抗新冠新药展望
原创 廖博士 廖博士国际新药快讯 今天
When might experimental drugs to treat Covid-19 be ready? A forecast
什么时候治疗Covid-19的实验药物可以成功？请看预报
Drug companies and medical researchers are making heroic efforts to deliver new medicines. Several dozen are now in development. Studies so far are mostly small and lack real control groups, making it hard for researchers to be sure of their conclusions.
制药公司和医学研究人员正在为研究新药而作出巨大的努力。现在有几十个新药正在研发中。迄今为止的研究大多规模较小，缺乏真正的对照组，这使得研究人员很难确定他们的结论。
Doctors on the front lines have been trying older medicines, such as the malaria drugs hydroxychloroquine and chloroquine, in the hopes that they will prove effective. Large studies of such medicines are already in process. But therelentless pace of the virus’ spread and a sense of desperation can only do so muchto speed up the development of new medicines. Normally, the process to develop new medicines can take a decade or more. And many experimental medicines fail. When it comes to infectious disease treatments,data from the Biotechnology Innovation Organization put the success rate of new medicines just starting clinical testing at 1 in 5.
一线的医生一直在尝试一些老药，比如抗疟药羟氯喹和氯喹，希望它们能被证明是有效的。对这类药物的大规模研究已经在进行中。但是，病毒无情的传播速度和绝望的感觉并不能加快新药的研发。通常开发新药的过程可能需要10年或更长时间。许多实验药物都失败了。在传染病治疗方面，生物技术创新组织的数据显示，即使是进入了临床试验阶段的新药成功率也只有20%。
Is there hope that something will be available soon to help us fight this virus, known as SARS-CoV-2? Here’s a look at what’s on tap and how soon it could be ready. For almost any treatment or preventative, supply could be an issue if large numbers of people need it. Lastly, please note: some of these treatments and vaccines are likely to fail. That is the unfortunate reality of how medicine works.
有没有希望快速找到抗SARS-CoV-2病毒的方法？下面我们就来看看有什么正在进行中，还有多久才能准备好。对于几乎所有的治疗或预防措施，如果大量的人需要的话，供应可能是一个瓶颈。最后，请注意：有些药物和疫苗可能会失败。这就是医学工作的不幸现实。
Existing antiviral medicines
现有抗病毒药物
Timeline: Available now, but efficacy testing could take a month or more.
时间表：现在可用，但疗效评估可能需要一个月或更长时间。
The early hope is on hydroxychloroquine and chloroquine, and many hospitals, including the University of California, San Francisco, and the University of Washington, include them in their treatment guidelines. Some doctors are combining hydroxychloroquine with azithromycin, an antibiotic. Much of the published evidence comes from a very small French study and reports from China. Larger, more rigorous clinical trials are starting, but they will take time. Favipiravir, a flu drug shown in Japan, appeared beneficial in another small study. These medicines, especially the malaria drugs, which are being mass-produced, will be used by doctors on the front lines, but we will have to wait for evidence.
现有抗病毒药物
早期的希望在于羟基氯喹和氯喹，许多医院，包括加州大学旧金山分校和华盛顿大学，都将其纳入治疗指南。一些医生正在把羟基氯喹和阿奇霉素（一种抗生素）结合起来。大部分公布的证据来自法国一项非常小的研究和来自中国的报告。更大规模、更严格的临床试验正在开始，但需要时间。Favipiravir是一种在日本上市的流感药物，在另一项小型研究中似乎是有益的。这些药物，特别是正在大规模生产的疟疾药物，将由一线医生使用，但我们必须等待证据。
Remdesivir
Timeline: First data could come in April
瑞德西韦
时间表：第一批数据可能在4月发布
Remdesivir, an antiviral medicine that failed as an Ebola treatment, was initially developed to work against a different coronavirus. There’s some evidence that it benefits Covid-19 patients. Six large studies are in progress, with the first, in severely ill patients in China, due to finish as early as April 3, according to a government website. A study in patients with milder disease will also finish in April, with two more due in May. In the meantime, Gilead has made the drug available to hundreds of patients on a compassionate use basis. However, it recently said that, due to overwhelming demand, it would suspend access to the drug for all but pregnant women and children.
