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[Originally published: March 10, 2022. Updated: April 25, 2022] （首次發表日期：2022年3月10日。更新時間：2022年4月25日） Note: Information in this article was accurate at the time of original publication. Because information about COVID-19 changes rapidly, we encourage you to visit the websites of the Centers for Disease Control & Prevention (CDC), World Health Organization (WHO), and your state and local government for the latest information. 注：本文所含信息在首次發表時是準確的。但是，由于Covid-19的相關信息瞬息萬變，我們建議您訪問CDC、世界衛生組織以及您所在國家以及當地政府網站來獲取最新信息。 Paxlovid is the latest COVID-19 treatment that’s been all over the news. The drug was granted an emergency use authorization (EUA) by the Food and Drug Administration (FDA) in December for anyone ages 12 and older who weighs at least 88 pounds—and Pfizer recently began Phase 2 and 3 trials in children and teens ages 6 to 17. Paxlovid作為最新的新冠治療藥物已出現在各個新聞報道中。2021年12月，食品藥品管理局（FDA）已為該藥批準了緊急使用許可（EUA）。該藥物適用于任何年齡在12歲及以上且體重至少為88磅的人群。輝瑞目前已開始在年齡在6-17歲的兒童和青少年之中展開第二期和第三期試驗。 Paxlovid is an oral antiviral pill that can be taken at home to help keep high-risk patients from getting so sick that they need to be hospitalized. So, if you test positive for the coronavirus (and your doctor writes you a prescription), you can take pills at home and lower your risk of going to the hospital. Paxlovid是一種口服的抗病毒藥片。該藥片可以在家中服用并幫助高風險患者遠離住院風險。因此，如果您的新冠測試結果為陽性（且醫生為您開具了藥方），您可在家中服藥并減少住院風險。 The drug, developed by Pfizer, appears to have a lot of positives: It had an 89% reduction in the risk of hospitalization and death in the clinical trial that supported the EUA, a number that was high enough to prompt the National Institutes of Health (NIH) to prioritize it over other COVID-19 treatments; it’s cheaper than many other COVID-19 drugs (it’s provided for free by the U.S. government while there is a public health emergency); and, perhaps most reassuring, it is expected to work against the Omicron variant. 輝瑞開發的這款藥物呈現出許多的優勢：在臨床試驗中，該藥物可以將住院和死亡風險減少89%，這一數據足以促使美國國家衛生研究院在新冠治療方案中優先批準該藥物。這款藥物要比許多其他新冠藥物便宜（當公眾健康情況緊急時，美國政府將免費提供該藥物）；并且，也許最讓人安心的是，這款藥物對奧密克戎也有效。 “I think it is the beginning of a ‘game-changer,’” says Scott Roberts, MD, a Yale Medicine infectious diseases specialist. “It's really our first efficacious oral antiviral pill for this virus. It shows clear benefit, and it really can prevent hospitalization and death in people who are at high risk.” 醫學博士、耶魯大學醫學院傳染病專家Scott Roberts表示：“我認為這是游戲規則改變者的開始。這確實是我們首款有效的針對新冠病毒的抗病毒藥片。這款藥物具有明顯的益處。它確實可以預防高風險人群住院和死亡。” It’s important to note that Paxlovid (the brand name for the drug, which is made up of two generic medications—nirmatrelvir and ritonavir) isn’t the only pill available to treat COVID-19. The FDA also granted an EUA in December to a pill from Merck called molnupiravir (Lagevrio), but some studies suggest that molnupiravir has only a 30% reduction in the risk for hospitalization and death from COVID-19. 有一點需要強調，那就是Paxlovid（藥物品牌名稱，由兩類藥物組成-nirmatrelvir 和ritonavir）并非是唯一可以治療新冠肺炎的藥物。在去年的12月，FDA還為Merck推出的一款藥物授予EUA。但是一些研究表明，molnupiravir只能使住院和死亡風險減少30%。 And as far as convenience, this medication is considered an improvement over treatments like remdesivir (approved by the FDA in October 2020), which is administered by intravenous (IV) injection. 從方便的角度而言，Paxlovid比其他治療藥物比如瑞德西韋（2020年10月由FDA批準）有進一步的改善。瑞德西韋采用靜脈注射（IV）的方式。 We asked Yale Medicine infectious diseases experts common questions about Paxlovid. Below are their responses. 