©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.(9)CONSORT:()TheRevisedCONSORTStatementforReportingRandomizedTrials:ExplanationandElaboration(1)DouglasG.Altman1,KennethF.Schulz2,DavidMoher3,MatthiasEgger4,FrankDavidoff5,DianaElbourne6,PeterC.G«tzsch7,ThomasLang8fortheCONSORTGroup1.ICRF(OX37LF);2.(POBox139503);3.ThomasC.ChalmersCente(K1H8L1);4.MRC(B582PR);5.(PA19106);6.(WC1E7HT);7.Cochrane(DK22100C);8.13849EdgewaterDrive,Lakewood,OH44107R4A16722531(2005)09071203(RCT),RCTRCT,CONSORT(,ConsolidatedStandardsofReportingTrials,)RCTCONSORT,RCTCONSORTCONSORT,RCTCONSORT,,,CONSORT::20050823:20050831119791980467,30%;198545,27%,199037,43%119(),15(13%),,RCT,217©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.(1),206RCT5%,1,50:,,,;,,,;,:,2RCT:CONSORTDerSimonian,,Rennie,CONSORTCONSORT(CONSORT)RCT,CONSORT,CONSORTCONSORTRCTCONSORTCONSORT,CONSORT,,3CONSORT:CONSORT1996,,()CONSORTRCT,CON2SORT,1996CONSORT,MeinertCONSORT1999,(702705),CONSORT,(),,,RCT,,,44.11:():::::RCT,MEDLINERCTRCT,317©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.(9),,,MEDLINERCTCochrane,1999MEDLINERCT100000RCT,RCT,,,,4.22::,,(),,():,,,,,,()(),,,,,,,(5)()AnnInternMed.2001;134:663694.(,,,,,,)ThisisaChineselanguagetranslationofanarticlethatinitiallyappearedintheAnnalsofInternalMedicine.(ChineseEvidence2BasedMedicineCenter)preparedthistranslation.TheAmericanCollegeofPhysicians(publisherofAnnalsofInternalMedicine)hasnotcheckedtheaccuracyofthistranslation.Theofficialversionofthisarticleis(DouglasG.Alt2man,KennethF.Schulz,DavidMoher,MatthiasEgger,FrankDavidoff,DianaElbourne,PeterC.G«tzsch,ThomasLangfortheCONSORTGroup.TherevisedCONSORTstatementforreportingrandomizedtrials:explanationandelaboration.AnnInternMed,2001;134:663694.a2vailableat).Usersshouldcitetheofficialversionwhencitingthedocument.(:)417ChineseJEvidence2BasedMedicine,2005,Vol15(10)MethodologyCONSORT:()TheRevisedCONSORTStatementforReportingRandomizedTrials:ExplanationandElaboration(2)DouglasG.Altman1,KennethF.Schulz2,DavidMoher3,MatthiasEgger4,FrankDavidoff5,DianaElbourne6,PeterC.G«tzsch7,ThomasLang8fortheCONSORTGroup1.ICRF(OX37LF);2.(POBox139503);3.ThomasC.Chalmers(K1H8L1);4.MRC(B582PR);5.(PA19106);6.(WC1E7HT);7.Cochrane(DK22100C);8.13849EdgewaterDrive,(OH44107)R4A16722531(2005)100786024.33a:(IUCD),2040,:;42;;;;;14;;(),RCT,,,(),(),:20050823:20050929,,364RCT,25%(Clinicalalerts)83163%,19%207090,3b:NorthwickPark4,,,,,()(),()68720055104:(etanercept,Enbrel),25mg,12,25mg,40mg,10mg12mg,1ml,,,,,,5::;;,,,,RCT6a:12,(PASI)75%PASIRCT,,,1,(1820),RCT,,(),,,,,196RCT702000640,369149,,,1/36b:(,),5min,CopalUA2251TakedaUA2751(AndrewStephens,Brighouse,WestYorkshire)Hawksley(Hawksley,Lancing,Sussex)1,3(15%),,(),,,(11a),()AnnInternMed.2001;134:667670.(,,,,,,)(:)7872005511MethodologyCONSORT:()TheRevisedCONSORTStatementforReportingRandomizedTrials:ExplanationandElaboration(3)DouglasG.Altman1,KennethF.Schulz2,DavidMoher3,MatthiasEgger4,FrankDavidoff5,DianaElbourne6,PeterC.G«tzsch7,ThomasLang8fortheCONSORTGroup1.ICRF(OX37LF);2.(POBox139503);3.ThomasC.Chalmers(K1H8L1);4.MRC(B582PR);5.(PA19106);6.(WC1E7HT);7.Cochrane(DK22100C);8.13849EdgewaterDrive,(OH44107)(610041)R4A16722531(2005)110863037a:4%,115%019(P=0105,),976,1000SF236,85%(,5%),5,20,20%,360(720),,,,:();();[()];,(6a):20050823:20050916(7b)(),,,,,19654,7346,200065,,(17)7b:61,,P0105,O2F(OpBrien2Flemingstoppingboundaries)368ChineseJEvidence2BasedMedicine,2005,Vol15(11)Z11985,P010471,5,19%,5%,,PP,P(P),,,(),8a:,(1),,,(3),(21),,,,,,32%48%,22,6818b:()()4,81038b:(8a),,10,5,,(),2,();,,,(018),,4682005511,,(3),,(8a),(),,,(3),,12%,2069%,8039%Adetugbo,,9:(),CE,()8,,,,,,,,,,,,(),,33Meta250,,(addsratios30%40%)3,,89%48%44%1976199773RCT5()AnnInternMed,2001;134:670673.(,,,,,)(:)5682005512MethodologyCONSORT:()TheRevisedCONSORTStatementforReportingRandomizedTrials:ExplanationandElaboration(4)DouglasG.Altman1,KennethF.Schulz2,DavidMoher3,MatthiasEgger4,FrankDavidoff5,DianaElbourne6,PeterC.G«tzsch7,ThomasLang8fortheCONSORTGroup1.ICRF(OX37LF);2.(POBox139503);3.ThomasC.Chalmers(K1H8L1);4.MRC(B582PR);5.(PA19106);6.(WC1E7HT);7.Cochrane(DK22100C);8.13849EdgewaterDrive,(OH44107)R4A16722531(2005)1209410310,,BradfordHiu,,,+(S)(C),,,SC,9,,,,,,(4),,,,,,:20050823:20050916,4Table4Generationandimplementationofarandomsequeuceoftreatments(),/()11a:,,,,,,149ChineseJEvidence2BasedMedicine,2005,Vol15(12),,,,()(),(),,,,,(II),,,,,,,,,,,,,,,,,,(),()(),,50651%,19633%,6838%3114(45%),5(16%)(masking),,,11b:,3(),,,Prasad,,56%26%(P=0.09),,,(),,(),,,12a:2FisherLogisticAt2492005512,,,95%,10095P()P(P=0.003),(P0.05),,,,196123(63%)12b:,Mantel2Haenszel2,()(CHART)CHART22,(),PP,,,,()RCTs,,(8b)RCT(16),,,()AnnInternMed,2001;134:670673.(,,,,,,)(:)349200661CONSORT:()TheRevisedCONSORTStatementforReportingRandomizedTrials:Explan