当前位置：文档之家 › 氨溴索大剂量-英文

氨溴索大剂量-英文

  • 格式：pdf
  • 大小：219.87 KB
  • 文档页数：5

下载文档原格式

  / 5

合集下载

  1. 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
  2. 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
  3. 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。

Short-termperioperativetreatmentwithambroxolreduces

pulmonarycomplicationsandhospitalcostsafterpulmonary

lobectomy:arandomizedtrial§

MajedRefai*,AlessandroBrunelli,FrancescoXiume´,MicheleSalati,

ValeriaSciarra,LauraSocci,LucaDiNunzio,ArmandoSabbatini

DepartmentofThoracicSurgery,UmbertoIRegionalHospitalAncona,Italy

Received9July2008;receivedinrevisedform28October2008;accepted10November2008;Availableonline13January2009

Abstract

Objective:Toassessinarandomizedclinicaltrialtheinfluenceofperioperativeshort-termambroxoladministrationonpostoperative

complications,hospitalstayandcostsafterpulmonarylobectomyforlungcancer.Methods:Onehundredandfortyconsecutivepatients

undergoinglobectomyforlungcancer(April2006—November2007)wererandomizedintwogroups.GroupA(70patients):ambroxolwas

administeredbyintravenousinfusioninthecontextoftheusualtherapyonthedayofoperationandonthefirst3postoperativedays(1000mg/

day).GroupB(70patients):fluidtherapyonlywithoutambroxol.Groupswerecomparedintermsofoccurrenceofpostoperativecomplications,

lengthofstayandcosts.Results:Therewerenodropoutsfromeithergroupandnocomplicationsrelatedtotreatment.Thetwogroupswerewell

matchedforperioperativeandoperativevariables.ComparedtogroupB,groupA(ambroxol)hadareductionofpostoperativepulmonary

complications(4vs13,6%vs19%,p=0.02),andunplannedICUadmission/readmission(1vs6,1.4%vs8.6%,p=0.1)rates.Moreover,the

postoperativestayandcostswerereducedby2.5days(5.6vs8.1,p=0.02)and2765Euro(2499Eurovs5264Euro,p=0.04),respectively.

Conclusions:Short-termperioperativetreatmentwithambroxolimprovedearlyoutcomeafterlobectomyandmaybeusedtoimplementfast-

trackingpoliciesandcutpostoperativecosts.Nevertheless,otherindependenttrialsareneededtoverifytheeffectofthistreatmentindifferent

settings.

#2008EuropeanAssociationforCardio-ThoracicSurgery.PublishedbyElsevierB.V.Allrightsreserved.

Keywords:Pulmonarylobectomy;Non-smallcelllungcancer;Postoperativecomplications;Ambroxol

1.Introduction

Despitenewtechniquesandrecentadvancesinhospital

carethatareimplementedtoimprovethequalityandreduce

costs,morbidityandhospitalcostsaftermajorlungresection

forlungcancerarestillhigh.

Thoracicsurgeonsarefacedwithanincreasingpopulation

ofelderlypatientswithasignificantprevalenceofchronic

obstructivedisease.Surgeryinthesepatientscanbe

associatedwithincreasedriskofmorbidityandmortality

causedbytheunderlyinglungdisease.

Thispatientpopulationislikelytohaveanincreased

incidenceofsignificantpostoperativepulmonarycomplica-

tionssuchasatelectasis,pneumonia,andacuterespiratory

failurerequiringintubationandmechanicalventilation[1].Thereforeeveryeffortmustbeimplementedtoruleoutor

reducethesecomplications.

Ambroxolisatrans-4[2-amino-3,5-dibromo-benzyl,

amino]cyclohexanol-hydrochloridewhichhasbeenshown

toincreasethenumberandactivityoftype2pneumocytes

[2],andthustoincreasesurfactantlevelsandlecithin/

sphyngomyelinratio[3]andmucociliaryclearance[4].

Weconductedarandomizedclinicaltrialtoassessthe

influenceofperioperativeshort-termambroxoladministra-

tiononpostoperativecomplications,hospitalstayandcosts

afterlobectomyforlungcancer.

2.Patientsandmethods

Thetrialwasdesignedandanalyzedaccordingto

ConsolidatedStandardsofReportingTrials(CONSORT)

recommendationsandchecklist(seeFig.1forCONSORT

flowchart)[5].Simpleunrestrictedrandomizationwasused

toallocatepatientsintothetwogroupsbeforeoperation.

