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Enferm. nefrol ; 23(1): 54-59, ene.-mar. 2020. tab, graf
Artigo em Espanhol | IBECS-Express | ID: ibc-ET5-1126


INTRODUCCIÓN: El entrenamiento es fundamental para garantizar el éxito de la Diálisis Peritoneal. OBJETIVO: Valorar la relación entre el tiempo de aprendizaje y la aparición del primer episodio de peritonitis, comparando entre pacientes jóvenes y ancianos. MATERIAL Y MÉTODO: Estudio observacional, retrospectivo. Se incluyó a los pacientes entrenados entre el 1 enero 2014 a 31 diciembre 2018, en el Complejo Asistencial Universitario de León. Se estudiaron variables demográficas, nivel de autonomía, tiempo de entrenamiento, primera peritonitis y germen causante. El punto de corte para diferenciar entre jóvenes y ancianos fue 70 años. Los datos se obtuvieron de la base de datos existente en nuestra unidad. RESULTADOS: Se estudiaron 112 pacientes, 68% hombres, edad media 62,68 ±15,69 años, 40% mayores de 70 años, el 82% eran autónomos para realizar la diálisis. La media de horas de entrenamiento fue 14,82±6,55; ancianos 18,13±7,93 horas, jóvenes 12,73±4,27, (p = 0,004). El 25% tuvieron peritonitis, 64% por gérmenes Gram+. La media al primer episodio fue 266±283 días. Los ancianos tardan 84 días menos de media en tener peritonitis. CONCLUSIONES: Aunque aparecieron más peritonitis en los pacientes que necesitaron más horas de entrenamiento, no se pudo establecer relación estadística alguna entre ambas variables; si bien los ancianos necesitan más tiempo para completar el entrenamiento y el primer episodio de peritonitis aparece más precozmente

INTRODUCTION: Training is essential to ensure the success of peritoneal dialysis. OBJECTIVE: Assess the relationship between learning time and the appearance of the first episode of peritonitis, comparing between young and older patients. MATERIAL AND METHOD: Observational, retrospective study. Trained patients were included between January 1, 2014 and December 31, 2018, in the University Assistance Complex of León. Demographic variables, level of autonomy, training time, first peritonitis and causative germ were studied. The cut-off point to differentiate between young and older was 70 years. The data was obtained from the unit's databases. RESULTS: 112 patients were studied, 68% men, mean age 62.68 ± 15.69 years, 40% over 70 years, 82% were autonomous to perform dialysis. The average training hours were 14.82±6.55; older 18.13±7.93 hours, younger 12.73±4.27, (p = 0.004). 25% had peritonitis, 64% for Gram+ germs. The mean appearance of the first episode was 266 ± 283 days. It takes 84 days less for the older patients to have peritonitis. CONCLUSIONS: Although more peritonitis appeared in patients who needed more training hours, no significant differences were found. Older patients need more time to complete the training and the first episode of peritonitis appears earlier

J Clin Pharmacol ; 60(4): 444-452, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31802506


Chemotherapy-induced peripheral neuropathy (henceforth, neuropathy) is often dose limiting and is generally managed by empirical dose modifications. We aimed to (1) identify an early time point that is predictive of future neuropathy using a patient-reported outcome and (2) propose a dose-adjustment algorithm based on simulated data to manage neuropathy. In previous work, a dose-neuropathy model was developed using dosing and patient-reported outcome data from Cancer and Leukemia Group B 40502 (Alliance), a randomized phase III trial of paclitaxel, nanoparticle albumin-bound paclitaxel or ixabepilone as first-line chemotherapy for locally recurrent or metastatic breast cancer. In the current work, an early time point that is predictive of the future severity of neuropathy was identified based on predictive accuracy of the model. Using the early data and model parameters, simulations were conducted to propose a dose-adjustment algorithm for the prospective management of neuropathy in individual patients. The end of the first 3 cycles (12 weeks) was identified as the early time point based on a predictive accuracy of 75% for the neuropathy score after 6 cycles. For paclitaxel, nanoparticle albumin-bound paclitaxel, and ixabepilone, simulations with the proposed dose-adjustment algorithm resulted in 61%, 48%, and 35% fewer patients, respectively, with neuropathy score ≥8 after 6 cycles compared to no dose adjustment. We conclude that early patient-reported outcome data on neuropathy can be used to guide dose adjustments in individual patients that reduce the severity of future neuropathy. Prospective validation of this approach should be undertaken in future studies.

