JAMA子刊:FDA为什么会加速批准阿尔茨海默病新药Aducanumab?

2021-07-16 K.K MedSci原创

这是20年来第一个治疗阿尔茨海默病的新药物。

阿尔茨海默病是美国第六大死因,它是一种神经退行性疾病,导致神经元不可逆的破坏、造成认知功能和记忆的丧失。随着时间的推移,患者会发展成严重痴呆症,失去独立性,并导致死亡。不幸的是,选择治疗的药物非常有限,以前批准的少数药物只改善症状,不能改变疾病的发展。毋庸置疑,阿尔茨海默病人有大量的医疗需求没有得到满足。

2021年6月7日,美国食品和药物管理局(FDA)批准了阿杜那单抗(Aduhelm),这是20年来第一个治疗阿尔茨海默病的新药物。7月13日,JAMA子刊刊登了Aduhelm新药获批之后,FDA给出的解释。

Billy Dunn et al. Approval of Aducanumab for Alzheimer Disease—the FDA’s Perspective.jama internal medicine.doi:10.1001/jamainternmed.2021.4607

Aduhelm是一种单克隆抗体(单抗),它可以与AD患者大脑中β淀粉样蛋白(β-amyloid,Aβ)沉积进行结合,然后激活免疫系统,将沉积蛋白清理出大脑,每月以静脉注射方式给药。有3项临床研究证明了该药有效性:研究103(NCT01677572)、研究301(NCT02477800)和研究302(NCT02484547)。NCT01677572是一项早期随机队列双盲研究,纳入197名参与者,评估的剂量高达10mg/kg,每4周给药一次。结果显示,Aβ斑块有较明显的剂量依赖性和时间依赖性减弱。

另外2项研究(301和302)是随机双盲安慰剂对照的的3期研究,分别包括1647和1638名参与者。这些研究提供了相互矛盾的结果。302号研究显示,在高剂量(现在的批准剂量为滴定后的10mg/kg)下,临床痴呆症评级和其他3个次要终点有明显改善。

加速审批的原因是在审批时对药物的最终临床效益仍不确定性的情况下,尽早提供治疗严重疾病的药物。加速批准需满足4个要求:

(1)该药物必须用于治疗医疗需求未得到满足的严重疾病;

(2)与现有疗法相比,该药物有望提供有意义的临床优势;

(3)必须显示该药物对替代性终点的影响;替代终点作为衡量临床结局、减少临床观察时间的有效指标,开始广泛应用于新药临床试验设计,也逐渐为FDA审评新药广泛接受。

(4)有合理的可能性预测该药物的临床效益。当FDA在加速审批下,批准一种药物时,它认识到在临床效益方面存在的不确定性,可能需要进一步的试验来验证该药物的有效性。关于Aduhelm,FDA已经要求进行其他试验。

Aduhelm符合上述条件。首先,阿尔茨海默病是一种严重的疾病,仅有的对症治疗方法还没有被证明能够延缓认知或记忆功能的丧失。第二,该药物通过一个关键的潜在病理过程,即大脑中的Aβ斑块的积累,有望提供比现有疗法更有意义的益处。第三,在3期试验和早期临床试验中,Aduhelm令人信服地减少了Aβ斑块。在Aduhelm治疗中,Aβ的减少和临床痴呆症评级的改善之间存在着普遍一致的联系。

该药物的主要风险是在接受Aduhelm治疗的患者中,Aβ相关影像异常的发生率增加。在3期研究(301和302)的汇总安全性分析中,41%接受Aduhelm的患者和10%的接受安慰剂的患者发生了上述情况。

在磁共振成像中,大脑淀粉样蛋白异常可以观察到水肿或血色素沉积(微出血和血色素沉着的迹象),通常(76%)没有症状。当症状发生时,它们很少(0.3%)被报告为严重的不良反应事件。无症状和有症状的淀粉样蛋白异常在很大比例的患者中都得到了解决。Aduhelm的安全性得到了良好的解释,并不影响批准。

由于Aduhelm的临床效益仍有不确定性,作为加速批准的一个项目,Biogen 公司被要求验证药物效益。由于这个项目需要观察阿尔茨海默病患者中的临床终点的变化,因此,这个项目正在计划进行更长时间的随机临床试验。

在权衡Aduhelm的好处和风险时,考虑到阿尔茨海默病会导致不可逆转的记忆、认知和日常活动能力的丧失。在听证会上,FDA听取了患者及其家属该疾病所造成的伤害,以及他们对治疗的渴望。许多家属或患者明确表示,他们愿意接受在临床获益方面的一些不确定性,以换取更早获得潜在有效药物,这也是加速审批的前提和意图。如果延迟批准,这些患者在这段时间内的脑功能损失,可能不会再恢复了。

