As a part of the multidisciplinary program Biological Effects of Environmental Pollution in Marine Coastal Ecosystems of the European Commission, this study aimed to validate immunological ...alterations as biomarkers of exposure to chemical contamination in polluted areas of Western Mediterranea. The status of the immune system has been assessed in mussels (
Mytilus galloprovincialis) by measuring several immunopathological and immunocompetence parameters. Alterations of total hemocyte counts, lysosomal stability, and phagocytosis were among the most reliable effects observed in polluted sites and suggested immunosuppressive conditions in contaminated mussels. An immunotoxicological index was calculated from the set of individual data. By providing a single value per sampling station to score immunological alterations in mussels, this novel approach allowed recognition of a gradient of perturbation correlated to pollution intensity in two of the three sites monitored. Processing a set of biological parameters by this method was found to increase the ecotoxicological relevance of such multiparametric studies for the assessement of chemical contamination in coastal waters.
Introduction
The objective of the study was to compare compliance and acceptability of a new auto-injector (AI) versus syringe for administration of methotrexate (MTX) in patients with rheumatoid ...arthritis (RA).
Methods
We conducted a randomized, open-label, parallel group study comparing AI to pre-filled syringe (PFS). Adult patients with RA (ACR/EULAR 2010) receiving MTX (orally or by injection) for at least 3 months were allocated to AI or PFS for 6 months and then were allocated to AI for 6 further months. Two co-primary endpoints were defined at M6: percentage of patients with compliance at least 80%; change in functional capacity assessed by Health Assessment Questionnaire (HAQ). Secondary endpoints included quality of life (RaQoL), RA activity (DAS28), and acceptability. Local safety at injection site was assessed at each visit.
Results
Two-hundred and sixty-five patients were randomized. The main analysis was conducted on per protocol set (99 AI and 98 PFS). Compliance was 96.2% in AI and 98.9% in PFS. Good complier rates were 89.9% and 94.9%, thus a difference of − 5.0% (− 18.9%; 8.9%). HAQ remained stable in both groups. No difference was found on RaQoL, change in RA activity, and safety profile. Autonomy, acceptability, and patient satisfaction were better with AI, and patients having had the experience of both AI and PFS preferred AI (
p
< 0.001).
Conclusions
Although this study did not demonstrate non-inferiority of AI versus PFS, compliance was excellent in the two groups, and AI, which was preferred by patients, is a valuable alternative to PFS for administration of MTX.
Trial Registration
ClinicalTrials.gov identifier, NCT02553018.
Funding
Nordic Pharma SAS.
HANDS OFF LOVE (France, 1927) Alexandre, Maxime; Aragon, Louis; Arp, Jean ...
Film Manifestos and Global Cinema Cultures,
04/2014
Book Chapter
All that can be invoked, that is of true value and force in the world, that is before all else to be defended, all that can place a man no matter what his standing in the discretion of judge let it ...for an instant be recalled the full meaning of the word judge, how at any moment by some accident your life may be at his mercy, whose decision can have the upper hand of anything, as for instance genius on all this is suddenly projected the startling light of a recent case. Both the nature of the defendant and
Using the Monte Carlo method, we have computed the equation of state of a system of hard spherocylinders (cylinders with a hemisphere at each end), of length-to-breadth ratio equal to 3, in the ...isotropic liquid phase. We obtain a pressure slightly smaller than that predicted by the scaled-particle theory (SPT). The SPT predicts a liquid to nematic transition when the density is increased; we have observed that the isotropic liquid phase is stable up to densities significantly higher than the SPT transition density. Using the free-volume theory, we have also determined the behaviour of the pressure at very high densities, for any value of the length-to-breadth ratio γ. Moreover, we have shown that the packing fraction (number density times the volume of one spherocylinder) corresponding to the beginning of the fusion of the solid is an increasing function of γ.