伊班膦酸钠-艾本-治疗老年重度骨质疏松症的临床试验-周臻臻

··R453.9A1006-7108201203-0259-04。61。1ugQd、0.63gTid312mg3mg311。30。、、、、、、VAS。1、P＜0.053.2%7.2%8.5%P＜0.010.9%1.2%P＞0.05P＞0.05。、、、P＞0.05。1P＜0.01。、。ClinicaltrialofibandronateforthetreatmentofsevereosteoporosisintheelderlyZHOUZhenzhenZHUXiuyingZHOUPingetal．TheSecondAffiliatedHospitalofHarbinMedicalUniversityHeilo[e-mail]ploretheefficacyandsafetyofibandronateAiBenintermittentintravenousinfusionforthetreatmentofsevereosteoporosisintheelderly.MethodsSixty-oneelderlypatientswithsevereosteoporosiswererandomlydividedintotwogroups.AllpatientsweretreatedwithAlpha-D31ugQdandzhenmushengu0.63gTid.PatientsinthetreatmentgroupwerealsotreatedwithinjectionofAiBenwiththefirstdoseof2mgandthefollowingdoseof3mgonceevery3monthsfor1year.Another30patientswereconsideredasthecontrolgroup.SerumcalciumphosphorusalkalinephosphataselivefunctionrenalfunctionandbonemineraldensityBMDofthefemoralnecklumbarspineandforearmofallpatientsweremeasuredbeforeandafterthetreatment.VisualanaloguescaleVASwasusedtoevaluatethepainofthepatients.Thesideeffectwasrecordedduringthestudy.ResultsBMDsofthelumbarspinefemoralneckandforearmofthepatientsinthetreatmentgroupincreasedsignificantlyafter1yeartreatmentofibandronateP＜0.05.BMDofthelumbarspinefemoralneckandforearmincreased3.2%7.2%and8.5%respectively.SerumalkalinephosphataseofpatientsinthetreatmentgroupdecreasedsignificantlyP＜0.01.BMDofthelumbarspineandforearmofpatientsinthecontrolgroupalsoincreased0.9%and1.2%respectivelybutthedifferencewasnotstatisticallysignificantP＞0.05.SerumalkalinephosphatasehadnochangeP＞0.05.SerumcalciumphosphorusliverfunctionandrenalfunctionhadnosignificantdifferencebeforeandaftertreatmentbothinthetreatmentandcontrolgroupP＞0.05.Onepatientinthetreatmentgroupdroppedoutofthestudyforseverebonepainbuttheothers95220123183ChinJOsteoporosMarch2012Vol18No．3Publishedonline．wanfangdate．com．cndoi10．3969/j．issn．1006-7108．2012．03．016hadnoseriousadverseevents.ThepainscoresofthepatientssignificantlyreducedP＜0.01.ConclusionIntermittentAiBenintravenousinfusioncaneffectivelyincreaseBMDinthesenilepatientswithsevereosteoporosisandrelievebonepainwithoutseriousadversereactions.TreatmentofcalciferolandcalciumintheelderlypatientswithsevereosteoporosiscanalsoincreaseBMDwithoutobvioussignificantdifference.TheresultsindicatethatAiBencombinedwithzhenmushenguandalpha-D3isoneofthefeasibleandeffectivetreatmentsinelderlypatientswithsevereosteoporosis．KeywordsSevereosteoporosisElderlyIbandronateBonemineraldensitySideeffect、1。9090007.01%2。6022.6%8050%。963。。FDA4。。11.120084201186165～871994WHO5。2。1.21.2.11μg/。0.63g/。1ml1mg/。60mg/。1.2.2LunarDPX-MDXRochePPDSysmexXE_2100SiemensFX-DDRXSiemenssensation10CTSiemens1.5TMAGNETOMAvanto。1.3。61。1ugQd、0.63gTid。3182365～8776.97±4.692mg3mg311。3072366～8477.32±3.88。、P＞0.05。1.41.4.1AKP、Ca、P、。1.4.2X2-4、。1.4.310VAS6。01～34～67～10。1.4.4XCTMRI。1.4.5。1.5SPSS17.0。±珋x±stP＜0.05。06220123183ChinJOsteoporosMarch2012Vol18No．322.1AKP12P＜0.011Ca、P、P＞0.05。160AKP珋x±sU/L83.00±24.136※66.27±22.151※78.47±21.992#81.03±32.505#※P＜0.01#P＞0.052.22-4、P＜0.053.2%7.2%8.5%2～40.9%1.2%P＞0.052。2.360VAS8.26±1.53VASP＞0.05VASP＜0.013。260珋x±sg/cm22-40.77963±0.117601*0.80480±0.111329*0.84253±0.161914※0.84990±0.176081※0.57397±0.099051#0.61537±0.103495#0.6237±0.10421※0.61777±0.092784※1/30.39236±0.109735*0.42587±0.119287*0.38173±0.060147※0.38613±0.062971※*P＜0.05#P＜0.01※P＞0.05360VAS8.26±1.863.01±1.02*7.84±1.934.05±1.74**P＜0.012.422。2.5138℃4、1～311。3。。。1mg1ICCTX81%～95%22mgCTX47。1mg12mg32mg31。。DIVADosingIntraVenousAdministration313mg212mg13mg2mg。302～4、、16220123183ChinJOsteoporosMarch2012Vol18No．38-13。P＜0.01、、。。、。、、。VAS。、516.7%826.7%。214-15。2。D。、。【】1.、A、D.2010163215-218．2..201125137-3943．3..2006256-257．4SambrookP.Quarterlyintravenousinjectionofibandronatetotreatosteoporosisinpostmenopausalwomen.ClinicalInterventionsinAging20072165-72.5.OP.2010315367-369．6.PKP.201035111710-1712．7BurckhardtPHüsiBThiébaudDetal．Longtermeffectsofasingledoseofintravenousibandronate.JMusculoskeletNeuronalInteract20033177-82．8..2009298869-871．9LamyOSandiniLPacheIetal．Intravenousibandronateinmenwithosteoporosisanopenpilotstudyover2years.JEndocrinolInvest2003268728-732.10ReginsterJYNeuprezABruyèreO.Ibandronateinprofiledrugcharacteristicsandclinicalefficacy.ExpertOpiniononDrugMetabolismandToxicology200847941-51．11MeiLiXiao-pingXingZhen-linZhangetal．Infusionofibandronateonceevery3monthseffectivelydecreasesboneresorptionmarkersandincreasesbonemineraldensityinChinesepostmenopausalosteoporoticwomena1-yearstudy.Journalofboneandmineralmetabolism2010283299-305．12.D32.200835681-682．13DelmasPDAdamiSStrugalaCetal．Intravenousibandronateinjectionsinpostmenopausalwomenwithosteoporosisoneyearresultsfromthedosingintravenousadministrationstudy.ArthritisRheum20065461838-1846．14BaltasCSBalanikaAPRaptouPDetal．ClinicalpracticeguidelinesproposedbytheHellenicFoundationofOsteoporosisforthemanagementofosteoporosisbasedonDXAresults.JMusculoskeletNeuronalInteract200554388-392．15CosmanF．Treatmentofosteoporosisan