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现在位置不用本金就能赚钱的方法>技术资料不用本金就能赚钱的方法>行业动态>新品动态>最新分析证实尼达尼布可延缓IPF疾病进展并降低急性加重风险

最新分析证实尼达尼布可延缓IPF疾病进展并降低急性加重风险

美通社2016年2月27日 9:47 点击:926

-- 通过测量用力肺活量(FVC)的下降率* [1-8],三项关键性研究的汇总数据证实,尼达尼布可以使疾病进展延缓约50%
-- 汇总分析还表明,尼达尼布可以使IPF急性加重的风险显著下降47% [1]
-- 尼达尼布可以使全因死亡率的风险下降30%,并使治疗期间死亡率显著下降43% [1,9,10]

德国殷格翰和康涅狄格州里奇菲尔德2016年2月26日电 /美通社/ -- 最近Respiratory Medicine杂志发表了TOMORROW和INPULSIS?试验的汇总分析。该分析进一步证实尼达尼布可显著降低特发性肺纤维化(IPF)(这是一种使患者衰弱并危及生命的肺部疾病)患者的急性加重风险47%。[1] IPF急性加重是指在没有警告性迹象或者已知原因的情况下,呼吸功能突然恶化,这也是IPF患者住院治疗的首要原因。[11] 因IPF急性加重住院的患者,约半数会在住院期间死亡。 [12] 这些发现结果也显示出,尼达尼布可以降低多种患者类型的死亡风险[1,9,10]并使疾病进展延缓约50%***。 [1-8]

 

ZUIJIN Respiratory MedicineZAZHIFABIAOLETOMORROWHEINPULSIS ?SHIYANDEHUIZONGFENXI。GAIFENXIJINYIBUZHENGSHINIDANIBUKEXIANZHUJIANGDITEFAXINGFEIXIANWEIHUA(IPF)(ZHEISHIYIZHONGSHIHUANZHESHUAIRUOBINGWEIJISHENGMINGDEFEIBUJIBING)HUANZHEDEJIXINGJIAZHONGFENGXIAN47%。

汇总分析的数据来自II期TOMORROW试验和两项III期INPULSIS?试验,总共包括1231位IPF患者(723位接受尼达尼布治疗,508位接受安慰剂治疗)。[1] 这三项临床试验的数据是尼达尼布在美国、欧洲、日本和其他国家获得上市批准的基础。

1NIANQILIANHESHUJUXIANSHI:[1]

HEANWEIJIXIANGBI,NIDANIBUKEYIXIANZHUJIANGDIZHILIAOYISHENGBAOGAODEIPFJIXINGJIAZHONGDEFENGXIANDA47%。

不用本金就能赚钱的方法ZONGTISHANGCHUXIANJIXINGJIAZHONGDEHUANZHESHULIANGGENGSHAO。NIDANIBUZUCHUXIANZHISHAOYICIJIXINGJIAZHONGDEHUANZHEBILISHI4.6%,ANWEIJIZUSHI8.7%。

不用本金就能赚钱的方法 “JIANGDIJIXINGJIAZHONGFENGXIANSHITEFAXINGFEIXIANWEIHUAGUANLIDEYIGEZHONGYAOZHILIAOMUBIAO,YINWEIJIXINGJIAZHONGHUIDUIBINGCHENGCHANSHENGBUKEYUZHIDEPOHUAIXINGYINGXIANG。JIXINGJIAZHONGWANGWANGHUIZAIJIGEYUENEIDAOZHIHUANZHESIWANG,”YINGGUONANANPUDUNDAXUEHUXINEIKEJIAOSHOULuca RicheldiCHENG。“ZHEIXIEFENXIHUITIGONGYUELAIYUEDUODEZHENGJU,BIAOMINGIPFHUANZHEKEYICUNHUODEGENGZHANGJIU,YINWEIJINQIHUOPIDEZHILIAOFANGSHIYIJINGDUIBINGCHENGCHANSHENGLEYINGXIANG。”

ZAIZHEIXIEWEIQI1NIANDEYANJIUZHONG,NIDANIBUZAISUOYOUCUNHUOZHONGDIANJUNBIAOXIANCHUYOULIQUSHI:

YUANWEIJIXIANGBI,NIDANIBUZHILIAODEHUANZHEQUANYINSIWANGFENGXIANXIAJIANG30%**(p = 0.0954)。[1]

不用本金就能赚钱的方法JIESHOUNIDANIBUZHILIAODEHUANZHE,ZHILIAOQIJIANSIWANGFENGXIAN(ZHILIAOQIJIANSIWANGLV)YEXIAJIANGLE43%(p = 0.0274)。[1,9,10]

