當地時間4月24日，美國食品和藥物管理局（FDA）向醫生髮出警告稱，不要隨意使用總統特朗普力捧的兩種瘧疾藥物治療新冠肺炎。
羥基氯喹和氯喹是美國食藥局批准用於治療或預防瘧疾的藥物，被批准用於如狼瘡等某些自身免疫性疾病。由於可能產生嚴重的副作用，美國食藥局要求僅應在醫院環境或臨床試驗中使用這兩種藥物。
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.
食藥局表示報告稱，紐約一家醫院為84名冠狀病毒患者使用了羥基氯喹和抗生素阿奇黴素進行治療，部分新冠肺炎患者中出現了 "嚴重的心律失常"。
“我們也意識到，通過門診處方使用這些藥物的患者越來越多，”食藥局表示。"因此，我們希望提醒醫護人員和患者注意與羥氯喹和氯喹相關的已知風險。“
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，美國食品藥品監督管理局（FDA）批准了對數量有限的新冠住院病例的“緊急用藥”許可，其他國家也在不同程度上授權研究測試羥氯喹作為治療或預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.
此前特朗普就曾通過多個途徑強力推崇將抗瘧疾藥用於治療新冠肺炎，並敦促美國食品和藥物管理局加速藥物的審批工作，但部分專家對藥物的治療效果表示懷疑，他們強調藥物應用缺乏科學研究，反對在安全性未得到驗證就進行過度銷售。但特朗普仍大力推銷並表示：該藥可能有副作用，但吃了不會死。
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.
隨著部分地區將該藥物投入臨床試驗，更多的數據引發了醫學界的擔憂。就在美國食藥局發佈最新警告的同一天，一組研究人員在《美國醫學會雜誌》上發表文章介紹了他們終止將氯喹作為COVID-19潛在治療方法的研究情況。他們在研究中發現，該藥物具有危險副作用，其毒性已經超過藥物可能帶來的益處。
在文章中，紐約大學的醫生髮現，羥氯喹和氯喹會引起異常的心律，例如QT間期延長和危險的快速心律，在84名接受了常規劑量的羥氯喹和阿奇黴素治療的冠狀病毒患者中，有9名出現心率異常現象，4名死於器官衰竭。研究表明，有心臟和腎臟疾病的患者在接受這些藥物治療時，心臟病風險會增加。
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.
