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特朗普说伦德西维尔被批准是因为它是媒体的“热点”

2020-05-02 19:02   美国新闻网   - 

唐纳德·特朗普(Donald Trump)总统热情地吹捧这种抗病毒药物,称其为媒体上的“热点”,该药物已被美国食品和药物管理局(FDA)授权用于治疗新型冠状病毒的紧急用途。

在临床试验中取得了令人鼓舞的结果后,雷莫西韦被授予紧急使用授权(EUA)几乎三分之一服用该药物的人比服用安慰剂的患者恢复得更快,尽管并没有显著提高存活率。专家警告说,这不是一种“灵丹妙药”疗法。

周五在白宫,特朗普与丹尼尔·奥戴(Daniel O'Day)在一起,丹尼尔·奥戴是制药公司Gilead的首席执行官,该公司提供150万瓶这种药物,足以治疗约14万名患者。

特朗普说:“该公司一直在新闻中,这是一个伟大的美国公司,在艾滋病毒和丙型肝炎方面做了令人难以置信的工作,”他补充道,“肝炎方面发生的事情是伟大的——一个伟大的医学故事。

2020年4月30日,美国总统唐纳德·特朗普在DC华盛顿白宫东厅发表演讲。他宣布药物remdesivir将用于治疗冠状病毒。

“我很高兴地宣布,吉列现在有一个来自美国食品和药物管理局的EUA。你知道吗,那是因为在过去的一段时间里,这也是报纸和媒体的热门话题,”他说,并将其描述为“对住院冠状病毒患者的重要治疗”

特朗普继续说道:“这确实是一个非常有希望的局面,”并称赞贾里德“为……做出了贡献”...不好的人,生病的人,有这种可怕瘟疫的人,这种瘟疫已经进入我们的国家,我们正在消灭它。

“我们将会有一些非常不可思议的结果,”特朗普补充道。

欧德在会上说,提供雷莫西韦是COVID-19治疗的“第一步”,治疗其他病毒的经验表明,“真正取得更好结果的方法是在抗病毒药物的基础上增加药物”。

2020年3月25日,弗吉尼亚州阿灵顿,智能手机屏幕上显示的冠状病毒图片旁边,显示着一个Gilead标志。

“这就是我们如何通过综合疗法将艾滋病毒传染给慢性病的真正方法。

“有许多伟大的公司都在致力于此,我们正在与业界的同事合作。我们正在一起努力,尽我们所能,”他补充道。

出席会议的还有美国食品和药物管理局局长斯蒂芬·哈恩,他称赞了从临床试验到获得美国食品和药物管理局授权的速度。

“这是一项重要的临床进展,显示COVID-19患者的恢复时间在统计学上显著缩短。这是COVID-19的首次授权治疗,”他说。

伦德西维尔,这种药物通过静脉注射给药,最初是为了治疗埃博拉病毒而开发的在Gilead的网站上被描述为“具有广谱抗病毒活性的核苷酸类似物”

它能够干扰病毒的基因组,并破坏其复制能力。

然而,该公司强调,该药物尚未在全球任何地方获得批准用于任何用途,但已显示出对抗病毒病原体MERS和SARS的良好效果,这两种病毒在结构上与COVID-19相似。

该公司表示:“在MERS和非典中,雷替西韦有限的临床前数据表明,雷替西韦可能具有抗COVID-19的潜在活性。”该公司称雷替西韦是“一种实验性药物,对任何病症的治疗都没有确定的安全性或有效性。”

疾病控制和预防中心关于使用面部覆盖物减缓COVID-19传播的建议

  • 疾病预防控制中心建议在难以保持社交距离的公共场合佩戴布质面罩。

  • 一个简单的布质面部覆盖物可以帮助那些被感染者和没有表现出症状的人减缓病毒的传播。

  • 布面可以由家用物品制成。指南由疾病预防控制中心提供。(http://www . CDC . gov/corona virus/2019-ncov/prevent-get-disk/DIY-cloth-face-covers . html)

  • 应该定期清洗布面。洗衣机就够了。

  • 通过不接触眼睛、鼻子和嘴来练习安全地去除面部覆盖物,并在去除覆盖物后立即洗手。

世界卫生组织关于避免冠状病毒疾病传播的建议(COVID-19)

卫生建议

  • 经常用肥皂和水洗手,或者用酒精洗手。

  • 咳嗽或打喷嚏后洗手;照顾病人时;食物准备之前、期间和之后;吃饭前;使用厕所后;当手明显变脏时;处理动物或废物后。

  • 与任何咳嗽或打喷嚏的人保持至少1米(3英尺)的距离。

  • 避免触摸你的手、鼻子和嘴。不要在公共场合吐痰。

  • 咳嗽或打喷嚏时,用纸巾或弯肘捂住口鼻。立即丢弃纸巾并清洁双手。

医疗建议

  • 如果你有任何症状,避免与其他人密切接触。

  • 如果你感觉不舒服,即使有轻微的症状,如头痛和流鼻涕,也要呆在家里,以避免疾病扩散到医疗机构和其他人。

  • 如果您出现严重症状(发烧、咳嗽、呼吸困难),请尽早就医,并提前联系当地卫生部门。

  • 记录最近与他人的任何联系和旅行细节,以提供给能够追踪和预防疾病传播的当局。

  • 了解卫生当局发布的COVID-19最新进展,并遵循他们的指导。

面具和手套的使用

  • 如果照顾病人,健康的人只需要戴口罩。

  • 如果你咳嗽或打喷嚏,请戴上口罩。

  • 当与频繁的手部清洁结合使用时,口罩是有效的。

  • 戴口罩时不要触摸。如果你触摸面具,请洗手。

  • 学习如何正确戴上、取下和处理口罩。扔掉口罩后,请洗手。

  • 不要重复使用一次性口罩。

  • 经常洗手比戴橡胶手套更能有效防止感染COVID-19。

  • COVID-19病毒仍然可以在橡胶手套上被发现,并通过触摸你的脸传播。

TRUMP SAYS FDA EMERGENCY APPROVAL OF REMDESIVIR FOR COVID-19 TREATMENT IS BECAUSE IT'S 'THE HOT THING' IN THE MEDIA

President Donald Trump enthusiastically touted the antiviral drug which has been authorized by the Food and Drug Administration (FDA) for emergency use in the treatment of the novel coronavirus, describing it as the "hot thing" in the media.

