RESUMO
Objective: To review the pharmacology, pharmacokinetics, and efficacy and safety data of a combination of olanzapine and samidorphan (OLZ/SAM) for the treatment of schizophrenia and bipolar I disorder, which mitigates the possible unwanted side effects of weight gain associated with olanzapine (OLZ). Data Sources: The review was done with a bibliographic survey of studies using MEDLINE/PubMed (January 1999-May 2021) database using the keywords olanzapine and samidorphan. Abstracts, scientific posters, and information from the manufacturer's product labeling were evaluated for inclusion. Inclusion criteria: phase 2, phase 3, and open-labeled studies that evaluated the use of OLZ/SAM for the treatment of schizophrenia and bipolar I disorder. Data Synthesis: We have included one phase 2 dose-ranging exploratory study, two phase 3 efficacy and safety studies, and several open-label extension studies without a comparator. For the treatment of schizophrenia, OLZ/SAM and OLZ alone were analyzed in 2 randomized, double-blind comparison studies of approximately 960 patients. Analysis indicated that OLZ (5-20 mg)/SAM (10 mg) significantly mitigated the side effect of weight gain compared with OLZ alone (control) while maintaining antipsychotic efficacy. For bipolar I disorder, OLZ/SAM was approved as an acute treatment for manic or mixed episodes, as well as an adjunct to valproate or lithium for manic/mixed episodes based on bridging strategy allowed by the Food and Drug Administration. Relevance to Patient Care and Clinical Practice: The combination of olanzapine and samidorphan demonstrated efficacy for the treatment of schizophrenia with a dosage range of 5 to 20 mg OLZ to a 10-mg fixed dose of samidorphan. Advantages of this drug combination include once-daily dosing, favorable tolerability, and most importantly, mitigation of weight gain, which may encourage adherence, when compared with OLZ alone. Conclusion: The new combination treatment of OLZ/SAM is a unique antipsychotic formulation to provide the recognized efficacious treatment of OLZ, while mitigating the weight gain and possibly the weight-related adverse effects secondary to OLZ monotherapy.
RESUMO
The ion exchange of the luminescent probe 1-pyrenemethylamine (PYMA) into zirconium phosphate (ZrP) layered materials has been accomplished. The matrices used were the hexahydrated 10.3 A phase of ZrP (10.3 A ZrP, where 10.3 A represents the interlayer distance) and butylammonium-exchanged ZrP (BAZrP) with an expanded 18.6 A interlayer distance. The XRPD patterns for the 10.3 A ZrP after PYMA exchange (PYMA-exchanged ZrP), at high PYMA concentrations, show an increase in the interlayer distance from 10.3 A in unexchanged 10.3 A ZrP to 23.5 A in PYMA-exchanged ZrP, indicating PYMA intercalation. The luminescence spectrum for the PYMA-exchanged ZrP exhibits an excimer band at 458 nm that is absent in the luminescence spectrum of PYMA in aqueous solution at low concentrations. The intensity of the excimer emission increased at low PYMA concentrations. These results are in contrast to experiments using the BAZrP matrix. The XRPD patterns for PYMA-exchanged BAZrP do not show changes in the interlayer distance, which suggests that PYMA is not being intercalated and is only surface bound. The luminescence spectrum for PYMA-exchanged BAZrP exhibits a lower emission intensity in its excimer band, at different PYMA concentrations, compared with the PYMA-exchanged ZrP excimer band. For PYMA-exchanged ZrP, we propose a process in which exchange at low PYMA concentrations occurs at external surface sites with clustering promoting excimer formation followed by exchange at high PYMA concentrations occurring at interior sites reducing excimer formation.
RESUMO
Antecedentes: en enero del año 2000. la Secretaría Distrital de Salud (SDS) formula el plan de estímulos a la calidad en la atención, para consolidar los lineamientos definidos para mejorar la prestación de servicios de los hospitales de Bogotá. Objetivos: reconocer el esfuerzo de las instituciones y de su equipo humano en el logro del mejoramiento de la gestión y consolidación del proceso de transformación de las ESE. Metodología: se diseñó un grupo de estándares de evaluación que fueron sometidos a una prueba de contenido y se seleccionaron; se capacitaron 35 evaluadores para llevar a cabo el proceso de evaluación, que se validó mediante una prueba piloto y, acorde con éste, se ajustó el proceso. Todas las instituciones de la red fueron evaluadas y calificadas por evaluadores pares y con base en la información obtenida, un grupo de jurados seleccionó las instituciones con mejor desempeño, quienes fueron premiados en ceremonia especial. Resultados: las instituciones han hecho esfuerzos por mejorar su gestión y calidad a pesar de las dificultades por las que está atravesando el sector. El nivel de desempeño y el grado de madurez varía entre las distintas instituciones y los niveles de complejidad. Así, el mayor desarrollo gerencial está en las instituciones de primer nivel, y el más bajo en el tercer nivel. Se observa el esfuerzo de las instituciones en cuanto a su gestión financiera, pero se necesita fortalecer la gestión asistencial en la mayoría de las instituciones. El funcionamiento de las redes está en vía de desarrollo, pero tiene un relativo grado de madurez en los niveles I y II.
Background: In January 2000, the District Health Secretariat (SDS) formulated the stimulus plan for quality care, to consolidate the guidelines defined to improve the provision of services in Bogotá's hospitals. Objectives: to recognize the efforts of the institutions and their human team in achieving management improvement and consolidation of the ESE transformation process. Methodology: a group of evaluation standards were designed and submitted to a content test and selected; 35 evaluators were trained to carry out the evaluation process, which was validated through a pilot test and, according to this, the process was adjusted. All the institutions in the network were evaluated and rated by peer evaluators and, based on the information obtained, a group of jurors selected the best performing institutions, which were awarded prizes at a special ceremony. Results: the institutions have made efforts to improve their management and quality despite the difficulties the sector is going through. The level of performance and degree of maturity varies among the different institutions and levels of complexity. Thus, the greatest managerial development is in the first level institutions, and the lowest in the third level. Institutions are making efforts in terms of financial management, but care management needs to be strengthened in most institutions. The functioning of the networks is in the process of development, but has a relative degree of maturity at levels I and II.