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LANCET:卡利拉嗪与利培酮单药治疗精神分裂症患者阴性症状的比较

2017-02-14 MedSci MedSci原创

虽然精神分裂症患者一些严重阴性症状足以引起持续性的损伤,但目前仍然缺乏有效的治疗选。近期,一项发表在权威杂志LANCET上的研究旨在评估新一代抗精神病药卡利拉嗪对成年患者阴性症状的效果。在此项随机、双盲、3b期试验中,研究者们招募了欧洲11个国家66个研究中心(主要是医院和大学诊所,少数私人诊所)中,具有长期(> 2年)、稳定的精神分裂症和主要阴性症状(> 6个月)的18-65岁的成年

虽然精神分裂症患者一些严重阴性症状足以引起持续性的损伤,但目前仍然缺乏有效的治疗选。


近期,一项发表在权威杂志LANCET上的研究旨在评估新一代抗精神病药卡利拉嗪对成年患者阴性症状的效果。

在此项随机、双盲、3b期试验中,研究者们招募了欧洲11个国家66个研究中心(主要是医院和大学诊所,少数私人诊所)中,具有长期(> 2年)、稳定的精神分裂症和主要阴性症状(> 6个月)的18-65岁的成年人。通过交互式网络反应系统将患者随机分配(1:1)至口服固定剂量卡利拉嗪(3mg,4.5mg [目标剂量]或6mg /天)或利培酮(3mg,4mg [目标剂量]或6mg /天)的26周单一疗法;先前的药物在2周内停止。

主要结果是从基线至第26周或治疗结束时对阴性症状的阳性和阴性综合征比例因子得分(PANSS-FSNS)的改变,所述阴性症状在改良意向治疗人群中进行随访评估。在接受至少一个剂量的研究药物的所有患者中评估安全性。研究在EudraCT注册,编号为2012-005485-36。

研究结显示:自2013年5月27日至2014年11月17日,筛选533例患者,461例(86%)患者随机接受治疗(卡利拉嗪230例,利培酮231例)。 460被包括在安全群体中(一个患者在研究药物摄入之前中止)。在卡利拉嗪组中,230名患者中的227名(99%)以及在利培酮组中230名患者中的229名(99%)包含在修改的意向治疗人群中(每组完成26周治疗的有178名[77%]) )。

卡利拉嗪的平均日剂量为4.2mg(SD 0.6),利培酮为3.8 mg(0.4)。在使用卡利拉嗪治疗中的123名(54%)患者以及使用利培酮治疗的131名(57%)患者中报道了在治疗中出现的不良事件(例如失眠,静坐不能,精神分裂症恶化,头痛,焦虑)。

使用卡利拉嗪治疗组使得PANSS-FSNS从基线到第26周的最小二乘平均变化大于利培酮治疗组(卡利拉嗪为-8.90分,利培酮为-7.44分,最小二乘均数差为-1.46,95%CI -2.39至-0.53; p = 0.0022;效应大小0.31)。利培酮组中的一名患者因出现与治疗无关的死亡。

此项结果支持卡利拉嗪治疗精神分裂症的阴性症状中有一定疗效。

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    2018-01-14 howi
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objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Wed Feb 15 09:47:30 CST 2017, time=2017-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=176219, encodeId=d8491e621960, content=结果支持卡利拉嗪治疗精神分裂症的阴性症状中有一定疗效, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NdicLmdJEK9VoiaDianY6fzHNN9iaGv80m39pMHU3eSnNN0kn1o0rdQ7Bz2f03Qibcf1ia7rKvxIt4UVlErF2d4gCmDC5/0, createdBy=98e31740255, createdName=cqykthl, createdTime=Wed Feb 15 08:38:56 CST 2017, time=2017-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=176208, encodeId=19f71e62080d, content=谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLC1BMzZWdMSPQWuib6BtQGicK8ygGBM6YakpfkRc67soFSuKbZr86enL1KggQZEZbgWSeicJibafmYfQ3AibicIHMwwicmDShfRFvvI38/0, createdBy=272a110164, createdName=laoli, createdTime=Wed Feb 15 08:18:53 CST 2017, time=2017-02-15, status=1, ipAttribution=)]
    2017-02-17 天涯183

