Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days.
Those randomly assigned to the experimental treatment group will take 400 milligrams (mg) of hydroxychloroquine twice on the first day and 200 mg twice daily for an additional six days. They also will take 500 mg of azithromycin on the first day and 250 mg daily for an additional four day
Children seem to be very sensitive to the toxic effects both drugs. Any dose higher than a single maximum therapeutic dose is considered potentially toxic in children.
>10 mg/kg of hydroxychloroquine base (13 mg/kg of hydroxychloroquine sulfate)
>10 mg/kg of chloroquine base (16.6 mg/kg chloroquine phosphate)
A dose only 2 to 3 times the therapeutic dose may be fatal in children. This equates to only 1 or 2 prescription tablets of 500 mg chloroquine phosphate in toddlers.
就像年初中国疫情严重的时候有300多个药物申报临床试验。现在全球注册申报的治疗新冠以及相关适应症的二期和三期临床药物试验有很多。只是见诸媒体的似乎只有CHQ。 我查了一下clinicaltrials.gov. 三期临床的trial 目前 active recruiting 的就有188 个。搜索限制到羟氯喹的三期临床有50个。说明这个药还在非常活跃的trial阶段。真的应该耐心的到随机双盲的实验结果出来了,最终通过data 最后决定是否approve。反过来说,新冠有这么多的不同的药物在trials 阶段,只要允许各个trials正常进行就是最大的公平。
说到双盲实验,我的理解它还是适合绝大多数药效和安全评估的金标准。现在有single arm trial, 但是有严格的前提条件,比如病人数极少的罕见病,无法招募足够的对照组病人,恶性疾病,伦理上不允许给测试组对照placebo. 新冠感染还是适合标准的双盲对照药效试验的。因为感染人数非常大,轻症很多,住院率并不高,死亡率也不高。此外trial设计上也有考虑给所有病人标准治疗基础上给和不给测试药物,所以也不大存在ethical issue。
媒体,政府,政治,群众们对治疗药物的批准过程如果啥也不做,就是给专业人士最大的支持了。
个人理解,不一定是对的,讨论没问题,批斗吵架就不回复了。谢谢。
俺楼下也说了。
关于好心俺有切身体会,俺家亲戚是某功信徒,经常跑到俺家传“福音”。
他们真的是为俺父母好,比如兴冲冲跑来说,俺给你退党/团了,你的罪孽消了,能上天堂了。俺帮你做什么了,老师说了,这样可以为亲人消孽。
from: nejm
https://www.nejm.org/doi/full/10.1056/NEJMoa2019014
Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days.
这个trial:
https://www.nih.gov/news-events/news-releases/nih-begins-clinical-trial-hydroxychloroquine-azithromycin-treat-covid-19
Those randomly assigned to the experimental treatment group will take 400 milligrams (mg) of hydroxychloroquine twice on the first day and 200 mg twice daily for an additional six days. They also will take 500 mg of azithromycin on the first day and 250 mg daily for an additional four day
Frontline doctor transcript for covid dosage:
https://www.rev.com/blog/transcripts/americas-frontline-doctors-scotus-press-conference-transcript
And the dose, my friends is 200 milligrams twice in a week and zinc daily. That’s the dose. I’m in favor of it being over the counter.
Clinical Trial 的osage明显要比这位doctor提议的要多很多, 这个会不会是临床试验结果氯喹有害无益的原因?
毕竟, 氢氯喹防疫应用有60,70年了, 就连cdc网站都说safe for children 和pregnant women.
https://www.cdc.gov/malaria/resources/pdf/fsp/drugs/Hydroxychloroquine.pdf?fbclid=IwAR1lVp5ucnLK9g_crh1lro-BHlgFiqXT7sOP30lNVtTLvWCxZT5dcbB4MuM
到这药有没有用。可不可怕。那时候,老头不戴口罩,整天开会,哈哈哈。
羟氯喹 400mg twice daily 有点偏高。 这个药不大可能非处方,因为毒性剂量和治疗剂量的范围不够大。尤其对儿童更危险。不是所谓的安全便宜有效的老药。
Children seem to be very sensitive to the toxic effects both drugs. Any dose higher than a single maximum therapeutic dose is considered potentially toxic in children.
>10 mg/kg of hydroxychloroquine base (13 mg/kg of hydroxychloroquine sulfate)
>10 mg/kg of chloroquine base (16.6 mg/kg chloroquine phosphate)
A dose only 2 to 3 times the therapeutic dose may be fatal in children. This equates to only 1 or 2 prescription tablets of 500 mg chloroquine phosphate in toddlers.
clinical trial 用的剂量太高。羟氯喹抑制病毒在细胞内繁殖复制,不是用来直接抑制炎症。应该早期使用,后期存疑。
transcript里面两位医生说到这个dosage, 搜: Speaker 9: (27:45) and Simone Gold: (29:15)
https://www.rev.com/blog/transcripts/americas-frontline-doctors-scotus-press-conference-transcript