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研究显示,将氯喹用于COVID-19可能导致死亡

2020-04-25 14:32   美国新闻网   - 

一项关于疟疾药物能否用作Covid-19治疗的随机临床试验被终止,因为其“主要结果”是死亡美国医学协会杂志显示。

3月23日至4月5日,巴西研究人员对81名患有新型冠状病毒引起的Covid-19的患者进行了观察,以了解氯喹药物是否能有效治疗这种高度传染性疾病。40名病人服用了低剂量的药物;其他41个,高剂量。他们还服用了抗生素阿奇霉素。

研究人员发现低剂量组有13人死亡,高剂量组有16人死亡。另外11人出现心脏异常。

该研究的作者写道:“克罗克维-19试验的初步发现表明,不应推荐更高剂量的氯喹用于治疗严重的Covid-19,特别是在同时接受阿奇霉素和奥司他韦的患者中,因为存在关于QTc间期延长和致死率增加的安全性问题。”。

氯喹是唐纳德·特朗普总统和他的一些支持者鼓吹的治疗Covid-19的药物之一。这种疾病没有被证实的治疗方法。

食品和药物管理局在周五发出了一个提醒,它还没有批准氯喹或其他药物来治疗这种冠状病毒。美国食品和药物管理局还表示,他们在4月3日发布了紧急使用授权,允许医院或临床试验在某些情况下仅使用氯喹和羟氯喹。

“虽然临床试验正在进行中,以确定这些药物对COVID-19的安全性和有效性,但这些药物的已知副作用应该予以考虑,”美国食品和药物管理局局长斯蒂芬·哈恩在一份声明中说。“我们鼓励做出个体患者决策的医疗保健专业人员密切筛查和监控这些患者,以帮助降低这些风险。食品和药物管理局将继续监测和调查这些潜在的风险,并在获得更多信息时公开沟通。”

在总统第一次开始讨论抗疟疾药物后的几个星期里,该药物成为福克斯新闻频道的电视名人经常讨论的话题。

特朗普也不是唯一对氯喹或羟氯喹感兴趣的知名政治家。纽约州州长安德鲁·科莫在他的每日新闻发布会上也提出了后者可能是一种有效的冠状病毒治疗的可能性,尽管主要是在该州进行的临床试验的背景下。

白宫助手表示,特朗普对推动一种既未被美国食品和药物管理局批准用于治疗这种新型冠状病毒,也未在临床试验中进行测试的药物感兴趣,是因为他渴望给美国人带来积极的消息,也是因为他希望Covid-19的治疗方法,如果能很快找到,能迅速结束社会疏远措施,这些措施导致了自1929年股市崩盘后数周以来从未出现过的那种经济低迷。

特朗普在退伍军人事务部的一项研究发表后的几天内停止提及该药物,该研究发现该药物可能导致接受该药物的患者死亡。

当被问及为何在周四的白宫冠状病毒特别工作组每日简报会上停止宣传时,特朗普否认自己这样做了。

“我们已经取得了很多非常好的结果,但也有一些结果可能不太好,”他说。他补充说,该药物的“许多、许多研究”正在进行中,但他告诉记者,他还没有看过退伍军人管理局的研究。

白宫没有立即回应新闻周刊征求意见。

CORONAVIRUS DRUG CHLOROQUINE SHOULD NOT BE USED FOR COVID-19 BECAUSE 'LETHALITY' IS 'PRIMARY OUTCOME,' STUDY SHOWS

A randomized clinical trial of whether a malaria drug could be used as a Covid-19 cure was shut down because its "primary outcome" was death, a study published Friday in the Journal of the American Medical Association showed.

Researchers in Brazil looked at 81 patients with Covid-19, the disease caused by the novel coronavirus, from March 23 to April 5 to see whether the drug chloroquine could be an effective treatment for the highly contagious disease. Forty patients were given a low-dose of the drug; 41 others, a high dose. They were also given the antibiotic azithromycin.

The researchers found that 13 people in the low-dose group died, as did 16 in the high-dose group. Another 11 developed heart abnormalities.

"The preliminary findings from the CloroCovid-19 trial suggest that a higher dosage of chloroquine should not be recommended for the treatment of severe COVID-19, especially among patients also receiving azithromycin and oseltamivir, because of safety concerns regarding QTc interval prolongation and increased lethality," the study's authors wrote.

Chloroquine is among the drugs that have touted by President Donald Trump and some of his supporters as possible cures for Covid-19. There are no proven cures or treatments for the disease.

The Food and Drug Administration on Friday issued a reminder that it has not approved chloroquine or other drugs to treat this coronavirus. The FDA also said reiterated that it issued an Emergency Use Authorization on April 3 that permits hospital or clinical trials only to use chloroquine and hydroxychloroquine in some cases.

"While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered," said FDA Commissioner Stephen M. Hahn in a statement. "We encourage health care professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks. The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available."

For weeks after the president first began discussing it, the anti-malaria drugs became a frequent topic of discussion among television personalities appearing on the Fox News Channel.

Trump also is not the only high-profile politician to show interest in chloroquine or hydroxychloroquine. New York Governor Andrew Cuomo also raised the possibility that the latter could be an effective coronavirus treatment at his daily press conferences, although mainly in the context of a clinical trial conducted by the state.

White House aides said that Trump's interest in pushing a medication that had neither been approved by the FDA to treat the novel coronavirus nor tested in a clinical trial was driven by his desire to bring Americans positive news, and by his hope that a cure for Covid-19, if quickly found, could bring a quick end to the social distancing measures which have caused an economic downturn of the sort not seen since the weeks following the 1929 stock market crash.

Trump stopped mentioning the drug in the days following publication of a Department Veterans Affairs study which found the drug possibly contributed to the deaths of patients who'd been receiving it.

When asked why he'd stopped promoting it at Thursday's White House Coronavirus Task Force daily briefing, Trump denied having done so.

"We've had a lot of very good results and we had some results that perhaps aren't so good," he said. He added that there were "many, many studies" of the drug in progress, but told reporters that he had not seen the VA study.

The White House did not immediately respond to Newsweek's request for comment.

 

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