RESUMO
The need for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) with high-risk (HR) features and adequate measurable residual disease (MRD) clearance remains unclear. The aim of the ALL-HR-11 trial was to evaluate the outcomes of HR Ph- adult ALL patients following chemotherapy or allo-HSCT administered based on end-induction and consolidation MRD levels. Patients aged 15 to 60 years with HR-ALL in complete response (CR) and MRD levels (centrally assessed by 8-color flow cytometry) <0.1% after induction and <0.01% after early consolidation were assigned to receive delayed consolidation and maintenance therapy up to 2 years in CR. The remaining patients were allocated to allo-HSCT. CR was attained in 315/348 patients (91%), with MRD <0.1% after induction in 220/289 patients (76%). By intention-to-treat, 218 patients were assigned to chemotherapy and 106 to allo-HSCT. The 5-year (±95% confidence interval) cumulative incidence of relapse (CIR), overall survival (OS), and event-free survival probabilities for the whole series were 43% ± 7%, 49% ± 7%, and 40% ± 6%, respectively, with CIR and OS rates of 45% ± 8% and 59% ± 9% for patients assigned to chemotherapy and of 40% ± 12% and 38% ± 11% for those assigned to allo-HSCT, respectively. Our results show that avoiding allo-HSCT does not hamper the outcomes of HR Ph- adult ALL patients up to 60 years with adequate MRD response after induction and consolidation. Better postremission alternative therapies are especially needed for patients with poor MRD clearance. This trial was registered at www.clinicaltrials.gov as # NCT01540812.
Assuntos
Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Adolescente , Adulto , Quimioterapia de Consolidação , Feminino , Transplante de Células-Tronco Hematopoéticas , Humanos , Quimioterapia de Indução , Quimioterapia de Manutenção , Masculino , Pessoa de Meia-Idade , Neoplasia Residual/diagnóstico , Neoplasia Residual/genética , Cromossomo Filadélfia , Leucemia-Linfoma Linfoblástico de Células Precursoras/diagnóstico , Leucemia-Linfoma Linfoblástico de Células Precursoras/genética , Prognóstico , Transplante Homólogo , Resultado do Tratamento , Adulto JovemRESUMO
Despite high complete remission (CR) rates with frontline therapy, relapses are frequent in adults with T-cell acute lymphoblastic leukemia (T-ALL) with limited salvage options. We analyzed the outcomes and prognostic factors for CR to salvage therapy and overall survival (OS) of patients with R/R T-ALL included in two prospective measurable residual disease-oriented trials. Seventy-five patients (70 relapsed, 5 refractory) were identified. Relapses occurred in bone marrow, isolated or combined in 50 patients, and in the central nervous system (CNS; isolated or combined) in 20. Second CR was attained in 30/75 patients (40%). Treatment with FLAG-Ida and isolated CNS relapse were independently associated with a higher CR rate after first salvage therapy. The median OS was 6.2 (95% confidence interval [CI], 3.9-8.6) months, with a 4-year OS probability of 18% (95% CI, 9%-27%). No differences in survival were observed according to the treatment with hematopoietic stem cell transplantation in patients in CR after first salvage therapy. Multivariable analysis showed a ≥12-month interval between first CR and relapse, CR after first salvage therapy and isolated CNS relapse as favorable prognostic factors for OS with hazard ratios (HR) (95% CI) of 1.931 (1.109-3.362), 2.958 (1.640-5.334), and 2.976 (1.157-7.655), respectively. This study confirms the poor outcomes of adults with R/R T-ALL among whom FLAG-Ida was the best of the rescue therapies evaluated. Late relapse, CR after first rescue therapy and isolated CNS relapse showed prognostic impact on survival. More effective rescue therapies are needed in adults with R/R T-ALL.
