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强直性脊柱炎新药资讯||医生关爱患者

2017-07-11 MedSci MedSci原创

关注

强直性脊柱炎（AS）是以骶髂关节和脊柱附着点炎症为主要症状的疾病。与HLA-B27呈强关联。强直性脊柱炎属风湿病范畴，病病因尚不明确，是以脊柱为主要病变部位的慢性病，目前尚无有效的治疗方法。但在临床研究中发现AS患者血清中也发现TNF-α显著升高，骶髂关节炎症部位则存在大量能表达TNF-α的T细胞和巨噬细胞，骶髂关节活检组织也发现有TNF-α大量表达。TNF-α作为一种重要的促炎症因子，介导了AS

强直性脊柱炎（AS）是以骶髂关节和脊柱附着点炎症为主要症状的疾病。与HLA-B27呈强关联。强直性脊柱炎属风湿病范畴，病病因尚不明确，是以脊柱为主要病变部位的慢性病，目前尚无有效的治疗方法。但在临床研究中发现AS患者血清中也发现TNF-α显著升高，骶髂关节炎症部位则存在大量能表达TNF-α的T细胞和巨噬细胞，骶髂关节活检组织也发现有TNF-α大量表达。TNF-α作为一种重要的促炎症因子，介导了AS病程中的许多炎症反应，包括免疫细胞活化增殖、多种细胞因子和酶的释放等，在局部软骨/骨破坏和全身性反应中都起了重要作用。


强直性脊柱炎治疗

目前在AS治疗领域，肿瘤坏死因子（TNF）-α拮抗剂被广泛用于AS患者治疗。TNF-α拮抗剂可直接与TNF-α结合而产生抗炎效应。肿瘤坏死因子（TNF）-α拮抗剂已被发现与传统药物相比，具有较低的不良反应和良好疗效，能明显提高患者的生活质量，代表着AS治疗的新趋势，而除了TNF-α拮抗剂外，目前尚无其它生物制剂治疗AS有效的证据。目前临床使用的TNF拮抗剂主要有英夫利昔单抗、依那西普及阿达木单抗，它们均可缓解及阻止类风湿关节炎的临床及影像学进展，显著减轻类风湿关节炎患者的症状、改善功能及提高生活质量等

临床试验

全国多家大型医院正在开展一项注射BAT1406注射液用于治疗强直性脊柱炎（AS）的III期临床研究，如您是强直性脊柱炎患者，欢迎您的随时参与本次临床研究。

本次临床招募和实施方案，已经在中国国家食品药品监督管理总局登记注册（注册号：CTR20160565）。该试验已获得国家药监局批准，临床试验批件号为2015L05751。按照本次临床实施方案规定，入选的患者将被随机分配接受BAT1406或修美乐治疗。

新药介绍

BAT1406注射液是由百奥泰生物科技（广州）有限公司开发的一款阿达木单抗注射液，用于治疗强直性脊柱炎（AS）。BAT1406的前期大量研究数据证明其和雅培原研阿达木单抗（修美乐）高度相似。其作用机理是通过与TNF-α特异性结合并中和其生物学功能，阻断其与p55及p75细胞表面TNF-α受体的相互作用，从而阻断TNF-α的致炎作用。

参加条件

1 患者年龄16～65岁，男性或女性
2 在筛选前已被诊断为强直性脊柱炎
3 在筛选时有活动性AS
4 育龄期妇女，必须在入组前行尿妊娠试验且结果为阴性，且不处于哺乳期；
5 患者自愿签署知情同意书
6 允许患者在筛选前使用稳定剂量的MTX（≤25mg/周）、柳氮磺胺吡啶（<3g/天）、NSAIDs和/或镇痛药，但稳定剂量至少已经持续4周以上，且试验期间剂量需保持不变；

医生将根据您的具体情况，进一步确认是否符合条件。符合条件者，将接受研究药物及治疗后的随访观察。该研究将为您免费提供研究药物（BAT1406和阿达木单抗注射液），并免除研究中规定的检查费。

