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.323 - ENOX0307Dawes JComparison of the pharmacokinetics of enoxaparin (Clexane) and unfractionated heparin(ENG)ACTA CHIR SCAND, (1990) SUPPL 556 68-74, 21REFThe pharmacokinetics of enoxaparin and unfractionated heparin were compared by crossoverstudy in 8 healthy volunteers, using three different assays.After intravenousadministration, unfractionated heparin was cleared with a half-life of 35 min.Theconcentration of enoxaparin, measured by competive binding assay, declined with the longerhalf-life of 60 min, and its anti-factor IIa and anti-factor Xa activities had half-livesof 40 and 275 min, respectively.These data may reflect more rapid clearance of longerchain molecules with anti- factor IIa activity, or release by enoxaparin of an endogenouscompound with anti-factor Xa activity.The bioavailability of sc enoxaparin was 3-foldgreater than that of unfractionated heparin ; unlike unfractinated heparin , enoxaparinwas almost completely absorbed.Peak plasma concentrations occurred 3 h after injection.The pharmacokinetic parameters of enoxaparin were not affected by dose ; by contrast, thehalf- life of unfractionated hepari was highly circadian variation, and neitherpreparation crossed the human placenta.324 - ENOX0516Frydman A; Collignon F; Bouthier J; Roland EPharmacokinetic aspects of enoxaparin (ENG)SIMP SATELLITE : UNA NUOVA PROPOSTA NELLA PREVENZIONE DELLA PATOLOGIA THROMBOEMBOLICA,MILAN, 15-21/07/90, (1990) 37-38The pharmacokinetics of enoxaparin have been extensively investigated in humans.Across-over study comparing the pharmacokinetics of four different subcutaneous doses ofenoxaparin i.e.20, 40, 60 and 80 mg in 12 healthy volunteers demonstrated obviousdifferences compared to the kinetics of unfractionated heparin reported in the literature.Using anti-Xa activity for the asseeement of pharmacokinetics of enoxaparin, the studydemonstrated that enoxaparin is linearly absorbed after subcutaneously injection withsignificant correlations between injected dose and the individual dose and the individualvalues of peak activity and between injected dose and the area under the curve of anti-Xaactivity.These data suggest that the absorbtion of enoxaparin from the injection site isstricly linear.The distribution of enoxaparin was demonstrated to be restricted to arelatively small apparent volume of distribution of about 7.0 liters.Plasma clearance ofenoxaparin was shoen to be small, about 1.25 l/h, with an elimination half life of about 4hours.In addition, the interindividual variability of the kinetics of enoxaparin was low,since the coefficient of variation did not exceed 20 to 25%.When compared to publisheddata with unfractionated heparin.These results have demonstrated that, in contrast toheparin, the subcutaneous absorbtion of enoxaparin is not dose dependent; its distributionis confined to the intravascular space, and its elimination half life exhibiting nodose-dependence, isapproximately four times greater.325 - ENOX0286Hlbmayer WM; Feichtinger C; Schwarz T; Gschnait F; Strasser A; Priesching A; Fischer MA simple test for monitoring plasma anti-Xa in patients after subcutaneous administrationsof enoxaparin (GER)WIEN KLIN WOCHENSCHR, (1990) 102 (14) 408-413, 17REFStudy of a new test to monitor plasma anti-Xa after sc administration of enoxaparin.Effects of sc administration of 20 mg or 40 mg enoxaparin were studied in blood samplesdrawn from 20 patients before and 1, 2, 3, 4, 6, 12 and 24 hours after injection.Thrombintime, APTT, Heptsest and the anti-Xa activity (amidolytic assay)were measured.Subcutaneous administration of 20 mg or 40 mg enoxaparin was followed by a barelysignificant rise in APTT (only at the higher dosage) and thrombin time four hours afterinjection.Heptest and amidolytic assay (S-2222) correlated weil and significantincreases, with maximum values 4 hours after injection, were seen after administration of20 mg as well of 40 mg enoxaparin.Higher mean values were achieved after injection of 40mg than 20 mg enoxaparin.The Heptest seems to be a quick and easily perfomed test, givingresults which agree well with those of the amidolytic anti-Xa activity reference method.326 - ENOX0209Kobayashi NPhase I study of enoxaparin (ENG)KYOTO SATELLITE SYMPOSIUM OF XIITH CONGRESS OF ISTH, (1989), KYOTO, 28/8/89Pharmacokinetics of enoxaparin (E) after sc and iv administration were studied in healthyvolunteers.The maximum anti-Xa was obtained 2-3 hours after sc injection of E (10, 20, 40mg), and was dependent on dose of E injected.Low anti-IIa activity was detected onltyafter 40 mg of E injection.The average half-life of 20, 40 or 60 mg of E in plasma was1.9, 2.5 or 2.8 hours, respectively, which was about twice as long as that of heparin (H).Mean plasma anti-Xa activity 5 min.After iv injection of 20, 40 or 60 mg plasma anti-IIaactivity 5 min.After the iv injection of 40 or 60 mg of E was 0.08, 0.65 IU/ml,respectively, and that of H was 1.87 IU/ml.After continuous the mean maximum anti-Xalevel for 20 mg or 40 mg of E was 0.16 or 0.42 IU/ml respectively.327 - ENOXLevine MN; Planes A; Hirsh J; Goodyear M; Vochelle N; Gent MThe relationship between anti-factor Xa level and clinical outcome in patients receivingenoxaparin low molecular weight heparin to prevent deep vein thrombosis sfter hipreplacement (ENG)THROMB HAEMOST, (1989) 62 (3) 940-944, 21REFThe relationship between both bleeding and inhibition of thrombosis and anti-factor Xalevels has been studied in 163 patients undergoing total hip replacement and receivingaprophylactic dose of given 12 hours preoperatively then once daily at 60 mg (50 patients)or at 40 mg (113 patients).Blood samples for anti-factor Xa levels were collected 12hours after the injection on the day of surgery (day 0) then on days 1, 3 and 6,postoperatively.18 patients developed wound hematoma and 19 patients developedvenographically deep vein thrombosis.The incidence of postoperative thrombosis was low(6.3%) when the minimal value of anti-factor Xa was 0.1 IU/ml.The risk of thrombosis was18.8% with anti-factor Xa or = 0.05 IU/ml.The risk of would hematoma was high (24.5%)when the anti-factor Xa level axceeded 0.2 IU/ml and was low (5.3%) with factor anti-Xalevel or = 0.2 IU/ml [ Pobierz całość w formacie PDF ]