Assuntos
Leucemia-Linfoma Linfoblástico de Células T Precursoras/terapia , Adolescente , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasia Residual , Leucemia-Linfoma Linfoblástico de Células T Precursoras/mortalidade , Prognóstico , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: We developed the Blexer system consisting of a database and a web interface for therapists that can host different types of adaptive and personally configurable virtual reality exergames based on Kinect (Microsoft Corp) motion capture to provide entertaining exercises for children with motor disabilities. It allows for parameter adjustment and the monitoring of results remotely, thereby providing a useful tool to complement traditional physical therapy sessions with home exercises. OBJECTIVE: The aim of this study was to observe the motor benefits achieved through the use of a video exergame and the importance and implications of correctly setting the game's difficulty parameters. METHODS: This was an observational case study of 6 children with different physical disabilities receiving physical therapy at school combined with the use of a fully configurable exergame under research that forms a part of the Blexer environment. The game integrates 4 repeatedly appearing upper limb exercises with individually adjustable difficulties (intermittent arm rising, arm forward and backward movement, rising and holding of one arm, and trunk control in all directions). The outcomes were 3 assessments of 2 efficacy measures: Box and Block Test and Jebsen Taylor Hand Function Test. RESULTS: A total of 5 children with cerebral palsy (mean 8.4, SD ï 2.7 years; Gross Motor Function Classification II-2/5, 40%; III-2/5, 40%; and IV-1/5, 20%) and 1 child with obstetric brachial plexus palsy (aged 8 years; Mallet Classification III) received between 8 and 11 sessions of training (10-20 minutes per session), depending on age, motivation, and fatigue. Significant associations were observed between game parameter settings and improvements in motor function, on the one hand, and between the type of improvement and disability severity, on the other: with adjusted game parameters goal and time in the range of 70% to 100%, only less affected children improved in the Box and Block Test (+11 blocks vs -1 block), and more affected children improved more in the Jebsen Taylor Hand Function Test (+90 seconds vs +27 seconds). CONCLUSIONS: When defining the difficulty parameters for an exergame, we suggest a classification in levels ranging from very easy to very hard. For practical use, we suggest setting the difficulty for the player to an easy or medium level rather than high-commitment goals, as this leads to a longer playtime with more fun and, therefore, seems to improve the results of the game and, consequently, mobility.
RESUMO
Native or pegylated (PEG) asparaginase (ASP) are commonly used in treatment of acute lymphoblastic leukemia (ALL), but have been scarcely compared in the same trial in adult patients. Native vs. PEG-ASP administered according to availability in each center were prospectively evaluated in adults with high-risk ALL. Ninety-one patients received native ASP and 35 PEG-ASP in induction. No significant differences were observed in complete remission, minimal residual disease levels after induction and after consolidation, disease-free survival, and overall survival. No significant differences in grades 3-4 toxicity were observed in the induction period, although a trend for higher hepatic toxicity was observed in patients receiving PEG-ASP. In this trial the type of ASP did not influence patient response and outcome.
