美國食品和藥物管理局日前授予輝瑞的新冠口服治療藥物緊急使用授權(quán)。據(jù)悉，這款名為Paxlovid的口服藥是美國藥監(jiān)局授權(quán)的第一款專門用于對抗新冠病毒的口服抗病毒藥物。

In a highly anticipated decision, the Food and Drug Administration authorized the first antiviral pill to treat COVID-19 at home.

在萬眾期待下，美國食品藥品監(jiān)督管理局日前批準了首款家庭用治療新冠肺炎的口服抗病毒藥物。

The pill, called Paxlovid, is made by Pfizer. It's taken twice a day for five days in combination with a second medicine called ritonavir, a generic antiviral.

這款名為Paxlovid的口服藥是輝瑞公司生產(chǎn)的。該藥須和抗病毒藥物利托那韋一起服用，每日兩次，一個療程要連續(xù)服用五天。

"Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic," said Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research. "This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19."

美國藥監(jiān)局藥物評估和研究中心主任派翠西亞·卡瓦佐尼博士表示：“首款新冠口服治療藥物今日獲批，標志著我們邁出了抗擊全球疫情的一大步，在出現(xiàn)新變異株的疫情關(guān)鍵時刻提供了抗擊新冠的新工具，并承諾讓新冠重癥高風險人群更便于獲得抗病毒治療?！?/p>

The Pfizer treatment could help keep people infected with the coronavirus from getting so sick that they need to be hospitalized.

這款輝瑞口服藥能有助于防止新冠病毒感染者發(fā)展成重癥，避免住院治療。

The results from a Pfizer study involving more than 2,200 people at high risk for developing serious COVID-19 found Paxlovid reduced the risk of hospitalization or death by 89%, compared with a placebo, when taken within three days of first symptoms of illness. When taken within five days, the drug reduced the risk of hospitalization and death by 88%.

一項涵蓋了2200多名新冠重癥高風險患者的輝瑞研究結(jié)果發(fā)現(xiàn)，相比安慰劑，患者在出現(xiàn)早期新冠癥狀三日內(nèi)服用Paxlovid能將住院或死亡風險降低89%，在五日內(nèi)服用能降低88%。

Early results from another Paxlovid study showed a 70% reduction in hospitalization risk among several hundred people at lower risk for severe disease.

另一項對Paxlovid口服藥的研究涵蓋了數(shù)百名新冠重癥低風險患者，早期結(jié)果顯示，可以將這一人群的住院風險降低70%。

Although it's not certain, Paxlovid's efficacy is unlikely to be reduced in treating people infected with the omicron variant of the coronavirus virus. The drug, which belongs to a family called protease inhibitors, doesn't target the virus's spike protein, as the vaccines do.

盡管尚不確定，但是用Paxlovid來治療奧密克戎變異株感染者應(yīng)該也同樣有效。與疫苗作用的靶標不一樣，Paxlovid是一種蛋白酶抑制劑，針對的不是病毒的纖突蛋白。

The federal government has a contract with Pfizer to buy 10 million courses of the treatment for $5.3 billion. But initial supplies of Paxlovid will be limited. The company says it will have 180,000 courses of treatment ready by the end of the year.

美國聯(lián)邦政府已和輝瑞公司簽約，以53億美元（約合人民幣338億元）的價格購入1000萬個療程的藥物。但是Paxlovid的初期供應(yīng)量會比較有限。輝瑞表示，年底前將生產(chǎn)出18萬個療程的藥物。

英文來源：美國國家公共廣播電臺

翻譯&編輯：丹妮