原文出处:

Billy Dunn et al. Approval of Aducanumab for Alzheimer Disease—the FDA’s Perspective.jama internal medicine.doi:10.1001/jamainternmed.2021.4607

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (7)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1818128, encodeId=7e9a1818128ed, content=<a href='/topic/show?id=4c9f9e777ac' target=_blank style='color:#2F92EE;'>#阿尔茨海#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97777, encryptionId=4c9f9e777ac, topicName=阿尔茨海)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sun Jan 09 12:33:19 CST 2022, time=2022-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062050, encodeId=7959106205006, content=期待更多证据, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e831560211, createdName=ZYY7209, createdTime=Tue Oct 19 20:39:44 CST 2021, time=2021-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1817105, encodeId=6f0b181e105fe, content=<a href='/topic/show?id=17b59e77626' target=_blank style='color:#2F92EE;'>#阿尔茨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97776, encryptionId=17b59e77626, topicName=阿尔茨)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Wed Jan 19 13:33:19 CST 2022, time=2022-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912653, encodeId=412a1912653c3, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sun Jul 25 11:33:19 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1470482, encodeId=58bb14e0482d3, content=<a href='/topic/show?id=45a79e7788c' target=_blank style='color:#2F92EE;'>#阿尔茨海默#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97778, encryptionId=45a79e7788c, topicName=阿尔茨海默)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5917090900, createdName=yhj-time, createdTime=Sun Jul 18 02:33:19 CST 2021, time=2021-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1000113, encodeId=3dad100011368, content=这个疾病影响很多人啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1f221859736, createdName=ms2658711348342440, createdTime=Fri Jul 16 20:09:03 CST 2021, time=2021-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036741, encodeId=c2cb1036e41eb, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Fri Jul 16 14:33:19 CST 2021, time=2021-07-16, status=1, ipAttribution=)]
  2. [GetPortalCommentsPageByObjectIdResponse(id=1818128, encodeId=7e9a1818128ed, content=<a href='/topic/show?id=4c9f9e777ac' target=_blank style='color:#2F92EE;'>#阿尔茨海#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97777, encryptionId=4c9f9e777ac, topicName=阿尔茨海)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sun Jan 09 12:33:19 CST 2022, time=2022-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062050, encodeId=7959106205006, content=期待更多证据, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e831560211, createdName=ZYY7209, createdTime=Tue Oct 19 20:39:44 CST 2021, time=2021-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1817105, encodeId=6f0b181e105fe, content=<a href='/topic/show?id=17b59e77626' target=_blank style='color:#2F92EE;'>#阿尔茨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97776, encryptionId=17b59e77626, topicName=阿尔茨)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Wed Jan 19 13:33:19 CST 2022, time=2022-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912653, encodeId=412a1912653c3, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sun Jul 25 11:33:19 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1470482, encodeId=58bb14e0482d3, content=<a href='/topic/show?id=45a79e7788c' target=_blank style='color:#2F92EE;'>#阿尔茨海默#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97778, encryptionId=45a79e7788c, topicName=阿尔茨海默)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5917090900, createdName=yhj-time, createdTime=Sun Jul 18 02:33:19 CST 2021, time=2021-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1000113, encodeId=3dad100011368, content=这个疾病影响很多人啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1f221859736, createdName=ms2658711348342440, createdTime=Fri Jul 16 20:09:03 CST 2021, time=2021-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036741, encodeId=c2cb1036e41eb, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Fri Jul 16 14:33:19 CST 2021, time=2021-07-16, status=1, ipAttribution=)]
    2021-10-19 ZYY7209

