differences in several other variables including laboratory assessments, vital signs, blood loss, blood transfusions, time in specialty-care unit, procedure duration, and length of hospital stay.On August 27, the U.S. FDA approved EVITHROM Thrombin, Topical (Human) for use in cardiovascular, neurological and general surgery. EVITHROM was developed in collaboration with OMRIX Biopharmaceuticals, Inc. ETHICON plans to make the product commercially available in the United States in Q4 2007."With EVITHROM, the first plasma-derived human thrombin, surgeons have a new option for hemostasis that is as effective as bovine-derived thrombin but that also reduces the risks of antibody formation associated with the use of thrombin derived from bovine sources," said Cataldo Doria, M.D., Thomas Jefferson University Hospital. Dr. Doria was lead author of the study.According to the study results, plasma-derived human thrombin and bovine thrombin have similar adverse event profiles. However, more patients who received bovine thrombin demonstrated seroconversion for at least one of the four antibodies assayed than did patients who received human thrombin (12.7% versus 3.3%, respectively).Results from a separate second study were also presented at the SABM meeting. This study compared the safety and effectiveness of EVICEL Fibrin Sealant (Human), which contains the same human thrombin as in EVITHROM, to manual compression (MC) in achieving hemostasis in vascular surgery. In the study, a higher percentage of patients who received EVICEL achieved hemostasis at four-, seven- and 10-minute time points than patients who received MC. In addition, a lower incidence of treatment failures was observed in the fibrin sealant group. The results of this study suggest that EVICEL is useful for achieving rapid hemostasis for indicated procedures while introducing no new safety concerns. EVICEL consists of human plasma-derived thrombin and fibrinogen and is currently the only aprotinin-free fibrin sealant commercially available in the U.S.EVITHROM and EVICEL are contraindicated in individuals known to have anaphylactic or severe systemic reaction to human blood products. As with all plasma-derived products, the risk of transmitting infectious agents cannot be completely eliminated. EVITHROM and EVICEL should not be injected directly into the circulatory system or used for the treatment of severe or brisk arterial bleeding. There is a potential risk of thrombosis if EVITHROM is absorbed systemically. About ETHICON, Inc.ETHICON, Inc., a Johnson & Johnson company, is a global medical device company that develops and markets surgical products for use in general surgery, wound management and women's health & urology. Johnson & Johnson Wound Management, a division of ETHICON, offers a complete portfolio of topical and advanced hemostatic products including SURGICEL Absorbable Hemostat, SURGIFOAM Absorbable Gelatin Sponge, EVICEL Fibrin Sealant (Human), and SURGIFLO Hemostatic Matrix with FlexTip. For more information about ETHICON.
Stay Lean, Active And Watch What You Eat To Avoid Cancer, New Report
Stay Lean, Active And Watch What You Eat To Avoid Cancer, New ReportA report issued by an international panel of experts says that the best way to significantly reduce the risk of getting cancer is to be lean, exercise vigorously every day, avoid fast food, eat less red meat, and avoid preserved meat such as ham and bacon, eat more plant-based foods and cut down on alcohol.The panel said that diet and lack of exercise cause one third of all cancers which could be prevented by changes in lifestyle. However, the overriding message from the detailed 537-page report titled "Food, Nutrition, Physical Activity, and the Prevention of Cancer", issued by the World Cancer Research Fund, is the strong link between obesity and cancer risk.Sir Michael Marmot, who is professor of epidemiology and public health at University College London, chaired the expert panel that reviewed 7,000 papers on the causes of cancer and consulted 200 experts worldwide. He said "the most striking thing to emerge from the report is the importance of overweight and obesity".Another panel member who chairs the International Obesity Task Force based in the UK, Dr W Philip T James, said the report had one message that was "as clear as a bell". The link between cancer and obesity is "so robust, it is going to rank close to the smoking problem in America pretty soon".The panel comprised 21 internationally renowned experts in cancer, epidemiology, obesity, nutrition, and public health, backed by teams of observers.However, the message does not stop with obesity. Every extra pound brings greater cancer risk says the report. Even if you are in the normal range of weight for your height, there is a significant difference between being in the lower weight region and being in the higher weight region.In terms of BMI (Body Mass Index), the panel recommends people stay within 18.5 and 25, which is the lower part of the "healthy" zone. BMI is a measure of obesity that divides the person's weight in kilograms by the square of the height in metres. Thus a person who weighs 150 pounds (68 kilograms) and stand 5 feet 9 inches tall (1.8 metres) has a BMI of 22.1, which is in the lower half of the healthy zone, as recommended by the panel.Too much body fat is a risk factor for oesophagal, pancreatic, endometrial, bowel, kidney and post-menopausal breast cancers said the report. And excess abdominal fat also increases risk of bowel cancer.The panel concluded that people should stay lean throughout their lives, young people should avoid piling on the pounds and stay slim. One panel member said he was "shocked" when he realised this.
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