Assuntos
Asparaginase/uso terapêutico , Polietilenoglicóis/uso terapêutico , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Leucemia-Linfoma Linfoblástico de Células Precursoras/genética , Adolescente , Adulto , Fatores Etários , Asparaginase/administração & dosagem , Asparaginase/efeitos adversos , Terapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Estadiamento de Neoplasias , Cromossomo Filadélfia , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/efeitos adversos , Leucemia-Linfoma Linfoblástico de Células Precursoras/mortalidade , Leucemia-Linfoma Linfoblástico de Células Precursoras/patologia , Análise de Sobrevida , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND AND OBJECTIVE: The prognosis of acute lymphoblastic leukemia (ALL) is poor in older adults and elderly patients, and subtype-oriented prospective trials are scarce in these patients. We present the results of three prospective parallel subtype-oriented protocols in fit patients older than 55 years. PATIENTS AND METHODS: In 2008, three prospective phase II trials in patients older than 55 years were activated: ALLOLD07 for Philadephia (Ph) chromosome-negative ALL, ALLOPH07 for Ph-positive ALL, and BURKIMAB08 for mature B-ALL. Early death (ED), complete remission (CR), disease-free survival (DFS), overall survival (OS) and toxicity were analyzed. RESULTS: 56, 53 and 21 patients from the ALLOLD07, ALLOPH07 and BURKIMAB08 trials, respectively, were evaluable. CR was 74%, 87% and 70%, with an ED rate of 13%, 11% and 15%, respectively. The medians of DFS were 8 and 38 months for ALLOLD07 and ALLOPH07 protocols, not being achieved in the BURKIMAB08 trial (p=0.001), and the median OS was 12, 37 and 25 months, respectively (p=0.030). Neutropenia, thrombocytopenia and infections were less frequent in the ALLOPH07 trial vs. ALLOLD07 and BURKIMAB trials, and renal toxicity and mucositis were more frequent in the BURKIMAB08 trial vs. the ALLOLD07 and ALLOPH07 trials. ECOG score and WBC count had prognostic significance for OS in ALLOPH07 and BURKIMAB08 trials, whereas no prognostic factors were identified in ALLOLD07 protocol. CONCLUSION: Subtype-oriented treatment had an impact in the outcome of older adults with ALL. The poorest outcome was observed in Ph-negative non-Mature B-cell ALL patients, for whom improvements in therapy are clearly needed.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Estudos de Viabilidade , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Leucemia-Linfoma Linfoblástico de Células Precursoras/mortalidade , PrognósticoRESUMO
OBJETIVO: Conocer y relacionar las tendencias de búsqueda de información sobre Emtricitabina/Tenofovir y las prácticas sexuales de riesgo (chemsex). MÉTODO: Estudio ecológico de los volúmenes de búsqueda relativo (VBR) obtenidos de la consulta directa a la herramienta «Google Trends», utilizando los Temas de búsqueda «Emtricitabina/Tenofovir» y «Chemsex», y «Truvada» como Término de Búsqueda. El periodo de búsqueda fue del 1 de enero de 2004 al 31 de diciembre de 2019. Fecha de consulta 16 de enero de 2020. RESULTADOS: El VBR = 100, máximo, se alcanzó en julio de 2012 para «Emtricitabina/Tenofovir», siendo la relación entre los términos de 100/97/10. La asociación entre «Emtricitabina/Tenofovir» y «Truvada» fue muy alta (R = 0,99; p < 0,001). Y las medias de los VBR para «Emtricitabina/Tenofovir» y «Chemsex» de 25,68 y 14,41 respectivamente. La evolución temporal del término «Emtricitabina/Tenofovir» fue lineal (R2 = 0,62; p < 0,001), mientras que para «Chemsex» se obtuvo creciente con ajuste exponencial (R2 = 0,54; p < 0,001). La correlación existente entre los VBR de los dos términos analizados mostró asociación directa significativa (R = 0,69; p < 0,001). CONCLUSIONES: Los hitos observados en el VBR coincidieron con momentos relacionados con eventos destacados. Se probó un crecimiento, a lo largo del tiempo, en la búsqueda de información tanto sobre los Temas Emtricitabina/Tenofovir como sobre "chemsex". Igualmente, se probó la relación entre ambos Temas. Estas conclusiones podrían estar relacionadas con el aumento de las prácticas sexuales de riesgo
