低分子量肝素联合IPC 对妇科肿瘤手术后DVT 的预防.docx

低分子量肝素联合IPC 对妇科肿瘤手术后DVT 的预防.docx

《低分子量肝素联合IPC 对妇科肿瘤手术后DVT 的预防.docx》由会员分享，可在线阅读，更多相关《低分子量肝素联合IPC 对妇科肿瘤手术后DVT 的预防.docx（24页珍藏版）》请在冰点文库上搜索。

低分子量肝素联合IPC对妇科肿瘤手术后DVT的预防

低分子量肝素联合IPC对妇科肿瘤手术后DVT的预防

Arandomizedtrialoflow-doseheparinandintermittent

pneumaticcalfcompressionforthepreventionofdeep

venousthrombosisaftergynecologiconcologysurgery

c

DanielL.Clarke-Pearson,MD,aIngridS.Synan,RN,aRichardDodge,MS,b

JohnT.Soper,MD,'AndrewBerchuck,MD,aandR.EdwardColeman,MD

Durham,NorthCarolina

OBJECTIVE:

Ouraimwastodeterminetherelativeefficacyandcomplicationsoflowdoseheparinandintermittentpneumaticcalfcompressionforthepreventionofpostoperativevenousthrombosisinpatientsundergoingsurgeryforgynecologicmalignancy.

STUDYDESIGN:

Randomizedtrialcomparing107patientstreatedwithlow-doseheparinto101patientstreatedwithintermittentpneumaticcalfcompressionwasperformed.Allpatientswereevaluatedwithiodine-125fibrinogenscanningofthelegs.Clinicalandlaboratoryvariablesassociatedwithbleedingcomplicationswererecordedprospectively.

RESULTS:

Venousthrombosiswasdiagnosedinsevenpatientsreceivinglow-doseheparinandinfourreceivingintermittentpneumaticcalfcompression（p=0.54）.Low-doseheparinpatientsreceivedmorebloodtransfusionspostoperatively（p=0.02）,hadincreasedvolumeofretroperitonealdrainage（p=0.02）,andtheactivatedpartialthromboplastintimewasmorefrequentlyprolonged（p=0.001）.

CONCLUSIONS:

Low-doseheparinandintermittentpneumaticcalfcompressionprovidesimilarreductioninreducingtheincidenceofpostoperativevenousthrombosis.However,Iow-doseheparinismorefrequentlyassociatedwithpostoperativebleedingcomplications.（AmJOBSTETGYNECOL

1993;168:

1146-54.）

Keywords:

Venousthrombosisprophylaxis,low-doseheparin,intermittentpneumaticcalfcompression,bleedingcomplications

Deepveinthrombosisandpulmonaryembolismareseriousandsometimesfatalcomplicationsthatcanoccuraftergynecologicsurgery.Overthepastdecadewehaveperformedseveralprospective,controlled,randomizedtrialstoevaluatetheefficacyofvarioustherapeuticmodalitiesaimedatpreventingpostoperativedeepveinthrombosis.Inwomenwithgynecologicmalignancieswefoundthatlow-doseheparingivenevery12hourspostoperativelyisineffectiveinpreventingdeepvenousthrombosis.1Wealsofoundthatintermit-tentpneumaticcalfcompressionusedintraoperativelyandfor24hourspostoperativelydidnotpreventdeepvenousthrombosis?

Subsequentlywedemonstratedthatgynecologiconcologypatientsdidbenefitfrom

eitherlow-doseheparinwhengivenastreeddosesevery8hourspreoperativelyandevery8hourspostoperatively''orintermittentpneumaticcall'compressionappliedintraoperativelyandmaintaine（ltotthefirst5postoperativedays.4

FromtheDivisionofGynecologicOncology,DepartmentofObstetricsandGynecology,"Biostatistics,ComputingandDataManagement,DukeComprehensiveCancerCenter,bandtheDivisionofNuclearMedicine,DepartmentofRadiology,DukeUniversityMedicalCenter.

PresentedbyinvitationattheEleventhAnnualMeetingofthe

AmericanGynecologicalandObstetricalSocietyHotSprings,Virginia,September10-12,1992.

Reprintrequests:

D.L.Clarke-Pearson,MD,Box3079,DukeUniversityMedicalCenter,Durham,NC27710.

Copyright~1993byMosby-YearBook,Inc.

0002-9378/93$1.00+.206/6/44822

Althoughthecostsofthesetwoprophylacticmethodsareapproximatelythesamethesideeffectsandpatientcompliancediffer.Thecurrentstudywasbasedonthehypothesisthatlow-doseheparinandintermittentpneumaticcalfcompressionhavesimilarefficacyinpreventingpostoperativedeepvenousthrombosisingynecologiconcologypatients.Becauseofthedifferencesinthemechanismsofactionofthesetwomethods,however,theremightbesignificantdifferencesincomplicationsoftherapy,especiallybleedingcomplications.Furthermore,thesecomplicationsmightinfluencetheoveralluseandtherapeuticindexofthetwomethodsandresultinchangesinmanagementinthefuture.

