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歐洲藥品管理局稱沒有發(fā)現(xiàn)葛蘭素史克的流感疫苗與嗜睡發(fā)作有關(guān)的證據(jù) 已有7人參與
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原文鏈接:http://medcitynews.com/2012/10/e ... hot-and-narcolepsy/ EU drugs agency sees no proof of link between GSK’s flu shot and narcolepsy 歐洲藥品管理局稱沒有發(fā)現(xiàn)葛蘭素史克的流感疫苗與嗜睡發(fā)作有關(guān)的證據(jù)。 European drugs regulators said on Friday that evidence suggesting a link between GlaxoSmithKline's Pandemrix flu vaccine and a sleeping disorder called narcolepsy is "insufficient" and does not lead to any new concerns. 本周五,歐洲藥品管理局人士稱:認(rèn)為葛蘭素史克的流感疫苗與睡眠障礙有關(guān)的證據(jù)不充分,且該證據(jù)并沒有引起任何新的顧慮。(新的,可能翻譯為“其他”會(huì)不會(huì)更好) does not lead to any new concerns.沒有把握 Pandemrix was designed to protect against the H1N1 pandemic flu which spread around the world in 2009 and 2010. At least 30.8 million people in Europe were vaccinated with it during the pandemic. 此疫苗是針對(duì)2009至2010年在全世界范圍傳播的H1N1流感而研發(fā)。H1N1流感流行期間,在歐洲至少有3080萬人接種了該疫苗。 The European Medicines Agency (EMA) began a review of the vaccine's safety in 2010 after Finnish researchers presented evidence suggesting it might be linked to a rise in cases of narcolepsy, a rare condition which causes a person to fall asleep suddenly and unexpectedly. 自2010年芬蘭研究人員提供證據(jù)認(rèn)為該疫苗可能與引起嗜睡發(fā)作的不良反應(yīng)事件升高有關(guān)(嗜睡發(fā)作即引起患者突然且無意識(shí)進(jìn)入睡眠狀態(tài)的罕見狀況)后,歐洲藥品管理局開始調(diào)查該疫苗的安全性。 "After careful consideration, the (committee) concluded that the data presented by the Finnish researchers are preliminary and that the evidence presented so far is insufficient to allow conclusions to be drawn," EMA said in a statement. 歐洲藥品管理局發(fā)表聲明道:經(jīng)過周密考慮,委員會(huì)認(rèn)為芬蘭研究人員只提供了初步研究數(shù)據(jù),且所提供的初步研究數(shù)據(jù)遠(yuǎn)不足以得出兩者之間有關(guān)的結(jié)論。 |

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