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1、Haifengetal.Trials2012,13:40http://www.trialsjournal.com/content/13/1/40TRIALSSTUDYPROTOCOLOpenAccessEffectofsequentialtreatmentwithsyndromedifferentiationonacuteexacerbationofchronicobstructivepulmonarydiseaseand“AECOPDRisk-Window”:studyprotocolforarandomizedplacebo-controlledtrial11,2*11212Wang
2、Haifeng,LiJiansheng,LiSuyun,YuXueqing,ZhangHailong,WangZhiwan,WuQiyi,2222ZhangPankui,WangZhongchao,LiFengleiandYanHaihongAbstractBackground:Frequentchronicobstructivepulmonarydisease(COPD)exacerbationisamajorcauseofhospitaladmissionandmortality.IthasbeenreportedthatTraditionalChineseMedicine(TCM)
3、mayrelieveCOPDsymptomsandreducetheincidenceofCOPDexacerbations,thusimprovinglifequalityofCOPDpatients.TheacuteexacerbationofCOPDrisk-window(AECOPD-RW)istheperiodafteranexacerbationandbeforethepatientreturnstobaseline.IntheAECOPD-RW,patientsareusuallyatincreasedriskofasecondexacerbation,whichmayle
4、adtohospitaladmissionandhighmortality.Itmaybebeneficialforacuteexacerbationofchronicobstructivepulmonarydisease(AECOPD)patientstoreceiveinterventionsduringAECOPD-RW.Duringexacerbationsthetreatmentprincipleistoeliminateexogenouspathogens,whereastheAECOPD-RWtreatmentprinciplefocusesonenhancingbodyr
5、esistance.Methods/Design:Aprospective,multi-center,single-blinded,double-dummyandrandomizedcontrolledclinicaltrialisbeingconductedtotestthetherapeuticeffectsofasequentialtwostagetreatment,whichincludeseliminatingpathogenandstrengtheningvitalqiwithsyndromedifferentiation.Atotalof364patientswillbee
6、nrolledinthisstudywith182ineachtreatmentgroup(TCMandcontrol).Patientsreceivedmedication(orcontrol)accordingtotheirassignedgroup.TCMforAECOPDwereadministeredtwicedailytopatientswithAECOPDover7to21days,followedbyTCMforAECOPD-RWover28days.Allpatientswerefollowedforsixmonths.Theclinicalsymptoms,themo
7、difiedmedicalresearchcouncildyspnea(MMRC)scaleandexacerbationswereusedastheprimaryoutcomemeasures.Pulmonaryfunction,qualityoflifeandmortalityratewereusedassecondaryoutcomemeasures.Discussion:Itishypothesizedthatsequent