我們向耶魯醫學院傳染病專家提出了有關Paxlovid的一些常見問題。以下是他們的回答。 How does Paxlovid work? Paxlovid的作用原理是什么？ Paxlovid is an antiviral therapy that consists of two separate medications packaged together. When you take your three-pill dose, two of those pills will be nirmatrelvir, the drug that inhibits the SARS-CoV-2 protein from replicating. The other is ritonavir, a drug that was once used to treat HIV/AIDS but is now used to boost levels of antiviral medicines. Paxlovid是一種抗病毒治療法，其包括兩種獨立的藥物，這兩種藥物被包裝在一起。當服用由三種藥片組成的藥物時，其中的兩種藥片是nirmatrelvir（奈瑪特韋），一種抑制SARS-CoV-2蛋白質進行復制的藥物。另一種是ritonavir（利托那韋），一種曾經用于治療HIV/AIDS的藥物，其在Paxlovid的用途主要是增強抗病毒藥物的濃度。 As a COVID-19 treatment, ritonavir essentially shuts down nirmatrelvir’s metabolism in the liver, so that it doesn’t move out of your body as quickly, which means it can work longer—giving it a boost to help fight the infection. 作為治療COVID-19的藥物，ritonavir的主要作用是停止nirmatrelvir在肝臟中的代謝，因此，nirmatrelvir不會被快速排出體外，這意味著其可以更長時間地發揮作用-因此有助于提升抗感染水平。 When should I take Paxlovid? 在什么情況下我要服用Paxlovid？ You have to take Paxlovid within five days of developing symptoms. Like all antivirals, Paxlovid works best early in the course of an illness—in this case, within the first five days of symptom onset, says Jeffrey Topal, MD, a Yale Medicine infectious diseases specialist who is involved in determining COVID-19 treatment protocols for Yale New Haven Hospital patients. 你要在出現癥狀后的五天內服用Paxlovid。和所有抗病毒藥物一樣， Paxlovid在病程初期作用最佳-對于Covid-19而言，在癥狀出現前五天內服用，Jeffrey Topal，醫學博士，耶魯醫學院傳染病專家表示。Jeffrey Topal參與了為耶魯紐黑文醫院的患者制定COVID-19治療方案。 “Once you’ve been ill with the virus for more than a week, the damage done to the body in a severe case can’t be undone by the antiviral,” he says. “一旦病毒在體內超過一周，在嚴重情況下，藥物無法修復病毒對身體所造成的損害，”他表示。 How often do I take Paxlovid? Paxlovid應該怎樣服用？ You take three Paxlovid pills twice daily for five days for a full course that adds up to 30 pills. It helps that the pills are packaged in a “dose card,” basically a medication blister pack that allows you to punch out the pills as needed. 完整的療程是3種Paxlovid藥片每天服用兩次，連續服用5天，總共是30粒藥。藥片被包裝在一個“劑量卡”中，劑量卡采用藥物泡罩包裝，你可以按需擠出藥物服用。 Is Paxlovid similar to Tamiflu? Paxlovid和達菲類似嗎？ “I think it's a good comparison,” says Dr. Roberts. Tamiflu is an antiviral drug that reduces flu symptoms. Both are prescription-only oral antiviral pills given early in illness. Roberts博士說：“這是一個非常好的比喻。”達菲是一種緩解流感癥狀的抗病毒藥物。兩種藥物都是處方藥，都是在病程初期服用的抗病毒藥物。 Tamiflu is taken twice a day for five days, and it must be started within 48 hours of flu onset. “When you give a patient Tamiflu beyond that, it doesn’t really change the course of their flu,” Dr. Roberts says. But there are also differences between the two, starting with the way they were studied, Dr. Topal adds. Researchers showed that Paxlovid can prevent hospitalization and death. But since influenza causes fewer severe cases, clinical trials focused on whether Tamiflu could shorten the length of flu illness—which it did, he says. 達菲是每天服用兩次，連續服用5天，而且其必須在流感開始后48小時內服用。Roberts博士表示：“如果在流感開始48小時之后再給患者開具該藥物，那么藥物實際上不會再對病程發揮任何作用。”但是，兩種藥物之間也存在差異，首先是研究它們的方式。Topal博士補充表示。研究人員表示，Paxlovid可以預防住院和死亡。但是，由于流感引起重癥的情況要比Covid-19要少，臨床試驗主要關注達菲是否能夠縮短流感的時間-而達菲確實能夠發揮這一作用。 Can anyone get a Paxlovid prescription? 任何人都可以獲得Paxlovid處方嗎? The FDA authorized Paxlovid for people ages 12 and older who weigh at least 88 pounds. But in order to qualify for a prescription, you must also have had a positive COVID-19 test result and be at high risk for developing severe COVID-19. FDA允許年齡在12歲及以上且體重至少為88磅的人服用Paxlovid。