瑞德西韦对埃博拉病毒无效，最初被开发用来对抗不同的冠状病毒。有证据表明它有益于Covid-19患者。据一家政府网站报道，六项大型研究正在进行中，其中第一项是针对中国重病患者的研究，最早将于4月3日完成。一项针对病情较轻患者的研究也将在4月份完成，5月份还有两项研究将完成。与此同时，吉拉德已经在同情性使用的基础上向数百名患者提供了这种药物。不过，该机构最近表示，由于需求巨大，它将暂停除孕妇和儿童以外的所有人获得该药。
Convalescent plasma
Timeline: May see some use immediately, but research could take months
It’s an old idea that has proven effective in other epidemics: give patients who are sick blood plasma from those who have recovered. It can work because the plasma contains antibodies against the virus, weaponizing the immune system of the sick patient. One recent study from China reported that of 10 patients given convalescent plasma, seven saw their viral loads become undetectable; it noted other improvements in their condition.
Takeda is developing a more refined version of this approach that uses more concentrated antibodies taken from blood. The product may be available in nine to 18 months.
恢复期血浆
时间表：可能会立即看到一些用处，但研究可能需要几个月
这是一个在其他流行病中被证明是有效的老方法：使用那些已经康复的病人血浆。它之所以能起作用，是因为血浆中含有抗病毒的抗体，使病人的免疫系统武装起来。中国最近的一项研究报告称，在10名接受恢复期血浆治疗的患者中，有7名患者的病毒载量变得无法检测；报告指出，他们的病情还有其他改善。
武田公司正在开发一种更精细的方法，使用从血液中提取的更浓缩的抗体。该产品可能在9至18个月后上市。
Arthritis drugs
Timeline: Data could be available by summer; drugs available now
Drugs against autoimmune diseases like rheumatoid arthritis work by tamping down the immune system. This could, ironically, be useful against in Covid-19, because the SARS-CoV-2 virus can make the body overreact, causing what’s called a “cytokine storm,” damaging the body.
Actemra, one such drug made by Roche, is approved for treating the cytokine storm when it is caused by cancer treatments. An unpublished 21-patient study in China showed Actemra reduced fevers and need for supplemental oxygen. Two other firms, Regeneron and Sanofi, launched a study of their similar drug, Kevzara, in Covid-19 patients; the pair has said results could be available as early as April. Roche has begun its own study of Actemra in the U.S. Both Actemra and Kevzara are artificial antibodies that target a protein involved in the immune system called IL-6.
关节炎药物
时间：数据可能在夏天前提供；药物现在有
抗风湿性关节炎等自身免疫性疾病的药物通过抑制免疫系统发挥作用。具有讽刺意味的是，这可能有助于对抗Covid-19，因为SARS-CoV-2病毒会使身体反应过度，导致所谓的“细胞因子风暴”，损害身体。
由罗氏公司生产的Actemra被批准用于治疗由癌症治疗引起的细胞因子风暴。中国一项未发表的21例患者研究显示，Actemra可以减少发烧和氧气的需要。另外两家公司Regeneron和赛诺菲（Sanofi）在Covid-19患者身上启动了一项类似药物Kevzara的研究；这两家公司表示，最早4月份就可以获得结果。罗氏公司已经开始在美国对Actemra进行自己的研究。Actemra和Kevzara都是针对免疫系统的IL-6的人工抗体。
Artificial antibodies against the virus
Timeline: Potentially early fall
Regeneron had success developing a mixture of antibodies against Ebola; it is now selecting two to use against SARS-CoV-2, with the expectation that trials could start by early summer. If all goes well, it could be available by early fall for some uses, like treating extremely sick patients. Eli Lilly, working with a Vancouver startup called AbCellera, has said it hopes to start trials of a similar approach within four months. Vir Biotechnology and Biogen are following a similar path.
抗病毒的人工抗体
时间：可能早秋
Regeneron公司成功地开发出了一种抗埃博拉的混合抗体；它现在正在选择两种抗体用于抗SARS-CoV-2，预计试验将在初夏开始。如果一切顺利的话，它可以在秋天早些时候用于某些病人，比如治疗病重的病人。与温哥华一家名为AbCellera的初创公司合作的礼来公司表示，希望能在4个月内开始类似方法的试验。Vir生物技术公司和Biogen也在走类似的道路。
New antivirals
Timeline: 2021 at the earliest
If existing antivirals cannot control SARS-CoV-2, brand new medicines may be needed. But this process is at square one, and even moving at full-speed could eat up months. Efforts are underway to search chemical libraries for medicines that could prove effective by the Bill and Melinda Gates Foundation and others. If they can find medicines that have gone through some previous testing, as remdesivir has, that could hasten the process.
