一直以为血浆疗法是现在治疗重症的方案之一，之前版上不是有人说她爸爸住院的时候就接受了人民的希望和血浆疗法然后治好了么？ https://nypost.com/2020/08/19/fda-halts-emergency-approval-of-covid-blood-plasma-treatment/ The Food and Drug Administration’s emergency authorization for blood plasma as a treatment for the coronavirus has been put on hold to allow for more data to be reviewed, according to a report. An emergency approval could still be issued by the FDA in the near future, H. Clifford Lane, clinical director at the National Institute of Allergy and Infectious Diseases, told the New York Times. Several top health experts — including Dr. Anthony Fauci and Dr. Francis Collins, director of the National Institutes of Health — intervened last week, saying that data on the treatment was too weak, two senior administration officials told the newspaper. Donated by patients who have survived COVID-19, antibody-rich plasma has been deemed safe, but clinical trials have not proved whether it can help people fighting the disease. Fauci, a member of the White House coronavirus task force, Lane and Collins urged fellow experts to hold off, citing emerging data from the country’s largest plasma study by the Mayo Clinic. “The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Lane told the Times on Tuesday. The emergency authorization was based on the history of plasma’s use in other disease outbreaks, as well as on animal research and several studies, including Mayo’s program, the paper reported. An FDA spokesperson declined to comment to the Times. Researchers from the FDA studied 20,000 patients who doctors believed might progress to severe or life-threatening stages of COVID-19, according to a recent CNN report. They received the so-called convalescent plasma between April 3 and June 11 for the study, which was published in Mayo Clinic Proceedings. The treatment — which has been used to treat measles, influenza and Ebola — takes advantage of the fact that people who recover from an infection develop virus-fighting antibodies in their blood. Transfusions of their convalescent plasma — the clear liquid after blood cells are removed — may give the immune systems of recipients a boost in fighting off the virus.
找到一个NIH对重症治疗的guideline https://www.covid19treatmentguidelines.nih.gov/critical-care/ 里面推荐的药物疗法 Pharmacologic Interventions: See the Remdesivir section for a detailed discussion of these recommendations. On the basis of the preliminary report from the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, the Panel recommends using dexamethasone 6 mg per day for up to 10 days for the treatment of COVID-19 in patients who are mechanically ventilated (AI) and in patients who require supplemental oxygen but who are not mechanically ventilated (BI). The Panel recommends against using dexamethasone in patients with COVID-19 who do not require supplemental oxygen (AI). If dexamethasone is not available, the Panel recommends using alternative glucocorticoids such as prednisone, methylprednisolone, or hydrocortisone (AIII). There are insufficient data for the Panel to recommend either for or against any other immunomodulatory therapy in patients with severe COVID-19 disease. In patients with COVID-19 and severe or critical illness, there are insufficient data to recommend empiric broad-spectrum antimicrobial therapy in the absence of another indication.
标题应该说是暂停了广泛approval 但是仍然允许emergency approval could still be issued 关注一下 看看NHS这边会不会跟进 梅干茶泡饭 发表于 2020-08-19 18:00
是吗？我的理解是原本是emergency authorization，现在被叫停了 The Food and Drug Administration’s emergency authorization for blood plasma as a treatment for the coronavirus has been put on hold to allow for more data to be reviewed, according to a report.
是吗？我的理解是原本是emergency authorization，现在被叫停了 The Food and Drug Administration’s emergency authorization for blood plasma as a treatment for the coronavirus has been put on hold to allow for more data to be reviewed, according to a report. 默雨润苗 发表于 2020-08-19 18:07
authorization应该是所有地方都可以用这个treatment 这个被取消了 但是emergency approval could still be issued可以个例review
https://nypost.com/2020/08/19/fda-halts-emergency-approval-of-covid-blood-plasma-treatment/
The Food and Drug Administration’s emergency authorization for blood plasma as a treatment for the coronavirus has been put on hold to allow for more data to be reviewed, according to a report. An emergency approval could still be issued by the FDA in the near future, H. Clifford Lane, clinical director at the National Institute of Allergy and Infectious Diseases, told the New York Times.
Several top health experts — including Dr. Anthony Fauci and Dr. Francis Collins, director of the National Institutes of Health — intervened last week, saying that data on the treatment was too weak, two senior administration officials told the newspaper.
Donated by patients who have survived COVID-19, antibody-rich plasma has been deemed safe, but clinical trials have not proved whether it can help people fighting the disease.
Fauci, a member of the White House coronavirus task force, Lane and Collins urged fellow experts to hold off, citing emerging data from the country’s largest plasma study by the Mayo Clinic.
“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Lane told the Times on Tuesday.
The emergency authorization was based on the history of plasma’s use in other disease outbreaks, as well as on animal research and several studies, including Mayo’s program, the paper reported.
An FDA spokesperson declined to comment to the Times.
Researchers from the FDA studied 20,000 patients who doctors believed might progress to severe or life-threatening stages of COVID-19, according to a recent CNN report.
They received the so-called convalescent plasma between April 3 and June 11 for the study, which was published in Mayo Clinic Proceedings.
The treatment — which has been used to treat measles, influenza and Ebola — takes advantage of the fact that people who recover from an infection develop virus-fighting antibodies in their blood.
Transfusions of their convalescent plasma — the clear liquid after blood cells are removed — may give the immune systems of recipients a boost in fighting off the virus.
https://www.covid19treatmentguidelines.nih.gov/critical-care/
里面推荐的药物疗法
Pharmacologic Interventions: See the Remdesivir section for a detailed discussion of these recommendations. On the basis of the preliminary report from the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, the Panel recommends using dexamethasone 6 mg per day for up to 10 days for the treatment of COVID-19 in patients who are mechanically ventilated (AI) and in patients who require supplemental oxygen but who are not mechanically ventilated (BI). The Panel recommends against using dexamethasone in patients with COVID-19 who do not require supplemental oxygen (AI). If dexamethasone is not available, the Panel recommends using alternative glucocorticoids such as prednisone, methylprednisolone, or hydrocortisone (AIII). There are insufficient data for the Panel to recommend either for or against any other immunomodulatory therapy in patients with severe COVID-19 disease. In patients with COVID-19 and severe or critical illness, there are insufficient data to recommend empiric broad-spectrum antimicrobial therapy in the absence of another indication.
是啊万一不小心控制住了咋办
我们这也是，单位发群信号召康复者捐血浆
今天在网上还看到有人在为家人求血浆，这叫停是表示立马就不能用了？
那如果是last hope呢？
关注一下 看看NHS这边会不会跟进
是吗？我的理解是原本是emergency authorization，现在被叫停了
The Food and Drug Administration’s emergency authorization for blood plasma as a treatment for the coronavirus has been put on hold to allow for more data to be reviewed, according to a report.
针对细胞风暴的啊，il6的俩做出来不理想，其他几个通路的还在trial 中和抗体应该也快了，还有筛库不知道会不会筛出来啥别的药
有更好的选择那就太好了！
authorization应该是所有地方都可以用这个treatment 这个被取消了 但是emergency approval could still be issued可以个例review
谢谢分享，要是有进展得来update啊
推荐你去追这个blog，应该算比较好懂的 https://blogs.sciencemag.org/pipeline/ 看不太明白的话reddit的covid19 sub里面有讨论贴
谢谢！