J Clin Oncol ; 37(28): 2537-2547, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31386610


PURPOSE: Antiangiogenic agents combined with chemotherapy have efficacy in the treatment of unresectable malignant pleural mesothelioma (MPM). Cediranib (AstraZeneca, Cheshire, United Kingdom), a vascular endothelial growth factor receptor and platelet-derived growth factor receptor inhibitor, demonstrated therapeutic potential in a prior phase I trial. We evaluated a phase II trial for efficacy. PATIENTS AND METHODS: SWOG S0905 ( identifier: NCT01064648) randomly assigned cediranib or placebo with platinum-pemetrexed for six cycles followed by maintenance cediranib or placebo in unresectable chemotherapy-naïve patients with MPM of any histologic subtype. Primary end point was Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 progression-free survival (PFS). Secondary end points included overall survival, PFS by modified RECIST v1.1, response (modified RECIST and RECIST v1.1), disease control, and safety/toxicity. The trial was designed to detect a difference in RECIST v1.1 PFS at the one-sided 0.1 level using a stratified log-rank test. RESULTS: Ninety-two eligible patients were enrolled (75% epithelioid and 25% biphasic or sarcomatoid). The cediranib arm had more grade 3 and 4 diarrhea, dehydration, hypertension, and weight loss. Cediranib improved PFS by RECIST v1.1 (hazard ratio, 0.71; 80% CI, 0.54 to 0.95; P = .062; 7.2 months v 5.6 months) and increased modified RECIST v1.1 response (50% v 20%; P = .006). By modified RECIST v1.1, cediranib numerically increased PFS (hazard ratio, 0.77; 80% CI, 0.59 to 1.02; P = .12; median, 6.9 months v 5.6 months). No significant difference in overall survival was observed. CONCLUSION: The addition of cediranib to platinum-pemetrexed improved PFS by RECIST v1.1 and response rate by modified RECIST in patients with unresectable MPM. Whereas adding antiangiogenics to chemotherapy has been a successful strategy for some patients, the cediranib toxicity profile and small incremental survival benefit precludes additional development in MPM.

Clin J Am Soc Nephrol ; 14(6): 882-893, 2019 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-31123180


BACKGROUND AND OBJECTIVES: Volume overload is frequent in prevalent patients on kidney replacement therapies and is associated with outcome. This study was devised to follow-up volume status of an incident population on peritoneal dialysis (PD) and to relate this to patient-relevant outcomes. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This prospective cohort study was implemented in 135 study centers from 28 countries. Incident participants on PD were enrolled just before the actual PD treatment was started. Volume status was measured using bioimpedance spectroscopy before start of PD and thereafter in 3-month intervals, together with clinical and laboratory parameters, and PD prescription. The association of volume overload with time to death was tested using a competing risk Cox model. RESULTS: In this population of 1054 participants incident on PD, volume overload before start of PD amounted to 1.9±2.3 L, and decreased to 1.2±1.8 L during the first year. At all time points, men and participants with diabetes were at higher risk to be volume overloaded. Dropout from PD during 3 years of observation by transfer to hemodialysis or transplantation (23% and 22%) was more prevalent than death (13%). Relative volume overload >17.3% was independently associated with higher risk of death (adjusted hazard ratio, 1.59; 95% confidence interval, 1.08 to 2.33) compared with relative volume overload ≤17.3%. Different practice patterns were observed between regions with respect to proportion of patients on PD versus hemodialysis, selection of PD modality, and prescription of hypertonic solutions. CONCLUSIONS: In this large cohort of incident participants on PD, with different treatment practices across centers and regions, we found substantial volume overload already at start of dialysis. Volume overload improved over time, and was associated with survival.

