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E. Niclas Jonsson Rujia Xie Scott F. Marshall Rosalin H. Arends 《British journal of clinical pharmacology》2016,81(4):688-699
AimsThe aims were to 1) develop the pharmacokinetics model to describe and predict observed tanezumab concentrations over time, 2) test possible covariate parameter relationships that could influence clearance and distribution and 3) assess the impact of fixed dosing vs. a dosing regimen adjusted by body weight.MethodsIndividual concentration–time data were determined from 1608 patients in four phase 3 studies conducted to assess efficacy and safety of intravenous tanezumab. Patients received two or three intravenous doses (2.5, 5 or 10 mg) every 8 weeks. Blood samples for assessment of tanezumab PK were collected at baseline, 1 h post‐dose and at weeks 4, 8, 16 and 24 (or early termination) in all studies. Blood samples were collected at week 32 in two studies. Plasma samples were analyzed using a sensitive, specific, validated enzyme‐linked immunosorbent assay.ResultsA two compartment model with parallel linear and non‐linear elimination processes adequately described the data. Population estimates for clearance (CL), central volume (V
1), peripheral volume (V
2), inter‐compartmental clearance, maximum elimination capacity (VM) and concentration at half‐maximum elimination capacity were 0.135 l day–1, 2.71 l, 1.98 l, 0.371 l day–1, 8.03 μg day–1 and 27.7 ng ml–1, respectively. Inter‐individual variability (IIV) was included on CL, V
1, V
2 and VM. A mixture model accounted for the distribution of residual error. While gender, dose and creatinine clearance were significant covariates, only body weight as a covariate of CL, V
1 and V
2 significantly reduced IIV.ConclusionsThe small increase in variability associated with fixed dosing is consistent with other monoclonal antibodies and does not change risk : benefit. 相似文献
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Venom from the scorpion Pandinus imperator potently and selectively blocks voltage-gated K+ channels in bullfrog neurones (Pappone, P. A. and Cahalan, M. D. 1987, J. Neurosci. 7, 3300-3305). Its effects on neuromuscular transmission have now been assessed. Twitch tension studies on chick biventer cervicis preparations showed that the venom (1 microgram/ml and above) significantly augmented responses to nerve but not muscle stimulation; there was little change in postjunctional sensitivity to cholinoceptor agonists or K+-induced depolarization. Electrophysiological studies on mouse triangularis sterni preparations revealed that the venom had no effect on spontaneous transmitter release, but increased evoked transmitter release. Extracellular recordings of nerve terminal action potentials showed that the venom selectively reduced the component of the waveform associated with K+ currents. These results confirm that this venom can selectively block neuronal K+ currents, and they show that this can facilitate the release of acetylcholine at the neuromuscular junction. 相似文献
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In newly diagnosed adult patients with epilepsy followed prospectively on monotherapy, carbamazepine and phenytoin were associated with a fall in plasma uric acid, but sodium valproate and phenobarbitone were associated with a rise in plasma uric acid. The mechanisms and significance of these findings are discussed. 相似文献
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We report a case of mild visuo-spatial neglect consequent upon right-hemisphere stroke. At the time of testing, the patient had a complete left visual field deficit but only a very slight left hemiparesis. Under conventional testing conditions, line bisection performed with the right hand showed more severe left neglect than when performed with the left hand. This pattern of performance could, however, be modified, both quantitatively and qualitatively, by changing the starting position of the patient's hand when bisecting horizontal lines. The results suggest that spatio-motor cueing has a more profound effect upon task performance than does differential hemispheric activation per se. We also provide a demonstration that, in a normal subject, the starting position of the hand is likewise a crucial determinant of task performance. In this case, however, there is also an interaction between the hand (and hence hemisphere) deployed and the position of that hand in space. 相似文献
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An area analysis is presented of deaths in Auckland that were ostensibly avoidable, by appropriate medical intervention and treatment. Mortality data from the National Health Statistics Centre for the period 1977-85 were used in the analysis. The definition of an avoidable death was based on the International Classification of Diseases (ICD) code using established criteria. Eight percent of deaths of people under 65 years of age met the criteria. The basic spatial entity for the analysis is the census area unit and maps of Auckland are presented to show the distribution of avoidable mortality. It is found that there are significant and consistent spatial variations. Three areas with avoidable mortality that is generally higher than elsewhere are apparent: in south Auckland; to the north-west of the central urban sector centered on Grey Lynn; and in the eastern parts of the central sector from Glenn Innes to Onehunga. 相似文献