OBJECTIVE: To know and relate the trends of searches for information about «Emtricitabina/Tenofovir» and risky sexual behaviour (chemsex). METHOD: Ecological study of relative search volumes (RSV) obtained from the direct search for the tool «Google Trends», using the Searching Issues «Emtricitabina/Tenofovir» and «Chemsex», and «Truvada» like Searching Term. The searching period was from 1 january 2004 to 31 december 2019. Consultation date 16 january 2020. RESULTS: RSV = 100, maximum, was reached in july 2012 by «Emtricitabina/Tenofovir», being the relationship between terms: 100/97/10. The association between «Emtricitabina/Tenofovir» and «Truvada» was rather high (R = 0.99; p < 0,001). And the averages of RSV of «Emtricitabina/Tenofovir» and «Chemsex» were 25.68 and 14.41 respectively. The temporal progress of the term «Emtricitabina/Tenofovir» was linear (R2 = 0.62; p < 0.001), meanwhile for «Chemsex» was increased with exponential adjustment (R2 = 0.54; p < 0.001). The existent correlation between the RSV of the two analyzed terms showed significant direct association (R = 0.69; p < 0.001). CONCLUSIONS: The observed milestones in the RSV coincide with moments associated with relevant events. A growth was proved along the time, in the search for information for the Themes Emtricitabina/tenofovir as well as for "chemsex". Likewise, the relation between both Themes was proved. These conclusions could be connected with the increase of the risky sexual behaviour
Assuntos
Ferramenta de Busca/tendências , Comportamento de Busca de Informação , Emtricitabina , Tenofovir , Sexo sem Proteção , Comportamento Sexual/efeitos dos fármacos , Comportamentos de Risco à Saúde , Ferramenta de Busca/estatística & dados numéricos , Profilaxia Pré-Exposição , Análise de Regressão , Fatores de Tempo , Fatores de RiscoRESUMO
OBJECTIVE: to develop the traceability control and the hazard analysis in the processes of parenteral nutrients (PN). METHOD: a standardized graphical notation was generated, describing in detail each of the stages in the overall process. The presence of hazards was analysed by sequencing decisions. The existence of Control Points (CP) or Critical Control Points (CCP) was estimated by Criticality Index (CI) for each hazard taking into account the probability of occurrence and the severity of the damage. The threshold for the IC was set in 6. RESULTS: a specific flow chart for the management and traceability of PN was obtained, defining each of the stages in CPs (validation and transcription of the prescription and administration) or CCPs (preparation, storage and infusion pump -flow and filter-). Stages regarding the delivery, the recovery and the recycle of the packing material of PNs are not considered CPs and, therefore, they were not included in the dashboard. CONCLUSIONS: PN must be dealt with in the frame of a standardized management system in order to improve patient safety, clinical relevance, maximize resource efficiency and minimize procedural issues. The proposed system provides a global management model whose steps are fully defined, allowing monitoring and verification of PN. It would be convenient to make use of a software application to support the monitoring of the traceability management and to store the historical records in order to evaluate the system.
Objetivo: desarrollar el control de la trazabilidad y el análisis de riesgos en el proceso de mezcla de nutrientes parenterales (NP). Método: se diseñó la notación gráfica normalizada, caracterizando cada una de las etapas dentro del proceso global. Se analizó la presencia de riesgos mediante la secuenciación de decisiones. La existencia de Puntos de Control (PC) o de Puntos Críticos de Control (PCC) se calculó mediante el Índice de Criticidad (IC) para cada uno de los riesgos, teniendo en cuenta la probabilidad del suceso y la gravedad de los daños. El punto de corte del IC se estableció en 6. Resultados: se obtuvo el diagrama de flujo específico para la gestión y trazabilidad de la NP, caracterizándose cada una de las etapas en PC (validación y transcripción de la prescripción y administración) o PCC (preparación, conservación y bomba de infusión -flujo y filtro-). Las etapas de entrega de la NP y de recuperación y reciclado del material de envasado no se consideraron PC y, en consecuencia, no fueron incluidos en el cuadro de gestión. Conclusiones: la NP debe integrarse en un sistema normalizado de gestión con el fin de mejorar la seguridad del paciente y la pertinencia clínica, maximizar la eficiencia de los recursos y minimizar los incidentes procesales. El sistema propuesto permite establecer una gestión global cuyas etapas quedan totalmente caracterizadas, permitiendo su control y verificación. Sería deseable disponer de una aplicación informática que facilitara el seguimiento de la gestión de la trazabilidad y tener un histórico de los registros que permita evaluar el sistema.
