Safety and Feasibility of Long-term Intravenous Sodium Nitrite Infusion in Healthy Volunteers 英文参考文献.docVIP

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Safety and Feasibility of Long-term Intravenous Sodium Nitrite Infusion in Healthy Volunteers 英文参考文献.doc

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Safety and Feasibility of Long-term Intravenous Sodium Nitrite Infusion in Healthy Volunteers 英文参考文献

SafetyandFeasibilityofLong-termIntravenousSodium NitriteInfusioninHealthyVolunteers RyszardM.Pluta1*,EdwardH.Oldfield1,2,KamranD.Bakhtian1,AliRezaFathi1,3,Rene′K.Smith1,HettyL. DeVroom1,MasoudNahavandi1,SukyungWoo4,WilliamD.Figg4,RussellR.Lonser1 1Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, United States of America, 2DepartmentofNeurologicalSurgery,UniversityofVirginiaHealthSciencesCenter,UniversityofVirginia,Charlottesville,Virginia,UnitedStatesofAmerica,3Department ofNeurosurgery,KantonsspitalAarauAG,Aarau,Switzerland,4MolecularPharmacologySectionandClinicalPharmacologyProgram,MedicalOncologyBranch,Centerfor CancerResearch,NationalCancerInstitute,NationalInstitutesofHealth,Bethesda,Maryland,UnitedStatesofAmerica Abstract Background: Infusion of sodium nitrite could provide sustained therapeutic concentrations of nitric oxide (NO) for the treatmentofavarietyofvasculardisorders.Thestudywasdevelopedtodeterminethesafetyandfeasibilityofprolonged sodiumnitriteinfusion. Methodology: Healthy volunteers, aged 21 to 60 years old, were candidates for the study performed at the National InstitutesofHealth(NIH;protocol05-N-0075)betweenJuly2007andAugust2008.Allsubjectsprovidedwrittenconsentto participate. Twelve subjects (5 males, 7 females; mean age, 38.869.2 years (range, 21–56 years)) were intravenously infusedwithincreasingdosesofsodiumnitritefor48hours(startingdoseat4.2mg/kg/hr;maximaldoseof533.8mg/kg/hr). Clinical,physiologicandlaboratorydatabefore,duringandafterinfusionwereanalyzed. Findings:Themaximaltolerateddoseforintravenousinfusionofsodiumnitritewas267mg/kg/hr.Doselimitingtoxicity occurredat446mg/kg/hr.Toxicityincludedatransientasymptomaticdecreaseofmeanarterialbloodpressure(morethan 15mmHg) and/or an asymptomatic increase of methemoglobin level above 5%. Nitrite, nitrate, S-nitrosothiols concentrations in plasma and whole blood increased in all subjects and returned to pr