FDA暂停COVID-19康复者血浆疗法

默雨润苗
楼主 (北美华人网)
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.

COHomeSearch
Fda这两天灭绝师太附体吗,刚灭了gilead和biomarin的药(非新冠相关),又来一个
Ruth
血浆疗法我一直理解是没办法万不得已的时候救命用的。
默雨润苗
重症的话除了人民的希望和血浆疗法,还有什么主要选择吗?地塞米松应该也算
huaren_ID
主要是其他方法多起来了吧。。。
kewiu
这个是应该的,现在的血浆疗法就是死马当活马医,根本不知道血浆里面有多少中和抗体
s
sunfic
治好的人太多 药太便宜 不好办
tiffany2013
只能上莲花清瘟了。
默雨润苗
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 prednisonemethylprednisolone, 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.
花花痴
治好的人太多 药太便宜 不好办
sunfic 发表于 2020-08-19 17:29

是啊万一不小心控制住了咋办
hofn
我们local 还在大力征召plasma donors 呢
applestore
血浆疗法不可控因素太多,血里面那么多东西,每个人的血都不一样,都是没办法应急用一下。
华人马甲
为啥又是fauci站出来说没用,是因为现在死人少了显得纽约无能么。
默雨润苗
我们local 还在大力征召plasma donors 呢
hofn 发表于 2020-08-19 17:47

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?
默雨润苗
血浆疗法不可控因素太多,血里面那么多东西,每个人的血都不一样,都是没办法应急用一下。
applestore 发表于 2020-08-19 17:51

那如果是last hope呢?
梅干茶泡饭
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
e
erniuth
有几个study出来的结果就是很不理想,血浆成分太复杂,现在有其他更有效的选择就不需要了 一开始觉得有用做了双盲没用的很常见了,不要想太多
默雨润苗
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.
e
erniuth
重症的话除了人民的希望和血浆疗法,还有什么主要选择吗?地塞米松应该也算
默雨润苗 发表于 2020-08-19 17:27

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
默雨润苗
有几个study出来的结果就是很不理想,血浆成分太复杂,现在有其他更有效的选择就不需要了 一开始觉得有用做了双盲没用的很常见了,不要想太多
erniuth 发表于 2020-08-19 18:03

有更好的选择那就太好了!
EdwardVIII
康復者血漿裏有抗體可以殺病毒,但重症主要是過激免疫反應,已經反應了以後外加抗體沒什麽用。
梅干茶泡饭
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

默雨润苗
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

erniuth 发表于 2020-08-19 18:07

谢谢分享,要是有进展得来update啊
sweetme
也不是都有用,我同事的孩子(30+)就是能用的办法都用了,最后还是需要移植肺
e
erniuth
回复 23楼默雨润苗的帖子
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
默雨润苗
回复 23楼默雨润苗的帖子
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
erniuth 发表于 2020-08-19 18:22

谢谢!
mfc
血浆疗法是不是弊大于利?