Assuntos
Nutrição Parenteral/normas , Serviço de Farmácia Hospitalar/organização & administração , Embalagem de Medicamentos , Humanos , Nutrição Parenteral/efeitos adversos , Soluções de Nutrição Parenteral/normas , Segurança do Paciente , PrescriçõesRESUMO
Alexithymia refers to a specific disturbance in emotional processing that is manifested by difficulties in identifying and verbalizing feelings and a tendency to focus on and amplify the somatic sensations that accompany emotional arousal. Alexithymia is conceptualized both as an affect-deficit disorder and a continuous personality variable. The main purpose of the present study was to investigate the stability levels of alexithymia with regard to changes in emotional distress levels caused by university exams. We tested 20 university students at four different times, before and after the exams. Alexithymic features and self-reported emotional distress (trait anxiety and physical symptoms) were measured. Whereas emotional distress measures changed significantly during the diverse phases, the level of alexithymia remained unchanged. We therefore conclude that alexithymia represents a constant trait.
Assuntos
Sintomas Afetivos/diagnóstico , Inventário de Personalidade/estatística & dados numéricos , Transtornos Somatoformes/diagnóstico , Estresse Psicológico/complicações , Adolescente , Adulto , Sintomas Afetivos/psicologia , Ansiedade/diagnóstico , Ansiedade/psicologia , Feminino , Humanos , Individualidade , Masculino , Psicometria , Transtornos Somatoformes/psicologia , Estudantes/psicologiaRESUMO
Objective: to develop the traceability control and the hazard analysis in the processes of parenteral nutrients (PN). Method: a standardized graphical notation was generated, describing in detail each of the stages in the overall process. The presence of hazards was analysed by sequencing decisions. The existence of Control Points (CP) or Critical Control Points (CCP) was estimated by Criticality Index (CI) for each hazard taking into account the probability of occurrence and the severity of the damage. The threshold for the IC was set in 6. Results: a specific flow chart for the management and traceability of PN was obtained, defining each of the stages in CPs (validation and transcription of the prescription and administration) or CCPs (preparation, storage and infusion pump flow and filter-). Stages regarding the delivery, the recovery and the recycle of the packing material of PNs are not considered CPs and, therefore, they were not included in the dashboard. Conclusions: PN must be dealt with in the frame of a standardized management system in order to improve patient safety, clinical relevance, maximize resource efficiency and minimize procedural issues. The proposed system provides a global management model whose steps are fully defined, allowing monitoring and verification of PN. It would be convenient to make use of a software application to support the monitoring of the traceability management and to store the historical records in order to evaluate the system (AU)
Objetivo: desarrollar el control de la trazabilidad y el análisis de riesgos en el proceso de mezcla de nutrientes parenterales (NP). Método: se diseñó la notación gráfica normalizada, caracterizando cada una de las etapas dentro del proceso global. Se analizó la presencia de riesgos mediante la secuenciación de decisiones. La existencia de Puntos de Control (PC) o de Puntos Críticos de Control (PCC) se calculó mediante el Índice de Criticidad (IC) para cada uno de los riesgos, teniendo en cuenta la probabilidad del suceso y la gravedad de los daños. El punto de corte del IC se estableció en 6. Resultados: se obtuvo el diagrama de flujo específico para la gestión y trazabilidad de la NP, caracterizándose cada una de las etapas en PC (validación y transcripción de la prescripción y administración) o PCC (preparación, conservación y bomba de infusión -flujo y filtro-). Las etapas de entrega de la NP y de recuperación y reciclado del material de envasado no se consideraron PC y, en consecuencia, no fueron incluidos en el cuadro de gestión. Conclusiones: la NP debe integrarse en un sistema normalizado de gestión con el fin de mejorar la seguridad del paciente y la pertinencia clínica, maximizar la eficiencia de los recursos y minimizar los incidentes procesales. El sistema propuesto permite establecer una gestión global cuyas etapas quedan totalmente caracterizadas, permitiendo su control y verificación. Sería deseable disponer de una aplicación informática que facilitara el seguimiento de la gestión de la trazabilidad y tener un histórico de los registros que permita evaluar el sistema (AU)
