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FDA批准夜间尿频治疗药物Noctiva

2017-03-05 佚名 医药魔方数据

3月3日,FDA宣布批准Noctiva(醋酸去氨加压素)鼻腔喷雾用于治疗夜间多尿导致至少起夜2次的成人尿频患者。这是FDA批准的第一个治疗夜间尿频的药物。FDA药品评价与研究中心(CDER)骨骼、生殖和泌尿产品办公室主任Hylton V. Joffe表示:“Noctiva的获批为夜间多尿患者提供了一种新的治疗选择,但是需要注意的是,Noctiva并不适用于所有原因导致的夜间多尿症,患者应该与其医生

3月3日,FDA宣布批准Noctiva(醋酸去氨加压素)鼻腔喷雾用于治疗夜间多尿导致至少起夜2次的成人尿频患者。这是FDA批准的第一个治疗夜间尿频的药物。

FDA药品评价与研究中心(CDER)骨骼、生殖和泌尿产品办公室主任Hylton V. Joffe表示:“Noctiva的获批为夜间多尿患者提供了一种新的治疗选择,但是需要注意的是,Noctiva并不适用于所有原因导致的夜间多尿症,患者应该与其医生讨论自己的症状,找明导致夜间多尿的原因,以确定是否适用Noctiva。”

导致夜尿的原因很多,比如充血性心衰、血糖控制不佳的糖尿病、服用利尿药、膀胱及前列腺疾病等。在处方Noctiva之前,医生应充分评估每一位患者的情况,确定治疗夜间的最佳方案。

Noctiva在睡前大约30分钟服用,通过增强肾脏对水的吸收而减少尿液产生。Noctiva仅被批准用于治疗夜间产尿过多的尿频,医生对可能产生夜间尿频的原因也应保持警惕,但对这类患者使用Noctiva可能会有潜在风险,比如过度饮水或症状性充血性心衰。

Noctiva的疗效在2项为期12周的随机、安慰剂对照研究中得到证实。研究共纳入1045例50岁以上夜间尿频患者。尽管Noctiva治疗患者的平均起夜次数较安慰剂组仅略微减少,但Noctiva治疗组起夜次数减少一半以上的患者比例更高,起夜次数低于1次的患者比例更高。

Noctiva最常见的不良反应包括鼻部不适、感冒症状、鼻咽炎、鼻充血、打喷嚏、血压升高、背痛、流鼻血、支气管炎和头晕。

Noctiva的药品标签中带有黑框警告,提示可能引起低钠血症的风险。严重的低钠血症如果得不到及时诊断和治疗,会导致危及生命。医生在处方Noctiva之前应确保患者的血钠水平正常。患者在服用Noctiva的前1个月,应每周检测一次血钠水平,之后每个月检测一次。低血钠风险较高的患者,比如大龄患者,Noctiva的起始剂量应降低。Noctiva禁用于已有症状的充血性心力衰竭患者或血压控制不理想的患者,禁用于孕妇。

之前已有多个含有去氨加压素成分的药物上市,但这些药物均未获批用于治疗夜间多尿。Noctiva由Serenity制药公司生产,Renaissance Lakewood公司负责市场销售。

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    2017-10-04 bugit
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    2018-01-18 habb
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    2017-03-15 121485632188547785

    新药吗

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1839493, encodeId=edc6183949332, 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=75, 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=Wed Oct 04 20:22:00 CST 2017, time=2017-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1921671, encodeId=281b19216e176, content=<a href='/topic/show?id=4f0a6469837' target=_blank style='color:#2F92EE;'>#治疗药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64698, encryptionId=4f0a6469837, topicName=治疗药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9d3459, createdName=周虎, createdTime=Wed Oct 18 23:22:00 CST 2017, time=2017-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1858317, encodeId=ad71185831ef5, content=<a href='/topic/show?id=21311323521' target=_blank style='color:#2F92EE;'>#OCT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13235, encryptionId=21311323521, topicName=OCT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19c567, createdName=habb, createdTime=Thu Jan 18 12:22:00 CST 2018, time=2018-01-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=180002, encodeId=3ba4180002fe, content=新药吗, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=40011656268, createdName=121485632188547785, createdTime=Wed Mar 15 07:34:37 CST 2017, time=2017-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568687, encodeId=44c8156868e00, content=<a href='/topic/show?id=a0a44e57469' target=_blank style='color:#2F92EE;'>#尿频#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47574, encryptionId=a0a44e57469, topicName=尿频)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5b9e15422888, createdName=lfcmxl, createdTime=Tue Mar 07 03:22:00 CST 2017, time=2017-03-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=178623, encodeId=b9301e8623fe, content=这个药物很有意义, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=48ce1618316, createdName=stupidox, createdTime=Sun Mar 05 16:28:56 CST 2017, time=2017-03-05, status=1, ipAttribution=)]
    2017-03-07 lfcmxl
  6. [GetPortalCommentsPageByObjectIdResponse(id=1839493, encodeId=edc6183949332, 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=75, 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=Wed Oct 04 20:22:00 CST 2017, time=2017-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1921671, encodeId=281b19216e176, content=<a href='/topic/show?id=4f0a6469837' target=_blank style='color:#2F92EE;'>#治疗药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64698, encryptionId=4f0a6469837, topicName=治疗药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9d3459, createdName=周虎, createdTime=Wed Oct 18 23:22:00 CST 2017, time=2017-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1858317, encodeId=ad71185831ef5, content=<a href='/topic/show?id=21311323521' target=_blank style='color:#2F92EE;'>#OCT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13235, encryptionId=21311323521, topicName=OCT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19c567, createdName=habb, createdTime=Thu Jan 18 12:22:00 CST 2018, time=2018-01-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=180002, encodeId=3ba4180002fe, content=新药吗, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=40011656268, createdName=121485632188547785, createdTime=Wed Mar 15 07:34:37 CST 2017, time=2017-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568687, encodeId=44c8156868e00, content=<a href='/topic/show?id=a0a44e57469' target=_blank style='color:#2F92EE;'>#尿频#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47574, encryptionId=a0a44e57469, topicName=尿频)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5b9e15422888, createdName=lfcmxl, createdTime=Tue Mar 07 03:22:00 CST 2017, time=2017-03-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=178623, encodeId=b9301e8623fe, content=这个药物很有意义, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=48ce1618316, createdName=stupidox, createdTime=Sun Mar 05 16:28:56 CST 2017, time=2017-03-05, status=1, ipAttribution=)]
    2017-03-05 stupidox

    这个药物很有意义

    0

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