静脉注射免疫球蛋白，如何帮助治疗新冠肺炎？

Researchers finding ways to use intravenous immunoglobulin for COVID-19 treatment.

As researchers and physicians try to identify ways to effectively treat and prevent COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, some are studying whether high-dose intravenous immunoglobulin (IVIg) could work. IVIg is a common blood plasma product that is used to treat other immune disorders.

当研究人员和医生试图找出有效治疗和预防新冠肺炎（由新型冠状病毒SARS-CoV-2引起的疾病）的方法时，一些人正在研究大剂量静脉注射免疫球蛋白（IVIg）是否有效。IVIg是一种常见的血浆产品，用于治疗其他免疫疾病。

IVIg is purified from the mixed plasma of healthy people, with protein being the main component, which is abundant in bacterial antibodies and viral Immunoglobulin G (IgG). It is clinically used as an adjunctive therapy for the treatment of severe pneumonia caused by influenza, in addition to other immune disorders. There have now been several small studies of the use of IVIg in treating COVID-19.

IVIg是从健康人的混合血浆中纯化的，蛋白质是主要成分，富含细菌抗体和病毒免疫球蛋白G（IgG）。它在临床上被用作治疗流感引起的严重肺炎以及其他免疫疾病的辅助疗法。目前已有几项关于IVIg治疗新冠肺炎的小型研究。

This is different than using convalescent antibodies to treat the disease. Convalescent antibodies refer to taking the blood from people who have recovered from the disease, isolating the plasma, and using their immunoglobulins, a type of immune cell, to treat patients. IVIg is acquired from a more general healthy population, and hospitals typically already have it in stock.

这与使用恢复期抗体治疗疾病不同。康复抗体是指从疾病康复者身上提取血液，分离血浆，并使用免疫球蛋白（一种免疫细胞）治疗患者。IVIg是从更一般的健康人群中获得的，医院通常已经有库存。

“We want to help now and see what we could do with the product that is readily available,” Flemming Nielsen, president of the U.S. subsidiary of Switzerland-based Octapharma AG, told the Wall Street Journal.

总部位于瑞士的Octapharma AG的美国子公司总裁弗莱明·尼尔森（Flemming Nielsen）告诉《华尔街日报》：“我们现在想提供帮助，看看我们能对现成的产品做些什么。”。

Octapharma is studying whether IVIg can help COVID-19 patients and working with other companies to manufacture coronavirus-specific immunoglobulin.

Octapharma正在研究IVIg是否能帮助新冠肺炎患者，并与其他公司合作生产冠状病毒特异性免疫球蛋白。

It’s not known if off-the-shelf IVIg would be effective in treating COVID-19, and how it works is not well understood.

Last year, well before anyone had heard of COVID-19, there was an acute shortage of immunoglobulin in the U.S. It wasn’t a particularly new shortage at that time, either, although now, because of the pandemic, there are concerns of significant shortages.

目前尚不清楚非现成IVIg对治疗新冠肺炎是否有效，也不清楚其工作原理。

去年，早在任何人听说新冠肺炎之前，美国就出现了严重的免疫球蛋白短缺。当时也不是特别新的短缺，尽管现在，由于疫情，人们担心会出现严重短缺。

In a January 2019 article written by John G. Boyle, president, and chief executive officer of the Immune Deficiency Foundation (IDF), he noted that manufacturing and distribution of Ig is complex. It is also considered a specialty drug, meaning it’s not usually available at the local pharmacy.

Michelle Vogel, vice president of patient advocacy for CSI Pharmacy, a specialty pharmacy, told WSJ, “We are just starting to recover from the shortage and this hit.”

在2019年1月由免疫缺乏基金会（IDF）主席兼首席执行官约翰·G·博伊尔（John G.Boyle）撰写的一篇文章中，他指出，Ig的制造和分销非常复杂。它也被认为是一种特殊的药物，这意味着它通常在当地药房不可用。

专业药房CSI Pharmacy的患者宣传副总裁米歇尔·沃格尔（Michelle Vogel）告诉《华尔街日报》，“我们刚刚开始从短缺和这次打击中恢复过来。”

Although it’s possible that IVIg will be effective, most in the field believe working with convalescent plasma makes more sense. Still, a retrospective study of 58 cases of severe or critical COVID-19 in the Wuhan Third Hospital from January to February 2020 suggested that IVIg within 48 hour of admission reduced ventilator use, reduced hospital and ICU length of stay, and ultimately improved 28-day mortality.

尽管IVIg可能会有效，但该领域的大多数人认为使用恢复期血浆更有意义。然而，对2020年1月至2月武汉第三医院58例严重或危重新冠肺炎病例的回顾性研究表明，入院48小时内IVIg减少了呼吸机的使用，缩短了医院和ICU的住院时间，最终提高了28天的死亡率

A broader study of electronic medical records at eight treatment centers in China suggested the benefit was much smaller. Octapharma is supporting a trial of 20 patients at Sharp HealthCare hospitals in the San Diego area. Another company, Spain-based Grifols SA, has released non-peer-reviewed data showing antibodies in its IVIg products might bind to the virus, which suggests the products could help COVID-19 patients. The company is working to get a study going in Spain. And physicians at Sainte-Anne Hospital in Paris are launching a trial of IVIG in COVID-19 patients, potentially in 140 COVID-19 patients on mechanical ventilation.

A big question, not only is effectiveness, but at what point during the disease would IVIg be effective, if at all. A study in three patients in China at the Jin Yin-tan Hospital in Wuhan seemed to suggest that IVIg works best early in the disease.

一项针对中国八家医疗中心电子病历的更广泛研究表明，这种益处要小得多。Octapharma正在圣地亚哥地区的Sharp HealthCare医院支持一项针对20名患者的试验。另一家位于西班牙的Grifols SA公司发布了未经审查的数据，显示其IVIg产品中的抗体可能与病毒结合，这表明该产品可以帮助新冠肺炎患者。该公司正在努力让一项研究在西班牙进行。巴黎圣安医院的医生正在对新冠肺炎患者进行IVIG试验，可能会对140名接受机械通气的新冠肺炎患者进行试验。

一个很大的问题，不仅是有效性，而且在疾病期间，IVIg在什么时候有效（如果有的话）。武汉金银滩医院对中国三名患者进行的一项研究似乎表明，IVIg在该病早期效果最好。

“The best timing of antivirals, if there are any, may lie on the phase before acceleration,” the researchers wrote. “When clinical deterioration begins, the first few days of deterioration may present a critical point when potent suppression of inflammatory cascade could save the patients from fatal immune-mediated injuries.”

They add, “The timing of IVIg administration is very critical in practice. Patients might not receive much benefit when overall systemic damage has already taken place.”

研究人员写道：“抗病毒药物的最佳时机（如果有的话）可能取决于加速前的阶段。”。“当临床恶化开始时，恶化的最初几天可能是一个临界点，此时有效抑制炎症级联反应可以使患者免于致命的免疫介导损伤。”

他们补充道，“IVIg给药的时机在实践中非常关键。当全身损害已经发生时，患者可能不会得到太多益处。

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