 研究中心列表（就近原则）

湖南：中南大学湘雅医院

山西：山西医科大学第一医院

湖北：武汉市普爱医院

江苏：盐城市第一人民医院

内蒙古：内蒙古医科大学附属

 点击下方图片即可报名加入强直性脊柱炎患者招募活动

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1770864, encodeId=1b3d1e708647c, content=<a href='/topic/show?id=3a5b300654c' target=_blank style='color:#2F92EE;'>#关爱#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30065, encryptionId=3a5b300654c, topicName=关爱)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2a0a38187382, createdName=jklm22, createdTime=Mon Jan 08 08:13:00 CST 2018, time=2018-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=296548, encodeId=2102296548db, content=看了这篇文章.让我这个患者的心不再迷茫.看到了希望.让我知道还是有很多医学研究者在兢兢业业的为解救我们的痛苦而努力着.谢谢你们.祝你们身体健康!一生平安!, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Gf1mcf0XYHFA0G9fjJZP1PNwYFN0H6hhS8QwdGYnNeJUZKwP3MjkIhzlCaCA8lEb5Y60TQkagDhXIhgHgF7lug/132, createdBy=ffa42295584, createdName=情天, createdTime=Thu Mar 15 21:33:02 CST 2018, time=2018-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946830, encodeId=6c7819468308a, content=<a href='/topic/show?id=9a3950183e9' target=_blank style='color:#2F92EE;'>#强直性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50183, encryptionId=9a3950183e9, topicName=强直性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKeia4TJeMGvEH3wKKIBNjuHuIic1HDNOB10j4tCd3nbylxkxm6HSMfEaKkSu6OZOak4uZv7UVicsWEg/132, createdBy=bc9a2500116, createdName=zywlvao, createdTime=Fri Aug 18 14:13:00 CST 2017, time=2017-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440338, encodeId=3535144033869, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Thu Jul 13 08:13:00 CST 2017, time=2017-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=221458, encodeId=de2e221458e0, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Wed Jul 12 16:23:56 CST 2017, time=2017-07-12, status=1, ipAttribution=)]
    2018-01-08 jklm22

    #关爱#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1770864, encodeId=1b3d1e708647c, content=<a href='/topic/show?id=3a5b300654c' target=_blank style='color:#2F92EE;'>#关爱#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30065, encryptionId=3a5b300654c, topicName=关爱)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2a0a38187382, createdName=jklm22, createdTime=Mon Jan 08 08:13:00 CST 2018, time=2018-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=296548, encodeId=2102296548db, content=看了这篇文章.让我这个患者的心不再迷茫.看到了希望.让我知道还是有很多医学研究者在兢兢业业的为解救我们的痛苦而努力着.谢谢你们.祝你们身体健康!一生平安!, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Gf1mcf0XYHFA0G9fjJZP1PNwYFN0H6hhS8QwdGYnNeJUZKwP3MjkIhzlCaCA8lEb5Y60TQkagDhXIhgHgF7lug/132, createdBy=ffa42295584, createdName=情天, createdTime=Thu Mar 15 21:33:02 CST 2018, time=2018-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946830, encodeId=6c7819468308a, content=<a href='/topic/show?id=9a3950183e9' target=_blank style='color:#2F92EE;'>#强直性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50183, encryptionId=9a3950183e9, topicName=强直性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKeia4TJeMGvEH3wKKIBNjuHuIic1HDNOB10j4tCd3nbylxkxm6HSMfEaKkSu6OZOak4uZv7UVicsWEg/132, createdBy=bc9a2500116, createdName=zywlvao, createdTime=Fri Aug 18 14:13:00 CST 2017, time=2017-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440338, encodeId=3535144033869, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Thu Jul 13 08:13:00 CST 2017, time=2017-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=221458, encodeId=de2e221458e0, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Wed Jul 12 16:23:56 CST 2017, time=2017-07-12, status=1, ipAttribution=)]
    2018-03-15 情天

    看了这篇文章.让我这个患者的心不再迷茫.看到了希望.让我知道还是有很多医学研究者在兢兢业业的为解救我们的痛苦而努力着.谢谢你们.祝你们身体健康!一生平安!

