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由于毒副作用,欧洲药品管理局建议限制Lemtrada在多发性硬化症中的使用

2019-04-15 不详 MedSci原创

欧洲药品管理局的药物警戒风险评估委员会(PRAC)已开始审查赛诺菲的多发性硬化症药物Lemtrada(alemtuzumab)。这项审查是在免疫介导的疾病新报告之后进行的,这些疾病是由于身体的防御系统无法正常工作引起的,包括心脏和血管问题,还有严重的药物毒性致命事件。

欧洲药品管理局的药物警戒风险评估委员会(PRAC)已开始审查赛诺菲的多发性硬化症药物Lemtrada(alemtuzumab)。这项审查是在免疫介导的疾病新报告之后进行的,这些疾病是由于身体的防御系统无法正常工作引起的,包括心脏和血管问题,还有严重的药物毒性致命事件。

该委员会建议,在检查期间,Lemtrada应该仅用于在经过至少两种疗法治疗后活动性复发缓解型多发性硬化症的成人患者,或者是在其他疾病改善疗法不能使用的情况下。

它还建议更新Lemtrada的产品信息,以告知患者和医护人员其免疫介导的病症,心脏和血管问题以及严重的中性粒细胞减少症。

Lemtrada与CD52结合,发挥抗体依赖性细胞介导的白血病细胞表面结合后导致细胞裂解。CD52是一个存在于B和T淋巴细胞表面的抗原,在大多数单核细胞,巨噬细胞,NK细胞和粒细胞亚群中存在。目前Lemtrada减缓活动性复发缓解型多发性硬化症的机制尚不完全清楚。

去年11月,美国食品和药物管理局发布警告称,MS患者接受Lemtrada治疗后头部和颈部动脉内层发生严重中风和撕裂。

原始出处:


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    2019-08-18 bsmagic9140
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createdName=showtest, createdTime=Thu Feb 13 03:29:00 CST 2020, time=2020-02-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1657157, encodeId=6834165e15724, content=<a href='/topic/show?id=3ca31e71903' target=_blank style='color:#2F92EE;'>#TRA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17719, encryptionId=3ca31e71903, topicName=TRA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=757b24868428, createdName=bsmagic9140, createdTime=Sun Aug 18 13:29:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1659387, encodeId=88d0165938e52, content=<a href='/topic/show?id=7f998e468c2' target=_blank style='color:#2F92EE;'>#药品管理#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87468, 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channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63568, encryptionId=6dbc635680d, topicName=毒副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=de89102, createdName=liuyong2980, createdTime=Mon May 06 04:29:00 CST 2019, time=2019-05-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1889999, encodeId=61221889999e6, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Fri Nov 08 21:29:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1264693, encodeId=c6081264693f5, content=<a href='/topic/show?id=150f19229c' target=_blank style='color:#2F92EE;'>#ADA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1922, encryptionId=150f19229c, topicName=ADA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad9f79, createdName=般若傻瓜, createdTime=Wed Apr 17 11:29:00 CST 2019, time=2019-04-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1339189, encodeId=06de1339189ea, content=<a href='/topic/show?id=447663054f5' target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Wed Apr 17 11:29:00 CST 2019, time=2019-04-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1425442, encodeId=b2eb1425442c0, content=<a href='/topic/show?id=b602630980d' target=_blank style='color:#2F92EE;'>#欧洲药品管理局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63098, encryptionId=b602630980d, topicName=欧洲药品管理局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c44f3972955, createdName=isabellayj, createdTime=Wed Apr 17 11:29:00 CST 2019, time=2019-04-17, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1983059, encodeId=ebd11983059a2, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Wed May 29 13:29:00 CST 2019, time=2019-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1824313, encodeId=cc771824313ef, content=<a href='/topic/show?id=56a932e7800' target=_blank style='color:#2F92EE;'>#副作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32778, encryptionId=56a932e7800, topicName=副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Thu Feb 13 03:29:00 CST 2020, time=2020-02-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1657157, encodeId=6834165e15724, content=<a href='/topic/show?id=3ca31e71903' target=_blank style='color:#2F92EE;'>#TRA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17719, encryptionId=3ca31e71903, topicName=TRA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=757b24868428, createdName=bsmagic9140, createdTime=Sun Aug 18 13:29:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1659387, encodeId=88d0165938e52, content=<a href='/topic/show?id=7f998e468c2' target=_blank style='color:#2F92EE;'>#药品管理#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87468, 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channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63568, encryptionId=6dbc635680d, topicName=毒副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=de89102, createdName=liuyong2980, createdTime=Mon May 06 04:29:00 CST 2019, time=2019-05-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1889999, encodeId=61221889999e6, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Fri Nov 08 21:29:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1264693, encodeId=c6081264693f5, content=<a href='/topic/show?id=150f19229c' target=_blank style='color:#2F92EE;'>#ADA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1922, encryptionId=150f19229c, topicName=ADA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad9f79, createdName=般若傻瓜, createdTime=Wed Apr 17 11:29:00 CST 2019, time=2019-04-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1339189, encodeId=06de1339189ea, content=<a href='/topic/show?id=447663054f5' target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Wed Apr 17 11:29:00 CST 2019, time=2019-04-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1425442, encodeId=b2eb1425442c0, content=<a href='/topic/show?id=b602630980d' target=_blank style='color:#2F92EE;'>#欧洲药品管理局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63098, encryptionId=b602630980d, topicName=欧洲药品管理局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c44f3972955, createdName=isabellayj, createdTime=Wed Apr 17 11:29:00 CST 2019, time=2019-04-17, status=1, ipAttribution=)]
    2019-08-21 zhangph
  6. 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  7. 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    2019-11-08 jml2009
  8. 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    2019-04-17 般若傻瓜
  9. 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术后半胸放疗已被用于治疗恶性胸膜间皮瘤,但它尚未在一个随机试验进行评估。研究人员评估了恶性胸膜间皮瘤患者进行新辅助化疗和外肺切除后大剂量半胸放疗的效果。研究人员做了一项Ⅱ期临床试验,在瑞士,比利时和德国14家医院完成。研究人员招收了经病理确诊的恶性胸膜间皮瘤患者;可切除TNM分期T1-3 N0-2,M0;WHO体力状况0-1;年龄18?70岁。在第一部分中,患者被给予新辅助化疗三个周期(顺铂75m

Nat Med:肿瘤免疫学的毒副作用

肿瘤免疫的未来发展方向将集中于减少免疫毒性,普及免疫治疗应用适应性展开

NEJM:丙肝药索非布韦对心脏有潜在的毒副作用?

索非布韦是丙型肝炎病毒(HCV)核苷酸类似物NS5B聚合酶抑制剂,目前有超过90%的慢性HCV患者在使用该药物进行治疗,且有报到称该药物的严重不良反应率<5%。研究者在415名使用索非布韦+达卡他韦/西米普韦/利巴韦林治疗患者中,发现了3例严重心动过缓事件(2014-1-2~12-31)(分别为患者1、2、3)。开始索非布韦治疗的10天内,患者2、3出现了症状性心动过缓,伴有晕厥发生。患者1、2、

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