但是，你必須新冠測試呈陽性且有重癥高風險性時才有資格獲得處方。 That means you must either have certain underlying conditions (including cancer, diabetes, obesity, or others) or be 65 or older (more than 81% of COVID-19 deaths occur in in this group). The more underlying medical conditions a person has, the higher their risk for developing a severe case of COVID-19, according to the CDC. The hope is that the restrictions on who can take Paxlovid will be relaxed over time. The FDA granted the EUA in December, just as a staggering number of people were infected with Omicron and the need for care skyrocketed, leading to supply issues. 這意味著你必須患有某些基礎疾病（包括癌癥、糖尿病、肥胖等）或者65歲及以上（超過81%的新冠死亡人數出現在這一年齡段）。根據CDC，一個人的基礎疾病越多，那么出現新冠重癥的風險也就越高。對于誰可以服用Paxlovid的限制有望在未來有所放松。當感染奧密克戎的人數直線上升且需要治療的需求開始井噴后，FAD在12月份頒發了EUA。 How well does Paxlovid work? Paxlovid的效果如何？ When it applied for FDA authorization, Pfizer presented data from a clinical trial conducted between mid-July and early December in 2021. The data showed that participants (all of whom were unvaccinated) who were given Paxlovid were 89% less likely to develop severe illness and death compared to trial participants who received a placebo. (While the recommendation is to take Paxlovid within five days of symptom onset, participants in the clinical trial took the drug within three days.) 申請FDA許可時，輝瑞提交了2021年7月中至12月初的臨床試驗數據。數據表明，與服用安慰劑的臨床試驗人員相比，服用Paxlovid的人員（均未接種疫苗）出現重癥和死亡的可能性減少了89%。（盡管建議是在癥狀出現后5天之內服用Paxlovid，臨床試驗的參與人員在3天內就服用了藥物）。 Scientists will continue to study the drug’s effectiveness as it is used to treat patients in the real world. 科學家們將在藥物用于治療現實生活中的患者期間繼續研究該藥物的藥效。 What do we know about how Paxlovid works in kids? Paxlovid對兒童的作用是怎樣的？ Pfizer launched a clinical trial in March to study the safety and efficacy of Paxlovid in children and teenagers ages 6 to 17 who have COVID-19 symptoms and test positive for the virus, and who are neither hospitalized nor at risk for severe disease. 輝瑞在3月所發布的一項臨床試驗主要研究Paxlovid對有新冠癥狀且病毒測試呈陽性的年齡在6-17歲的兒童的安全性和藥效。這些兒童既沒有住院也沒有重癥風險。 While Paxlovid is authorized for use in adolescents and teenagers ages 12 and up, and weighing at least 88 pounds, that age group wasn’t tested in the original clinical trial. But because many children reach 88 pounds—considered to be an adult weight—the FDA has allowed extensions of EUAs for medications such as monoclonal antibodies and remdesivir in younger age groups, adds Dr. Topal. 盡管Paxlovid允許用于年齡在12歲及以上并且體重至少為88磅的未成年人和青少年，這一年齡段的青少年并未在最初的臨床試驗中接受試驗。但是，由于許多兒童的體重都達到了88磅（被認為屬于成人體重），FDA為用于少兒年齡段的單克隆抗體和瑞德西韋提供了EUA拓展。 “Based on the pharmacokinetics of the drugs in Paxlovid, the differences in metabolism and excretion—liver and kidney function specifically—of these drugs in this age group are thought to be similar to that of adults,” Dr. Topal says. Topal表示：“根據Paxlovid藥物的動力學，這一年齡段藥物在代謝和排泄-特別是肝臟和腎臟功能方面的差異被認為和成人的藥物類似。” Does Paxlovid work against Omicron? Paxlovid對奧密克戎有作用嗎？ Paxlovid’s clinical trials took place before Omicron became predominant, but Pfizer says the drug works against the highly contagious variant. Three laboratory-based studies claim to back this up—two of those studies were conducted by Pfizer, while the third was done by Pfizer in partnership with the Icahn School of Medicine at Mount Sinai. These studies have not yet been published in peer-reviewed medical journals. Paxlovid的臨床試驗是在奧密克戎大規模傳染時完成的，但是輝瑞表示，藥物對高度傳染性的病毒變體有效。