风湿免疫疾病超药品说明书用药专家共识—强直性脊柱炎

··———20161212AnkylosingSpondylitisAShumanleukocyteantigenHLA-B27、、、。AS0．25%2～3∶1。AS、。AS。、。non-ster-oidalanti-inflammatorydrugsNSAIDs、tumornecrosisfactorTNF-α、、。TNF-α、、、、TNF-。1ASChinaFoodandDrugAdministrationCFDAAS1。ASCFDAAS。1。2AS2．1NSAIDsNSAIDsAS。2015AmericanCollegeofＲheumatologyACＲ、Spondyli-tisAssociationofAmericaSAASpondyloarthritisＲesearchandTreatmentNetworkSPAＲTANASASNSAIDsNSAIDs100%NSAIDsNSAIDs90%NSAID～100%1。CFDA、FDAEMA14NSAIDs2CFDA、、、、、、AS1。NSAIDs、、、、、AS。ASThom-sonClassⅠClassⅡaCategoryBFDAASASThomsonClassⅡaClassⅡbCate-goryA3。、、CFDA、FDAEMAASThomsonHealthcareMICＲOMEDEXAS、、AS。2010AS21NSAID2NSAIDsNSAID22～4NSAIDs。NSAIDs、、、。2。·1·20171271PharmacyToday2017JanuaryVol．27No．1guide.medlive.cn1ASASAS1．TNF－αTNF-、、2．、、、3．*、*、＊＊－A、＊＊、＊＊4．NSAIDs△、△△、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、▲、、、▲▲、、、、、、、*AS“”＊＊△、、、△△▲、▲▲、、、。·2·PharmacyToday2017JanuaryVol．27No．120171271guide.medlive.cn2NSAIDsCFDA、FDAEMAASCFDAFDAEMAThomsonHealthcareMICＲOMEDEX√√√ClassIClassIIbCategoryB√√√ClassIClassICategoryB√√－ClassIClassICategoryAClassIClassIIaCategoryB√×√AS√××AS√××AS√×－ClassIClassICategoryA√×－AS×√－ClassIClassIIaCategoryB×××ClassIIaClassIIbCategoryA×××AS××－AS××－AS××－ASCFDAFDAEMA“√”AS“×”AS“－”。2．22015ACＲ、SAA、SPAＲTANAS1NSAIDsASTNF-αTNF-α80%～90%TNF-αASTNF-α100%。NSAIDsTNF-αASTNF-α～100%AS1。TNF-αTNF-α。CFDAAS。methotrexateMTX。2．2．1TNF-αTNF-αＲNA、TNF-αAS3。2006ASAS/EULAＲAS4。2010ASAS/EULAＲAS5。2010ASAS、C2。ThomsonHealthcareMICＲOMEDEXThomsonClassⅡaClassⅡbC。3。·3·20171271PharmacyToday2017JanuaryVol．27No．1guide.medlive.cn3AS*＊＊、Thomson、。60mg/120mg/60～120mg/dFDAAS。ThomsonClassIIaClassIIbCategoryA、、、、/、、、。0．1g/0．2g/0．2g/1FDAAS。ThomsonClassIClassIIaCategoryB。25mg/25～50mg/d、50～100mg/dFDAAS。ThomsonClassⅡaClassⅡbCategoryC//、、、、、、、、、、、。2．5mg/5mg5mg/1mL、10mg/1mL、7．5～10mg/、、MICＲOMEDEXAS。。5mg/、FDAAS。MICＲOMEDEXAS。、、、、、、、、、、、5mg/FDAAS。ThomsonClassIClassIIaCategoryB300mg/2～3300～600mgMICＲOMEDEX。。20mg/30～60mg/d3MICＲOMEDEX。20mg/320～60mgMICＲOMEDEX。*、、CFDA、FDAASThomsonHealthcareMICＲOMEDEXAS。＊＊ThomsonHealthcareMICＲOMEDEX。AS25～50mg/d、50～100mg/d。2013150mg/d30ASAS20AS3·4·PharmacyToday2017JanuaryVol．27No．120171271guide.medlive.cn2g/dn=33NSAIDsn=3726。。。、。。、、、、、、、。2．2．2MTX2006ASAS/EULAＲASMTXASMTXTNF-αASMTX4。2010ASAS/EULAＲASMTXASMTX5。2015ACＲ、SAA、SPAＲTANAS3MTXAS。200151AS1000mg/dMTX7．5mg7。2004、、ASMTX7．5mg248。200720NSAIDsASMTX15mg4MTX20mg1225%ASAS2010%ASAS40ASAS709。MTXAS10。ThomsonHealthcareMICＲOMEDEXMTXAS。TNF-αASTNF-αNSAIDs2010ASASMTX2。MTX10mg1。MTX、、、。。2．32．3．