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冠状病毒药物试验显示早期治疗提高了康复机会

2020-04-30 09:21   美国新闻网   - 

各家公司都在竞相寻找一种有效的药物来对抗导致COVID-19的冠状病毒,一项针对remdesivir的试验研究显示,早期治疗增加了患者出院的机会。

在研究的第14天,62%在症状出现后10天内接受药物治疗的患者能够出院。据生产remdesivir的Gilead Sciences称,在症状出现超过10天后接受治疗的患者中,只有49%能够出院。

世界各地的官员已经报告了超过300万例非典病例,这是该病毒的官方名称,截至周三,已有218,456人死亡。虽然目前还没有已知的针对这种病毒疾病的治疗方法,但公司正在寻找一种安全有效的治疗方法,因为它可以拯救生命,并有助于加快旨在阻止病毒传播的社会限制的进程。

抗病毒药物Remdesivir正在多个国家进行试验研究,但没有重要的研究,不清楚它是否能证明自己是世界需要的治疗方法。

4月8日,在德国汉堡的埃彭道夫大学医院,一瓶雷得西维尔药物在关于研究开始的新闻发布会上被拿走。基列德科学公司的一项新的试验研究结果表明,早期接受该药物治疗的患者比后来接受治疗的患者更有可能出院。

第三阶段简单试验评估了COVID-19严重病例住院患者的5天和10天给药持续时间。这项研究中来自15个国家的397名患者都有肺炎和不需要机械通气就能降低氧气水平的证据。患者接受为期5天或10天的标准护理,同时接受remdesivir治疗。

该试验的结果显示,服用该药物10天的患者与仅服用该药物5天的患者相比,病情有所改善。两个治疗组中超过一半的患者在第14天出院,50%患者的临床改善时间在5天治疗组为10天,在10天治疗组为11天。

贾勒德的首席医疗官默达·帕西博士在一份声明中说:“这项研究表明,一些患者有可能接受为期五天的治疗,这可能会显著增加我们目前使用的雷得昔韦的患者数量。”。“在大流行的背景下,这一点尤其重要,有助于医院和卫生保健工作者治疗更多急需护理的患者。”

在贾里德试验结果的消息传出后,前食品和药物管理局局长斯科特·戈特利布博士从4月5日起转发了一条推特帖子,描述了接受治疗的重要性。戈特利布认为,如果没有有效的药物,病毒将在社会背景下传播,迫使美国以80%的经济运行。但是药物不是唯一的解决办法。

“这些药物都不是完全的解决方案。但它们可以成为通向[的桥梁,一种疫苗和一个足以恢复信心的过渡步骤;拯救生命,”戈特利布在推特上写道。“再加上[有]公共卫生工具,我们包里有一种药物,我们可以制造#COVID19可控的威胁。赌注再高不过了。"

国家过敏和传染病研究所也在进行这种药物的试验。Gilead声称“积极的数据”正在浮现,但没有提供更多的细节。除了在人体内测试这种药物,NIAID还在研究它在猴子身上的效果。

在比较两组恒河猴时——一组给予remdesivir,另一组不给予remdesivir接受治疗的那组比未接受治疗的那组“健康状况明显更好”。七天之后,接受治疗的人肺部的病毒水平较低,肺部损伤也较小。

类似于Gilead的人类研究,NIAID的研究得出的数据支持了早期治疗有益的信念。

Remdesivir尚未获得许可,尚未确定其在治疗COVID-19方面是否安全或有效。Gilead正在进行另一项试验,以确定与护理标准相比,中度病例患者5天和10天给药持续时间的安全性和有效性。这些结果预计将在5月底公布。

CORONAVIRUS DRUG TRIAL SHOWS EARLY TREATMENT GAVE PATIENTS GREATER CHANCE OF LEAVING HOSPITAL

Companies are racing to find an effective drug to use against the coronavirus that causes COVID-19, and a trial study for remdesivir showed early treatment increases the chances a person will leave the hospital.

On Day 14 of the study, 62 percent of patients who received the drug within 10 days of symptoms onset were able to be discharged from the hospital. Only 49 percent of those who received treatment after more than 10 days of symptoms were able to be released, according to Gilead Sciences, which produces remdesivir.

Officials worldwide have reported more than 3 million cases of SARS-CoV-2, the official name for the virus, and as of Wednesday, 218,456 people have died. While there's no known treatment for the virus's disease, COVID-19, companies are searching for a safe and effective treatment, as it could save lives and help speed up the process of easing social restrictions aimed at stopping the virus from spreading.

Remdesivir, an antiviral drug, is being studied in trials in multiple countries, but without significant research, it's unclear if it'll prove itself to be the treatment the world needs.

A vial of the drug remdesivir is held during a press conference about the start of a study at the University Hospital Eppendorf in Hamburg, Germany, on April 8. Results from a new trial study by Gilead Sciences show that patients who were treated early with the drug were more likely to be released from the hospital than those who were treated later.

The Phase III SIMPLE trial evaluated five- and 10-day dosing durations in hospitalized patients with severe cases of COVID-19. All 397 patients from 15 countries in the study had evidence of pneumonia and reduced oxygen levels that didn't require mechanical ventilation. Patients were given a standard of care, as well as remdesivir, for either five or 10 days.

Topline results from the trial showed patients who received the drug for 10 days had improvements similar to those in patients who took the drug for only five days. More than half of patients in both treatment groups were discharged from the hospital by Day 14, and the time to clinical improvement for 50 percent of patients was 10 days in the five-day treatment group and 11 days in the 10-day group.

"The study demonstrates the potential for some patients to be treated with a five-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir," Dr. Merdad Parsey, Gilead's chief medical officer, said in a statement. "This is particularly important in the setting of a pandemic, to help hospitals and health care workers treat more patients in urgent need of care."

After news broke of Gilead's trial results, Dr. Scott Gottlieb, a former commissioner of the Food and Drug Administration, reposted a Twitter thread from April 5 that described the importance of having a treatment. Without effective drugs, the virus will circulate in the background of society, according to Gottlieb, forcing America to operate with an 80 percent economy. But medicine can't be the sole solution.

"None of these drugs is a complete solution. But they can be a bridge to [a] vaccine and interim step powerful enough to restore confidence; save lives," Gottlieb tweeted. "Coupled [with] tools of public health, with a drug in our bag, we can make #COVID19 a manageable threat. The stakes could not be higher."

The National Institute of Allergy and Infectious Diseases is also conducting a trial with the drug. Gilead claimed that "positive data" was emerging from it but did not provide additional details. Along with testing the drug in humans, the NIAID is studying the effect it had in monkeys.

In comparing two groups of rhesus macaques—one that was given remdesivir and one that was not—the group that was treated was in "significantly better health" than the untreated group. After seven days, those that were treated had lower levels of the virus in their lungs, as well as less lung damage.

Similarly to Gilead's human study, the NIAID study produced data that supported the belief that early treatment is beneficial.

Remdesivir isn't licensed and has yet to be determined to be safe or effective in treating COVID-19. Gilead is conducting another trial to determine the safety and efficacy of the five- and 10-day dosing durations for patients with moderate cases, compared with the standard of care. Those results are expected at the end of May.

 

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