痛风管理指南版Word文档下载推荐.docx

痛风管理指南版Word文档下载推荐.docx

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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