Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects 英文参考文献.docVIP

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Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects 英文参考文献.doc

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Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects 英文参考文献

Smithlineetal.BMCClinicalPharmacology2012,12:4 /1472-6904/12/4 RESEARCH ARTICLE OpenAccess Pharmacokineticsofhigh-doseoralthiamine hydrochlorideinhealthysubjects HowardASmithline1,4*,MichaelDonnino2andDavidJGreenblatt3 Abstract Background:Highdoseoralthiaminemayhavearoleintreatingdiabetes,heartfailure,andhypermetabolic states.Thepurposeofthisstudywastodeterminethepharmacokineticprofileoforalthiaminehydrochlorideat 100mg,500mgand1500mgdosesinhealthysubjects. Methods:Thiswasarandomized,double-blind,single-dose,4-waycrossoverstudy.Pharmacokineticmeasures werecalculated. Results:TheAUC0-10 hr andCmaxvaluesincreasednonlinearlybetween100mgand1500mg.Theslopeofthe AUC0-10 hr vsdose,aswellastheCmax vsdose,plotsaresteepestatthelowestthiaminedoses. Conclusion:Ourstudydemonstratesthathighbloodlevelsofthiaminecanbeachievedrapidlywithoralthiamine hydrochloride.Thiamineisabsorbedbybothanactiveandnonsaturablepassiveprocess. TrialRegistration:ClinicalT:NCBackground Thiamine is used to treat various genetic disorders Thiamine,vitaminB1,wasisolatedin1926andsynthe- linked to the above metabolic pathways and thiamine sizedin1936.Itsimportanceforpreventing illness was deficiencysyndromes(beriberiandWernicke-Korsakoff known as early as the turn of the century. Thiamine syndrome).Oralthiaminemayalsohavearoleintreat- requirements arerelated toenergymetabolism; specifi- ingsomeofthepathophysiologic conditions associated cally,0.33mgofthiaminearerequiredforevery4400kJ with diabetes, heart failure, and hypermetabolic states ofenergy.ForadultstheDRIofthiamineisbetween1.1 and1.4mgperday.Theprimaryactiveformofthevita- [2-5]. The optimum dosing for these beneficial effects is min, thiamine diphosphate (ThDP), is also known as unknown.Raresideeffectsofthiaminehavebeenattrib- thiamine pyrophosphate (TPP). ThDP is a necessary uted to allergic reactions. And although, ganglionic cofactor for enzymes related to carbohydrate metabo- blockadecanoccuratextremelyhighi