实验流行病学-PPT课件.ppt

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1、横断面研究监测生态学研究病例对照研究队列研究描述性研究分析性研究临床试验现场试验社区干预项目理论流行病学流行病学研究方法观察性研究实验性研究理论性研究验证假设检验假设产生假设流行病学研究方法ResearchMethodofEpidemiology1JamesLind(1716-1794)维C缺乏－坏血病(1747)VitaminCdeficiency--scurvy第一节概述Overview2EdwardSalk脊髓灰质炎疫苗(poliomyelitisvaccine)现场试验(1955)－美国+加拿大疫苗组(vaccine)

2、安慰奖200,745人，安慰剂组（placebo）201,229人保护率(Protectiverate)：60-90%ThomasFrancis,Jr3一、定义(definition)Patientsorhealthadults)wererandomlydividedintoexperimentgroupandcontrolgroup，interventionwasgiventotheindividualsofexperimentgroup，andtheoutcomesoftwogroupswerefollowedupandc

3、omparedinordertodetermineeffectofintervention.将研究对象（病人或正常人）随机分配给实验组和对照组，将干预措施给予实验组人群后，随访观察(followup)一段时间并比较两组人群的结局,以便确定干预措施的效果。4二、基本原则(basicprinciple)对照的原则control随机的原则randomization盲法的原则blinding重复的原则duplication5Theresearchquestioncannotbeansweredbyobservationalstudie

4、sEarlierobservationalstudieshavenotansweredtheresearchquestionExistingknowledgeisnotsufficienttodetermineclinicalorpublichealthpolicyAnexperimentislikelytoprovideanimportantextensionofthisknowledgeWhentochooseanexperimentaldesign?6三、基本特征(basiccharacteristic)前瞻前瞻性研究干

5、预施加一种或多种人为干预处理随机研究对象随机分配到比较组对照有平行的或可比的实验组和对照组ProspectiveInterventionortreatmentRandomallocationParalleledcontrolgroup7四、实验流行病学的类型(typesofexperimentalepidemiology)ClinicaltrialFieldtrialorfieldexperimentCommunitytrial.临床试验现场试验社区试验8(一)个体试验(individualtrial)研究对象（未患病者）实验

6、组（干预组）对照组有效无效有效无效9（二）社区试验(communitytrial)10FieldTrialorFieldExperimentEffectofHepatitisBVaccineAgainstHepatitisBinfectionsofhepatitisBChildrenexperimentgroup(vaccine)controlgroup(placebo)followup10year(randomly)11CommunityTrial(communityinterventiontrial)Fluoridatio

7、nofDrinkingWatertoPreventSaprodontia(randomly)communitiesPrevalenceofsaprodontiafluoridationofdrinkingwaterNofluoridationofdrinkingwaterCommunityACommunityB12（三）临床试验(clinicaltrial)研究对象（病人）实验组（干预组）对照组有效无效有效无效13ClinicalTrialTherapeuticEfficacyofDrugAeffectsofDrugApati

8、entsexperimentgroup(DrugA)controlgroup(placebo)followup(randomly)14PhasesofClinicalTrials(FDA)Phase1:Safety,Clinicalpharmacologyandtoxicol