新型抗病毒药物
时间表：最早2021年
如果现有的抗病毒药物不能控制SARS-CoV-2，可能需要全新的药物。但这才刚刚开始，即使全速前进也要数月的时间。目前正在筛选化学库的药物，由比尔和梅琳达·盖茨基金会（Bill and Melinda Gates Foundation）和其他机构进行验证。如果他们能像雷德西韦一样，找到经过一些先前研究过的药物，则可能会加速这一过程。
Vaccines
Timeline: Late 2021, possibly many years
There is one approach that could deliver a vaccine faster than others: It uses messenger RNA to make cells produce proteins that could lead to immunity. This approach has never been used in a widely available vaccine. The biotech Moderna is in the lead here, but others, such as BioNTech, working with Pfizer, are working on a similar approach.
疫苗
时间：2021年底，可能是很多年
有一种方法可以比其他方法更快地提供疫苗：它使用信使RNA使细胞产生蛋白质，从而导致免疫。这种方法从未在广泛使用的疫苗中使用过。Moderna生物技术公司在这方面处于领先地位，但其他公司，如与辉瑞合作的BioNTech，也在研究类似的方法。
It could take 18 months to be sure that approach works and is broadly safe. Other approaches are being developed in tandem, including one from Sanofi, now used for flu vaccines, that manufactures vaccines in insect cells. However, Moderna said in a filing with the SEC Monday that its vaccine might be available for some groups, including health care workers, as early as fall 2020.
可能需要18个月的时间来确保该方法的有效性和广泛的安全性。其他的方法也在同步开发中，包括赛诺菲公司的一种方法，该公司现在用于流感疫苗，用昆虫细胞生产疫苗。不过，Moderna公司周一在向美国证交会提交的一份文件中表示，该公司的疫苗最早可能在2020年秋季提供给包括医疗工作者在内的一些群体。
“If you look across the many programs that have been launched, if you look at history, not all of those programs will be successful,” said Rajeev Venkayya, president of Takeda’s global vaccines unit, during a press conference last week. “And I think that is something that I don’t think we’ve effectively communicated to the public. Just because we start a vaccine program doesn’t mean that we will definitely get a vaccine on the other end.”
The good news about having so many efforts in progress, is it increases the chances that one will succeed.
武田公司全球疫苗部门总裁Rajeev Venkaya上周在记者招待会上说：“如果你纵观已经启动的许多项目，纵观历史，并非所有这些项目都会成功。”。“我认为这是我们没有有效地与公众沟通的问题。仅仅因为我们启动了疫苗计划，并不意味着我们肯定会成功。”
好消息的有这么多项目在进行，这增加了成功的机会。
重点词汇学习
1. convalescent.[ˌkɑːnvəˈlesnt] adj. 康复期的; 正在康复的; 渐愈的;
2. control group.对照组
3. on the front lines.前线的
4. Malaria.抗疟
5. Hydroxychloroquine.羟氯喹
6. Chloroquine.氯喹
7. in process.进行中
8. relentless.无情的
9. When it comes to.谈到…..
10. azithromycin.阿奇霉素
11. take time.需要时间
12. mass-produce.大规模生产
13. Remdesivir.瑞德西韦
14. severely ill.重病
15. compassionate use.同情性使用
16. plasma.血浆
17. weaponize.使适合用作武器; They were close to weaponizing ricin — a lethal plant toxin. 他们快把蓖麻毒素——一种致命的植物毒素——研发为武器了。
18. rheumatoid arthritis.风湿性关节炎
19. tamp down the immune system.抑制免疫系统
20. ironically.具有讽刺意味
21. cytokine storm.细胞因子风暴
22. square one : the initial stage or starting point the failure set us back to square one Etymology for square one：from the use of numbered squares in some board games
23. at the earliest.最早也要
24. at full-speed.全速
25. in the lead.处于领先地位
26. in tandem.同步
27. look across.眺望; Look across the square. you'll see a tunnel.
28. heroic.非常大的；巨大的 This was foolishness on a heroic scale . 这简直是天大的蠢事。
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