中药大规模临床试验及其管理与质量控制

:(No.2004BA716B01);(No.30600834)Correspondence:Hong2caiSHANG,MD;Tel:[phone];E2mail:[e-mail]1,2,1,1,1,1,1,1,1,2,31.,3001932.,6100413.,610041:,,:;;;;:R285.6;:A;:167221977(2007)0120001204Administrationandqualitycontroloflarge2scaleclinicaltrialsoftradition2alChinesemedicineHong2caiSHANG1,2,Jun2huaZHANG1,Guo2huaDAI1,Hong2boCAO1,MingREN1,Yao2zuXIANG1,YangWANG1,Bo2liZHANG1,You2pingLI2,31.ClinicalResearchAssessmentCentre,TianjinUniversityofTraditionalChineseMedicine,Tianjin300193,China2.ClinicalMedicinePost2doctoralFlowStationofSichuanUniversity,Chengdu,SichuanProvince610041,China3.ChinaEvidence2BasedMedicineCentre,Chengdu,SichuanProvince610041,ChinaAbstract:Large2scaleclinicaltrialisanimportantmeasureofclinicalevaluationondrugs.Thispaperintroducestheconceptandfeaturesoflarge2scaleclinicaltrial,thepossibilityandnecessityoflarge2scaleclinicaltrialoftraditionalChinesemedicine,aswellasitsadministrationandqualitycontrol,withMyocardialInfarctionSecondaryPreventionStudyinTraditionalChineseMedicine(MISPS2TCM),aNationalProgramSubject,asanexample.Keywords:Chineseherbaldrugs;clinicaltrials;administration;qualitycontrolShangHC,ZhangJH,DaiGH,CaoHB,RenM,XiangYZ,WangY,ZhangBL,LiYP.JChinIntegrMed/ZhongXiYiJieHeXueBao.2007;5(1):124.ReceivedOctober23,2006;publishedonlineJanuary15,2007.Freefulltext(PDF)isavailableat(),(),,(),2080,12007151JournalofChineseIntegrativeMedicine,January2007,Vol.5,No.1[1],(SystolicHypertensionintheElderly-Chinesetrial,Syst2China)2(ChineseCardiacStudy,CCS21)(Post2strokeAnti2hypertensionTreatmentStudy,PATS)(ChineseAcuteStrokeTrial,CAST)(ShanghaiTrialofNifedipineintheElderly,STONE)(ChinaCoronarySecondaryPreventionStudy,CCSPS),,,2,,,,,,[2],,:(1);(2),,;(3),,;(4),CONSORT;(5),,,[35],,,,,3,,,[6],[7],3.1,;,;,,,3.2,,,,,3.3(InternationalConferenceofHarmonization,ICH)(GoodClinicalPrac2tice,GCP),,;,3.4,,3.5,,3.6,,3.7,;,,3.8,3.9,,,,3.10,,22007151JournalofChineseIntegrativeMedicine,January2007,Vol.5,No.1(),3.11,,23.12,,,3.13,,,,3.14,,,4(MyocardialInfarctionSecondaryPreventionStudyinTraditionalChineseMedicine,MISPS2TCM)20058,,,,15,75,4000,;;,,4.1,10,,,,4.2,20058,,,,,,,,,,,4.35,,,,4.4,(standardoperationproce2dure,SOP),,,,,4.5,,,4.6,(IndependentDataMonitorCommittee,IDMC),IDMC6;4.7,,,,4.8,,,,,,5:,,32007151JournalofChineseIntegrativeMedicine,January2007,Vol.5,No.1(WorldHealthOrganization/WesternPacificRegionalOffice,WHO/WPRO)[2],,[8],[9],REFERENCES1WangW,LiuLS,GongLS,etal.Assessmentofcost2effectivenessoftreatmentforcardio2cerebrovasculardiseasesfromlarge2samplerandomizedclinicaltrialsinChina.ZhonghuaXinXueGuanBingZaZhi.2003;31(1):24228.ChinesewithabstractinEnglish.,,,...2003;31(1):24228.2LiuJP.Clinicalresearchmethodologyforevidence2basedChinesemedicine.Beijing:PeoplesMedicalPublishingHouse.2006:7.Chinese...:.2006:7.3WangJS,ZhangJH,HuHY,etal.Meta2analysisofnotoginsengsaponinandcompoundSalviaemiltiorrhizaeinjectionfortreatmentofcerebralinfarction.ZhongguoYiYuanYaoXueZaZhi.2006;26(3):3172319.Chi2nese.,,,.Meta..2006;26(3):3172319.4WangLP,XieY.Systematicreviewonacupunctureandmoxibustionfortreatmentofdysphagiaafterstroke.ZhongguoZhenJiu.2006;26(2):1412146.ChinesewithabstractinEnglish.,...2006;26(2):1412146.5LiuJP,ManheimerE,ShiY,etal.Systematicreviewandmeta2analysisontheintegrativetraditionalChineseandWesternmedicineintreatingSARS.ZhongguoZhongXiYiJieHeZaZhi.2005;25(12):108221088.ChinesewithabstractinEnglish.,ManbeimerE,,.SARSMeta2..2005;25(12):108221088.6HuangJ,WangW.Large2scaleclinicaltrialsofcardio2cerebrovasculardiseases.Nanjing:JiangsuScientificandTechnicalPublishers.1998:1.Chinese.,..:.1998:1.7WangW,LiuLS.Qualitycontroloflarge2scaleclinicaltrialforcardiovasculardrugs.ZhonghuaXinXueGuanBingZaZhi.1999;27(2):1532154.Chinese.,...1999;27(2):1532154.8WuTX,LiYP,LiJ,etal.StatementforChineseclini2caltrialregistrationandpublishingsystem.ZhongXiYiJieHeXueBao.2006;4(4):3332334.Chinese.,,,...2006;4(4):3332334.9LiuJP.MethodologicalqualityassessmentofclinicaltrialsintraditionalChinesemedicine:theprinciplesofevidence2basedmedicine.ZhongXiYiJieHeXueBao.2006;4(1):126.ChinesewithabstractinEnglish..:..2006;4(1):126.PubMed(OpenAccessJournal),,,200716,PubMedPubMed,PubMed(FullTextLinkOut)PDFPubMed