关于我国中药不良反应监测工作现状和发展的思考

:11(100061);21;31:,Tel:[phone],E2mail:[e-mail]1213,,,,,;;;PonderingonCurrentStatusandDevelopmentofMonitoringonAdverseReactionofTraditionalChineseMedicineinChinaZHANGLi,YANGXiao2hui,andCAOLi2yaetalCenterforDrugReevaluation,StateFoodandDrugAdministration,Beijing(100061)AbstractWiththewideusageoftraditionalChinesemedicine(TCM)andthediversityofitsdosage2forms,thereportsaboutadversereaction(ADR)causedbyTCMweregraduallyincreased.AsthecradleofTCMwithtremendousmanufacturingenterpriseengagedforthispurpose,toestablishandperfecttheTCMADRmonitoringistheproblemthatTCMindustryshouldfaceto.Inthispaper,thekeypointofTCMADRmonitoringwasmadeclearbyanalysingthecurrentsituationandtheproblemspresentedinTCMADRmonitor2inginChina,andindicatedthatthenowdaydevelopinggoalsofTCMADRmonitoringaretoestablishandper2fectthetechnologicsystemforTCMADRmonitoring,strengthentherelatedbasicresearchandenhanceinter2nationalcommunicationandcooperationinthisfield.KeywordstraditionalChinesemedicine;adverseveaction;monitor;currentstatus,,,,,,,1(adversedrugreaction,ADR)1999ADR,6,ADR199911,()()();20011271,ADR20043,,,,,,,ADR2002,31,()ADR,,,ADR,ADRADR:18520057257CJITWM,July2005,Vol.25,No.7©1995-2005TsinghuaTongfangOpticalDiscCo.,Ltd.Allrightsreserved.,1,ADR,ADR2,,ADR,20012003ADR1315%,7712%,3,,2001152,2002320,2003663,1980199920,,2732,19801989280,143;199019992452,435;2732,1156,42%2,:(1);(2)ADR;(3)3,ADR,,ADR,ADR,2005412,8(),38,111(),1183,ADR,20034,,2004,,;,320047,ADR,,,,2,,4,,,,,,ADR,,51999,ADR,,71,10,20023(Fo2rumonHarmonizationofHerbalMedicine,FHH),,,FHH/,20047,ADRFHH,,;,,,,,,:1,,,,4228520057257CJITWM,July2005,Vol.25,No.7©1995-2005TsinghuaTongfangOpticalDiscCo.,Ltd.Allrightsreserved.211,,,;,,,,,212,,,,,,213,,,,ADR4,,ADR,:(1)ADRADR,,,;(2)ADR,ADR,,,,ADR,;,ADR,,1,,,,,,,,,,,,,2,,,,,:(1),;(2),;(3),,,,,ADR,,,(),,,3,,,311,,;()38520057257CJITWM,July2005,Vol.25,No.7©1995-2005TsinghuaTongfangOpticalDiscCo.,Ltd.Allrightsreserved.,,312,,,,,:(1),ADR3,,ADR;(2),,,,,ADR,,;(3),;(4),;(5),,,,,ADR313,,4,ADR,,,ADR,,,,,,,5,,,,:(1),;(2),,;(3),,;(4),6,,3,,3,,1,,..2004;1(2)36.CaoLY,ChenYX,ShenL.Theconsiderationonthetechnol2ogyandorganizationdevelopmentdirectionofADRmonitoringofourcountry.ChinJPharmacovigilance2004;1(2)36.2,.20.2001;(1)1821.LuQL,FangJJ.AsurveyoftwentyyearsADRcausedbytraditionalChinesemedicine.AdversedrugreactionJ2001;(1)1821.3.6.(aristolochiaefangchi)andrelatedpreparationscontainingthesecrudedrugs.(8)496498.ZhangL,YangXH,ZhangSC.TheanalysisandstrategyonTCMADR.ActaMedicaSinica2004;19(8)496498.(:2004-12-23)48520057257CJITWM,July2005,Vol.25,No.7©1995-2005TsinghuaTongfangOpticalDiscCo.,Ltd.Allrightsreserved.