    期待更多证据

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1818128, encodeId=7e9a1818128ed, content=<a href='/topic/show?id=4c9f9e777ac' target=_blank style='color:#2F92EE;'>#阿尔茨海#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97777, encryptionId=4c9f9e777ac, topicName=阿尔茨海)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sun Jan 09 12:33:19 CST 2022, time=2022-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062050, encodeId=7959106205006, content=期待更多证据, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e831560211, createdName=ZYY7209, createdTime=Tue Oct 19 20:39:44 CST 2021, time=2021-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1817105, encodeId=6f0b181e105fe, content=<a href='/topic/show?id=17b59e77626' target=_blank style='color:#2F92EE;'>#阿尔茨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97776, encryptionId=17b59e77626, topicName=阿尔茨)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Wed Jan 19 13:33:19 CST 2022, time=2022-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912653, encodeId=412a1912653c3, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sun Jul 25 11:33:19 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1470482, encodeId=58bb14e0482d3, content=<a href='/topic/show?id=45a79e7788c' target=_blank style='color:#2F92EE;'>#阿尔茨海默#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97778, encryptionId=45a79e7788c, topicName=阿尔茨海默)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5917090900, createdName=yhj-time, createdTime=Sun Jul 18 02:33:19 CST 2021, time=2021-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1000113, encodeId=3dad100011368, content=这个疾病影响很多人啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1f221859736, createdName=ms2658711348342440, createdTime=Fri Jul 16 20:09:03 CST 2021, time=2021-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036741, encodeId=c2cb1036e41eb, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Fri Jul 16 14:33:19 CST 2021, time=2021-07-16, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1818128, encodeId=7e9a1818128ed, content=<a href='/topic/show?id=4c9f9e777ac' target=_blank style='color:#2F92EE;'>#阿尔茨海#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97777, encryptionId=4c9f9e777ac, topicName=阿尔茨海)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sun Jan 09 12:33:19 CST 2022, time=2022-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062050, encodeId=7959106205006, content=期待更多证据, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e831560211, createdName=ZYY7209, createdTime=Tue Oct 19 20:39:44 CST 2021, time=2021-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1817105, encodeId=6f0b181e105fe, content=<a href='/topic/show?id=17b59e77626' target=_blank style='color:#2F92EE;'>#阿尔茨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97776, encryptionId=17b59e77626, topicName=阿尔茨)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Wed Jan 19 13:33:19 CST 2022, time=2022-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912653, encodeId=412a1912653c3, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sun Jul 25 11:33:19 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1470482, encodeId=58bb14e0482d3, content=<a href='/topic/show?id=45a79e7788c' target=_blank style='color:#2F92EE;'>#阿尔茨海默#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97778, encryptionId=45a79e7788c, topicName=阿尔茨海默)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5917090900, createdName=yhj-time, createdTime=Sun Jul 18 02:33:19 CST 2021, time=2021-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1000113, encodeId=3dad100011368, content=这个疾病影响很多人啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1f221859736, createdName=ms2658711348342440, createdTime=Fri Jul 16 20:09:03 CST 2021, time=2021-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036741, encodeId=c2cb1036e41eb, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Fri Jul 16 14:33:19 CST 2021, time=2021-07-16, status=1, ipAttribution=)]
    2021-07-25 snf701207
  5. [GetPortalCommentsPageByObjectIdResponse(id=1818128, encodeId=7e9a1818128ed, content=<a href='/topic/show?id=4c9f9e777ac' target=_blank style='color:#2F92EE;'>#阿尔茨海#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97777, encryptionId=4c9f9e777ac, topicName=阿尔茨海)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sun Jan 09 12:33:19 CST 2022, time=2022-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062050, encodeId=7959106205006, content=期待更多证据, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e831560211, createdName=ZYY7209, createdTime=Tue Oct 19 20:39:44 CST 2021, time=2021-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1817105, encodeId=6f0b181e105fe, content=<a href='/topic/show?id=17b59e77626' target=_blank style='color:#2F92EE;'>#阿尔茨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97776, encryptionId=17b59e77626, topicName=阿尔茨)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Wed Jan 19 13:33:19 CST 2022, time=2022-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912653, encodeId=412a1912653c3, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sun Jul 25 11:33:19 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1470482, encodeId=58bb14e0482d3, content=<a href='/topic/show?id=45a79e7788c' target=_blank style='color:#2F92EE;'>#阿尔茨海默#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97778, encryptionId=45a79e7788c, topicName=阿尔茨海默)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5917090900, createdName=yhj-time, createdTime=Sun Jul 18 02:33:19 CST 2021, time=2021-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1000113, encodeId=3dad100011368, content=这个疾病影响很多人啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1f221859736, createdName=ms2658711348342440, createdTime=Fri Jul 16 20:09:03 CST 2021, time=2021-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036741, encodeId=c2cb1036e41eb, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Fri Jul 16 14:33:19 CST 2021, time=2021-07-16, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1818128, encodeId=7e9a1818128ed, content=<a href='/topic/show?id=4c9f9e777ac' target=_blank style='color:#2F92EE;'>#阿尔茨海#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97777, encryptionId=4c9f9e777ac, topicName=阿尔茨海)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sun Jan 09 12:33:19 CST 2022, time=2022-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062050, encodeId=7959106205006, content=期待更多证据, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e831560211, createdName=ZYY7209, createdTime=Tue Oct 19 20:39:44 CST 2021, time=2021-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1817105, encodeId=6f0b181e105fe, content=<a href='/topic/show?id=17b59e77626' target=_blank style='color:#2F92EE;'>#阿尔茨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97776, encryptionId=17b59e77626, topicName=阿尔茨)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Wed Jan 19 13:33:19 CST 2022, time=2022-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912653, encodeId=412a1912653c3, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sun Jul 25 11:33:19 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1470482, encodeId=58bb14e0482d3, content=<a href='/topic/show?id=45a79e7788c' target=_blank style='color:#2F92EE;'>#阿尔茨海默#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97778, encryptionId=45a79e7788c, topicName=阿尔茨海默)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5917090900, createdName=yhj-time, createdTime=Sun Jul 18 02:33:19 CST 2021, time=2021-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1000113, encodeId=3dad100011368, content=这个疾病影响很多人啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1f221859736, createdName=ms2658711348342440, createdTime=Fri Jul 16 20:09:03 CST 2021, time=2021-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036741, encodeId=c2cb1036e41eb, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Fri Jul 16 14:33:19 CST 2021, time=2021-07-16, status=1, ipAttribution=)]
    2021-07-16 ms2658711348342440

