HOOKWORM INFESTATION AS THERAPY IN CROHN'S ：钩虫感染在克罗恩病的治疗.docx

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1、HOOKWORMINFESTATIONASTHERAPYINCROHN,S:钩虫感染在克罗恩病的治疗HOOKWORM1NFESTAT1ONASTHERAPY1NCROHNSDlSEASEFortunPJl,PritchardD2,BrittonJ3,SitholeJS4,ColeAT5,HawkeyCJl1WolfsonDigestiveDiseasesCentre,UniversityHospitalNottingham,NG72UH2SchoolofPharmacy,UniversityofNottingham,UniversityPark,NG72RD3DivisionofEpidemi

2、ologyandPublicHealth,NottinghamUniversityMedicalSchool,Nottingham,NG72IiH4.TrentKDSU,UniversityofNottinghan,SchoolofConununityHealthSciences,NottinghamUniversityMedicalSchool,Nottingham,NG72UH5DerbyCityGeneralHospital,Derby,DE223NEPROTOCO1.(23.03.06)VERSION2.2ContentsAbbreviationsIntroductionPrincip

3、alResearchQuestionSecondaryResearchGoalsProposedtrialTrialDesignStudypopulationInclusioncriteriaExclusioncriteriaTreatmentallocationPatientswhorequiresteroidsattrialentryUnblindingTreatmentProposedOutcomeMeasuresStudyFlowChartScreeningtestsImmunologicalmethodsHoxp3SafetyMeasuresDataSafetyMonitoringR

4、easonsfordiscontinuationofstudySamplesizeStatisticalanalysisRationalefortheStudyReferencesAppendix1Crohn,sDiseaseActivityIndexAppendix2HarveyBradshawIndex(HBI,simpleindex)Appendix3IBDQAppendix4EQ-5DAppendix5AdverseEventDefinitionsAPPendiX6SOP1AdverseEventReportingAppendix7SOP2DataMonitoringCommittee

5、Appendix8SOP3OptimalClinicalPractice34555666667778910101011111111111213141516-22232425-3233-3435-36AbbreviationsCDCDAICICRFFBCHbHBIIBDIBDQIFNI1.1.FTScidTh1Th2TNFTregTrlUECrohnsdiseaseCrohnsdiseaseactivityindexConfidenceintervalCasereportformfullbloodcounthaemoglobinHarveyBradshawIndexInflammatoryboweldiseaseInflammatoryboweldiseasequestionnairegammainterferoninterleukinliverfunctiontestssubacutecombinedimmunodeficiencyThelper1Thelper2tumournecrosisfactoralpharegulatoryTlymphocyteregulatoryTlymphocyte(type1)urea.