    非常好的文章

    0

  4. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=176208, encodeId=19f71e62080d, content=谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLC1BMzZWdMSPQWuib6BtQGicK8ygGBM6YakpfkRc67soFSuKbZr86enL1KggQZEZbgWSeicJibafmYfQ3AibicIHMwwicmDShfRFvvI38/0, createdBy=272a110164, createdName=laoli, createdTime=Wed Feb 15 08:18:53 CST 2017, time=2017-02-15, status=1, ipAttribution=)]
  7. 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objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Wed Feb 15 09:47:30 CST 2017, time=2017-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=176219, encodeId=d8491e621960, content=结果支持卡利拉嗪治疗精神分裂症的阴性症状中有一定疗效, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NdicLmdJEK9VoiaDianY6fzHNN9iaGv80m39pMHU3eSnNN0kn1o0rdQ7Bz2f03Qibcf1ia7rKvxIt4UVlErF2d4gCmDC5/0, createdBy=98e31740255, createdName=cqykthl, createdTime=Wed Feb 15 08:38:56 CST 2017, time=2017-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=176208, encodeId=19f71e62080d, content=谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLC1BMzZWdMSPQWuib6BtQGicK8ygGBM6YakpfkRc67soFSuKbZr86enL1KggQZEZbgWSeicJibafmYfQ3AibicIHMwwicmDShfRFvvI38/0, createdBy=272a110164, createdName=laoli, createdTime=Wed Feb 15 08:18:53 CST 2017, time=2017-02-15, status=1, ipAttribution=)]
    2017-02-16 txqjm

    谢谢了,学习了

    0

  8. 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objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Wed Feb 15 09:47:30 CST 2017, time=2017-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=176219, encodeId=d8491e621960, content=结果支持卡利拉嗪治疗精神分裂症的阴性症状中有一定疗效, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NdicLmdJEK9VoiaDianY6fzHNN9iaGv80m39pMHU3eSnNN0kn1o0rdQ7Bz2f03Qibcf1ia7rKvxIt4UVlErF2d4gCmDC5/0, createdBy=98e31740255, createdName=cqykthl, createdTime=Wed Feb 15 08:38:56 CST 2017, time=2017-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=176208, encodeId=19f71e62080d, content=谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLC1BMzZWdMSPQWuib6BtQGicK8ygGBM6YakpfkRc67soFSuKbZr86enL1KggQZEZbgWSeicJibafmYfQ3AibicIHMwwicmDShfRFvvI38/0, createdBy=272a110164, createdName=laoli, createdTime=Wed Feb 15 08:18:53 CST 2017, time=2017-02-15, status=1, ipAttribution=)]
    2017-02-15 1e10c84am36(暂无匿称)

    文章真心不错耶

    0

  9. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=176208, encodeId=19f71e62080d, content=谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLC1BMzZWdMSPQWuib6BtQGicK8ygGBM6YakpfkRc67soFSuKbZr86enL1KggQZEZbgWSeicJibafmYfQ3AibicIHMwwicmDShfRFvvI38/0, createdBy=272a110164, createdName=laoli, createdTime=Wed Feb 15 08:18:53 CST 2017, time=2017-02-15, status=1, ipAttribution=)]
    2017-02-15 cqykthl

    结果支持卡利拉嗪治疗精神分裂症的阴性症状中有一定疗效

    0

  10. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=176208, encodeId=19f71e62080d, content=谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLC1BMzZWdMSPQWuib6BtQGicK8ygGBM6YakpfkRc67soFSuKbZr86enL1KggQZEZbgWSeicJibafmYfQ3AibicIHMwwicmDShfRFvvI38/0, createdBy=272a110164, createdName=laoli, createdTime=Wed Feb 15 08:18:53 CST 2017, time=2017-02-15, status=1, ipAttribution=)]
    2017-02-15 laoli

    谢谢分享!

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