    这个疾病影响很多人啊

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1818128, encodeId=7e9a1818128ed, content=<a href='/topic/show?id=4c9f9e777ac' target=_blank style='color:#2F92EE;'>#阿尔茨海#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97777, encryptionId=4c9f9e777ac, topicName=阿尔茨海)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sun Jan 09 12:33:19 CST 2022, time=2022-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1062050, encodeId=7959106205006, content=期待更多证据, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e831560211, createdName=ZYY7209, createdTime=Tue Oct 19 20:39:44 CST 2021, time=2021-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1817105, encodeId=6f0b181e105fe, content=<a href='/topic/show?id=17b59e77626' target=_blank style='color:#2F92EE;'>#阿尔茨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97776, encryptionId=17b59e77626, topicName=阿尔茨)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Wed Jan 19 13:33:19 CST 2022, time=2022-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912653, encodeId=412a1912653c3, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sun Jul 25 11:33:19 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1470482, encodeId=58bb14e0482d3, content=<a href='/topic/show?id=45a79e7788c' target=_blank style='color:#2F92EE;'>#阿尔茨海默#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97778, encryptionId=45a79e7788c, topicName=阿尔茨海默)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5917090900, createdName=yhj-time, createdTime=Sun Jul 18 02:33:19 CST 2021, time=2021-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1000113, encodeId=3dad100011368, content=这个疾病影响很多人啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1f221859736, createdName=ms2658711348342440, createdTime=Fri Jul 16 20:09:03 CST 2021, time=2021-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036741, encodeId=c2cb1036e41eb, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Fri Jul 16 14:33:19 CST 2021, time=2021-07-16, status=1, ipAttribution=)]
    2021-07-16 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

相关资讯

2021年上半年盘点:FDA批准52款新药,6款生物制品

2021年1月至6月,美国FDA共计批准了52款新药,6款生物制品(CDER批准)。按照企业提交的申请分类包括新分子实体类占比50%,新酯新盐类或其他非共价键的衍生物类5%,新剂型10%,新配方26%

康方生物PD-1获FDA突破性疗法资格,三线治疗转移性鼻咽癌

2020年9月,康方生物宣布派安普利单抗三线治疗转移性鼻咽癌的注册性临床试验达到了由独立影像评估的客观缓解率(ORR)主要终点。

FDA批准**疗法治疗致命儿童代谢缺陷

美国FDA批准了Origin Biosciences的新药Nulibry(fosdenopterin)上市,用于降低因A型钼辅因子缺乏(MoCD)导致的死亡风险。FDA药物评估和研究中心罕见病、儿科、

2021年上半年盘点:FDA批准抗肿瘤药物汇总

2021年上半年,FDA批准涉及22种药物的35个适应症(其中加速批准适应症14个)。FDA批准了共22款抗癌新疗法,包括靶向,免疫检查点抑制剂,过继性细胞免疫疗法等等,覆盖了几乎全部的癌症种类,值得

FDA批准针对复发性心包炎的疗法

美国FDA已批准Kiniksa Pharmaceuticals开发的IL-1抑制剂Arcalyst(rilonacept)上市,用于治疗12岁以上复发性心包炎(recurrent pericardit

2021 ASCO大会日程预告1(6月4日)

开幕式上,ASCO主席洛里-皮尔斯博士(Lori Pierce)将发表主题演讲,并邀请卫生政策方面的专家作为演讲嘉宾。