YANJIUHAIGUANCHADAO,HEANWEIJIXIANGBI,JIXINGJIAZHONGHUOZHEQITAHUXIXITONGYUANYINDAOZHISIWANGDEFENGXIANXIAJIANG38%(p = 0.0779)。[1]

GENJUYONGLIFEIHUOLIANG(FVC)DENIANXIAJIANGLV,CIFENXIYEZHENGSHILENIDANIBUKEYISHIJIBINGJINZHANYANHUANYUE50%。NIDANIBUZUDEFVCZONGTIXIAOZHENGNIANXIAJIANGLVSHI-112.4 mL/year,ANWEIJIZUSHI-223.3 mL/year(CHAZHI:110.9 mL/year),ZHEIZHENGSHILENIDANIBUZAIYANHUANJIBINGJINZHANFANGMIANDEYOULIXIAOYING。HUIZONGFENXIZHONGNIDANIBUANQUANXINGHENAISHOUXINGSHUJUYUTOMORROWHEINPULSISDANXIANGSHIYANDEJIEGUOYIZHI。ZUICHANGBAOGAODEBULIANGFANYINGSHIFUXIE。[1]

不用本金就能赚钱的方法“SANXIANGLEISISHEJIDEGUANJIANXINGYANJIUDEFENXIJIEGUOJINYIBUQUERENNIDANIBUZAIJIANGDITEFAXINGFEIXIANWEIHUASIWANGLVHEJIXINGJIAZHONGFANGMIANDEHUOYI。ZHEIXIEDOUSHIGUANLIIPFDEZHONGYAOKAOLVYINSU,WOMENRENWEIZHEIXIEXINSHUJUYOUZHUYUZHIDAOYISHENGHEHUANZHETAOLUNZHILIAOFANGFA,”BOLINGEYINGEHANHUXIZHILIAOLINGYUYIXUEFUZERENWilliam MezzanotteBOSHIBIAOSHI。

 

 

关于尼达尼布的TOMORROW和INPULSIS?试验 [1]

TOMORROWSHIYANDEDIYIJIEDUANSHIZAIIPFHUANZHEZHONGKAIZHANDEZHENDUINIDANIBUDESUIJI、ANWEIJIDUIZHAO、52ZHOU、IIQIJILIANGTANSUOXINGSHIYAN,SHIYANJIEGUOXIANSHINIDANIBU150 mgMEIRI2CIKEJIANGDIYONGLIFEIHUOLIANG(FVC)XIAJIANGLV、JIANSHAOYANJIUZHEBAOGAODEJIXINGJIAZHONGJIWEICHIYONGSHENGQIAOZHIHUXIWENJUAN(SGRQ)PINGGUDEYUJIANKANGXIANGGUANDESHENGHUOZHILIANG。INPULSISSHIYANSHILIANGXIANGSHEJIXIANGTONGDE、SUIJI、ANWEIJIDUIZHAOIIIQISHIYAN,SHIYANPINGGULEIPFHUANZHESHIYONGNIDANIBU150 mgMEIRI2CIGONG52ZHOUDELIAOXIAOHEANQUANXING。INPULSISSHIYANDEZHUYAOZHONGDIANSHIFVCDENIANXIAJIANGLV;GUANJIANXINGCIYAOZHONGDIANSHIJULIYANJIUZHESHOUCIBAOGAOJIXINGJIAZHONGDESHIJIANHESGRQZONGFENJIAOJIXIANDEBIANHUAZHI,JUNWEIQI52ZHOU。

GONGYOU1231WEIHUANZHENARUTOMORROWHEINPULSISSHIYANDEHUIZONGFENXI(723WEIHUANZHEJIESHOUNIDANIBUZHILIAO,508WEIJIESHOUANWEIJIZHILIAO)。

NIDANIBUYOULIDEFENGXIANHUOYIBIDEDAOJINYIBUKENDING,BINGXIANSHICHUKEBEIJIESHOUDEANQUANXINGHENAISHOUXING。

关于尼达尼布

尼达尼布是一种小分子的酪氨酸激酶抑制剂,由勃林格殷格翰开发用于治疗IPF。[13]每日2次,每次1粒尼达尼布胶囊,在各种IPF患者类型中可延缓疾病进展,降低肺功能年下降率达50% ***。[1-8] 其中包括早期IPF患者(FVC大于不用本金就能赚钱的方法90%预计值), [4] 高分辨率计算机断层成像(HRCT)发现少量影像学纤维化病灶(无蜂窝样)的患者 [5]和肺气肿患者。[6] 大部分患者出现的尼达尼布副作用均可得到有效控制。 [2]