Diálise Peritoneal , Desequilíbrio Hidroeletrolítico , Estudos de Coortes , Humanos , Masculino , Estudos Prospectivos , Diálise Renal
Enferm. nefrol ; 22(1): 52-58, ene.-mar. 2019. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-183594


Introducción: El tratamiento conservador es una opción de tratamiento en la enfermedad renal crónica. Esta elección es decisión del paciente y/o familia. Objetivo: Analizar el proceso de elección de tratamiento conservador, identificar el perfil de paciente que lo elige, su supervivencia y quien comunica la elección. Material y Método: Estudio observacional, retrospectivo. Se incluyeron pacientes que eligieron tratamiento conservador entre 2010-2017. Los datos se obtuvieron de los registros de enfermería en historia clínica. Se recogieron variables demográficas, supervivencia, Índice de Comorbilidad de Charlson, índice de Barthel y valores de los pacientes utilizando la herramienta Tarjetas de valores. Resultados: Se estudiaron 95 pacientes: 41,05% hombres, edad media 82,36±9 años, 27,37% institucionalizados. La familia comunicó la elección en el 62,11% de los casos. La media del filtrado glomerular al inicio de la información fue 11,53±2,73 ml/min, mediana del Charlson 8 (13-3), Barthel 55 (100-0) puntos. En el proceso de evidenciar valores, la tarjeta más elegida fue "personal sanitario responsable del tratamiento". La supervivencia media fue 496,19 días±553,8. Viven menos los hombres y los institucionalizados, sin diferencia significativa. El riesgo de muerte es mayor, al aumentar el Charlson y disminuir el filtrado glomerular (p=0,01). La familia comunicó la elección de seguir tratamiento conservador en el 62,11% de los casos. Conclusiones: El paciente que opta por tratamiento conservador es, una persona anciana, dependiente, con comorbilidades, supervivencia media en torno a 18 meses y en más de la mitad de los casos es la familia quien comunica la decisión de optar por ese tratamiento

Introduction: Conservative treatment is a treatment option in chronic kidney disease. The election of this treatment is determined by patient and / or the family. Objective: The objective of the study was to analyze the process of choosing conservative treatment, identify the patient profile, the patient' survival and who communicate the election. Material and Method: Observational, retrospective study. Patients who chose conservative treatment between 2010-2017 were included. The data were obtained from nursing records in clinical history. Demographic variables, survival, Charlson Comorbidity Index, Barthel Index and patient values were collected using the Values Cards tool. Resultados: The sample was 95 patients, 41.05% men, mean age 82.36±9 years, 27.37% institutionalized. The family reported the choice in 62.11% of the cases. The mean glomerular filtration rate at the beginning of the information was 11.53±2.73 ml/min, the median of Charlson index: 8 (13-3), median of Barthel index: 55 (100-0) points. In the process of contrasting values, the most chosen card was "health personnel responsible for treatment". The median survival was 496.19±553.8 days. Men and the institutionalized live less, without significant difference. The risk of death is greater, as the Charlson index increases and the glomerular filtration rate decreases (p=0.01). The family announced the election to continue conservative treatment in 62.11% of cases. Conclusions: Patients who opts for conservative treatment are elderly persons, dependents, with comorbidities, average survival of 18 months, and in more than half of the cases, the family is the one that communicates the decision to opt for that treatment

Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Insuficiência Renal Crônica/terapia , Tratamento Conservador/métodos , Fragilidade/epidemiologia , Taxa de Filtração Glomerular , Fatores de Risco , Preferência do Paciente/estatística & dados numéricos , Tomada de Decisões , Estudos Retrospectivos , Análise de Sobrevida , Idoso Fragilizado/estatística & dados numéricos
Clin Colorectal Cancer ; 17(1): e121-e125, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29233486


