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[【学科前沿】] FDA:强生的糖尿病愈合药Regranex可能致癌!!!

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发表于 2008-4-25 07:49:25 | 显示全部楼层 |阅读模式
Cancer risk seen with J&J foot gel: FDA

WASHINGTON (Reuters) - A Johnson & Johnson foot gel used by diabetics may increase the risk of cancer and death, U.S. health officials said on Thursday in announcing an investigation into the issue.
华盛顿(路透社)报道 —美国健康官员在周四的内部调查报告中宣布,强生的一种糖尿病足部愈合凝胶药有增加癌症和死亡的危险。

The Food and Drug Administration said a study of the gel, called Regranex, found an increase in the number of cancer deaths among patients who had been prescribed the gel three or more times.
FDA说,发现一种叫Regranex的凝胶药在用该处方三次或更多次的患者中增加了癌症和死亡率。

Regranex, approved for U.S. patients in 1997, is a prescription gel used to treat diabetic leg and foot wounds.
Regranex,1997年被U.S.批准用于治疗糖尿病患者的足部创伤。

\"At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex,\" the FDA said in a statement. \"Because there are known risks associated with diabetic foot and leg ulcers that do not heal, the potential risk of using Regranex should be weighed against the benefit for each individual patient.\"
“这一次,FDA相信有若干证据表明用Regranex重复治疗的患者增加了癌症死亡的危险。” FDA在一份声明中说,“大家所知,危险与糖尿病患者的腿足溃疡没有治愈相关联,每个单独的患者冒着使用Regranex的危险来治疗。”

Barbara Montresor, a spokeswoman for Johnson & Johnson's Ethicon Inc unit that makes the gel, said the company was working with the agency and that Regranex is safe when used as directed.
Barbara Montresor,强生公司中一个制造这种凝胶药的女发言人说,公司正在与代理商积极处理中;并且在Regranex直接使用时是安全的

Patients with diabetes -- a disease in which blood levels of sugar are too high -- are more susceptible to developing leg and foot wounds because they are less able to feel their feet.
糖尿病患者— 一种血液中含糖太多的疾病— 很容易导致腿足创伤因而几乎不能触摸他们的足。

Concern arose following a study of adult diabetes patients through an insurance plan database that found an increase in cancer deaths from January 1998 through June 2003. No single type of cancer was identified, the FDA said.
通过一个保险计划数据库的建立引发了一项成人糖尿病患者的研究,既从1998年1月到2003年六月增加的癌症死亡。鉴别非单一模型的癌症,FDA说。

The agency did not say who conducted the study or how many patients were included, and an FDA spokeswoman declined to comment.
代理商没说这项研究包括了多少患者,而一个FDA的女发言人也拒绝对此评论。

In an earlier study completed in 2001, more cancers were found in Regranex patients than in those who did not use the gel, the agency added.
代理商补充说,早在2001年的研究中,发现在用Regranex的患者中比没用这种药的患者中有更多的癌症。

Ethicon's Montresor did not immediately respond to a request seeking more details on the studies.
对这项研究被要求提供更多的详细资料Ethicon's Montresor没有立即回应。

Shares of Johnson & Johnson closed down 8 cents at $64.62 on the New York Stock Exchange.
由此,强生在纽约市场的股票下降了8美分至64.62美元。
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