Nintedanib加西地那非治疗特发性

SCI

26September

NintedanibplusSildenafilinPatientswithIdiopathicPulmonaryFibrosis

KolbMartin,RaghuGanesh,WellsAtholUetal.NintedanibplusSildenafilinPatientswithIdiopathicPulmonaryFibrosis.[J].N.Engl.J.Med.,.

WeillDepartmentofMedicine,WeillCornellMedicalCollege,NewYork–PresbyterianHospitalandWeillCornellMedicalCenter,YorkAve.,Box96,Rm.Y-,NewYork,NY,oratfjm

med.cornell.edu

Background背景

Nintedanibisanapprovedtreatmentforidiopathicpulmonaryfibrosis(IPF).Asubgroupanalysisofapreviouslypublishedtrialsuggestedthatsildenafilmayprovidebenefitsregardingoxygenation,gasexchangeasmeasuredbythediffusioncapacityofthelungsforcarbonmonoxide(DlCO),symptoms,andqualityoflifeinpatientswithIPFandseverelydecreasedDlCO.Thatideawastestedinthistrial

Nintedanib是特发性肺纤维化（IPF）的批准治疗方法。先前发表的一项试验的亚组分析表明，西地那非可以提供氧气，气体交换的益处，通过肺部对一氧化碳（DlCO）的扩散能力，症状和IPF患者的生活质量以及严重降低的DlCO来衡量。这个想法在这个试验中进行了测试。

Methods方法

Werandomlyassigned,ina1:1ratio,patientswithIPFandaDlCOof35%orlessofthepredictedvaluetoreceivenintedanibatadoseofmgtwicedailyplussildenafilatadoseof20mgthreetimesdaily(nintedanib-plus-sildenafilgroup)ornintedanibatadoseofmgtwicedailyplusplacebothreetimesdaily(nintedanibgroup)for24weeks.TheprimaryendpointwasthechangefrombaselineinthetotalscoreontheSt.George’sRespiratoryQuestionnaire(SGRQ)atweek12(thetotalscorerangesfrom0to,withhigherscoresindicatingworsehealth-relatedqualityoflife).Secondaryendpointsincludedmeasuresofdyspneaandsafety.

我们以1：1的比例随机分配DlCO预测值为35％或更低的IPF患者，一组(nintedanib-plus-sildenafil组)每日两次接受mgnintedanib加每日三次20mg西地那非，一组（nintedanib组）每日两次接受mgnintedanib，加每日三次安慰剂，两组均持续24周。主要终点是第12周St.George’s呼吸问卷（SGRQ）总分从基线的变化（总分从0到，分数越高表明与健康相关的生活质量越差）。次要终点包括呼吸困难和安全性的测量。

Results结果

Atotalofpatientsunderwentrandomization.TherewasnosignificantdifferenceintheadjustedmeanchangefrombaselineintheSGRQtotalscoreatweek12betweenthenintedanib-plus-sildenafilgroupandthenintedanibgroup.AbenefitfromsildenafiltreatmentwasnotobservedwithregardtodyspneaasmeasuredwiththeuseoftheUniversityofCalifornia,SanDiego,ShortnessofBreathQuestionnaire.Nonewsafetysignalswereobserved,as







































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