《7423.oralren-1654insciaticaaphase2,randomized,double-blind,placebo-controlled,multi-centerstudyinsubjectswithp.pdf

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1、2SProceedingsoftheNASS21stAnnualMeeting/TheSpineJournal6(2006)1S161StherhBMP-2groupwerefusedcomparedwith86.8%inthecontrolgroupCONCLUSIONS:TheseresultsshowthattreatmentwithREN-1654,at(p5.0737).Bothstudygroupsshowedsimilarimprovementsinclinicaltheonedoselevelthatwasinvestigatedmaygivepatientswit

2、hlumbosa-outcomes.TherewerenodifferencesamonggroupsinadverseeventscralradiculopathyamodestdegreeoflegpainreliefbyacceleratingtheexceptthattherateofnonunionfailurewaslowerintherhBMP-2grouprateofreductioninmaximumlegpainduringthefirsttwoweeksoftreat-(6patients;2.5%)thaninthecontrolgroup(16patient

3、s;7.1%)(p5.042).ment.Thesepreliminaryresults,inarelativelysmallproof-of-principleCONCLUSIONS:SubstitutingrhBMP-2forICBGrevealedseveralim-study,warrantadditionalinvestigationofthisagent.provementsinlumbarfusionprocedures:reducedoperativetimeandbloodFDADEVICE/DRUGSTATUS:REN-1654:Investigational/

4、notapproved.lossandbetterfusionoutcomes.Inbothgroups,painwasreducedfromCONFLICTOFINTEREST:Author(EJC)Clinicaltrialfunding:preoperativelevelsandresultsweremaintainedat24months.TheuseRenovis.ofrhBMP-2caneliminatetheneedforharvestingiliaccrestboneinsuccessfulposterolaterallumbarfusions.doi:10.101

5、6/j.spinee.2006.06.004FDADEVICE/DRUGSTATUS:AMPLIFYrhBMP-2Matrix:Investiga-tional/notapproved.CONFLICTOFINTEREST:Author(JDI)Consultant:MedtronicSofa-morDanek.7:48doi:10.1016/j.spinee.2006.06.0034.CanCervicalNerveRootBlocksPreventSurgeryforCervicalRadiculopathy?AProspective,Randomized,Controlled

6、,Double-BlindStudyK.DanielRiew,MD,YongjungKim,MD,LouisGilula,MD,7:42Young-BaeKim,MD;WashingtonUniversitySchoolofMedicine,3.OralREN-1654inSciatica:APhase2,Randomized,St.Louis,MO,USADouble-Blind,Placebo-Controlled,Multi-CenterStudyinSubjectsWithPainDuetoLumbosacralRadiculopathyBACKGROUNDCONTEXT:

7、AlthoughpatientswhoarerecommendedEugeneJ.Carragee,MD1,JackA.Klapper,MD2,MichaelK.Schaufele,tohavecervicalblocksoftenaskabouttheefficacyofsuchinjections,MD3,JaroKarppinen,MD4,JonLevine,MD,PhD5,PeterShabe,MS6,thereisminimaldatawithwhichtoa