Bothpatientsanddatamanageranalyzingtheoutcomewerewww.elsevier.com/locate/ejctsEuropeanJournalofCardio-thoracicSurgery35(2009)469—473

§Presentedatthe16thEuropeanConferenceonGeneralThoracicSurgery,

Bologna,Italy,June8—11,2008.

*Correspondingauthor.Address:ViaS.Vincenzo5/f,Polverigi60020,Italy.

Tel.:+390715964439;fax:+390715964433.

E-mailaddress:majedit@yahoo.com(M.Refai).

1010-7940/$—seefrontmatter#2008EuropeanAssociationforCardio-ThoracicSurgery.PublishedbyElsevierB.V.Allrightsreserved.

doi:10.1016/j.ejcts.2008.11.015blindedtogroupallocation.Randomizationwasperformed

bycomputerizednumericalsequence.

Samplesizewassettoreachastatisticalpowerof90%to

detectanexpecteddifferenceinpostoperativestayofat

least2days.Exclusioncriteriawerewedgeresection/

segmentectomy(62patients)orpneumonectomy(20

patients),andlungresectionassociatedwithchestwall

resection(4patients).Allpatientsgavetheirinformed

consenttoparticipateinthestudyandtousetheirdataina

prospectivedatabase.Thisstudyprotocolwasapprovedby

thelocalinstitutionalreviewboard(IRB).

Onehundredandfortyconsecutivepatients(females:28,

males:112)undergoinglobectomyforlungcancerfromApril

2006throughNovember2007wererandomizedbysimple

unrestrictedrandomizationintotwogroupsbeforeopera-

tion.GroupA(70patients):ambroxolwasadministeredby

intravenousinfusion(1000mg/day)inthecontextofthe

usualfluidtherapyonthedayofoperationandonthefirst

threepostoperativedays.GroupB(70patients):fluid

therapyonlywasadministeredwithoutambroxol.Onthe

secondandthirdpostoperativedayspatientsinbothgroups

receivedonlytheamountoffluidnecessarytoadminister

ambroxolorplacebo(500ml).

Therewerenodropoutsfromeithergroupandno

complicationsrelatedtotreatment.

Allpatientsweresubjectedtoastrictpreoperative

evaluationandcontraindicationstomajorlungresections

wereaccordingtotheAmericanCollegeofChestPhysician

criteria(ppoFEV1<30%,ppoDLCO<30%,VO2peak<10ml/

kg/min)[6].

Allpatientswereoperatedoninasinglededicated

thoracicsurgerycenterbyqualifiedthoracicsurgeons.

Alllobectomieswereperformedbymuscle-sparinglateral

thoracotomy.Short-termantibioticprophylaxiswithcefazo-

linwasadministered.Postoperativetreatmentwasstandar-dizedforallpatientsandfocusedonearlymobilizationand

physicalrehabilitation.Physicalrehabilitationwassuper-

visedtwiceadaybyaspecialistphysiotherapistwith

standardexercisesaimedatchestphysiotherapyandphysical

rehabilitation.Thoracotomychestpainwascontrolledby

intravenouscontinuousinfusionofnon-opiatesandwas

titratedtoachieveavisualanalogicpainscore(VAS)below

four(range0—10)duringthefirst48—72hafterthe

operation.Patientsweremobilizedassoonaspossibleand

bronchodilatorswereadministeredonlyincaseofan

objectiveevidenceofreversibleobstructionafterbronch-

odilatoradministrationatthepreoperativepulmonary

functiontests(PFTs).

Allpatientsweremanagedinadedicatedthoracicward

withspecializedpersonnelandresortedtointensivecareunit

(ICU)onlyincaseofcardiorespiratorycomplicationsrequir-

ingactivelife-supportingtreatments.

Thefollowingoutcomeswereanalyzed:

Totalcardiopulmonarymorbidity,cardiaccomplications,

pulmonarycomplications,mortality,postoperativestay

andcosts.

Postoperativemorbidityandmortalitywereconsideredas

thoseoccurringwithin30dayspostoperativelyorfora

longerperiodifthepatientwasstillinthehospital.

Forthepurposeofthisstudyandforthesakeof

comparisonwithpreviousstudies[7—9]thefollowing

complicationswereincluded:

Pulmonary,respiratoryfailurerequiringmechanical

ventilationformorethan48h;pneumonia(chestX-rays

infiltrates,increasedwhitebloodcellcount,fever);

atelectasisrequiringbronchoscopy;adultrespiratory

distresssyndrome(ARDS);pulmonaryedema;pulmonary

embolism;M.Refaietal./EuropeanJournalofCardio-thoracicSurgery35(2009)469—473470

Fig.1.ConsolidatedStandardsofReportingTrials(CONSORT)flowchart.