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 | Translate: 翻译：               FDA Approved Human Medical Experiments with Artificial Blood; Hundreds Died FDA批准人类医学实验用人工血液;数百人丧生 Tuesday, September 30th, 2008 星期二， 2008年9月三十零日 By通过 David Gutierrez大卫古铁雷斯 | The FDA allowed tests to proceed on new varieties of artificial blood even though it should have been aware that the products drastically increased patients’ risk of heart attacks and death, according to a review conducted by the National Institutes of Health and Public Citizen, and published in the Journal of the American Medical Association . |美国食品和药物管理局允许试验着手对新品种的人工血液即使它本来应该认识到，产品急剧增加病人的风险，心脏病发作和死亡，根据审查进行的美国国立卫生研究院和公民，并发表在美国医学协会。 “It’s hard to understand,” lead researcher Charles Natanson said. “这是不难理解， ”首席研究员查尔斯Natanson说。 “They already had data that these products could cause heart attacks and evidence that they could kill.” “他们已经有数据，这些产品可能会导致心脏病和证据表明，他们可能会扼杀。 ” At question are new kinds of artificial blood that do not require refrigeration.目前的问题是新类型的人造血液，不需要冷藏。 No such products are approved for use in the United States, although at least one variety has been approved in South Africa.没有这样的产品批准用于在美国，但至少有一个品种已批准在南非。 Using FDA data acquired as part of a利用获得的数据林业局的一部份 Public Citizen公民 lawsuit, the researchers conducted a meta-analysis of 16 studies involving a total of 3,711 patients and five kinds of artificial blood.诉讼中，研究人员进行了一项荟萃分析研究16份，涉及3711病人和五种人工血液。 They found that the blood substitutes raised patients’ risk of death by 30 percent.他们发现，血液代用品提高患者的死亡风险百分之三十。 While一会儿 the FDA美国食品和药物管理局 should have known of this risk as early as 2000, it has approved five studies since then and is considering another.应该知道这个风险，早在2000年，它已批准了五个研究，自那时起，并正在考虑另一种。 In one of those trials alone, 11 of the 714 patients receiving the experimental blood substitute had在其中一个试验，仅11 714名患者接受实验的血液替代品 heart attacks心脏病发作 , and 47 died. ，和47人死亡。 “It didn’t matter what type of patient you studied,” Natanson said. “这并不重要何种类型的病人你研究” ， Natanson说。 “There was no one product that was responsible for this. “没有一个产品是负责这一点。 It was similar regardless of the patient population studied, the company that manufactured the product, whether the study was published or unpublished, or the chemical characteristics of the individual products.这是类似的，不论病人的人口研究，该公司生产的产品，无论是研究或未公开发表，或化学特征的个别产品。 The effect was robust.”效果是强大的。 “ But the FDA did not reveal this risk to doctors and hospitals that were considering participation in future studies, the researchers found.但是，美国并没有透露这方面的风险向医生和医院，正在考虑参加今后的研究中，研究人员发现。 “The risk appears to be a class risk. “风险似乎是一类风险。 It appears to be present for all products,” said William D. Hoffman, former chief medical officer for Biopure, one of the makers of the new artificial blood.这似乎是目前所有产品说， “威廉D霍夫曼，前首席医疗官的Biopure ，一个制造商的新的人造血液。 “They should all be on hold until they figure out what is causing the toxicity.” “他们都应该被搁置，直到他们找出是什么原因造成的毒性。 ” Sources for this story include:来源这个故事包括： www.washingtonpost.com . 。 Have Your Say: FDA Approved Human Medical Experiments with Artificial Blood; Hundreds Died 你说： FDA批准人类医学实验用人工血液;数百人丧生 Please read our请仔细阅读我们的 posting guidelines before posting张贴在发布前的指导方针 . 。 Alternatively或者 you can discuss this report here你可以讨论这份报告在这里 . 。 Related News 相关新闻
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