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41.
Micha?l Philippe Emilie Hénin Yves Bertrand Dominique Plantaz Sylvain Goutelle Nathalie Bleyzac 《The AAPS journal》2015,17(5):1157-1167
Optimal immunosuppressive therapy in acquired severe aplastic anemia (SAA) remains to be refined, especially cyclosporine (CsA) use. Current recommendations state that CsA trough blood concentrations (TBC) should be maintained between 200 and 400 ng/mL despite the lack of supporting data. This study aimed at quantifying relationships between CsA exposure and neutrophil response and determining an effective range for CsA TBC. Twenty-three SAA patients treated with CsA were retrospectively analyzed. Nonlinear mixed effect modeling approaches were used to develop a pharmacokinetic-pharmacodynamic model. The pharmacokinetic model described the relationships between CsA doses and TBC. The pharmacodynamic model allowed to estimate boundaries for optimal CsA effects, neutrophils being used as biomarker of response. A time-to-event model linked effective concentration to time-to-therapeutic success. CsA TBC were adequately described by a two-compartment model with first-order absorption, a lag time, and a linear elimination. The efficient range of CsA TBC was estimated between 87 and 120 ng/mL. Model-based simulations and external validation in three additional patients confirmed these results. This original modeling approach was successful in describing the relationship between CsA TBC and neutrophil response in SAA patients. Although further evaluation of the model is necessary, this work suggests that an optimal CsA TBC target of 100 ng/mL would be associated with a better neutrophil response in children with SAA.KEY WORDS: aplastic anemia, cyclosporine, modeling, pharmacokinetics, regulatory T lymphocytes 相似文献
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Is Going Beyond Rasch Analysis Necessary to Assess the Construct Validity of a Motor Function Scale?
Tiffanie Guillot Sylvain Roche Pascal Rippert Dalil Hamroun Jean Iwaz René Ecochard Carole Vuillerot 《Archives of physical medicine and rehabilitation》2018,99(9):1776-1782.e9
Objective
To examine whether a Rasch analysis is sufficient to establish the construct validity of the Motor Function Measure (MFM) and discuss whether weighting the MFM item scores would improve the MFM construct validity.Design
Observational cross-sectional multicenter study.Setting
Twenty-three physical medicine departments, neurology departments, or reference centers for neuromuscular diseases.Participants
Patients (N=911) aged 6 to 60 years with Charcot-Marie-Tooth disease (CMT), facioscapulohumeral dystrophy (FSHD), or myotonic dystrophy type 1 (DM1).Interventions
None.Main Outcome Measure(s)
Comparison of the goodness-of-fit of the confirmatory factor analysis (CFA) model vs that of a modified multidimensional Rasch model on MFM item scores in each considered disease.Results
The CFA model showed good fit to the data and significantly better goodness of fit than the modified multidimensional Rasch model regardless of the disease (P<.001). Statistically significant differences in item standardized factor loadings were found between DM1, CMT, and FSHD in only 6 of 32 items (items 6, 27, 2, 7, 9 and 17).Conclusions
For multidimensional scales designed to measure patient abilities in various diseases, a Rasch analysis might not be the most convenient, whereas a CFA is able to establish the scale construct validity and provide weights to adapt the item scores to a specific disease. 相似文献45.
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Nathan J Kolla Brittany Matthews Alan A Wilson Sylvain Houle R Michael Bagby Paul Links Alexander I Simpson Amina Hussain Jeffrey H Meyer 《Neuropsychopharmacology》2015,40(11):2596-2603
Antisocial personality disorder (ASPD) often presents with highly impulsive, violent behavior, and pathological changes in the orbitofrontal cortex (OFC) and ventral striatum (VS) are implicated. Several compelling reasons support a relationship between low monoamine oxidase-A (MAO-A), an enzyme that regulates neurotransmitters, and ASPD. These include MAO-A knockout models in rodents evidencing impulsive aggression and positron emission tomography (PET) studies of healthy subjects reporting associations between low brain MAO-A levels and greater impulsivity or aggression. However, a fundamental gap in the literature is that it is unknown whether brain MAO-A levels are low in more severe, clinical disorders of impulsivity, such as ASPD. To address this issue, we applied [11C] harmine PET to measure MAO-A total distribution volume (MAO-A VT), an index of MAO-A density, in 18 male ASPD participants and 18 age- and sex-matched controls. OFC and VS MAO-A VT were lower in ASPD compared with controls (multivariate analysis of variance (MANOVA): F2,33=6.8, P=0.003; OFC and VS MAO-A VT each lower by 19%). Similar effects were observed in other brain regions: prefrontal cortex, anterior cingulate cortex, dorsal putamen, thalamus, hippocampus, and midbrain (MANOVA: F7,28=2.7, P=0.029). In ASPD, VS MAO-A VT was consistently negatively correlated with self-report and behavioral measures of impulsivity (r=−0.50 to −0.52, all P-values<0.05). This study is the first to demonstrate lower brain MAO-A levels in ASPD. Our results support an important extension of preclinical models of impulsive aggression into a human disorder marked by pathological aggression and impulsivity. 相似文献
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Mariette C Fabre S Balon JM Finzi L Triboulet JP 《Gastroentérologie clinique et biologique》2002,26(5):454-462
OBJECTIVE: Surgery is the treatment of reference for early-stage esophageal cancer, but 5-year survival is only 20% to 25%. After complete resection (R0), survival is significantly longer than after incomplete resection, with microscopic (R1) or macroscopic (R2) penetration. The purpose of this work was to identify retrospectively the factors predictive of complete resection of operable esophageal cancers.PATIENTS AND METHODS: Between January 1982 and March 2001, 746 patients with esophageal cancer underwent curative surgery. R0 resection was performed in 585 patients (78.4%), R1 in 61 (8.2%) and R2 in 100 (13.4%). Univariate and multivariate analysis included 28 preoperative, clinical, tumor and therapeutic parameters.RESULTS: Multivariate analysis showed that factors predictive of complete resection R0 were: absence of any modification of the esophageal axis on the barium swallow (P=0.054), a partial or complete response to preoperative radio-chemotherapy (P=0.042), tumor height<10 cm (P=0.1) and tumor diameter<30 mm (P=0.01). Three groups of patients were identified from the 2 most significant variables. Group 1: no deviation of the axis on the barium swallow (n=501). Group 2: deviation of the axis on the barium swallow and partial or complete response to radiochemotherapy (n=91). Group 3: deviation of the axis on the barium swallow and no response to radiochemotherapy or no preoperative treatment (n=126). For the three groups, rate of R0 resection was 82.6%, 80.1% and 61.1% and 5-year actuarial survival 36%, 27% and 14%, respectively. These rates were significantly different between groups (P<10(- 4)) and two by two (P<0.04).CONCLUSION: Complete resection of esophageal cancer is predictable. After validation with an independent population the findings presented here could be used to establish stratification criteria for future therapeutic trials. 相似文献
50.
Despina Moshous Emmanuel Martin Wassila Carpentier Annick Lim Isabelle Callebaut Danielle Canioni Fabian Hauck Jacek Majewski Jeremy Schwartzentruber Patrick Nitschke Nicolas Sirvent Pierre Frange Capucine Picard Stéphane Blanche Patrick Revy Alain Fischer Sylvain Latour Nada Jabado Jean-Pierre de Villartay 《The Journal of allergy and clinical immunology》2013