1996食管PH计的使用指南英文AGA.docx

1996食管PH计的使用指南英文AGA.docx

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1996食管PH计的使用指南英文AGA

AMERICANGASTROENTEROLOGICALASSOCIATION

AmericanGastroenterologicalAssociationMedicalPositionStatement:

GuidelinesontheUseofEsophagealpHRecording

ThisdocumentpresentstheofficialrecommendationsoftheAmericanGastroenterologicalAssociation（AGA）ontheuseofesophagealpHrecording.ItwasapprovedbytheAGAPatientCareCommitteeonJanuary25,1996,andbytheAGAGoverningBoardonFebruary3,1996.

ThefollowingguidelinesweredevelopedtoassistthephysicianintheappropriateuseofesophagealpHrecordinginpatientcare.TheyemanatefromacomprehensivereviewofthemedicalliteraturepertainingtothepHrecordingtechnique.1EsophagealpHrecordingiswidelyavailableand,whendoneinatechnicallyappropriatemanner,providesquantitativedataonbothesophagealacidexposureandonthetemporalcorrelationbetweenpatientsymptomsandrefluxevents.Despitethesestrengths,theinherentweaknessofthetechniqueisitsinabilitytoprovecausalitybetweensymptomsorsyndromesandacidrefluxevents.Alternatively,causalityisreasonablyassumedinclinicalpracticebythesubstantialreductionoreliminationofsuspectedrefluxsymptomsduringatherapeutictrialofaprotonpumpinhibitor.Inviewofthisviablealternative,themajorindicationsforesophagealpHmonitoringareindocumentingthefailureofeithermedicalorsurgicaltherapy.ThispositionstatementshouldhelptheclinicianapplyesophagealpHstudiesmostbeneficiallywithinthecontextofotherclinicaloptions.

GuidelinesfortheClinicalUseofEsophagealpHRecording

∙EsophagealpHrecordingisindicatedtodocumentabnormalesophagealacidexposureinanendoscopy-negativepatientbeingconsideredforsurgicalantirefluxrepair（pHstudydoneafterwithholdingantisecretorydrugregimenfor

1week）.

∙EsophagealpHrecordingisindicatedtoevaluatepatientsafterantirefluxsurgerywhoaresuspectedtohaveongoingabnormalreflux（pHstudydoneafterwithholdingantisecretorydrugregimenfor

1week）.

∙EsophagealpHrecordingisindicatedtoevaluatepatientswitheithernormalorequivocalendoscopicfindingsandrefluxsymptomsthatarerefractorytoprotonpumpinhibitortherapy（pHstudydoneafterwithholdingantisecretorydrugregimenfor

1weekifthestudyisdonetoconfirmexcessiveacidexposureorwhiletakingtheantisecretorydrugregimenifsymptom-refluxcorrelationistobescored）.

∙EsophagealpHrecordingispossiblyindicatedtodetectrefractoryrefluxinpatientswithchestpainaftercardiacevaluationusingasymptomrefluxassociationscheme,preferablythesymptomassociationprobabilitycalculation（pHstudydoneafteratrialofprotonpumpinhibitortherapyforatleast4weeks）.

∙EsophagealpHrecordingispossiblyindicatedtoevaluateapatientwithsuspectedotolaryngologicmanifestations（laryngitis,pharyngitis,chroniccough）ofgastroesophagealrefluxdiseaseaftersymptomshavefailedtorespondtoatleast4weeksofprotonpumpinhibitortherapy（pHstudydonewhilethepatientcontinuestakingtheirantisecretorydrugregimentodocumenttheadequacyoftherapy）.

∙EsophagealpHrecordingispossiblyindicatedtodocumentconcomitantgastroesophagealrefluxdiseaseinanadultonset,nonallergicasthmaticsuspectedofhavingreflux-inducedasthma（pHstudydoneafterwithholdingantisecretorydrugsfor

1week）.Note:

apositivetestdoesnotprovecausality!

∙EsophagealpHrecordingisnotindicatedtodetectorverifyrefluxesophagitis（thisisanendoscopicdiagnosis）.

∙EsophagealpHrecordingisnotindicatedtoevaluatefor"alkalinereflux."

References

1.KahrilasPJ,QuigleyEMM.ClinicalesophagealpHrecording:

atechnicalreviewforpracticeguidelinedevelopment.Gastroenterology1996;110:

1982-1996.

ClinicalEsophagealpHRecording:

ATechnicalReviewforPracticeGuidelineDevelopment

ThisliteraturereviewandtherecommendationshereinwerepreparedfortheAmericanGastroenterologicalAssociationPatientCareCommittee.Followingexternalreview,thepaperwasapprovedbytheCommitteeonDecember21,1995.