尼达尼布靶向作用于生长因子受体,已经证明生长因子受体参与肺纤维化的发生机制。最重要的是尼达尼布可以抑制血小板源生长因子受体(PDGFR)、成纤维细胞生长因子受体(FGFR)和血管内皮生长因子受体(VEGFR)。 [2, 14, 15] 一般认为,尼达尼布可通过阻断参与肺纤维化过程的信号转导通路发挥延缓IPF疾病进展、减缓肺功能下降速率的作用。[2,15,16]

* Lung function decline measured by forced vital capacity (FVC)
** On-treatment mortality was defined as deaths recorded during the 52-week study period and 28-day follow-up
*** Including those with preserved lung function (FVC>90%pred), no honeycombing on HRCT and concomitant emphysema

CANKAOWENXIAN

  1. 不用本金就能赚钱的方法Richeldi L, et al. Pooled analysis of data from the TOMORROW and INPULSIS? trials. Resp Med 02/2016. DOI: 10.1016/ j.rmed.2016.02.001. Available at:

  2. Richeldi L, du Bois RM, Raghu G, et al; for the INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;380(22):2071-2082

  3. OFEV? Summary of Product Characteristics. Boehringer Ingelheim International GmbH.January 2016.

  4. Kolb M, Richeldi L, Kimura T, Stowasser S, Hallmann C, du Bois RM. Effect of baseline FVC on decline in lung function with nintedanib in patients with IPF: results from the INPULSIS?trials. Poster presented at the 110th American Thoracic Society Conference; Denver, Colorado, May 15–20, 2015.

  5. Raghu G, Wells A, Nicholson AG, et al. Consistent effect of nintedanib on decline in FVC in patients across subgroups based on HRCT diagnostic criteria: results from the INPULSIS?trials in IPF. Poster presented at the 110th American Thoracic Society Conference; Denver, Colorado, May 15–20, 2015.

  6. Cottin V, Taniguchi H, Richeldi L, et al. Effect of baseline emphysema on reduction in FVC decline with nintedanib in the INPULSIS? trials. Abstract presented at the 18th International Colloquium on Lung and Airway Fibrosis; Mont Tremblant, Canada, September 20-24, 2014. Available at:  .

  7. Costabel U., et al. Efficacy of nintedanib in idiopathic pulmonary fibrosis across pre-specified subgroups in INPULSIS?. AJRCCM. 2015; 15-10031.

  8. Keating GM. Nintedanib: A Review of Its Use in Patients with Idiopathic Pulmonary Fibrosis. Drugs. 2015 Jul;75(10):1131-40. doi: 10.1007/s40265-015-0418-6.

  9. Data on file. Boehringer Ingelheim International: Kirsten AM, et al. Pooled analysis of mortality data from the TOMORROW and INPULSIS? trials of nintedanib in idiopathic pulmonary fibrosis (IPF). Poster presented at 56th Congress of the German Respiratory Society; Berlin, Germany. March 18-21 2015.

  10. Cottin V. Nintedanib: a new treatment for idiopathic pulmonary fibrosis. Clinical Investigation 05/2015; DOI: 10.4155/cli.15.27

  11. Kubo H, et al. Anticoagulant therapy for idiopathic pulmonary fibrosis. Chest 2005, 128:1475–1482.

  12. Kim D. S., Acute exacerbations in patients with idiopathic pulmonary fibrosis. Respir Res. 2013;14:86

  13. Song JW, et al. Acute exacerbation of idiopathic pulmonary fibrosis: incidence, risk factors and outcome. Eur Respir J. 2011;37:356-363.

  14. 不用本金就能赚钱的方法Selman M, et al. Idiopathic pulmonary fibrosis: prevailing and evolving hypotheses about its pathogenesis and implications for therapy. Ann Intern Med. 2001;134:136-51.

  15. Hilberg F, et al. BIBF 1120: triple angiokinase inhibitor with sustained receptor blockade and good antitumor efficacy. Cancer Res. 2008;68:4774-4782.

  16. Wollin L, et al. Antifibrotic and Anti-inflammatory Activity of the Tyrosine Kinase Inhibitor Nintedanib in Experimental Models of Lung Fibrosis. J Pharmacol Exp Ther. 2014;349:209–220.

  17. 不用本金就能赚钱的方法Ley B., et al. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. AJRCCM. 2011;183:431–40.

  18. Raghu G, et al. Incidence and prevalence of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2006;174:810-816.

  19. Fernandez Perez E, et al. Incidence, prevalence, and clinical course of idiopathic pulmonary fibrosis: a population-based study. Chest. 2010;137:129-37.

  20. 不用本金就能赚钱的方法NHLBI, NIH. What Is Idiopathic Pulmonary Fibrosis? Available at:.

  21. Pulmonary Fibrosis Foundation. Symptoms. Available at: .

  22. 不用本金就能赚钱的方法Collard H, et al. Acute Exacerbations of Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2007;176:636–643.

消息来源: 勃林格殷格翰

(来源: 美通社


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