Chiesi慢性阻塞性肺病三联疗法ICS/LABA/LAMA III期临床收获积极数据

2016-09-14 佚名 生物谷

意大利著名药企凯西制药集团(Chiesi)近日公布了慢性阻塞性肺病(COPD)三联疗法一项III期临床研究(TRILOGY)的积极数据。此次公布的为期一年期的数据证明,与标准的ICS/LABA组合疗法相比,其三联疗法ICS/LABA/LAMA在多个临床疗效参数方面均表现出统计学意义的显著卓越疗效。 该项研究中,年龄超过40岁确诊为重度或极重度COPD且最近发生至少一次急性发作(exacerbat

意大利著名药企凯西制药集团(Chiesi)近日公布了慢性阻塞性肺病(COPD)三联疗法一项III期临床研究(TRILOGY)的积极数据。此次公布的为期一年期的数据证明,与标准的ICS/LABA组合疗法相比,其三联疗法ICS/LABA/LAMA在多个临床疗效参数方面均表现出统计学意义的显著卓越疗效。

该项研究中,年龄超过40岁确诊为重度或极重度COPD且最近发生至少一次急性发作(exacerbation)的患者,首先接受固定剂量的吸入性糖皮质激素/长效β受体激动剂(ICS/LABA)治疗2周,随后再随机分配至2组,其中一组继续接受ICS/LABA治疗,另一组转向通过单一呼吸器给药的固定剂量超精细配方ICS/LABA/LAMA治疗。

经过26周治疗后,固定剂量三联疗法在早上肺功能(在摄入每日剂量药物之前)FEV1(1秒用力呼气量)平均比ICS/LABA治疗组高81毫升,数据具有统计学显著差异。此外,在摄入首次日剂量药物后2h的肺功能,给药2小时后FEV1平均比ICS/LABA治疗组高117毫升。这表明三联疗法的起效非常迅速,而这是COPD临床治疗的一个关键因素,能够提高患者治疗的依从性。

此外,患者生活质量也得到明显改善。圣乔治呼吸问卷评估显示,三联治疗组平均提高4个单位,而这被认为是具有临床意义的阈值。

经过52周治疗后,与标准ICS/LABA治疗组相比,三联疗法治疗组中度至重度COPD发作的年发生率降低了23%。这是非常关键的,因为与其他任何因素相比,急性发作所导致的COPD患者生活质量的恶化要严重的多,常常导致COPD患者住院治疗,同时也是导致COPD患者死亡的主要原因。

就在上周,英国制药巨头葛兰素史克(GSK)也公布了该公司三联疗法FF/UMEC/VI(一种固定剂量组合的ICS/LAMA/LABA)的一项头对头关键III期临床研究(FULTIL)的积极数据。该研究显示,用于治疗COPD时,采用肺功能及健康相关生活质量2方面评价,FF/UMEC/VI疗效均优于阿斯利康的药物Symbicort Turbohaler(布地奈德/福莫特罗,一种ICS/LABA组合),达到了研究的共同主要终点。

