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FDA批准用于过敏性结膜炎的局部滴眼液

2017-06-02 常 路 环球医学

西替利嗪是与组胺受体位点竞争性结合以减少肿胀、瘙痒和血管舒张的第二代抗组胺药(H1受体拮抗剂)。日前,美国食品和药物管理局(FDA)已经批准了抗组胺药西替利嗪作为首个局部眼部制剂用于治疗与过敏性结膜炎相关的眼部瘙痒。据悉,西替利嗪眼用溶液0.24%(Zerviate,Nicox SA)的疗效已在具有过敏性结膜炎病史患者的三项随机、双盲、安慰剂对照、结膜抗原攻击临床试验中证实。

西替利嗪是与组胺受体位点竞争性结合以减少肿胀、瘙痒和血管舒张的第二代抗组胺药(H1受体拮抗剂)。日前,美国食品和药物管理局(FDA)已经批准了抗组胺药西替利嗪作为首个局部眼部制剂用于治疗与过敏性结膜炎相关的眼部瘙痒。

据悉,西替利嗪眼用溶液0.24%(Zerviate,Nicox SA)的疗效已在具有过敏性结膜炎病史患者的三项随机、双盲、安慰剂对照、结膜抗原攻击临床试验中证实。

在评估疗效发作和持续时间的两项试验中,与溶媒相比,Zerviate在治疗后15分钟和8小时显示出统计学和临床上显着的眼部瘙痒减少。

而每个受影响眼睛的Zerviate推荐剂量为1滴,每天2次,间隔约8小时。

最常报道的不良反应为眼部充血、滴注部位疼痛和视力下降,在临床试验中用Zerviate或溶媒治疗的患者中约1%至7%发生。

此外,西替利嗪经批准的口服制剂具有良好的系统性功效和安全性,全世界暴露超过3亿患者-年。

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    2018-09-06 1581f80970m

    学习一下,谢谢分享

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    2018-03-20 bugit
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    2017-11-30 xsm928
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    2017-06-04 chg122
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    2017-06-03 榄枷檬

    谢谢分享

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=343284, encodeId=2a9d343284d4, content=学习一下,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f6512108074, createdName=1581f80970m, createdTime=Thu Sep 06 22:08:18 CST 2018, time=2018-09-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839511, encodeId=614118395110b, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Mar 20 07:57:00 CST 2018, time=2018-03-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1705115, encodeId=29dd1e0511523, content=<a href='/topic/show?id=a04166612d3' target=_blank style='color:#2F92EE;'>#滴眼液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66612, encryptionId=a04166612d3, topicName=滴眼液)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=62d830929644, createdName=xsm928, createdTime=Thu Nov 30 18:57:00 CST 2017, time=2017-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2046840, encodeId=481f204684061, content=<a href='/topic/show?id=6f5294036b1' target=_blank style='color:#2F92EE;'>#过敏性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94036, encryptionId=6f5294036b1, topicName=过敏性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0a8e213, createdName=hongbochen, createdTime=Tue Oct 31 07:57:00 CST 2017, time=2017-10-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1677487, encodeId=a82a16e7487bd, content=<a href='/topic/show?id=2ebbe881920' target=_blank style='color:#2F92EE;'>#结膜炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78819, encryptionId=2ebbe881920, topicName=结膜炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=803827523485, createdName=tm10051990, createdTime=Tue Apr 03 02:57:00 CST 2018, time=2018-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1645524, encodeId=693316455245a, content=<a href='/topic/show?id=f09c9405003' target=_blank style='color:#2F92EE;'>#过敏性结膜炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94050, encryptionId=f09c9405003, topicName=过敏性结膜炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0bee23217751, createdName=mhzhuang@stu.e, createdTime=Mon Oct 02 21:57:00 CST 2017, time=2017-10-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405724, encodeId=88171405e2497, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Sun Jun 04 13:57:00 CST 2017, time=2017-06-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=205803, encodeId=6cd620580388, content=谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=143, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Pw2csslt7CukWiabqiblnQAXaDEiaxhu025c3P0XshccTrbvGWBjKvnHIxbK3vqa80P7WGIFuicCFet97TicrNKpgB3TdabxP1vMh/0, createdBy=28851960965, createdName=榄枷檬, createdTime=Sat Jun 03 01:00:19 CST 2017, time=2017-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=205796, encodeId=91fe205e969a, content=新药物治疗方法,谢谢。, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Sat Jun 03 00:26:46 CST 2017, time=2017-06-03, status=1, ipAttribution=)]
    2017-06-03 惠映实验室

    新药物治疗方法,谢谢。

    0

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