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美国食药局警告:不要随便使用特朗普推荐的药!

CGTN 2020-08-24
当地时间4月24日,美国食品和药物管理局(FDA)向医生发出警告称,不要随意使用总统特朗普力捧的两种疟疾药物治疗新冠肺炎。

羟基氯喹和氯喹是美国食药局批准用于治疗或预防疟疾的药物,被批准用于如狼疮等某些自身免疫性疾病。由于可能产生严重的副作用,美国食药局要求仅应在医院环境或临床试验中使用这两种药物。

The U.S. Food and Drug Administration (FDA) on Friday warned doctors against prescribing a malaria drug touted by President Donald Trump for treating the new coronavirus except in hospitals and research studies.

In an alert, regulators flagged reports of sometimes fatal heart side effects among coronavirus patients taking hydroxychloroquine or the related drug chloroquine.

The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause a number of side effects, including heart rhythm problems, severely low blood pressure and muscle or nerve damage.

食药局表示报告称,纽约一家医院为84名冠状病毒患者使用了羟基氯喹和抗生素阿奇霉素进行治疗,部分新冠肺炎患者中出现了 "严重的心律失常"。

“我们也意识到,通过门诊处方使用这些药物的患者越来越多,”食药局表示。"因此,我们希望提醒医护人员和患者注意与羟氯喹和氯喹相关的已知风险。“

The warning comes as doctors at a New York hospital published a report that heart rhythm abnormalities developed in most of 84 coronavirus patients treated with hydroxychloroquine and the antibiotic azithromycin, a combo Trump has promoted.

Both drugs are known to sometimes alter the heartbeat in dangerous ways, and their safety or ability to help people with COVID-19 is unknown. A National Institutes of Health experts panel earlier this week recommended against taking that drug combo except in a formal study because of the potential side effects.

"It is important that health care providers are aware of the risks of serious and potentially life-threatening heart rhythm problems that can occur with these drugs," the FDA said in a statement. The agency did not specify the number of reports it has received of side effects or deaths.

Calls to U.S. poison control centers about the malaria drugs increased last month to 79, compared to 52 in March 2019, according to Dr. Christopher Hoyte of the Rocky Mountain Poison Center in Denver, Colorado. The problems reported include abnormal heart rhythms, seizures, nausea and vomiting, Hoyte said.

上月,美国食品药品监督管理局(FDA)批准了对数量有限的新冠住院病例的“紧急用药”许可,其他国家也在不同程度上授权研究测试羟氯喹作为治疗或预防新冠病毒的安全性。

Last month, the FDA authorized limited use of the malaria drugs for hospitalized patients with COVID-19 who aren't enrolled in ongoing research. The FDA said the drugs' risks are manageable when patients are carefully screened and monitored by doctors. A number of studies are testing hydroxychloroquine as a treatment or for prevention of COVID-19.

Regulators said they are now investigating dangerous side effects and deaths reported with the malaria drugs to poison control centers and other health authorities.

此前特朗普就曾通过多个途径强力推崇将抗疟疾药用于治疗新冠肺炎,并敦促美国食品和药物管理局加速药物的审批工作,但部分专家对药物的治疗效果表示怀疑,他们强调药物应用缺乏科学研究,反对在安全性未得到验证就进行过度销售。但特朗普仍大力推销并表示:该药可能有副作用,但吃了不会死。

Trump has repeatedly touted hydroxychloroquine during his regular coronavirus briefings, suggesting its skeptics would be proven wrong. He has offered patient testimonials that the drug is a lifesaver. But a number of early coronavirus studies have suggested problems or no benefit.

随着部分地区将该药物投入临床试验,更多的数据引发了医学界的担忧。就在美国食药局发布最新警告的同一天,一组研究人员在《美国医学会杂志》上发表文章介绍了他们终止将氯喹作为COVID-19潜在治疗方法的研究情况。他们在研究中发现,该药物具有危险副作用,其毒性已经超过药物可能带来的益处。


在文章中,纽约大学的医生发现,羟氯喹和氯喹会引起异常的心律,例如QT间期延长和危险的快速心律,在84名接受了常规剂量的羟氯喹和阿奇霉素治疗的冠状病毒患者中,有9名出现心率异常现象,4名死于器官衰竭。研究表明,有心脏和肾脏疾病的患者在接受这些药物治疗时,心脏病风险会增加。

In Friday's report in the journal Nature Medicine, doctors at New York University and NYU Langone Health found a significant prolonging of what's called the heart's QT interval two to five days after coronavirus patients were given usual doses of hydroxychloroquine and azithromycin. The drugs can alter the QT interval, or the time it takes the heart to charge between beats. When that time is too long, it can trigger a rhythm problem that can lead to sudden death. 

Nine of the 84 patients had severe prolongation of this interval. Four patients died from organ failure but there was no evidence heart problems contributed. Severe disease or other health problems may play a role in whether the heartbeat abnormality develops, the researchers speculated.

The results show how important it is that these drugs only be used in a study where patients are closely tracked, said one independent expert, Dr. Rais Vohra, an emergency medicine specialist at the Fresno branch of the University of California, San Francisco.

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