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Resumen Los fracasos y complicaciones en el campo de la cirugía bucal son analizados generalmente desde un punto de vista técnico o biológico. En términos generales, a partir del espíritu fragmentario del conocimiento, se tiende a enfocar la atención odontológica en la parte técnica y teórica. Actualmente se están produciendo cambios socioculturales que están generando modificaciones en los paradigmas de la atención odontológica, considerando también la comunicación con el paciente y la situación psicológica tanto del paciente como del equipo profesional. En este editorial se busca reflexionar sobre estos temas analizando perspectivas más integradas para lograr un mayor equilibrio en la atención profesional.

Abstract Failures and complications in the field of oral surgery are generally analyzed from a technical or biological point of view. In general terms, based on the fragmentary spirit of knowledge, dental care tends to be focused on the technical and theoretical knowledge. We are currently witnessing sociocultural changes that are producing modifications in the paradigms of dental care, also considering communication with the patient and the psychological situation of both the patient and the professional team. This editorial seeks to reflect on these issues, considering the most integrated visions to achieve greater balance in professional care.

RESUMO

Los fracasos y complicaciones en el campo de la cirugía bucal son analizados generalmente desde un punto de vista técnico o biológico. En términos generales, a partir del es- píritu fragmentario del conocimiento, se tiende a enfocar la atención odontológica en la parte técnica y teórica. Actual- mente se están produciendo cambios socioculturales que están generando modificaciones en los paradigmas de la atención odontológica, considerando también la comunicación con el paciente y la situación psicológica tanto del paciente como del equipo profesional. En este editorial se busca reflexionar so- bre estos temas analizando perspectivas más integradas para lograr un mayor equilibrio en la atención profesional (AU)

Failures and complications in the field of oral surgery are generally analyzed from a technical or biological point of view. In general terms, based on the fragmentary spirit of knowledge, dental care tends to be focused on the technical and theoretical knowledge. We are currently witnessing so- ciocultural changes that are producing modifications in the paradigms of dental care, also considering communication with the patient and the psychological situation of both the patient and the professional team. This editorial seeks to re- flect on these issues, considering the most integrated visions to achieve greater balance in professional care (AU)

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OBJECTIVE: To develop recombinant factor IX (FIX) variants with augmented clotting activity. RESULTS: We generated three new variants, FIX-YKALW, FIX-ALL and FIX-LLW, expressed in SK-Hep-1 cells and characterized in vitro and in vivo. FIX-YKALW showed the highest antigen expression level among the variants (2.17 µg-mL), followed by FIX-LLW (1.5 µg-mL) and FIX-ALL (0.9 µg-mL). The expression level of FIX variants was two-five fold lower than FIX-wild-type (FIX-WT) (4.37 µg-mL). However, the biological activities of FIX variants were 15-31 times greater than FIX-WT in the chromogenic assay. Moreover, the new variants FIX-YKALW, FIX-LLW and FIX-ALL also presented higher specific activity than FIX-WT (17, 20 and 29-fold higher, respectively). FIX variants demonstrated a better clotting time than FIX-WT. In hemophilia B mice, we observed that FIX-YKALW promoted hemostatic protection. CONCLUSION: We have developed three improved FIX proteins with potential for use in protein replacement therapy for hemophilia B.

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The problem of safe obstetrical care has special relevance in recent years due to the interest of health professionals in reducing adverse events and improving healthcare. However, this is pursued in complex, uncertain and variable scenarios and risks, where human behavior may increase the probability of error. We often have to make short term decisions when attending two patients simultaneously - mother and fetus-, and the mother expects a deferential treatment during pregnancy, delivery and the puerperium. These processes involve multiple activities and tasks, and failures may occur. Faced with the paradigm change of involving the patient in the care and decision making process, we have to provide them with the most complete evidence, to avoid contingencies and to obtain the best possible results.

En los últimos años, el problema de la seguridad de la atención en obstetricia ha tenido especial relevancia debido al interés de los profesionales de la salud en reducir los eventos adversos y mejorar su atención. Sin embargo, esta se realiza en escenarios de complejidad variable e incertidumbre, donde existen riesgos múltiples y el comportamiento del factor humano es proclive a incrementar la probabilidad de errores. Al atenderse dos pacientes simultáneamente -la madre y el feto-, en muchos casos debemos tomar decisiones a corto plazo y la madre espera un trato deferencial con expectativa permanente en cualquiera de los momentos de la atención prenatal, parto y puerperio. Estos procesos involucran excesivas actividades y tareas donde la frecuencia de fallas es significativamente alta. Ante el cambio de paradigma, donde el paciente es involucrado en el proceso de atención y colabora en la toma de decisiones, debemos de brindar la información más completa, basada en la mejor evidencia, para evitar eventos adversos prevenibles y lograr los mejores resultados.

