熱いMeek
2020-02-02T12:02:30+00:00
关于针对新型冠状病毒吉利德的特效药瑞德西伟目前的流言和断章取义真的是满天飞,笔者能力有限,汇总了一些信息,供泥潭网友查看。希望这帖子不要被迅速冲水了。
NGA是个好论坛,我们都爱她。如果有疑问或对信息来源有异议,请提出,不要虚空立靶。在大家都恐慌的时候,有能力的人认真给大家一些信息,我相信浮躁的信息之下,总还是有人相信老派作风,玩论坛嘛,抵不过一个认真二字。
本人现已不从事医药相关行业,某些专业词汇翻译出现问题或谬误,请论坛内的医生即时指出,我会马上做修改,实事求是,错了就是错了。若有大谬误,可直接编辑掉全文。
利益相关:不持有吉利德或同类小分子抗病毒药物研发药企股票。
现在特效药是个什么情况?
美国药企吉利德之前有一种小分子抗病毒药物叫做Remdesivir(瑞德西伟),原来是用于治疗埃博拉病毒的实验性药物。由于之前可用于同为冠状病毒的中东呼吸综合征病毒(MERS)与SARS的治疗展现了有效性,吉利德的药品自然被考虑是认为是一个合理的,在危机时刻的一个选择。
依照目前的新闻,目前的临床实验的进展喜人,已经启动总样本量270例,入组轻、中度新冠肺炎患者,由中日友好医院曹彬教授牵头,试验预期于2月3日开始,4月27日结束。(我在Clinical trial上未找到本篇的临床招募报告,或还未释放。)
另外,放上知乎大V 杀生丸在1月24日[/color]写下的这篇文章,非常建议有医学背景的同学们读一下。医者仁心,真心佩服杀博他的远见,和在那个时间说话的勇气。
[url]https://zhuanlan.zhihu.com/p/103890473?utm_source=wechat_timeline[/url]
这药有多好?
目前只有一例例子,孤立难证。但唯一例子上效果可观。
原文太长,不全部摘录了。简单地说,入院第六天(病理第十天)的时候基本严重得要上呼吸机了,双肺罗音,肺部条状浑浊,症状和非典类似。第七天给药瑞德西伟后,在细菌性感染指标下降后抗生素暂停使用,第八天血氧饱和度恢复至94%-96%,可直接吸氧,原两侧下叶罗音不显现,之后生理指标显著好转。有趣的一点是:[color=crimson]在病人第七天的粪便里,病毒核酸检测呈阳性。
[img]https://img.nga.178.com/attachments/mon_202002/03/-7Q5-bev6ZxT3cS12a-gj.png.thumb.jpg[/img]
这药真出了,贵吗?
现在很难判断。还是看到时候怎么议价。
下图为第三方渠道找的用于实验室采购的价格,无法保证准确,吉利德网站和相关新闻上未找到对应的价格链接(如果有找到的朋友可以进行补充)。从表格上看,一例100mg的价格39500人民币,很难说算得上便宜。以目前临床实验中的给药频率首日200mg后连续给药100mg/连续9日来计算,真不是老百姓能负担得起的。(药品仅供实验室使用,不适合也不允许个人进行采购与给药。泥潭精英切勿盲目跟风朋友圈进行购买。)
特朗普特批,是真是假?
