痛风管理指南版.docx
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痛风管理指南版.docx
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痛风管理指南版
ABSTRACT
Objective:
Toprovideguidanceforthemanagementofgoutincludingindicationsforandoptimaluseofurate-loweringtherapy(ULT),treatmentofgoutflares,andlifestyleandothermedicationrecommendations.
Methods:
Fifty-sevenpatientinterventioncomparatoroutcome(PICO)questionsweredeveloped.Thiswasfollowedbyasystematicliteraturereviewincludingnetworkmeta-analyseswithratingoftheavailableevidenceaccordingtoGRADEmethodology,andpatientinput.Agroupconsensusprocesswasusedtocomposethefinalrecommendationsandgradetheirstrengthasstrongorconditional.
Results:
Forty-tworecommendations(including16strongrecommendations)weregenerated.Strongrecommendationsincludedinitiationofurate-loweringtherapy(ULT)forallpatientswithtophaceousgout,radiographicdamageduetogout,orfrequentgoutflares;allopurinolasthepreferredfirst-lineULT,includinginthosewithmoderate-to-severechronickidneydisease(CKD>3);usingalowstartingdoseofallopurinol(<100mg/day,andlowerinCKD)orfebuxostat(<40mg/day);atreat-to-targetmanagementstrategywithULTdosetitrationguidedbyserialserumurate(SU)measurementswithaSUtargetof<6mg/dL.WheninitiatingULT,concomitantanti-inflammatoryprophylaxistherapywasstronglyrecommendedforadurationofatleast3-6months.Formanagementofgoutflares,colchicine,NSAIDs,orglucocorticoids(oral,intra-articular,orintramuscular)werestronglyrecommended.
Discussion:
Thisguidelineprovidesdirectionforcliniciansandpatientsmakingdecisionsonthemanagementofgout,usingGRADEmethodologyandinformedbyaconsensusprocessbasedonevidencefromthecurrentliteratureandpatientpreferences.
SIGNIFICANCE&INNOVATION
∙Forpatientswithindicationsforurate-loweringtherapy(ULT),westronglyrecommendedtheuseofatreat-to-targetstrategythatissupportedbyrandomizedclinicaltrialdataandpatientpreferences.
∙Westronglyrecommendallopurinolasfirst-lineULT,includingforthosewithmoderate-to-severechronickidneydisease(CKD>3).
∙Westronglyrecommendusinganti-inflammatoryprophylaxiswhenstartingULTforatleast3-6monthsratherthan<3months.
∙Weconductednetworkmeta-analyses(NMA)tosupportdecision-makingregardinguseofULTandanti-inflammatoryagents,withGRADEmethodologyforsummarizingsupportingevidence.
INTRODUCTION
Goutisthemostcommonformofinflammatoryarthritis,affecting9.2millionadults(3.9%)intheUnitedStates
(1).Whiletheetiologyofgoutiswell-understoodandthereareeffectiveandinexpensivemedicationstotreatgout,gapsinqualityofcarepersist(2-4).The2012AmericanCollegeofRheumatology(ACR)(5,6)andotherinternationalspecialtysocietyguidelinesrecommendtreat-to-targetstrategieswithuseofurate-loweringtherapy(ULT)(7-10).Despitetheserecommendations,overthepast2decadestherehasbeennoincreaseinULTutilization.AdherencetoULTremainspoor(2,11),thelowestamong7commonchronicmedicalconditions(12).Complicatingtheseefforts,theprior2012ACRguidelineshavebeencriticizedduetolowqualityofevidencesupportingtreat-to-targetrecommendations(13,14).
Sincethe2012ACRgoutguidelines(5,6),severalclinicaltrialshavebeenconductedthatprovideadditionalevidenceregardingthemanagementofpatientswithgout,leadingtheACRGuidelinesSubcommitteetodeterminethatnewguidelineswerewarranted.
METHODS
ThisguidelinefollowstheACRguidelinedevelopmentprocess(https:
//www.rheumatology.org/Practice-Quality/Clinical-Support/Clinical-Practice-Guidelines)usingtheGradingofRecommendationsAssessment,DevelopmentandEvaluation(GRADE)methodologytoratethecertaintyofevidenceanddeveloprecommendations(15-17),withanemphasisondevelopingactionableguidelines.ACRpolicyguidedmanagementofconflictsofinterestanddisclosures(https:
//www.rheumatology.org/Practice-Quality/Clinical-Support/Clinical-Practice-Guidelines/Gout).SupplementaryAppendix1presentsadetaileddescriptionofthemethods.
Briefly,theCoreTeam,ExpertPanel,andVotingPanel(consistingofrheumatologists,ageneralinternist,anephrologist,aphysicianassistantandapatientrepresentative)generated57Patient-Intervention-Comparator-Outcome(PICO)questionstoaddress:
IndicationsforULT(5questions),approachestoinitiatingULT(7questions),ongoingULTmanagement(18questions),goutflares(10questions),andlifestyleandothermedicationstrategiesinpatientswithgout(9questions)andinindividualswithasymptomatichyperuricemia(8questions).PICOquestionswerepostedontheACRwebsiteforpubliccomment(October30-November30,2018).