Materialandmethods

AllpatientsadmittedtotheDivisionofGynecologicOncologyformajorsurgeryforknownorpresumedgynecologicmalignancieswereeligibleforthisstudyafterinformedwrittenconsentwasobtained,asapprovedbytheInstitutionalReviewBoard.Becauseoftheveryhighincidenceofdeepveinthrombosisassociatedwithpelvicexenteration,patientswerestratifiedbeforerandomizationiftheyweretoundergoapelvicexenteration.Patientswerethenassignedrandomlybymeansoftherandomnumbertabletooneofthetwotreatmentregimens.Regimen1（low-doseheparin）wasadministeredidenticallytoourprevioussuccessfultrial3andwasgiveninthefollowingmanner:

5000unitsofheparinwasgivensubcutaneouslyat2PM,10pm,and6AMbeforestartingsurgeryat8Au.Ifapatientwasadmittedseveraldaysbeforesurgery,heparinwasstartedonadmissionandcontinuedevery8hoursuntilsurgeryPostoperativelythepatientreceived5000unitsofheparinsubcutaneouslyevery8hoursfor7postoperativedays.Ifthepatientwasnotfullyambulatorybytheseventhpostoperativeday,heparinwascontinueduntilfullambulationwasestablished.Ontheotherhand,ifthepatientwasdischargedfromthehospitalbeforetheseventhpostoperativeday,theheparinwasdiscontinuedatthetimeofhospitaldischarge.Patientsassignedtoregimen2hadintermittentpneumaticcalfcompression（Venodyne,Needham,Mass.）initiatedattheinductionofanesthesiaandcontinuedwhilethepatientwasintheoperatingroom,recoveryroom,andrecumbentinherhospitalbed.Thepneumaticcom-pressionsleeveswereremovedwhilethepatientambulatedpostoperatively.Intermittentpneumaticcalfcom-pressionwascontinuedtot5postoperativedays.Ifthepatientwasnotfullyambulatorybythefifthpostoperativeday,intermittentpneumaticcalfcompressioncontinueduntilthepatientambulatedcompletely.Ifthepatientwasdischargedfromthehospitalbeforethefifthpostoperativcday,pneumaticcalfcompressionwasterminatedatthetimeofhospitaldischarge.

Historyandphysicalexaminationwereperformedattiletimeofthehospitaladmission,withspecificattentiontocoexistingriskfactorsthe'thromboemboliccomplications6Anypatientwithapasthistoryofableedingdiathesis,thromboembolismwithinthepast3months,oranticoagulant（warfarinorheparin）useintheprevious6weekswasexcludedfromthestudy.Patientsalsounderwentlaboratorytesting,includingevaluationofhematocrit,plateletcount,activatedpartialthromboplastintime,andprothrombintime.Patientswereexcludedfromthistrialiftheirplateletcountwas<100,000/mF'ortheactivatedpartialthromboplastintimeorprothrombintimewasprolonged>1.2timescontrolvalue.Allpatientsunderwentamajorabdominalorpelvicsurgicalprocedureundergeneralanesthesia.

Deepveinthrombosiswasassessedbymeansofthefibrinogenuptaketest,onthebasisofidentificationbyscintillationcountingofiodine-125-labeledfibrinogenincorporatedintoacutethrombiforminginthelegveins.Theaccuracyofthistest,whencorrelatedwithvenography,hasbeenestablished,andcriteriafordiagnosishavebeendescribed.7125Ifibrinogencountingwasperformedat2-inchintervalsoverthedeepveinsofthecalfandthigh.Oralsupersaturatedpotassiumiodinewasgivenpreoperativelytoblockthyroiduptakeof125Iiodide.125Ifibrinogen（100uCi）wasadministeredintravenouslytoallpatientsimmediatelyaftersurgery.Beginningonthefirstpostoperativeday,thefibrinogenuptaketestwasperformeddailyuntilthepatientwasdischarged.Deepveinthrombosiswasdiagnosedwhen125Icountswereincreased>20%overcountsintheadjacentscansiteorinthesamesiteonthecontralaterallegoroverthepreviousdays'countsatthesamelocation,withpersistencefor2consecutivedays.Ifthefibrinogenstudysuggestedthrombusformationinthepoplitealregionorthigh,ascendingvenographywasusedtoconfirmdeepveinthrombosis.WeperformedvenographyaccordingtothetechniquesdescribedbyRabinovandPaulin.8Patientswerefollowedbythefibrinogenuptaketestthroughouttheirhospitalizationandwerefollowedclinicallyforthefirst30dayspost-operatively.

Signsandsymptomsofdeepveinthrombosisandpulmonaryembolismwerealsoevaluateddaily.Symptomsofdeepveinthrombosiswereevaluatedbyimpedanceplethysmography,duplexDopplerultrasonography,andascendingcontrastvenography,ifclinicallyindicated.Symptomsandsignsofpulmonaryembolismwereassessedfurtherbyventilation-perfusionlungscanandpulmonaryarteriography.

Clinicalevidenceofbleedingcomplicationswereassesseddaily,includingestimatedoperativebloodloss,transfusionsduringsurgeryandpostoperatively,woundhematomaandseparation,pelvichematomaorlymphocyst,andretroperitonealsuctiondrainagevolume.Laboratorystudies,includinghematocrit,prothrombintime,activatedpartialthromboplastintime,andplateletcount,wererecordedpreoperativelyandeveryotherdaybeginningonthefirstpostoperativeday.

Toassesstheeffectsofcategoricvariablessuchastreatmentandraceontheoccurrenceofdeepveinthrombosis,weusedtheFisherexacttest.Forcontinuousvariables,suchasageandweight,logisticregressionwasused,withthedependentvariablebeingthepresenceorabsenceofdeepveinthrombosis.Then,tocontrolforpotentialconfoundingfactorsandtoinvestigatesimultaneouseffectsofseveralofthesevariables,weperformedmultiplelogisticregressionanalyses.Clinicalhemorrhagicparameterssuchasestimatedbloodlosswerecomparedbetweenthetwogroupsbymeansofrank-sumtestsforcontinuousvariablesandbytheFisherexacttestfordiscretevariables.A