Ourpresentconceptofpepticesophagitisdatesbackto1935,whenWinkelsteinsuggestedthatgastricsecretionswerethecauseofmucosaldamageobservedinpepticesophagitis.1Theterm"refluxesophagitis"waslaterintroducedin1946byAllison,acknowledgingthatirritantgastricjuiceswererefluxedfromthestomachtotheesophagus.2Subsequently,itbecameevidentthatmanypatientswithrefluxsymptomsdidnothaveendoscopicorpathologicalevidenceofesophagitis.AnotherlandmarkinourunderstandingofthisdiseasecamewiththeadventofesophagealpHmonitoring.AlthoughSpencerfirstdescribedthetechniqueofusingaglasspHelectrodetomonitorintraesophagealpHcontinuously,3JohnsonandDeMeesterwerethefirsttostudynormalvolunteersaswellassymptomaticpatientsandtoanalyzeesophagealacidexposuredataquantitatively.4Insodoing,theyintroducedtheconceptofphysiologicalreflux;sincethen,ithasbecomeincreasinglydifficulttodefinethelimitsofpathologicalreflux.Thisdilemmanecessitatedtheintroductionofthedescriptorgastroesophagealrefluxdisease（GERD）toencompassabroaderdefinitionofrefluxdisease:

individualswithanysymptomaticconditionorhistopathologicalterationresultantfromepisodesofgastroesophagealreflux.However,exactlywhereGERDbeginsalongthecontinuumextendingfromphysiologicalrefluxatoneendtocomplicatedesophagitisattheotherisproblematic.5AlthoughambulatoryesophagealpHtestingispotentiallyusefulinresolvingthisdifficulty,theproblemofdefinitionpersists,leadingtoconsiderableconfusionregardingtheclinicalindicationsforandinterpretationofambulatoryesophagealpHstudies.Thus,theobjectsofthisreviewaretwofold.First,thetechnicalaspectsandlimitationsofperformingclinicalambulatoryesophagealpHstudieswillbediscussed.Second,ourcurrentunderstandingofthediagnosticcriteriaofgastroesophagealrefluxsyndromeswillbesummarized,emphasizingthepotentialroleof24-hourambulatoryesophagealpHmonitoringindiagnosisandmanagement.Note,however,thatthisreviewpertainstoadultpatients,andsomeconclusionsandrecommendationsmightdifferforpediatricpatients.

Thiscriticalassessmentwasaccomplishedbyretrievingandreviewingdatapublishedinthemedicalliterature.Foreachsyndrome,relevantkeywordswereusedtosearchtheNationalLibraryofMedicinedatabasebetween1980andSeptember1994.Thedescriptorsusedforthesearchwerehydrogenionconcentration,esophagusor（exploded）esophagealdiseases,and（exploded）monitoring,physiologic.Thesearchidentified433citations.Paperswereincludedinthediscussionif

（1）theyweredesignedtoaddressoneoftheclinicallyrelevantobjectivesenumeratedabove,

（2）thepHrecordingmethodologyusedwasvalidandconsistentwithcurrentmethodologicalstandards,and（3）thereportedfindingswerebasedonanappropriateexperimentaldesign.Additionally,selectedstudiespublishedduringthereviewprocessofthismanuscript（September1994toNovember1995）thattheauthorsbelievedtobeofgreatsignificancewereincludedinthefinaldraft.Becauseofvariationsinstudypopulationsandprotocolsandthelackofasufficientnumberofcomparablepapers,wedidnotbelievethatapooledstatisticalanalysisofresultswasappropriateinaddressingclinicalutility.

TechnicalAspectsofAmbulatorypHRecordings

Duringthepastdecade,esophagealpHmonitoringhasevolvedintoarelativelystandardizedmethodwithrespecttoinstrumentation.ItisnotourintenttoreviewthatevolutionortodescribethemultitudeofmethodologicalmodificationsappliedtothepHmonitoringtechniquefordataacquisitioninaninvestigativesetting.Rather,wewillexaminethemethodologicalvariablesofthetestasappliedinclinicalpracticealongwithdatashowingtheimpactofthesevariablesonpHrecordingsobtained.ThebasicequipmentrequirementsforambulatoryesophagealpHstudiesareaportabledataloggerfordatastorage,apHelectrode,acomputer,andsoftwareforanalysisofpHdata.

DataLoggers

ModerndataloggersforambulatoryesophagealpHstudiesarelightweight,battery-poweredunitsthatcanbewornonwaistbeltsorshoulderstraps.SeveralmodelsarecurrentlyavailableintheUnitedStateswithcostsrangingfrom$10,000to$15,000.UnlikebedsiderecordingsthatcontinuouslyrecordpHdata,dataloggerssampleintraesophagealpHat6-8-secondintervals.ThemaineffectofthislimitedsamplingrateistomissintraesophagealpHdecreasesto<4forperiodsofonlyafewseconds.However,thishasnegligibleimpactonthecalculationofoverallacidexposuretime,6andtheconsensusamongauthorsisthatthesebriefpHdecreasesareofnoclinicalrelevance.7,8Anessentialfeatureofadataloggerisaneventmarkerthatcanbeactivatedbythepatientduringthestudytoindicatethetimingofsymptoms,meals,recumbency（sleep）,etc.ThepatientalsorecordstheseeventsonadiarycardsothatspecificsymptomsandeventscansubsequentlybecorrelatedwiththepHtracing.Thus,therawdataobtainedfromanambulatorypHstudyarethenumberofrefluxevents,theesophagealacidexposuretimeassociatedwitheachevent,andthetimingandnatureofsymptoms.

pHElectrodes

SeveraltypesofpHelectrodesareavailableforambulatoryesophagealpHrecording:

antimonymonocrystallineelectrodeswithaseparateskinreferenceelectrode,unipolarglasselectrodeswithaskinreference,orcombinedglasselectrodes（built-inreferenceelectrode）.Desirableelectrodecharacteristicsarestability（nodrift）,shortresponsetime,linearresponse