Anin-personPatientPanelof8malepatientswithgout,moderatedbyoneofthevotingpanelmembers(JS),reviewedtheevidencereport(alongwithasummaryandinterpretationbythemoderator)andprovidedpatientperspectivesandpreferences.
TheCoreTeampre-specifiedoutcomesascriticalorimportantforeachPICOforthesystematicliteraturereview.OutcomesvariedacrossPICOtopic(seeSupplementaryAppendix2fordetail).Goutflare,SU(andtophusforPICO1)werespecifiedascriticaloutcomesforallPICOsspecifictoULT.PainwasidentifiedascriticalforPICOsspecifictogoutflare.Goutflarewasspecifiedastheonlycriticaloutcomeformanagementoflifestylefactors.Allotheroutcomeswerespecifiedasimportant.Withoutstandardizeddefinitionsforgoutflareasanoutcome(18),flaredefinitionsvariedbydurationoffollow-upinthevariousstudies.BasedonPatientPanelinput,wespecifiedthatlongertermoutcomes(e.g.,24-month)wouldbecritical,whileshorterdurations(e.g.,<12-month)wereconsideredimportant;itwasrecognizedthatveryshorttime-points(e.g.,
<6-months)mayreflecttheexpectedflaresduringULTinitiation.
Weconductedsystematicliteraturereviews(including2networkmeta-analyses[NMA])toaddresseachPICOquestion.ThefirstNMAevaluatedtheimpactofstartingULTvs.noULTandtherelativeimpactofthevariousULTagents(seeSupplementaryAppendix3fordetail).ThesecondNMAevaluatedanti-inflammatoryagentsingoutflaremanagement(seeSupplementaryAppendix4fordetail).ToaccomplishthissecondNMA,wegroupedsimilaragentsintonodes(e.g.,aceticacidderivatives,profens,COX-2agents,corticosteroids,IL-1inhibitors).
ThelowestlevelofevidencefortheoutcomesdeemedcriticaltopatientsdeterminedthecertaintyofevidenceforeachPICO(15).ForPICOSspecifictoULT,onthebasisofinputfromthepatientpanel,priorfocusgroupworkcitingtheimportanceofSU,goutflareandtophitopatients(19)andpriorguidancefromtheGRADEworkinggroup(20)wemadethefollowingdecisions.Wheretherewasmoderateorhighcertaintyofevidencedemonstratingimprovementinanyoneofthese3outcomes,wedeemedthissufficientevidencetosupportastrongrecommendation.Thecertaintyofevidencefromtheothertwooutcomeswerethendesignatedasimportantbutnotcriticaltosupporttherecommendation.ThecertaintyoftheevidenceforeachrecommendationispresentedinTables1-8,andthecertaintyofevidenceforeachoutcomewithineachPICOisinthefullevidencereport(seeSupplementaryAppendix5).
Weadditionallyreporttheresults,usingthemoreconservativeratingoftheevidenceusingthelowestlevelofevidenceforanyofthecriticaloutcomes.Applyingthesemoreconservativerules,thesummarycertaintyofevidencefell(incomparisontothereportedresults)forsomeoftheULTrecommendationstatements,whichwouldresultinalowerstrengthofrecommendationfor2recommendations,(PICO2,ULTindicationforpatientswitherosionsandPICO27,switchingtopegloticaseforULTfailure).Thedetailsareavailableintheevidencereport.
Medicationcosts(notpartofthesystematicliteraturereview)reportedasAverageWholesalePricingassourcedfromLexicomp®onAugust23,2019,wereprovidedtotheVotingPanelascostoftreatmentwasincludedaspartoftheevaluationofrisksandbenefitsoftreatmentmedications(seeSupplementaryAppendix6).
PICOquestionsweredraftedintorecommendationstatementsandweresenttotheVotingPanelwiththeevidencereportpriortoRound1voting.Ataface-to-facemeeting,theVotingPanelagainrevieweddraftrecommendations,asummaryofthevotingfromRound1,theevidencereport,andsummaryofPatientPanelstatements.(OnepatientfromthePatientPanel(JES)andthePatientPanelmoderator(JS)attendedtheVotingPanelandwereavailabletoanswerquestionsaboutthePatientPanelstatements.)Tobecomearecommendation(fororagainst)inthisguideline,atleast70%consensusoftheVotingPanelwasrequired.
Thestrengthofeachrecommendationwasratedasstrongorconditional.Strongrecommendationsreflectdecisionssupportedbymoderateorhighcertaintyofevidencewherethebenefitsconsistentlyoutweightherisks,and,withonlyrareexceptions,aninformedpatientandtheirproviderwouldbeexpectedtoreachthesamedecision.Conditionalrecommendationsreflectscenariosforwhichthebenefitsandrisksmaybemorecloselybalancedand/oronlylowcertaintyofevidenceornodataareavailable.
Recommendationsinthisguidelineapplytopatientswithgout,withtheexceptionofasinglerecommendationregardingtheuseofurate-loweringtherapyinindividualswithasymptomatichyperuricemiadefinedasanindividualwithserumurate>=6.8mg/dLwithnopriorgoutflaresorsubcutaneoustophi.PatientswithevidenceofMSUdepositiononadvancedimagingmaystillbeconsideredasymptomaticsolongastheyhavenothadapriorgoutflareorsubcutaneoustophi.
Theseguideline
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