Remdesivir has been granted an Emergency Use Authorization (EUA) following promising results in clinical trials in which almost a third of those who took the drugrecovered more quickly than those given a placebo, although it did not significantly improve survival rates. Experts have warned that it is not a "magic bullet" cure.

In the White House on Friday, Trump was alongside Daniel O'Day, the chief executive of pharmaceutical company Gilead which is providing 1.5 million vials of the drug, enough to treat around 140,000 patients.

Trump said: "The company has been in the news, and it's a great American company that's done incredible work on HIV and hepatitis C," adding, "what's happening with hepatitis is the great—a great medical story.

U.S. President Donald Trump speaks in the East Room of the White House in Washington, DC on April 30, 2020. He announced the drug remdesivir would be used as a treatment for the coronavirus.

"I'm pleased to announce that Gilead now has an EUA from the FDA for remdesivir. And you know what, that is because that's been the hot thing also in the papers and in the media for the last little while," he said, describing it as "an important treatment for hospitalized coronavirus patients."

Trump went on: "It's really a very promising situation," and praised Gilead for "making a contribution to... people that are not doing well, people that are sick, people that have this horrible plague that's set into our country and that we're getting rid of.

"We're going to be having some really incredible results," Trump added.

O'Day said at the meeting that the move to provide remdesivir "is the first step" in the treatment of COVID-19 and that the experience of treating other viruses has shown that "the way to actually even get better results is to add medicines on top of an antiviral.

A Gilead logo is displayed on a smartphone next to a screen showing a coronavirus graphic on March 25, 2020 in Arlington, Virginia.

"That was really how we were able to get HIV to a chronic illness—by a combination of therapies.

"There's a lot of great companies out there that are working on this, that we're collaborating with, my colleagues in the industry. And we're all working together to do everything we can," he added.

Also at the meeting was FDA Commissioner Stephen Hahn who praised the speed of getting it from clinical trial to FDA authorization.

"This is an important clinical advance that showed a statistically significant reduction in time to recovery for patients with COVID-19. And it's the first authorized therapy for COVID-19," he said.

Remdesivir, which is given by intravenous infusion and was originally developed to treat Ebola, is described on Gilead's website as a "nucleotide analog with broad-spectrum antiviral activity."

It is able to interfere with the virus's genome and can disrupt its ability to replicate.

However the company emphasized that the drug has not been approved anywhere globally for any use but has shown promising results against viral pathogens MERS and SARS, which are structurally similar to COVID-19.

"The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19," the company said, describing it as "an experimental medicine that does not have established safety or efficacy for the treatment of any condition."

Centers for Disease Control and Prevention Advice on Using Face Coverings to Slow Spread of COVID-19

  • CDC recommends wearing a cloth face covering in public where social distancing measures are difficult to maintain.

  • A simple cloth face covering can help slow the spread of the virus by those infected and by those who do not exhibit symptoms.

  • Cloth face coverings can be fashioned from household items. Guides are offered by the CDC. (https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/diy-cloth-face-coverings.html)

  • Cloth face coverings should be washed regularly. A washing machine will suffice.

  • Practice safe removal of face coverings by not touching eyes, nose, and mouth, and wash hands immediately after removing the covering.

World Health Organization advice for avoiding spread of coronavirus disease (COVID-19)

Hygiene advice

  • Clean hands frequently with soap and water, or alcohol-based hand rub.

  • Wash hands after coughing or sneezing; when caring for the sick; before, during and after food preparation; before eating; after using the toilet; when hands are visibly dirty; and after handling animals or waste.

  • Maintain at least 1 meter (3 feet) distance from anyone who is coughing or sneezing.

  • Avoid touching your hands, nose and mouth. Do not spit in public.

  • Cover your mouth and nose with a tissue or bent elbow when coughing or sneezing. Discard the tissue immediately and clean your hands.

Medical advice

  • Avoid close contact with others if you have any symptoms.

  • Stay at home if you feel unwell, even with mild symptoms such as headache and runny nose, to avoid potential spread of the disease to medical facilities and other people.

  • If you develop serious symptoms (fever, cough, difficulty breathing) seek medical care early and contact local health authorities in advance.

  • Note any recent contact with others and travel details to provide to authorities who can trace and prevent spread of the disease.

  • Stay up to date on COVID-19 developments issued by health authorities and follow their guidance.

Mask and glove usage

  • Healthy individuals only need to wear a mask if taking care of a sick person.

  • Wear a mask if you are coughing or sneezing.

  • Masks are effective when used in combination with frequent hand cleaning.

  • Do not touch the mask while wearing it. Clean hands if you touch the mask.

  • Learn how to properly put on, remove and dispose of masks. Clean hands after disposing of the mask.

  • Do not reuse single-use masks.

  • Regularly washing bare hands is more effective against catching COVID-19 than wearing rubber gloves.

  • The COVID-19 virus can still be picked up on rubber gloves and transmitted by touching your face.

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