    0

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    2017-08-18 zywlvao

    #强直性#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1770864, encodeId=1b3d1e708647c, content=<a href='/topic/show?id=3a5b300654c' target=_blank style='color:#2F92EE;'>#关爱#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30065, encryptionId=3a5b300654c, topicName=关爱)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2a0a38187382, createdName=jklm22, createdTime=Mon Jan 08 08:13:00 CST 2018, time=2018-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=296548, encodeId=2102296548db, content=看了这篇文章.让我这个患者的心不再迷茫.看到了希望.让我知道还是有很多医学研究者在兢兢业业的为解救我们的痛苦而努力着.谢谢你们.祝你们身体健康!一生平安!, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Gf1mcf0XYHFA0G9fjJZP1PNwYFN0H6hhS8QwdGYnNeJUZKwP3MjkIhzlCaCA8lEb5Y60TQkagDhXIhgHgF7lug/132, createdBy=ffa42295584, createdName=情天, createdTime=Thu Mar 15 21:33:02 CST 2018, time=2018-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946830, encodeId=6c7819468308a, content=<a href='/topic/show?id=9a3950183e9' target=_blank style='color:#2F92EE;'>#强直性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50183, encryptionId=9a3950183e9, topicName=强直性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKeia4TJeMGvEH3wKKIBNjuHuIic1HDNOB10j4tCd3nbylxkxm6HSMfEaKkSu6OZOak4uZv7UVicsWEg/132, createdBy=bc9a2500116, createdName=zywlvao, createdTime=Fri Aug 18 14:13:00 CST 2017, time=2017-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440338, encodeId=3535144033869, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Thu Jul 13 08:13:00 CST 2017, time=2017-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=221458, encodeId=de2e221458e0, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Wed Jul 12 16:23:56 CST 2017, time=2017-07-12, status=1, ipAttribution=)]
    2017-07-13 1249898am16暂无昵称

    #脊柱炎#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1770864, encodeId=1b3d1e708647c, content=<a href='/topic/show?id=3a5b300654c' target=_blank style='color:#2F92EE;'>#关爱#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30065, encryptionId=3a5b300654c, topicName=关爱)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2a0a38187382, createdName=jklm22, createdTime=Mon Jan 08 08:13:00 CST 2018, time=2018-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=296548, encodeId=2102296548db, content=看了这篇文章.让我这个患者的心不再迷茫.看到了希望.让我知道还是有很多医学研究者在兢兢业业的为解救我们的痛苦而努力着.谢谢你们.祝你们身体健康!一生平安!, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Gf1mcf0XYHFA0G9fjJZP1PNwYFN0H6hhS8QwdGYnNeJUZKwP3MjkIhzlCaCA8lEb5Y60TQkagDhXIhgHgF7lug/132, createdBy=ffa42295584, createdName=情天, createdTime=Thu Mar 15 21:33:02 CST 2018, time=2018-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946830, encodeId=6c7819468308a, content=<a href='/topic/show?id=9a3950183e9' target=_blank style='color:#2F92EE;'>#强直性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50183, encryptionId=9a3950183e9, topicName=强直性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKeia4TJeMGvEH3wKKIBNjuHuIic1HDNOB10j4tCd3nbylxkxm6HSMfEaKkSu6OZOak4uZv7UVicsWEg/132, createdBy=bc9a2500116, createdName=zywlvao, createdTime=Fri Aug 18 14:13:00 CST 2017, time=2017-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440338, encodeId=3535144033869, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Thu Jul 13 08:13:00 CST 2017, time=2017-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=221458, encodeId=de2e221458e0, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Wed Jul 12 16:23:56 CST 2017, time=2017-07-12, status=1, ipAttribution=)]
    2017-07-12 三生有幸9135

    学习一下谢谢分享

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