低分子量肝素联合IPC 对妇科肿瘤手术后DVT 的预防.docx
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低分子量肝素联合IPC 对妇科肿瘤手术后DVT 的预防.docx
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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
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- 低分子量肝素联合IPC 对妇科肿瘤手术后DVT 的预防 分子量 肝素 联合 IPC 妇科 肿瘤 手术 DVT 预防