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 | Translate: 翻譯：               FDA Approved Human Medical Experiments with Artificial Blood; Hundreds Died FDA批准人類醫學實驗用人工血液;數百人喪生 Tuesday, September 30th, 2008 星期二， 2008年9月三十零日 By通過 David Gutierrez大衛古鐵雷斯 | 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 . |美國食品和藥物管理局允許試驗著手對新品種的人工血液即使它本來應該認識到，產品急劇增加病人的風險，心髒病發作和死亡，根據審查進行的美國國立衛生研究院和公民，並發表在美國醫學協會。 “It’s hard to understand,” lead researcher Charles Natanson said. “這是不難理解， ”首席研究員查爾斯Natanson說。 “They already had data that these products could cause heart attacks and evidence that they could kill.” “他們已經有數據，這些產品可能會導致心髒病和證據表明，他們可能會扼殺。 ” At question are new kinds of artificial blood that do not require refrigeration.目前的問題是新類型的人造血液，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.沒有這樣的產品批准用於在美國，但至少有一個品種已批准在南非。 Using FDA data acquired as part of a利用獲得的數據林業局的一部份 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.訴訟中，研究人員進行了一項薈萃分析研究16份，涉及3711病人和五種人工血液。 They found that the blood substitutes raised patients’ risk of death by 30 percent.他們發現，血液代用品提高患者的死亡風險百分之三十。 While一會兒 the FDA美國食品和藥物管理局 should have known of this risk as early as 2000, it has approved five studies since then and is considering another.應該知道這個風險，早在2000年，它已批准了五個研究，自那時起，並正在考慮另一種。 In one of those trials alone, 11 of the 714 patients receiving the experimental blood substitute had在其中一個試驗，僅11 714名患者接受實驗的血液替代品 heart attacks心髒病發作 , and 47 died. ，和47人死亡。 “It didn’t matter what type of patient you studied,” Natanson said. “這並不重要何種類型的病人你研究” ， Natanson說。 “There was no one product that was responsible for this. “沒有一個產品是負責這一點。 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of the patient population studied, the company that manufactured the product, whether the study was published or unpublished, or the chemical characteristics of the individual products.這是類似的，不論病人的人口研究，該公司生產的產品，無論是研究或未公開發表，或化學特徵的個別產品。 The effect was robust.”效果是強大的。 “ But the FDA did not reveal this risk to doctors and hospitals that were considering participation in future studies, the researchers found.但是，美國並沒有透露這方面的風險向醫生和醫院，正在考慮參加今後的研究中，研究人員發現。 “The risk appears to be a class risk. “風險似乎是一類風險。 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.這似乎是目前所有產品說， “威廉D霍夫曼，前首席醫療官的Biopure ，一個製造商的新的人造血液。 “They should all be on hold until they figure out what is causing the toxicity.” “他們都應該被擱置，直到他們找出是什麼原因造成的毒性。 ” Sources for this story include:來源這個故事包括： www.washingtonpost.com . 。 Have Your Say: FDA Approved Human Medical Experiments with Artificial Blood; Hundreds Died 你說： FDA批准人類醫學實驗用人工血液;數百人喪生 Please read our請仔細閱讀我們的 posting guidelines before posting張貼在發布前的指導方針 . 。 Alternatively或者 you can discuss this report here你可以討論這份報告在這裡 . 。 Related News 相關新聞
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