[Originally published: March 10, 2022. Updated: April 25, 2022]

（首次发表日期：2022年3月10日。更新时间：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发表时是准确的。但是，由于Covid-19的相关信息瞬息万变，我们建议您访问CDC、世界卫生组织以及您所在国家以及当地政府网站来获取最新信息。

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作为最新的新冠治疗药物已出现在各个新闻报道中。2021年12月，食品药品管理局（FDA）已为该药批准了紧急使用许可（EUA）。该药物适用于任何年龄在12岁及以上且体重至少为88磅的人群。辉瑞目前已开始在年龄在6-17岁的儿童和青少年之中展开第二期和第三期试验。

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是一种口服的抗病毒药片。该药片可以在家中服用并帮助高风险患者远离住院风险。因此，如果您的新冠测试结果为阳性（且医生为您开具了药方），您可在家中服药并减少住院风险。

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.

辉瑞开发的这款药物呈现出许多的优势：在临床试验中，该药物可以将住院和死亡风险减少89%，这一数据足以促使美国国家卫生研究院在新冠治疗方案中优先批准该药物。这款药物要比许多其他新冠药物便宜（当公众健康情况紧急时，美国政府将免费提供该药物）；并且，也许最让人安心的是，这款药物对奥密克戎也有效。

“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.”

医学博士、耶鲁大学医学院传染病专家Scott Roberts表示：“我认为这是游戏规则改变者的开始。这确实是我们首款有效的针对新冠病毒的抗病毒药片。这款药物具有明显的益处。它确实可以预防高风险人群住院和死亡。”

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.

有一点需要强调，那就是Paxlovid（药物品牌名称，由两类药物组成-nirmatrelvir 和ritonavir）并非是唯一可以治疗新冠肺炎的药物。在去年的12月，FDA还为Merck推出的一款药物授予EUA。但是一些研究表明，molnupiravir只能使住院和死亡风险减少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.

从方便的角度而言，Paxlovid比其他治疗药物比如瑞德西韦（2020年10月由FDA批准）有进一步的改善。瑞德西韦采用静脉注射（IV）的方式。

We asked Yale Medicine infectious diseases experts common questions about Paxlovid. Below are their responses.

我们向耶鲁医学院传染病专家提出了有关Paxlovid的一些常见问题。以下是他们的回答。

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是一种抗病毒治疗法，其包括两种独立的药物，这两种药物被包装在一起。当服用由三种药片组成的药物时，其中的两种药片是nirmatrelvir（奈玛特韦），一种抑制SARS-CoV-2蛋白质进行复制的药物。另一种是ritonavir（利托那韦），一种曾经用于治疗HIV/AIDS的药物，其在Paxlovid的用途主要是增强抗病毒药物的浓度。

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.

作为治疗COVID-19的药物，ritonavir的主要作用是停止nirmatrelvir在肝脏中的代谢，因此，nirmatrelvir不会被快速排出体外，这意味着其可以更长时间地发挥作用-因此有助于提升抗感染水平。

When should I take Paxlovid?

在什么情况下我要服用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.

你要在出现症状后的五天内服用Paxlovid。和所有抗病毒药物一样， Paxlovid在病程初期作用最佳-对于Covid-19而言，在症状出现前五天内服用，Jeffrey Topal，医学博士，耶鲁医学院传染病专家表示。Jeffrey Topal参与了为耶鲁纽黑文医院的患者制定COVID-19治疗方案。

“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.

“一旦病毒在体内超过一周，在严重情况下，药物无法修复病毒对身体所造成的损害，”他表示。

How often do I take Paxlovid?

Paxlovid应该怎样服用？

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.

完整的疗程是3种Paxlovid药片每天服用两次，连续服用5天，总共是30粒药。药片被包装在一个“剂量卡”中，剂量卡采用药物泡罩包装，你可以按需挤出药物服用。

Is Paxlovid similar to Tamiflu?

Paxlovid和达菲类似吗？

“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博士说：“这是一个非常好的比喻。”达菲是一种缓解流感症状的抗病毒药物。两种药物都是处方药，都是在病程初期服用的抗病毒药物。

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.

达菲是每天服用两次，连续服用5天，而且其必须在流感开始后48小时内服用。Roberts博士表示：“如果在流感开始48小时之后再给患者开具该药物，那么药物实际上不会再对病程发挥任何作用。”但是，两种药物之间也存在差异，首先是研究它们的方式。Topal博士补充表示。研究人员表示，Paxlovid可以预防住院和死亡。但是，由于流感引起重症的情况要比Covid-19要少，临床试验主要关注达菲是否能够缩短流感的时间-而达菲确实能够发挥这一作用。

Can anyone get a Paxlovid prescription?

