资源描述:
《2012年欧洲抗风湿大会年会(EULAR)日本艾拉莫德研究进展》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
1、2012年欧洲抗风湿大会年会(EULAR)日本艾拉莫德研究进展EFFICACYANDSAFETYEVALUATIONOFIGURATIMOD,ANOVELANTI-RHEUMATICAGENT-ADOUBLE-BLIND,COMPARATIVESTUDYOFIGURATIMOD-MTXCOMBINATIONINRHEUMATOIDARTHRITISPATIENTSWITHANINADEQUATERESPONSETOMTXM.Hara,H.Ishiguro,K.Katauama,M.Kondo,T.Suminda,T.Minmori,S.Soen,K.Nagai
2、,T.Yamaguchi,K.YamamtotandIguraimodClinicalStudyGroupObjectivesThisstudywasconductedtoevaluatetheefficacyandsafetyofacombinationtherapyofiguratimodandMTXinJapaneseRApatientswithaninadequateresponsetoMTXT-614MW:374.37N-[7-[(Methanesulfonyl)amion]-4-oxo-6-phenoxy-4h-1-benzopyran-3-yl]
3、formamideModeofactionforiguratimodModeofactionforiguratimodStudyDesignAplacebo-controlled,double-blind,comparativestudy(24weeks)wasconducted,followedwithadditionalopen-labelstudy.MTX6or8mg/w(stabledoes)Folicacid5mg/wBasictherapy-4w0w28w32w52w24wScrwashoutDouble-blindphaseOpen-labelp
4、haseIMgroupn=164Iguratimod+MTX·Iguratimod+MTX(IM·IMgroup)Iguratimod25mg/day(4week)50mg/dayPreviousDMARDtherapyRandomized,placebo-controlledstudy(24week)PMgroupn=88Placebo+MTX·Iguratimod+MTX(PM·IMgroup)PlaceboIgratimodDemographicandClinicalCharacteristicsIMn=164PMn=88PValueGenderMale
5、30(18.3)18(20.5)P=0.737#1Female134(81.7)70(79.5)Age(year)Mean±SD54.8±9.953.5±10.0P=0.323#1≥6532(19.5)16(18.2)Weight(kg)Mean±SD56.04±9.1956.40±10.25P=0.780#2DurationofRA(month)Mean±SD53.8±35.050.3±34.0P=0.443#2DurationofRA(year)<245(27.4)24(27.3)2-550(30.5)29(33.0)5-1069(42.1)35(39.8
6、)ConcomitantSteroid86(52.4)48(54.4)P=0.791#1ConcomitantNSAIDs151(92.1)81(92.0)P=1.000#1CRP(mg/dl)1.84±1.941.71±1.58P=0.570#2#1:Fisher’sexacttest#2:t-testIM:Iguratimod+MTXPM:Placebo+MTX(%)DemographicandClinicalCharacteristicsIMn=164PMn=88PValueTenderjointcount12.5±6.513.3±8.1P=0.358#
7、2Swollenjointcount11.5±6.311.1±5.7P=0.674#2Diseaseactivity(physicianVAS,mm)52.6±18.353.2±19.0P=0.797#2Pain(VAS,mm)47.5±22.246.4±23.1P-0.731#2Diseaseactivity(patientVAS,mm)47.7±24.350.1±23.5P=0.458#2HAQ-DI(unit)0.818±0.5530.734±0.512P=0.242#2CRP(mg/dl)1.84±1.941.71±1.58P=0.570#2ESR(m
8、m/hr)45.6±21.041.8±