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This work investigated the use of hydrophobic interaction membrane chromatography for intermediate purification of recombinant human Factor IX (rFIX) produced by CHO cells. The first purification step was based on a strong anion exchange monolith, thus forming a purification process fully based on convective media, which allow operation at high flow rates and low pressure drops, as well as modular scale-up. Although the starting material was challenging (CHO cell culture supernatant harvested at 70% cell viability), the two-step purification process showed promising results, with a global purification factor of 298, a global recovery of 69%, and DNA and endotoxin levels close to regulatory limits. Final host cell DNA (68.8 ng per dose of 500 IU), endotoxins (60 EU per dose of 500 IU) and activated FIX (FIXa/FIX = 2.33%) were in levels close to those recommended by regulatory authorities. HCP removal was of 99.98%, decreasing from 9 424 358 ppm in the supernatant to a final HCP value of 2071 ppm. The use of a supernatant harvested at higher viability and/or the addition of a third polishing step focusing on HCP removal could allow meeting the desired HCP range of 50-100 ppm, as well as the regulatory requirements for the other critical contaminants.

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El uso de dispositivos médicos en el hogar, originalmente diseñados para uso hospitalario, ha aumentado. Su uso es complejo e inseguro debido a la inexperiencia del usuario y el entorno no controlado. El objetivo de este estudio es evaluar la seguridad en el uso de este tipo de dispositivos a través de la creación de un modelo conceptual que identifica los riesgos que podrían surgir para un grupo de usuarios inexpertos que los operan. A través de un estudio de usabilidad y siguiendo la metodología Grounded Theory se identificaron problemas y errores que emergen a través del uso en el hogar de dos dispositivos médicos distintos con la finalidad de crear un modelo conceptual. El modelo conceptual obtenido es representado en una herramienta de evaluación, que permite a los interesados identificar el dispositivo médico más apropiado para un usuario específico, detectando las debilidades que pueden llevar a un uso inseguro. La herramienta creada efectivamente permite detectar las características de riesgo, considerando cada situación particular de uso.

The use of medical devices in the home environment, originally designed for hospital use has increased. Its use is complex and uncertain because of the inexperience of the lay user and the uncontrolled environment. The objective of this study is to evaluate the safety in the use of these devices through the creation of a conceptual model that identifies the risks that could arise for a group of lay users who operate them. Through a usability study and following the Grounded Theory methodology problems and errors were identified emerging through the home use of two different medical devices in order to create a conceptual model. The conceptual model obtained is reified as an evaluation tool that allows stakeholders to identify the most suitable medical device for a specific user, detecting the weaknesses that may lead to an unsafe use. The evaluation tool created effectively allows detecting risky characteristics, considering the particular situation of use.

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We explored the potential of fusion of hepatic locus control region 1 (HCR-1) with HCR-2 to express B-domain-deleted human factor VIII (FVIII) in four cell lines. B-domain-deleted human FVIII expression was controlled by HCR-1/HCR-2, followed by liver specific and ubiquitous promoters. Chimera enhancer HCR-1/HCR-2, followed by cytomegalovirus (CMV) promoter, gave 2-fold more FVIII expression in all cell lines (105.6 ± 2.8 for Hek-293, 68.8 ± 3.8 for HepG2, 34.8 ± 1.3 for CHO, and 27.2 ± 1.6 ng-mL-1-106 cells-1 for L.N.) when compared to the vector with CMV alone (54.8 ± 3.3 for Hek-293, 32.4 ± 1.2 for HepG2, 18.6 ± 1.1 for CHO, and 10.1 ± 1.7 ng-mL-1-106 cells-1 for L.N.). Elongation factor 1-α gene and human CMV promoters were more efficient than the promoters from the human α-1-antitrypsin gene, and fviii was less efficient in hepatic cell lines. HCR-1/HCR-2, followed by strong promoters, increases FVIII expression in vitro. Our results underscore the importance of cis sequences for enhancing in vitro FVIII expression; this may be helpful for designing new strategies to improve heterologous expression systems.

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