三項試驗研究都表示支持這一觀點-其中兩項研究由輝瑞完成，第三項研究由輝瑞和美國西奈山伊坎醫學院共同完成。這些研究目前尚未發表在經同行審查的醫學期刊上。 What are the side effects from Paxlovid? Paxlovid有哪些副作用？ Most people who take Paxlovid should not experience serious side effects, explains Dr. Roberts. “Paxlovid is usually very well-tolerated,” he says. Common side effects, which are usually mild, include: 大部分服用Paxlovid 的人應該不會有非常嚴重的副作用，Roberts博士解釋道。“Paxlovid通常具有非常良好的耐受性，”他說。常見的副作用往往是輕微的，具體包括 Altered or impaired sense of taste 味覺發生變化或受損 Diarrhea 腹瀉 Increased blood pressure 血壓升高 Muscle aches 肌肉疼痛 Since Paxlovid is cleared by the kidneys, dose adjustments may be required for patients with mild-to-moderate kidney disease, explains Dr. Topal. “For patients with severe kidney disease—or who are on dialysis—or those with severe liver disease, Paxlovid is not recommended; the levels of the drug can become too high and could cause increased side effects,” he says. 由于Paxlovid是通過腎臟代謝，對于患有輕度至中度腎病的患者服用的劑量可能需要調整。“對于患有嚴重腎病的患者-或正在透析-或患有嚴重肝病的患者，不建議服用Paxlovid；藥物的濃度會過高并可能會導致副作用增加，”他表示。 It’s worth noting that Paxlovid is still being studied, so it is possible that all of the risks are not yet known. (The FDA has provided a fact sheet on Paxlovid with a full list of known side effects.) 值得注意的是，Paxlovid仍在研究階段，因此所有的風險可能仍然處于未知狀態。（FAD已經提供了一張有關Paxlovid的資料清單，清單上完整列出了已知的副作用。） Do I still need to be 'up to date' on vaccination if Paxlovid is available? 有了Paxlovid后，我還需要接種最新的疫苗嗎？ Vaccination remains a key part of prevention, even as more drugs become available, says Dr. Topal. He pictures prevention as an upside-down pyramid. Vaccination, mitigation efforts, such as masking, and testing would be at the base—and medications at the top point. Topal博士表示，即使還會出現更多治療新冠的藥物，疫苗仍然是預防的關鍵舉措。他將預防比作是一個倒過來的金字塔。疫苗，預防措施，比如佩戴口罩以及測試都是基礎-藥物則處于塔頂。 “Early testing is key to making these drugs work,” he says. “It’s always been the Achilles’ heel of these antiviral drugs that most people don’t get tested—or they don’t have access to testing.” “早期檢測是使這些藥物發揮作用的關鍵。大部分人不去檢測-或者他們無法檢測是這些抗病毒藥物最致命的弱點。” He encourages taking a test even if you think you only have a cold or allergies—and if you can get one. “Home testing is a huge part of the way to really ‘operationalize’ these medications,” he says, adding that while home tests may not be as highly sensitive as the laboratory-based polymerase chain reaction (PCR) tests, they are still very helpful in making a diagnosis. 他鼓勵人們-如果可以檢測的話，還是去檢測，哪怕你認為自己僅僅是感冒了或過敏了。“居家檢測是讓這些藥物真正發揮作用的關鍵。”他補充表示，盡管居家檢測的靈敏度也許不會像實驗室的PCR檢測那么高，但是對于診斷還是非常有幫助的。 Dr. Topal says people also should remember that Paxlovid, even with its high efficacy, is not perfect, and even if it were, viruses can mutate and develop resistance to antiviral medications. “Will some people still be hospitalized? Yes—no medication is perfect,” he says. “But for many high-risk patients, this medication can really reduce that risk.” If you are experiencing symptoms of COVID-19 and think you are eligible for a treatment, you can visit the government Test-to-Treat Locater. You can use the site to search for the places near you where you can fill a COVID-19 prescription, or identify sites that provide testing, medical care, and COVID-19 medications. Topal博士表示，人們應該了解，盡管Paxlovid的效果很好，但它并非是完美的藥物。即使它很完美，病毒也會變異而且會對抗病毒藥物產生抵抗。“那么還是會有人住院嗎？是的-沒有哪種藥物是完美的，”他說。“但是，對于許多高風險的患者，這一藥物確實能夠減少風險。”如果你有COVID-19的癥狀并且認為自己符合服藥條件，你可以訪問政府的Test-toTreat Locater。您可以使用該網站查詢離您最近的、可以申請COVID-19處方藥的地方，或查詢可以提供測試、醫護以及COVID-19藥物的地方。 文章來源：Yale Medicine 翻譯&編輯：上海譯銳翻譯 圖片來源：Getty Images