Assuntos
Humanos , Nutrição Parenteral/métodos , Soluções de Nutrição Parenteral/farmacologia , Composição de Medicamentos/métodos , Composição de Alimentos , Controle de Qualidade , Gestão da Qualidade Total/normas , Avaliação de Processos em Cuidados de Saúde/métodos , Sistemas de Informação em Farmácia Clínica/organização & administraçãoRESUMO
La intensidad afectiva describe las diferencias individuales con que los sujetos experimentan sus emociones. En este trabajo se estudia la relación entre los patrones de reactividad fisiológica al estrés inducido experimentalmente en relación al nivel de Intensidad Afectiva. Para ello seleccionamos un grupo formado por 41 mujeres, a quienes evaluamos su nivel de Intensidad Afectiva empleando la Escala de Intensidad Afectiva (Larsen, 1984). Fueron sometidas a un procedimiento experimental compuesto por seis fases: I-adaptación, TI-relajación, III-estrés (tarea aritmética), IV-relajación, V-estrés (visionado de un vídeo estresante), y VI-relajación. Durante cada una de las fases se evaluó el nivel de reactividad autónoma, empleando el índice de Sudoración Palmar (ISP), un procedimiento de registro sensible al número de glándulas sudoríparas activas. Los resultados mostraron diferencias significativas en los niveles de activación autónoma en relación al nivel de intensidad afectiva durante las diversas fases del procedimiento experimental. Se concluye afirmando que el nivel de intensidad afectiva modula la reactividad fisiológica autónoma al estrés (AU)
Assuntos
Adolescente , Adulto , Feminino , Humanos , Estresse Psicológico/psicologia , Sintomas Afetivos/psicologia , Sudorese , Análise de VariânciaRESUMO
Alexithymia refers to a specific disturbance in emotional processing that is manifested through difficulties in identifying and verbalizing feelings. The main objective of this investigation has been the study about the relationship between subjective and autonomic physiological reactivity pattern to stressful laboratory situation, related with alexithymia level, assessed by the Toronto Alexithymia Scale, TAS-20. The experiment involved six phases: I-adaptation, II-relaxation, III-stress (mental arithmetic), IV-relaxation, V-stress (watching a distressing film), and VI-relaxation. During all periods, the subjective self-perception of physiological activation and autonomic reactivity (using the Palmar Sweat Index), was assessed. Results showed a significantly dissociation by group between subjective self-perception of physiological arousal and self-perception of affective arousal in questionnaire scores, during adaptation period exclusively. The results dont show significant correlations among groups between the subjective self-perception of activation and the autonomous reactivity. These results are discussed in terms of their alexithymic characteristics they are associated with autonomic arousal (AU)
La alexitimia describe una alteración en el procesamiento emocional, manifestada mediante dificultades en la identificación y expresión emocional. Este trabajo examina la relación entre los patrones fisiológicos autónomos y subjetivos de activación en respuesta a una situación de estrés inducido experimentalmente, y el nivel de alexitimia, evaluado mediante la Escala de Alexitimia de Toronto, TAS-20. El experimento consta de seis fases: I-adaptación, II-relajación, III-estrés (aritmético), IV-relajación, V-estrés (visual), y VI-relajación. Durante el procedimiento experimental se registró tanto la percepción subjetiva de activación como la reactividad autónoma, empleando el Índice de Sudoración Palmar. Los resultados muestran diferencias significativas entre la percepción subjetiva de activación fisiológica y afectiva en función del nivel de alexitimia, exclusivamente durante el periodo de adaptación. Asimismo, no aparecen diferencias significativas entre la percepción subjetiva de activación y la reactividad autónoma. Los resultados se discuten en términos de la vinculación de la alexitimia con la activación autonómica (AU)