在查阅了吉利德官方的发言后,并没有找到新闻中引用的“特朗普特批”云云,在Bloomberg也未找到国内各媒体引用的原文(如果有找到消息源请私信)。
吉利德的发言综合一下就这几个意思:
针对新型冠状病毒,各方(FDA,CDC中国CDC,食药监,WHO,NAID等)都非常紧密合作,大家都在共同做贡献,现在瑞德西伟的有效性和安全性还没有通过Clinical trial的Phase III 实验,还不能算得上可以上市,但事急从权,当地当局也同意了,我们就先上马一批药物给你们用一下,并同步进行Phase III的临床实验和实验室实验。
吉利德官方发言节选翻译:
目前瑞德西伟未在全球任何一地被证明通过任何病症的安全性与有效性测试。受外科医生的要求,当地监管部分在衡量了在未有针对治疗新型冠状病毒的数据的前提下,提供实验性药物风险与收益后,监管部门支持吉利德提供了向小部分2019-新型冠状病毒患者提供了瑞德西伟用于急救。
吉利德与安全卫生当局正致力于建立一个随机可控的药理实验来确认瑞德西伟(Remdesivir)针对于2019-新型冠状病毒的安全性与有效性。同时我们也在展开适当的实验室测试瑞德西伟针对2019-新型冠状病毒。结语:
苦难发生在我们身边,我们更该冷静、理性且客观地看待现在的问题,冲动地发泄自己的不满只会让人与人之间的裂痕更大。愿大家多展现一点善意。
References:
NGA是个好论坛,我们都爱她。如果有疑问或对信息来源有异议,请提出,不要虚空立靶。在大家都恐慌的时候,有能力的人认真给大家一些信息,我相信浮躁的信息之下,总还是有人相信老派作风,玩论坛嘛,抵不过一个认真二字。
本人现已不从事医药相关行业,某些专业词汇翻译出现问题或谬误,请论坛内的医生即时指出,我会马上做修改,实事求是,错了就是错了。若有大谬误,可直接编辑掉全文。
利益相关:不持有吉利德或同类小分子抗病毒药物研发药企股票。
现在特效药是个什么情况?
美国药企吉利德之前有一种小分子抗病毒药物叫做Remdesivir(瑞德西伟),原来是用于治疗埃博拉病毒的实验性药物。由于之前可用于同为冠状病毒的中东呼吸综合征病毒(MERS)与SARS的治疗展现了有效性,吉利德的药品自然被考虑是认为是一个合理的,在危机时刻的一个选择。
依照目前的新闻,目前的临床实验的进展喜人,已经启动总样本量270例,入组轻、中度新冠肺炎患者,由中日友好医院曹彬教授牵头,试验预期于2月3日开始,4月27日结束。(我在Clinical trial上未找到本篇的临床招募报告,或还未释放。)
另外,放上知乎大V 杀生丸在1月24日[/color]写下的这篇文章,非常建议有医学背景的同学们读一下。医者仁心,真心佩服杀博他的远见,和在那个时间说话的勇气。
[url]https://zhuanlan.zhihu.com/p/103890473?utm_source=wechat_timeline[/url]
这药有多好?
目前只有一例例子,孤立难证。但唯一例子上效果可观。
原文太长,不全部摘录了。简单地说,入院第六天(病理第十天)的时候基本严重得要上呼吸机了,双肺罗音,肺部条状浑浊,症状和非典类似。第七天给药瑞德西伟后,在细菌性感染指标下降后抗生素暂停使用,第八天血氧饱和度恢复至94%-96%,可直接吸氧,原两侧下叶罗音不显现,之后生理指标显著好转。
Day6的造影 ...
[img]https://img.nga.178.com/attachments/mon_202002/03/-7Q5-gapcZpT3cS1e0-nd.jpeg[/img]
原文关于病情的发展与给药 ...
A chest radiograph taken on hospital day 3 (illness day 7) was reported as showing no evidence of infiltrates or abnormalities (Figure 3). However, a second chest radiograph from the night of hospital day 5 (illness day 9) showed evidence of pneumonia in the lower lobe of the left lung (Figure 4). These radiographic findings coincided with a change in respiratory status starting on the evening of hospital day 5, when the patient’s oxygen saturation values as measured by pulse oximetry dropped to as low as 90% while he was breathing ambient air. On day 6, the patient was started on supplemental oxygen, delivered by nasal cannula at 2 liters per minute. Given the changing clinical presentation and concern about hospital-acquired pneumonia, treatment with vancomycin (a 1750-mg loading dose followed by 1 g administered intravenously every 8 hours) and cefepime (administered intravenously every 8 hours) was initiated.