原始出处:Chiesi’s triple combo inhaler shows benefit in COPD


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    2016-09-21 tomyang96
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createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5K46ZAxBHmHsph32KkfsWGwmickB6RsCUD8KruE4vo5CpvXfdu16GBpp4ibh6WJu1o9iatP1LWKDmvmic/0, createdBy=be6f1940165, createdName=1e0ece0dm09(暂无匿称), createdTime=Tue Sep 27 00:44:00 CST 2016, time=2016-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1783070, encodeId=29751e83070bd, content=<a href='/topic/show?id=ecb94639f5' target=_blank style='color:#2F92EE;'>#Chiesi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4639, encryptionId=ecb94639f5, topicName=Chiesi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat Jan 21 04:40:00 CST 2017, time=2017-01-21, status=1, ipAttribution=)]
    2016-11-23 redcrab
  4. 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createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5K46ZAxBHmHsph32KkfsWGwmickB6RsCUD8KruE4vo5CpvXfdu16GBpp4ibh6WJu1o9iatP1LWKDmvmic/0, createdBy=be6f1940165, createdName=1e0ece0dm09(暂无匿称), createdTime=Tue Sep 27 00:44:00 CST 2016, time=2016-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1783070, encodeId=29751e83070bd, content=<a href='/topic/show?id=ecb94639f5' target=_blank style='color:#2F92EE;'>#Chiesi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4639, encryptionId=ecb94639f5, topicName=Chiesi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat Jan 21 04:40:00 CST 2017, time=2017-01-21, status=1, ipAttribution=)]
    2016-10-24 juliusluan78
  5. 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createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5K46ZAxBHmHsph32KkfsWGwmickB6RsCUD8KruE4vo5CpvXfdu16GBpp4ibh6WJu1o9iatP1LWKDmvmic/0, createdBy=be6f1940165, createdName=1e0ece0dm09(暂无匿称), createdTime=Tue Sep 27 00:44:00 CST 2016, time=2016-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1783070, encodeId=29751e83070bd, content=<a href='/topic/show?id=ecb94639f5' target=_blank style='color:#2F92EE;'>#Chiesi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4639, encryptionId=ecb94639f5, topicName=Chiesi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat Jan 21 04:40:00 CST 2017, time=2017-01-21, status=1, ipAttribution=)]
    2017-08-02 lxg951
  6. 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createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5K46ZAxBHmHsph32KkfsWGwmickB6RsCUD8KruE4vo5CpvXfdu16GBpp4ibh6WJu1o9iatP1LWKDmvmic/0, createdBy=be6f1940165, createdName=1e0ece0dm09(暂无匿称), createdTime=Tue Sep 27 00:44:00 CST 2016, time=2016-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1783070, encodeId=29751e83070bd, content=<a href='/topic/show?id=ecb94639f5' target=_blank style='color:#2F92EE;'>#Chiesi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4639, encryptionId=ecb94639f5, topicName=Chiesi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat Jan 21 04:40:00 CST 2017, time=2017-01-21, status=1, ipAttribution=)]
    2017-07-06 amy0559
  7. 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createdBy=fc1f24335670, createdName=医生2402, createdTime=Sun Aug 20 00:40:00 CST 2017, time=2017-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2011748, encodeId=47462011e48dd, content=<a href='/topic/show?id=f0ed106e342' target=_blank style='color:#2F92EE;'>#LAMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10673, encryptionId=f0ed106e342, topicName=LAMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=85aa264, createdName=redcrab, createdTime=Wed Nov 23 16:40:00 CST 2016, time=2016-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1915925, encodeId=9635191592563, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Mon Oct 24 19:40:00 CST 2016, time=2016-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2057581, encodeId=5235205e58182, content=<a href='/topic/show?id=c02b106e29a' target=_blank style='color:#2F92EE;'>#LAM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10672, encryptionId=c02b106e29a, topicName=LAM)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04ce158, createdName=lxg951, createdTime=Wed Aug 02 10:40:00 CST 2017, time=2017-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1671845, encodeId=f3a816e18455f, content=<a href='/topic/show?id=58378220131' target=_blank style='color:#2F92EE;'>#肺病#</a>, beContent=null, objectType=article, channel=null, 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createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5K46ZAxBHmHsph32KkfsWGwmickB6RsCUD8KruE4vo5CpvXfdu16GBpp4ibh6WJu1o9iatP1LWKDmvmic/0, createdBy=be6f1940165, createdName=1e0ece0dm09(暂无匿称), createdTime=Tue Sep 27 00:44:00 CST 2016, time=2016-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1783070, encodeId=29751e83070bd, content=<a href='/topic/show?id=ecb94639f5' target=_blank style='color:#2F92EE;'>#Chiesi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4639, encryptionId=ecb94639f5, topicName=Chiesi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat Jan 21 04:40:00 CST 2017, time=2017-01-21, status=1, ipAttribution=)]
    2016-09-24 licz0433
  8. 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  9. 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createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5K46ZAxBHmHsph32KkfsWGwmickB6RsCUD8KruE4vo5CpvXfdu16GBpp4ibh6WJu1o9iatP1LWKDmvmic/0, createdBy=be6f1940165, createdName=1e0ece0dm09(暂无匿称), createdTime=Tue Sep 27 00:44:00 CST 2016, time=2016-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1783070, encodeId=29751e83070bd, content=<a href='/topic/show?id=ecb94639f5' target=_blank style='color:#2F92EE;'>#Chiesi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4639, encryptionId=ecb94639f5, topicName=Chiesi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat Jan 21 04:40:00 CST 2017, time=2017-01-21, status=1, ipAttribution=)]
    2016-09-27 1e0ece0dm09(暂无匿称)

    学习了谢谢

    0

  10. 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createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5K46ZAxBHmHsph32KkfsWGwmickB6RsCUD8KruE4vo5CpvXfdu16GBpp4ibh6WJu1o9iatP1LWKDmvmic/0, createdBy=be6f1940165, createdName=1e0ece0dm09(暂无匿称), createdTime=Tue Sep 27 00:44:00 CST 2016, time=2016-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1783070, encodeId=29751e83070bd, content=<a href='/topic/show?id=ecb94639f5' target=_blank style='color:#2F92EE;'>#Chiesi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4639, encryptionId=ecb94639f5, topicName=Chiesi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat Jan 21 04:40:00 CST 2017, time=2017-01-21, status=1, ipAttribution=)]
    2017-01-21 lidong40