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南达科他州将举行首个羟氯喹全州临床试验

2020-04-14 17:25   美国新闻网   - 

据州长克里斯蒂·诺姆称,南达科他州将率先在全州范围内开展羟氯喹临床试验,这是一种新冠状病毒的潜在治疗方法。

周一,诺姆宣布将开始临床试验,使南达科他州成为第一个在全州范围内进行临床试验的州。唐纳德·特朗普(Donald Trump)总统支持将这种药物作为一种可能的病毒治疗方法,但尚未进行足够的临床试验来确定其疗效或使用安全性。

诺姆说,她一直在与特朗普政府沟通,包括副总统迈克·彭斯和白宫冠状病毒特别工作组的其他成员,以确保他们了解该州的计划。第一剂药物于周末抵达拉什莫尔山州,诺伊姆说患者可能已经在接受该药物。

诺姆在周一的简报会上说:“我们正在采取行动,帮助每一个人对付这种病毒,并愿意与之斗争,变得更好,回家与家人团聚。”。

桑福德健康将领导这项工作,但平均健康和纪念碑健康也将参与试验。据州长称,试验将从约2000人开始,但该州有足够的剂量治疗多达10万人。诺姆说,除了治疗病人,这项试验还将为该州提供未来对抗病毒所需的数据。

根据桑福德健康公司首席医疗官艾莉森·苏特尔博士的说法,该试验将由两部分组成。第一方面,被确定为注册组成部分,将给予每一个南达科他州谁测试阳性COVID-19,是一个可行的候选人,选择接受羟氯喹。第二方面将是一项随机试验,对象是接触过COVID-19的人,包括卫生保健工作者、与检测呈阳性的人生活在一起的人以及弱势人群。

在这张照片中,3月26日在伦敦展示了一种硫酸羟氯喹药丸。周一,州长克里斯蒂·诺姆宣布南达科他州将开始羟氯喹的临床试验,这是第一个在全州范围内进行临床试验的州。

Suttle说,这种药物的服用方式类似于Zithromax Z-Pak,你服用负荷剂量大约四五天,但它会在体内停留长达50天。因此,它可以帮助可能接触到病毒的人对抗病毒。通过潜在的限制感染的数量,萨特说他们可以阻止病毒的传播。

“我们今天希望通过这些临床试验,向所有可能受COVID影响的人提供这种药物,真正提供一种治疗,提供希望,增加我们对药物的了解,并知道什么是有效的,”Suttle说。

羟氯喹已被用于治疗疟疾,并显示出它能有效治疗非典-CoV-2的迹象,非典-CoV-2是新冠状病毒的正式名称。然而,有人担心使用这种药物作为治疗手段,因为它会对心脏产生不良影响。周四,国家卫生研究院宣布一项临床试验正在进行,参与者来自纳什维尔的范德比尔特大学医学中心。

范德比尔特大学医学中心的急诊内科医生韦斯利·赛尔夫博士在一份声明中说:“尽管支持其有效性的临床数据极其有限,但许多美国医院目前仍将羟氯喹作为COVID-19住院患者的一线治疗药物。”。"因此,迫切需要羟氯喹治疗COVID-19的数据来指导临床实践."

该试验旨在招募超过500名目前因COVID-19住院的成年人,或在急诊室接受预期住院治疗的成年人。

根据公共卫生部的数据,南达科他州已经有868例病例和6例死亡。诺姆说,她对羟氯喹试验感到“兴奋”,尤其是在这个新闻令人沮丧的时期。

诺姆说:“病毒的科学告诉我们,我们不能阻止它,但是我们可以减缓它,我们可以在对付它的时候照顾好人们。”。"这一声明将确保我们尽可能以最好的方式做到这一点。"

SOUTH DAKOTA WILL BECOME FIRST TO HOLD STATEWIDE CLINICAL TRIAL OF HYDROXYCHLOROQUINE TO TREAT CORONAVIRUS

South Dakota will pioneer efforts for statewide clinical trials for hydroxychloroquine, a potential treatment for a new coronavirus, according to Governor Kristi Noem.

On Monday, Noem announced a clinical trial would begin, making South Dakota the first state to hold statewide clinical trials. President Donald Trump championed the drug as a possible treatment for the virus but sufficient clinical trials haven't been conducted to determine its efficacy or the safety of its use.

Noem said she has been in communication with the Trump administration, including Vice President Mike Pence and other members of the White House Coronavirus Task Force, to ensure they were abreast of the state's plans. The first doses of the drug arrived in the Mount Rushmore State over the weekend and Noem said patients may already be receiving the drug.

"We're going on offense to help every single person deal with this virus and be willing to fight it and get better and go home to their families," Noem said during Monday's briefing.

Sanford Health will lead the effort, but Avera Health and Monument Health will also participate in the trial. The trial will start with about 2,000 people, according to the governor, but the state has enough doses to treat up to 100,000 people. Along with treating patients, Noem said the trial will give the state the data it needs to fight the virus in the future.

The trial will have two components, according to Dr. Allison Suttle, Sanford Health's chief medical officer. The first side, identified as the registry component, will give every South Dakotan who has tested positive COVID-19 and is a viable candidate, the option to receive hydroxychloroquine. The second side will be a randomized trial for people who were exposed to COVID-19, including health care workers, someone who lives with someone who tested positive and people within the vulnerable population.

In this photo illustration a hydroxychloroquine sulfate medication pill is displayed on March 26 in London. On Monday, Governor Kristi Noem announced that South Dakota will begin clinical trials for hydroxychloroquine, making it the first state to hold statewide clinical trials.

Suttle said the drug is taken similar to a Zithromax Z-Pak, where you take a loading dose for about four or five days but it stays inside your body for up to 50 days. Therefore, it could help individuals who may be exposed to fight the virus, according to Suttle. By potentially limiting the number of infections, Suttle said they can stop the virus from spreading.

"What we hope today by having these clinical trials, by offering this medication to all of those who may be impacted by COVID, is to really provide a treatment, to provide hope, to increase the information that we know about medications and to know what works," Suttle said.

Hydroxychloroquine has been used to treat malaria and showed signs it could be effective in treating SARS-CoV-2, the official name for the new coronavirus. However, there have been concerns about the use of the drug as a treatment, as it can have adverse effects on the heart. On Thursday, the National Institutes of Health announced a clinical trial was underway with participants at Vanderbilt University Medical Center in Nashville.

"Many U.S. hospitals are currently using hydroxychloroquine as first-line therapy for hospitalized patients with COVID-19 despite extremely limited clinical data supporting its effectiveness," Dr. Wesley Self, emergency medicine physician at Vanderbilt University Medical Center, said in a statement. "Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice."

The trial aimed to enroll more than 500 adults who are currently hospitalized with COVID-19 or are in an emergency department with anticipated hospitalization.

South Dakota has had 868 cases and six deaths, according to the Department of Public Health. Noem said she was "excited" about the hydroxychloroquine trial, especially during a time period when much of the news is discouraging.

"The science of the virus tells us that we can't stop it but that we can slow it down and that we can take care of people while we're dealing with it," Noem said. "This announcement will make sure that we do it the best way possible."

 

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