On hospital day 6 (illness day 10), a fourth chest radiograph showed basilar streaky opacities in both lungs, a finding consistent with atypical pneumonia (Figure 5), and rales were noted in both lungs on auscultation. Given the radiographic findings, the decision to administer oxygen supplementation, the patient’s ongoing fevers, the persistent positive 2019-nCoV RNA at multiple sites, and published reports of the development of severe pneumonia3,4 at a period consistent with the development of radiographic pneumonia in this patient, clinicians pursued compassionate use of an investigational antiviral therapy. Treatment with intravenous remdesivir (a novel nucleotide analogue prodrug in development10,11) was initiated on the evening of day 7, and no adverse events were observed in association with the infusion. Vancomycin was discontinued on the evening of day 7, and cefepime was discontinued on the following day, after serial negative procalcitonin levels and negative nasal PCR testing for methicillin-resistant Staphylococcus aureus.
On hospital day 8 (illness day 12), the patient’s clinical condition improved. Supplemental oxygen was discontinued, and his oxygen saturation values improved to 94 to 96% while he was breathing ambient air. The previous bilateral lower-lobe rales were no longer present. His appetite improved, and he was asymptomatic aside from intermittent dry cough and rhinorrhea. As of January 30, 2020, the patient remains hospitalized. He is afebrile, and all symptoms have resolved with the exception of his cough, which is decreasing in severity.
On hospital day 6 (illness day 10), a fourth chest radiograph showed basilar streaky opacities in both lungs, a finding consistent with atypical pneumonia (Figure 5), and rales were noted in both lungs on auscultation. Given the radiographic findings, the decision to administer oxygen supplementation, the patient’s ongoing fevers, the persistent positive 2019-nCoV RNA at multiple sites, and published reports of the development of severe pneumonia3,4 at a period consistent with the development of radiographic pneumonia in this patient, clinicians pursued compassionate use of an investigational antiviral therapy. Treatment with intravenous remdesivir (a novel nucleotide analogue prodrug in development10,11) was initiated on the evening of day 7, and no adverse events were observed in association with the infusion. Vancomycin was discontinued on the evening of day 7, and cefepime was discontinued on the following day, after serial negative procalcitonin levels and negative nasal PCR testing for methicillin-resistant Staphylococcus aureus.
On hospital day 8 (illness day 12), the patient’s clinical condition improved. Supplemental oxygen was discontinued, and his oxygen saturation values improved to 94 to 96% while he was breathing ambient air. The previous bilateral lower-lobe rales were no longer present. His appetite improved, and he was asymptomatic aside from intermittent dry cough and rhinorrhea. As of January 30, 2020, the patient remains hospitalized. He is afebrile, and all symptoms have resolved with the exception of his cough, which is decreasing in severity.
[img]https://img.nga.178.com/attachments/mon_202002/03/-7Q5-bev6ZxT3cS12a-gj.png.thumb.jpg[/img]
这药真出了,贵吗?
现在很难判断。还是看到时候怎么议价。
下图为第三方渠道找的用于实验室采购的价格,无法保证准确,吉利德网站和相关新闻上未找到对应的价格链接(如果有找到的朋友可以进行补充)。从表格上看,一例100mg的价格39500人民币,很难说算得上便宜。以目前临床实验中的给药频率首日200mg后连续给药100mg/连续9日来计算,真不是老百姓能负担得起的。(药品仅供实验室使用,不适合也不允许个人进行采购与给药。泥潭精英切勿盲目跟风朋友圈进行购买。)
瑞德西韦价格 ...
[img]https://img.nga.178.com/attachments/mon_202002/03/-7Q5-a78jZnT3cS10u-ih.png[/img]
特朗普特批,是真是假?
在查阅了吉利德官方的发言后,并没有找到新闻中引用的“特朗普特批”云云,在Bloomberg也未找到国内各媒体引用的原文(如果有找到消息源请私信)。
吉利德的发言综合一下就这几个意思:
针对新型冠状病毒,各方(FDA,CDC中国CDC,食药监,WHO,NAID等)都非常紧密合作,大家都在共同做贡献,现在瑞德西伟的有效性和安全性还没有通过Clinical trial的Phase III 实验,还不能算得上可以上市,但事急从权,当地当局也同意了,我们就先上马一批药物给你们用一下,并同步进行Phase III的临床实验和实验室实验。
吉利德官方发言节选翻译:
目前瑞德西伟未在全球任何一地被证明通过任何病症的安全性与有效性测试。受外科医生的要求,当地监管部分在衡量了在未有针对治疗新型冠状病毒的数据的前提下,提供实验性药物风险与收益后,监管部门支持吉利德提供了向小部分2019-新型冠状病毒患者提供了瑞德西伟用于急救。
吉利德与安全卫生当局正致力于建立一个随机可控的药理实验来确认瑞德西伟(Remdesivir)针对于2019-新型冠状病毒的安全性与有效性。同时我们也在展开适当的实验室测试瑞德西伟针对2019-新型冠状病毒。
原文 ...
