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合成生物药物可利霉素(Carrimycin)治疗COVID-19:FDA已允许开展III期临床试验

2020-12-30 Allan MedSci原创

Carrimycin已成为世界上第一款用于重症COVID-19患者的合成生物药物,美国食品药品监督管理局(FDA)已允许开展Carrimycin治疗COVID-19的III期临床试验。

可利霉素(Carrimycin)已成为世界上第一款用于重症COVID-19患者的合成生物药物,美国食品药品监督管理局(FDA)已允许开展Carrimycin治疗COVID-19的III期临床试验。前期数据已经表明,Carrimycin可以有效治疗重症COVID-19患者,帮助他们在14天之内从严重症状中恢复过来。

FDA批准的国际多中心III期临床试验将于2021年1月开始,为期六个月。它将在美国、阿根廷、巴西、哥伦比亚、印度、墨西哥、秘鲁、菲律宾和乌克兰进行。但是,随着大流行的发生,可以调整地点。该试验将涉及300例患者,一半在实验组,另一半在对照组。

Carrimycin除具有抗菌作用外,还具有抗病毒、抗炎和抗纤维化作用。它最初旨在治疗由细菌引起的成人社区获得性感染。它是一款由沈阳同联集团在中国使用合成生物学技术开发的药物。

2020年初的实验室测试表明它具有很强的抗冠状病毒作用,可抑制细胞中SARS-CoV-2的复制。

原始出处:

https://www.firstwordpharma.com/node/1787346?tsid=4

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    2021-03-11 kalseyzl
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  5. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524911, encodeId=6d5715249114d, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Fri Jan 01 08:38:24 CST 2021, time=2021-01-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588070, encodeId=b69015880e0d9, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Fri Jan 01 08:38:24 CST 2021, time=2021-01-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594848, encodeId=5f5d1594848db, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Fri Jan 01 08:38:24 CST 2021, time=2021-01-01, status=1, ipAttribution=)]
    2021-08-12 juliusluan78
  6. 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  7. 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    2021-01-01 guihongzh
  8. 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美FDA发布德美研发的新冠疫苗分析报告:符合紧急使用授权标准

美国食品和药物管理局(FDA)8日发布一份分析报告称,临床研究结果显示,德国生物新技术公司和美国辉瑞制药有限公司合作开发的新冠疫苗符合FDA规定的紧急使用授权的标准。

创新靶向药RET抑制剂Pralsetinib扩展适应症获美国FDA批准,用于治疗甲状腺癌

近日,美国食品药品监督管理局(FDA)加速批准了创新靶向药RET抑制剂普拉替尼(pralsetinib)的扩展适应症,用于治疗携带RET变异的甲状腺癌患者。这是肿瘤精准治疗领域的又一重要里程碑。

深度盘点:2020年FDA批准53款新药上市,肿瘤药占1/3

2020年的上半年,美国FDA的药物评估与研究中心(CEDR)已经批准了

FDA批准武田的ICLUSIG(ponatinib)治疗耐药或不耐药的慢性粒细胞白血病

慢性粒细胞性白血病(CML)占整体白血病患者的15%。这种白血病表现为人体骨髓中的主要粒细胞不受管制地增长,并在血液中积累而形成。

拓展阅读

如何设定重症患者和手术室中的初始呼吸频率?对使用机械通气的 COVID-19 患者的初始设置的影响。

讨论机械通气患者呼吸频率设置,不同患者情况不同,重症患者常需较高呼吸频率,对 COVID-19 患者也给出相应设置建议。

无创正压通气中的头盔

介绍新冠大流行使头盔作为输送呼气末正压等的接口受关注。阐述头盔通气设置、临床证据等,表明其在急性呼吸衰竭中安全且可能有优势,但需准确选择患者和密切监测。

European Child & Adolescent Psychiatry:COVID-19大流行对门诊饮食失调管理流行率和神经性厌食症严重程度的影响

本研究发现COVID-19大流行期间,女孩的饮食失调症流行率显著增加,但住院患者的病情严重程度未见显著变化。这提示大流行期间,门诊服务需求显著增加。

JAMA子刊:COVID-19疫苗接种对儿童哮喘的影响

研究发现更高的COVID-19疫苗接种率可能对症状性哮喘有保护作用。

JAMA Intern Med:奈玛特韦-利托那韦与成人感染SARS-CoV-2急性期后遗症

目前新冠急性期后遗症(PASC)已经对全球人类的生活质量和身体状态产生了严重影响。本研究结果显示疗程15天的奈玛特韦-利托那韦用于伴有PASC的患者是安全的,但并未明显改善PASC症状的严重程度。

Haematologica:地塞米松治疗COVID-19增加血液恶性肿瘤患者死亡率

该研究旨在分析不同治疗策略对血液肿瘤患者生存率的影响,研究发现,血液恶性肿瘤患者使用地塞米松治疗COVID-19与更高的90天死亡率相关,特别是在未同时应用抗病毒治疗的情况下。

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