12015ACＲ、SAA、SPAＲTANASAS100%1、。AS。ASFDAAS3。2．3．2NSAIDsAS100%。1。NSAIDsAS、、100%。。、、1。NSAIDsAS100%。、。1～21。CFDA-A、AS。2．4TNF-αNSAIDs·5·20171271PharmacyToday2017JanuaryVol．27No．1guide.medlive.cnAS。2010ASAS2。、。MetaAS11～13ThomsonHealthcareMICＲOMEDEX。2～3300～600mg、。30～60mg/d3、、、、、、、。320～60mg、。NSAIDsTNF-αASCFDANSAIDsTNF-αAS。ASTNF-αNSAIDsAS、MTX。2．5CFDA。“”2。“”、3。Thomson、、43。、、、5。4。A、B、C4。56。4ClassIEffectiveClassIIaEvidenceFavorsEfficacyClassIIbEvidenceisInconclusiveClassIIIIneffective5ClassIＲecommendedClassIIaＲecommendedInMostClassIIbＲecommendedInSomeClassIIINotＲecommendedClassIndeterminate6CategoryA、、CategoryBCategoryCNoEvidence·6·PharmacyToday2017JanuaryVol．27No．120171271guide.medlive.cn1WardMMDeodharAAklEAetal．AmericanCollegeofＲheuma-tology/SpondylitisAssociationofAmerica/SpondyloarthritisＲesearchandTreatmentNetwork2015recommendationsforthetreatmentofankylosingspondylitisandnonradiographicaxialspondyloarthritisJ．ArthritisＲheumatol2016682282-298．2．J．2010148557-559．3FiresteinGSBuddＲCGabrielSEetal．Kelley'sTextbookofＲheumatology9thedition1217．4ZochlingJvanderHeijdeDBurgos-VargasＲetal．ASAS/EU-LAＲrecommendationsforthemanagementofankylosingspondylitisJ．AnnＲheumDis2006654442-452．5BraunJvandenBergＲBaraliakosXetal．2010updateoftheASAS/EULAＲrecommendationsforthemanagementofankylosingspondylitisJ．AnnＲheumDis2011706896-904．6DengXZhangJZhangJetal．Thalidomidereducesrecurrenceofankylosingspondylitisinpatientsfollowingdiscontinuationofetaner-ceptJ．ＲheumatolInt201333140914137AltanLBinglUKarakoYetal．Clinicalinvestigationofmetho-trexateinthetreatmentofankylosingspondylitisJ．ScandJＲheu-matol2001305255-259．8Gonzalez-LopezL1Garcia-GonzalezAVazquez-Del-MercadoMetal．EfficacyofmethotrexateinankylosingspondylitisarandomizeddoubleblindplacebocontrolledtrialJ．JＲheumatol20043181568-1574．9HaibelHBrandtHCSongIHetal．Noefficacyofsubcutaneousmethotrexateinactiveankylosingspondylitisa16-weekopen-labeltrialJ．AnnＲheumDis2007663419-421．10vandenBergＲBaraliakosXBraunJetal．Firstupdateofthecurrentevidenceforthemanagementofankylosingspondylitiswithnon－pharmacologicaltreatmentandnon-biologicdrugsasystematicliteraturereviewfortheASAS/EULAＲmanagementrecommenda-tionsinankylosingspondylitisJ．ＲheumatologyOxford20125181388-1396．11．MetaJ．201333181542-1544．12LiHGuoFLuoYCetal．Efficacyoftripterygiumglycosidestabletintreatingankylosingspondylitisasystematicreviewandmeta-analysisofrandomizedcontrolledtrialsJ．ClinＲheumatol201534111831-1838．13．J．201431275-80．1《———》[e-mail][e-mail]@tom．com·7·20171271PharmacyToday2017Janu