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11.
Sabine Zollner Elmar Raquet Philipp Claar Jochen Müller-Cohrs Hubert J. Metzner Thomas Weimer Ingo Pragst Gerhard Dickneite Stefan Schulte 《Thrombosis research》2014
Introduction
rVIII-SingleChain (CSL627), a novel recombinant coagulation factor VIII (FVIII), is under investigation in a phase I/III clinical programme (AFFINITY) for the treatment of haemophilia A. Non-clinical studies were conducted to investigate the pharmacokinetic/pharmacodynamic profile of rVIII-SingleChain in comparison with full-length recombinant FVIII.Materials and Methods
Binding affinity of rVIII-SingleChain for von Willebrand factor was investigated by surface plasmon resonance analysis. The pharmacokinetic profile of rVIII-SingleChain was compared with a marketed full-length recombinant FVIII concentrate (Advate®) in haemophilia A mice, von Willebrand factor knock-out mice, Crl:CD (SD) rats, rabbits and cynomolgus monkeys. Systemic FVIII activity or antigen levels were recorded. Procoagulant activity was measured in an FeCl3-induced arterial occlusion model and by recording thrombin generation activity (ex vivo) after administration of 200–250 IU/kg rVIII-SingleChain or full-length FVIII to haemophilia A mice.Results
rVIII-SingleChain displayed a high affinity for von Willebrand factor (KD = 44 pM vs. 139 pM for full-length recombinant FVIII). In all animal species tested, rVIII-SingleChain had more favourable pharmacokinetic properties than full-length recombinant FVIII: clearance was decreased and area under the curve and terminal half-life were enhanced vs. full-length recombinant FVIII, while in vivo recovery and volume of distribution were equivalent. rVIII-SingleChain showed a prolonged thrombin generation potential and prolonged procoagulant activity vs. full-length recombinant FVIII in an FeCl3-induced arterial occlusion model.Conclusions
rVIII-SingleChain had a higher affinity for von Willebrand factor than full-length recombinant FVIII and displayed favourable pharmacokinetic/pharmacodynamic properties in non-clinical models. 相似文献12.
Portal hyperperfusion is detrimental to small-for-size livers (SFSLs) in liver transplantation. Surgical techniques modulating portal inflow provide the most effective approach to protect the SFSL. In this report, we describe a technique creating an allograft portacaval shunt that effectively attenuates portal inflow without a requirement of extensive surgical dissection in the recipient during the transplantation. 相似文献
13.
Andrea R. Marcadis Richard Teo Wenqi Ouyang Josefina C. Farrá John I. Lew 《Surgery》2018,163(3):633-637
Background
The effect of altered parathyroid hormone metabolism in renal insufficiency on intraoperative parathyroid hormone monitoring during parathyroidectomy is not well known. This study evaluates operative outcomes in patients undergoing parathyroidectomy guided by intraoperative parathyroid hormone monitoring for primary hyperparathyroidism with mild and moderate renal insufficiency.Methods
A retrospective review of prospectively collected data in 604 patients with sporadic primary hyperparathyroidism undergoing parathyroidectomy guided by intraoperative parathyroid hormone monitoring was performed. Patients were stratified by stage of chronic kidney disease (CKD); those with overt secondary hyperparathyroidism (CKD stages IV and V) were excluded. Rates of bilateral neck exploration, multiglandular disease, and long-term operative outcomes, including success, failure, and recurrence were compared.Results
Of the 604 patients, 38% (230/604) had normal renal function or stage I CKD, 44% (268/604) had stage II CKD, and 18% (106/604) had stage III CKD. Overall, there were no differences in the rates of bilateral neck exploration or multiglandular disease or in rates of operative success, failure, or recurrence in patients with normal renal function and stages I to III CKD.Conclusion
Parathyroidectomy guided by intraoperative parathyroid hormone monitoring is performed with high operative success uniformly in primary hyperparathyroidism patients with mild and moderate renal insufficiency with outcomes similar to those with normal renal function. 相似文献14.
Adam Tanious Mathew Wooster Paul A. Armstrong Bruce Zwiebel Shane Grundy Martin R. Back Murray L. Shames 《Journal of vascular surgery》2018,67(5):1353-1359
Objective
A number of adjunctive “off-the-shelf” procedures have been described to treat complex aortic diseases. Our goal was to evaluate parallel stent graft configurations and to determine an optimal formula for these procedures.Methods
This is a retrospective review of all patients at a single medical center treated with parallel stent grafts from January 2010 to September 2015. Outcomes were evaluated on the basis of parallel graft orientation, type, and main body device. Primary end points included parallel stent graft compromise and overall endovascular aneurysm repair (EVAR) compromise.Results
There were 78 patients treated with a total of 144 parallel stents for a variety of pathologic processes. There was a significant correlation between main body oversizing and snorkel compromise (P = .0195) and overall procedural complication (P = .0019) but not with endoleak rates. Patients were organized into the following oversizing groups for further analysis: 0% to 10%, 10% to 20%, and >20%. Those oversized into the 0% to 10% group had the highest rate of overall EVAR complication (73%; P = .0003). There were no significant correlations between any one particular configuration and overall procedural complication. There was also no significant correlation between total number of parallel stents employed and overall complication. Composite EVAR configuration had no significant correlation with individual snorkel compromise, endoleak, or overall EVAR or procedural complication. The configuration most prone to individual snorkel compromise and overall EVAR complication was a four-stent configuration with two stents in an antegrade position and two stents in a retrograde position (60% complication rate). The configuration most prone to endoleak was one or two stents in retrograde position (33% endoleak rate), followed by three stents in an all-antegrade position (25%). There was a significant correlation between individual stent configuration and stent compromise (P = .0385), with 31.25% of retrograde stents having any complication.Conclusions
Parallel stent grafting offers an off-the-shelf option to treat a variety of aortic diseases. There is an increased risk of parallel stent and overall EVAR compromise with <10% main body oversizing. Thirty-day mortality is increased when more than one parallel stent is placed. Antegrade configurations are preferred to any retrograde configuration, with optimal oversizing >20%. 相似文献15.
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