任何人都可以获得Paxlovid处方吗?

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允许年龄在12岁及以上且体重至少为88磅的人服用Paxlovid。但是，你必须新冠测试呈阳性且有重症高风险性时才有资格获得处方。

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.

这意味着你必须患有某些基础疾病（包括癌症、糖尿病、肥胖等）或者65岁及以上（超过81%的新冠死亡人数出现在这一年龄段）。根据CDC，一个人的基础疾病越多，那么出现新冠重症的风险也就越高。对于谁可以服用Paxlovid的限制有望在未来有所放松。当感染奥密克戎的人数直线上升且需要治疗的需求开始井喷后，FAD在12月份颁发了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.)

申请FDA许可时，辉瑞提交了2021年7月中至12月初的临床试验数据。数据表明，与服用安慰剂的临床试验人员相比，服用Paxlovid的人员（均未接种疫苗）出现重症和死亡的可能性减少了89%。（尽管建议是在症状出现后5天之内服用Paxlovid，临床试验的参与人员在3天内就服用了药物）。

Scientists will continue to study the drug’s effectiveness as it is used to treat patients in the real world.

科学家们将在药物用于治疗现实生活中的患者期间继续研究该药物的药效。

What do we know about how Paxlovid works in kids?

Paxlovid对儿童的作用是怎样的？

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.

辉瑞在3月所发布的一项临床试验主要研究Paxlovid对有新冠症状且病毒测试呈阳性的年龄在6-17岁的儿童的安全性和药效。这些儿童既没有住院也没有重症风险。

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.

尽管Paxlovid允许用于年龄在12岁及以上并且体重至少为88磅的未成年人和青少年，这一年龄段的青少年并未在最初的临床试验中接受试验。但是，由于许多儿童的体重都达到了88磅（被认为属于成人体重），FDA为用于少儿年龄段的单克隆抗体和瑞德西韦提供了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：“根据Paxlovid药物的动力学，这一年龄段药物在代谢和排泄-特别是肝脏和肾脏功能方面的差异被认为和成人的药物类似。”

Does Paxlovid work against Omicron?

Paxlovid对奥密克戎有作用吗？

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的临床试验是在奥密克戎大规模传染时完成的，但是辉瑞表示，药物对高度传染性的病毒变体有效。三项试验研究都表示支持这一观点-其中两项研究由辉瑞完成，第三项研究由辉瑞和美国西奈山伊坎医学院共同完成。这些研究目前尚未发表在经同行审查的医学期刊上。

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 的人应该不会有非常严重的副作用，Roberts博士解释道。“Paxlovid通常具有非常良好的耐受性，”他说。常见的副作用往往是轻微的，具体包括

Altered or impaired sense of taste

味觉发生变化或受损

Diarrhea

腹泻

Increased blood pressure

血压升高

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是通过肾脏代谢，对于患有轻度至中度肾病的患者服用的剂量可能需要调整。“对于患有严重肾病的患者-或正在透析-或患有严重肝病的患者，不建议服用Paxlovid；药物的浓度会过高并可能会导致副作用增加，”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仍在研究阶段，因此所有的风险可能仍然处于未知状态。（FAD已经提供了一张有关Paxlovid的资料清单，清单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，我还需要接种最新的疫苗吗？

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，即使还会出现更多治疗新冠的药物，疫苗仍然是预防的关键举措。他将预防比作是一个倒过来的金字塔。疫苗，预防措施，比如佩戴口罩以及测试都是基础-药物则处于塔顶。

“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.”

“早期检测是使这些药物发挥作用的关键。大部分人不去检测-或者他们无法检测是这些抗病毒药物最致命的弱点。”

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.

他鼓励人们-如果可以检测的话，还是去检测，哪怕你认为自己仅仅是感冒了或过敏了。“居家检测是让这些药物真正发挥作用的关键。”他补充表示，尽管居家检测的灵敏度也许不会像实验室的PCR检测那么高，但是对于诊断还是非常有帮助的。

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，人们应该了解，尽管Paxlovid的效果很好，但它并非是完美的药物。即使它很完美，病毒也会变异而且会对抗病毒药物产生抵抗。“那么还是会有人住院吗？是的-没有哪种药物是完美的，”他说。“但是，对于许多高风险的患者，这一药物确实能够减少风险。”如果你有COVID-19的症状并且认为自己符合服药条件，你可以访问政府的Test-toTreat Locater。您可以使用该网站查询离您最近的、可以申请COVID-19处方药的地方，或查询可以提供测试、医护以及COVID-19药物的地方。

文章来源：Yale Medicine

翻译&编辑：上海译锐翻译

图片来源：Getty Images