英国NICE批准Ofev用于间质性肺病 (ILD)

2021-10-18 Allan MedSci原创

间质性肺病 (ILD) 是一群主要侵犯肺泡上皮细胞、肺微血管内皮细胞、基底膜以及肺内血管及淋巴周围组织的疾病。

间质性肺病 (ILD) 是一群主要侵犯肺泡上皮细胞、肺微血管内皮细胞、基底膜以及肺内血管及淋巴周围组织的疾病。ILD是一个术语，用于描述200多种肺部疾病的集合。大约13-40%的ILD患者可能会出现进行性纤维化表型（PF-ILD），PF-ILD患者通常具有进行性和自我延续的间质肺组织瘢痕形成。

英国国家健康与护理卓越研究所 (NICE) 已推荐勃林格殷格翰的Ofev (nintedanib) 用于治疗具有进行性表型 (PF-ILD) 的慢性纤维化间质性肺病成年患者。

该建议得到了INBUILD III期试验数据的支持，该试验发现Ofev达到了显著减缓疾病进展的主要终点——定义为与安慰剂相比，Ofev组PF-ILD患者52周内用力肺活量 (FVC) 绝对下降。

在这项在15个国家/地区进行的双盲、安慰剂对照的III期试验中，尽管接受治疗，所有患者在过去24 个月内均符合间质性肺病进展的标准，并且FVC至少为预测值的 45%。根据高分辨率CT上的纤维化模式对随机化进行分层。

该试验共治疗了663名患者。在总体人群中，nintedanib组患者调整后的FVC下降率为每年 -80.8 毫升，安慰剂组患者为每年 -187.8 毫升，组间差异为每年 107.0 毫升（95% 置信区间 [CI]， 65.4 至 148.5，P<0.001)（图1）。在具有UIP样纤维化模式的患者中，nintedanib组患者的FVC调整后下降率为每年-82.9毫升，安慰剂为每年-211.1毫升，差异为128.2毫升（95% CI，70.8 至 185.6； P<0.001）。腹泻是最常见的不良事件，据报道，分别有 66.9% 和 23.9% 的接受nintedanib和安慰剂治疗的患者出现腹泻。与安慰剂组相比，nintedanib组的肝功能检测异常更常见

图1.用力肺活量 (FVC) 从基线的变化

原始出处：

http://www.pharmatimes.com/news/nice_approves_ofev_for_pf-ild_1381094

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2022-09-23 zjshifan_98647306

#间质性#

126 0
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2021-12-30 amy0559

#肺病#

100 0
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2022-09-07 circumcision

#FEV#

118 0
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2022-06-30 ms3994565386320060

#ILD#

112 0
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2021-10-20 fusion

#NICE#

146 0
[GetPortalCommentsPageByObjectIdResponse(id=1815848, encodeId=15f1181584893, content=<a href='/topic/show?id=82e99e291b0' target=_blank style='color:#2F92EE;'>#间质性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97291, encryptionId=82e99e291b0, topicName=间质性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=99cf2500102, createdName=zjshifan_98647306, createdTime=Fri Sep 23 18:57:31 CST 2022, time=2022-09-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1671976, encodeId=4e7c16e19767a, content=<a href='/topic/show?id=58378220131' target=_blank style='color:#2F92EE;'>#肺病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82201, encryptionId=58378220131, topicName=肺病)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2f0826868454, createdName=amy0559, createdTime=Thu Dec 30 20:57:31 CST 2021, time=2021-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058468, encodeId=ef672058468f5, content=<a href='/topic/show?id=1b69e363bb' target=_blank style='color:#2F92EE;'>#FEV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7363, encryptionId=1b69e363bb, topicName=FEV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Wed Sep 07 19:57:31 CST 2022, time=2022-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1662030, encodeId=f0cc166203093, content=<a href='/topic/show?id=260c9e210e' target=_blank style='color:#2F92EE;'>#ILD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=112, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9721, encryptionId=260c9e210e, topicName=ILD)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b79025361884, createdName=ms3994565386320060, createdTime=Thu Jun 30 12:57:31 CST 2022, time=2022-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1289105, encodeId=3bb91289105fc, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Wed Oct 20 11:57:31 CST 2021, time=2021-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1521659, encodeId=1d01152165956, content=<a href='/topic/show?id=18bb8e08622' target=_blank style='color:#2F92EE;'>#英国NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=131, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87086, encryptionId=18bb8e08622, topicName=英国NICE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ce711379167, createdName=lvygwyt2785, createdTime=Wed Oct 20 11:57:31 CST 2021, time=2021-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558451, encodeId=1103155845167, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Wed Oct 20 11:57:31 CST 2021, time=2021-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564460, encodeId=48f5156446011, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Wed Oct 20 11:57:31 CST 2021, time=2021-10-20, status=1, ipAttribution=)]
2021-10-20 lvygwyt2785

#英国NICE#

131 0
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2021-10-20 医者仁心

#Ofev#

0 0
[GetPortalCommentsPageByObjectIdResponse(id=1815848, encodeId=15f1181584893, content=<a href='/topic/show?id=82e99e291b0' target=_blank style='color:#2F92EE;'>#间质性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97291, encryptionId=82e99e291b0, topicName=间质性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=99cf2500102, createdName=zjshifan_98647306, createdTime=Fri Sep 23 18:57:31 CST 2022, time=2022-09-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1671976, encodeId=4e7c16e19767a, content=<a href='/topic/show?id=58378220131' target=_blank style='color:#2F92EE;'>#肺病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82201, encryptionId=58378220131, topicName=肺病)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2f0826868454, createdName=amy0559, createdTime=Thu Dec 30 20:57:31 CST 2021, time=2021-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058468, encodeId=ef672058468f5, content=<a href='/topic/show?id=1b69e363bb' target=_blank style='color:#2F92EE;'>#FEV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7363, encryptionId=1b69e363bb, topicName=FEV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Wed Sep 07 19:57:31 CST 2022, time=2022-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1662030, encodeId=f0cc166203093, content=<a href='/topic/show?id=260c9e210e' target=_blank style='color:#2F92EE;'>#ILD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=112, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9721, encryptionId=260c9e210e, topicName=ILD)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b79025361884, createdName=ms3994565386320060, createdTime=Thu Jun 30 12:57:31 CST 2022, time=2022-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1289105, encodeId=3bb91289105fc, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=146, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Wed Oct 20 11:57:31 CST 2021, time=2021-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1521659, encodeId=1d01152165956, content=<a href='/topic/show?id=18bb8e08622' target=_blank style='color:#2F92EE;'>#英国NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=131, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87086, encryptionId=18bb8e08622, topicName=英国NICE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ce711379167, createdName=lvygwyt2785, createdTime=Wed Oct 20 11:57:31 CST 2021, time=2021-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558451, encodeId=1103155845167, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Wed Oct 20 11:57:31 CST 2021, time=2021-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564460, encodeId=48f5156446011, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Wed Oct 20 11:57:31 CST 2021, time=2021-10-20, status=1, ipAttribution=)]
2021-10-20 respect

#Ofev#

107 0

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英国NICE批准Ofev用于间质性肺病 (ILD)

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