"Gilead is working closely with global health authorities to respond to the novel coronavirus (2019-nCoV) outbreak through the appropriate experimental use of our investigational compound remdesivir. Together with the U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Department of Health and Human Services (DHHS), the China CDC and National Medical Product Administration (NMPA), the World Health Organization (WHO), and the U.S. National Institute of Allergies and Infectious Diseases (NIAID), and along with individual researchers and clinicians, Gilead is focused on contributing our antiviral expertise and resources to help patients and communities fighting 2019-nCoV.
Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. At the request of treating physicians, and with the support of local regulatory agencies, who have weighed the risks and benefits of providing an experimental drug with no data in 2019-nCoV, Gilead has provided remdesivir for use in a small number of patients with 2019-nCoV for emergency treatment in the absence of any approved treatment options.
Gilead is working with health authorities in China to establish a randomized, controlled trial to determine whether remdesivir can safely and effectively be used to treat 2019-nCoV. We are also expediting appropriate laboratory testing of remdesivir against 2019-nCoV samples.
While there are no antiviral data for remdesivir that show activity against 2019-nCoV at this time, available data in other coronaviruses give us hope. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are coronaviruses that are structurally similar to 2019-nCoV. There are also limited clinical data available from the emergency use of remdesivir in the treatment of patients with Ebola virus infection.
Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide."
Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. At the request of treating physicians, and with the support of local regulatory agencies, who have weighed the risks and benefits of providing an experimental drug with no data in 2019-nCoV, Gilead has provided remdesivir for use in a small number of patients with 2019-nCoV for emergency treatment in the absence of any approved treatment options.
Gilead is working with health authorities in China to establish a randomized, controlled trial to determine whether remdesivir can safely and effectively be used to treat 2019-nCoV. We are also expediting appropriate laboratory testing of remdesivir against 2019-nCoV samples.
While there are no antiviral data for remdesivir that show activity against 2019-nCoV at this time, available data in other coronaviruses give us hope. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are coronaviruses that are structurally similar to 2019-nCoV. There are also limited clinical data available from the emergency use of remdesivir in the treatment of patients with Ebola virus infection.
Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide."
苦难发生在我们身边,我们更该冷静、理性且客观地看待现在的问题,冲动地发泄自己的不满只会让人与人之间的裂痕更大。愿大家多展现一点善意。
References:
Ref ...
吉利德官网关于新型冠状病毒的发言:
[url]https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-the-company-ongoing-response-to-the-2019-new-coronavirus[/url]
Clinical trial Gov Search:
[url]https://clinicaltrials.gov/ct2/results?cond=New+Coronavirus&term=&cntry=&state=&city=&dist=[/url]
新英格兰-美国首例患者的适用病理情况:
[url]https://www.nejm.org/doi/10.1056/NEJMoa2001191[/url]
第三方药物售卖瑞德西伟网站价格:
[url]https://www.medchemexpress.com/Remdesivir.html[/url]
[url]https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-the-company-ongoing-response-to-the-2019-new-coronavirus[/url]
Clinical trial Gov Search:
[url]https://clinicaltrials.gov/ct2/results?cond=New+Coronavirus&term=&cntry=&state=&city=&dist=[/url]
新英格兰-美国首例患者的适用病理情况:
[url]https://www.nejm.org/doi/10.1056/NEJMoa2001191[/url]
第三方药物售卖瑞德西伟网站价格:
[url]https://www.medchemexpress.com/Remdesivir.html[/url]