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Concept Study (concept + study)

Distribution by Scientific Domains

Medical Sciences	75%

Selected Abstracts

Efficacy on Renal Function of Early Conversion from Cyclosporine to Sirolimus 3 Months After Renal Transplantation: Concept Study

AMERICAN JOURNAL OF TRANSPLANTATION, Issue 5 2009
Y. Lebranchu
Sirolimus (SRL) allows to minimize the use of cyclosporine (CsA), but de novo administration after transplantation is associated with various complications. We report a prospective, open-label, multicenter randomized study to evaluate conversion from a CsA-based regimen to a SRL-based regimen 3 months after transplantation. One hundred ninety-two of a total of 237 patients were eligible at 3 months to be converted to SRL (n = 95) or to continue CsA (n = 97). All patients were also given mycophenolate mofetil (MMF) and oral steroids, planned to be discontinued at month 8. The primary endpoint, the clearance estimated according to Cockcroft and Gault at week 52, was significantly better in the SRL group (68.9 vs. 64.4 mL/min, p = 0.017). Patient and graft survival were not statistically different. The incidence of acute rejection episodes, mainly occurring after withdrawal of steroids, was numerically but not statistically higher in the SRL group (17% vs. 8%, p = 0.071). Sixteen patients discontinued SRL, mainly for adverse events (n = 11), and seven patients discontinued CsA for renal failure or acute rejection. Significantly, more patients in the SRL group reported aphthous, diarrhea, acne and high triglyceride levels. Conversion CsA to SRL 3 months after transplantation combined with MMF is associated with improvement in renal function. [source]

Plant cell calcium-rich environment enhances thermostability of recombinantly produced ,-amylase from the hyperthermophilic bacterium Thermotoga maritime

BIOTECHNOLOGY & BIOENGINEERING, Issue 5 2009
Monica C. Santa-Maria
Abstract In the industrial processing of starch for sugar syrup and ethanol production, a liquefaction step is involved where starch is initially solubilized at high temperature and partially hydrolyzed with a thermostable and thermoactive ,-amylase. Most amylases require calcium as a cofactor for their activity and stability, therefore calcium, along with the thermostable enzyme, are typically added to the starch mixture during enzymatic liquefaction, thereby increasing process costs. An attractive alternative would be to produce the enzyme directly in the tissue to be treated. In a proof of concept study, tobacco cell cultures were used as model system to test in planta production of a hyperthermophilic ,-amylase from Thermotoga maritima. While comparable biochemical properties to recombinant production in Escherichia coli were observed, thermostability of the plant-produced ,-amylase benefited significantly from high intrinsic calcium levels in the tobacco cells. The plant-made enzyme retained 85% of its initial activity after 3,h incubation at 100°C, whereas the E. coli -produced enzyme was completely inactivated after 30,min under the same conditions. The addition of Ca2+ or plant cell extracts from tobacco and sweetpotato to the E. coli -produced enzyme resulted in a similar stabilization, demonstrating the importance of a calcium-rich environment for thermostability, as well as the advantage of producing this enzyme directly in plant cells where calcium is readily available. Biotechnol. Bioeng. 2009; 104: 947,956. © 2009 Wiley Periodicals, Inc. [source]

Psychotherapy as monotherapy for the treatment of bipolar II depression: a proof of concept study

BIPOLAR DISORDERS, Issue 1 2009
Holly A Swartz
Objectives:, We conducted a proof of concept study to determine the feasibility of using an individual psychotherapy, Interpersonal and Social Rhythm Therapy (IPSRT), as monotherapy for the acute treatment of bipolar II depression. Methods:, Unmedicated individuals (n = 17) meeting DSM-IV criteria for bipolar II disorder and currently depressed received weekly psychotherapy (IPSRT) for 12 weeks. After 12 weeks of acute treatment, individuals received an additional 8 weeks of follow-up treatment consisting of continued weekly IPSRT with supplementary lamotrogine for IPSRT non-responders. Results:, By week 12, 41% (n = 7) of the sample responded to IPSRT monotherapy (defined as ,50% reduction in depression scores without an increase in mania scores), 41% (n = 7) dropped out of or were removed from the study, and 18% (n = 3) did not respond to treatment. By week 20, 53% (n = 9) had achieved a response and 29% (n = 5) achieved a full remission of symptoms. Conclusions:, Interpersonal and Social Rhythm Therapy appears to be a promising intervention for a subset of individuals with bipolar II depression. A randomized controlled trial is needed to systematically evaluate the efficacy of IPSRT as an acute monotherapy for bipolar II depression. [source]