参考综合详解2014 joi.pdfVIP

Research

OriginalInvestigation

EffectofFluconazoleProphylaxisonCandidiasis

andMortalityinPrematureInfants

ARandomizedClinicalTrial

DanielK.BenjaminJr,MD,PhD;MarkL.Hudak,MD;ShahnazDuara,MD;DavidA.Randolph,MD,PhD;MargaritaBidegain,MD,MHS-CL;

GratiasT.Mundakel,MD;GirijaNatarajan,MD;DavidJ.Burchfield,MD;RobertD.White,MD;KarenE.Shattuck,MtalieNeu,MD,MPH;

CatherineM.Bendel,MD;M.RogerKim,MD;NeilN.Finer,MD;DanL.Stewart,MD;AntonioC.Arrieta,MD;KellyC.Wade,MD;DavidA.Kaufman,MD;

PaoloManzoni,MD;KristiO.Prather,MPH;DanielaTestoni,MD,MHS;KatherineY.Berezny,MPH;P.BrianSmith,MD,MPH,MHS;

fortheFluconazoleProphylaxisStudyTeam

IMPORTANCEInvasivecandidiasisinprematureinfantscausesdeathandneurodevelop-

mentalimpairment.Fluconazoleprophylaxisreducescandidiasis,butitseffectonmortality

andthesafetyoffluconazoleareunknown.

OBJECTIVEToevaluatetheefficacyandsafetyoffluconazoleinpreventingdeathorinvasive

candidiasisinextremelylow-birth-weightinfants.

DESIGN,SETTING,ANDPATIENTSThisstudywasarandomized,blinded,placebo-controlled

trialoffluconazoleinprematureinfants.Infantsweighinglessthan750gatbirth(N=361)

from32neonatalintensivecareunits(NICUs)intheUnitedStateswererandomlyassignedto

receiveeitherfluconazoleorplacebotwiceweeklyfor42days.Survivinginfantswere

evaluatedat18to22monthscorrectedageforneurodevelopmentaloutcomes.Thestudy

wasconductedbetweenNovember2008andFebruary2013.

INTERVENTIONSFluconazole(6mg/kgofbodyweight)orplacebo.

MAINOUTCOMESANDMEASURESTh