BACKGROUND: Neoadjuvant chemoradiation (NCRT) is standard treatment for locally advanced rectal cancer. Pathologic complete response (pCR) has associated with improved survival. In modern phase III trials of NCRT, pCR ranges from 10% to 20%. Cetuximab improves response in KRAS (KRAS proto-oncogene) wild type (wt) metastatic colorectal cancer. S0713 was designed to assess improvement in pCR with additional use of cetuximab with induction chemotherapy and NCRT for locally advanced, KRAS-wt rectal cancer. PATIENTS AND METHODS: Patient eligibility: stage II to III biopsy-proven, KRAS-wt rectal adenocarcinoma; no bowel obstruction; adequate hematologic, hepatic and renal function; performance status of 0 to 2. Target enrollment: 80 patients. TREATMENT: induction chemotherapy with wCAPOX (weekly capecitabine and oxaliplatin) and cetuximab followed by the same regimen concurrent with radiation (omitting day 15 oxaliplatin). If fewer than 7 pCRs were observed at planned interim analysis after 40 patients received all therapy, the study would close. Eighty eligible patients would provide 90% power given a true pCR rate > 35% at a significance of 0.04. The regimen would lack future interest if pCR probability was ≤ 20%. RESULTS: Between February 2009 and April 2013, 83 patients registered. Four were ineligible and 4 not treated, leaving 75 evaluable for clinical outcomes and toxicity, of whom 65 had surgery. Of 75 patients, 20 had pCR (27%; 95% confidence interval [CI], 17%-38%); 19 (25%) had microscopic cancer; 36 (48%) had minor/no response (including 10 without surgery). Three-year disease-free survival was 73% (95% CI, 63%-83%). CONCLUSION: Our trial did not meet the pCR target of 35%. Toxicity was generally acceptable. This regimen cannot be recommended outside the clinical trial setting.

Adenocarcinoma/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cetuximab/administração & dosagem , Neoplasias Retais/tratamento farmacológico , Adenocarcinoma/mortalidade , Adulto , Idoso , Capecitabina/administração & dosagem , Quimiorradioterapia Adjuvante/métodos , Intervalo Livre de Doença , Feminino , Humanos , Quimioterapia de Indução/métodos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Terapia Neoadjuvante/métodos , Oxaliplatina/administração & dosagem , Neoplasias Retais/mortalidade , Neoplasias Retais/radioterapia
Medicina (Bogotá) ; 40(1(120)): 143-144, Ene-Mar, 2018.
Artigo em Espanhol | LILACS | ID: biblio-910253


Introducción: La vasculitis ANCA-positiva es una patología que se caracteriza por daño en vasos de pequeño calibre secundario a auto-anticuerpos. El compromiso del sistema nervioso central es poco común, con complicaciones serias y de difícil diagnóstico. Por eso presenta-mos 3 casos de pacientes con paquimeningitis hipertrófica como manifestación neurológica de vasculitis ANCA-positiva, estudiados en el Hospital Universitario San Ignacio de Bogotá. Casos:Se tratan de dos hombres y una mujer. El hombre del primer caso presentó clínica progresiva de 1 año de evolución de dolor ocular, alteración de la agudeza visual, limitación para los movimientos oculares y disartria (Imagen 1).

Anticorpos Anticitoplasma de Neutrófilos , Meningite , Vasculite
Perit Dial Int ; 37(5): 503-508, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28931697


End-stage renal disease (ESRD) is common in the elderly population, and renal replacement therapy (RRT) is often required. However, in this particular subgroup of patients, the choice between hemodialysis (HD) and peritoneal dialysis (PD) is often not an easy decision to make. Published literature has adequately demonstrated that PD prevalence is significantly less than HD across all patient age groups despite several advantages. We also know that elderly patients are less likely to complete a PD assessment, due to both medical and social barriers. Additionally, elderly patients are often reluctant to go ahead with PD despite being eligible PD candidates, mainly due to the fear of performing self-therapy. Recently, many new assisted PD (asPD) programs have cropped up in several countries. The main aim of these programs is to overcome barriers to PD and to promote PD utilization among elderly and non-self-sufficient patients. Although asPD has proven to be associated with good clinical results, there still remain concerns about its greater use. In this review, we will first describe an ideal asPD model and then enumerate examples of strategies and outcomes associated with successful asPD programs worldwide.

Custos de Cuidados de Saúde , Falência Renal Crônica/terapia , Diálise Peritoneal Ambulatorial Contínua/métodos , Idoso , Cuidadores , Comportamento de Escolha , Serviços de Assistência Domiciliar , Humanos , Diálise Peritoneal Ambulatorial Contínua/efeitos adversos , Diálise Peritoneal Ambulatorial Contínua/economia
Enferm. nefrol ; 20(3): 209-214, jul.-sept. 2017. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-166837


Una de las actividades que se realizan en el proceso educativo con herramientas de ayuda a la toma de decisión (HATD) es ayudarles a explorar sus valores mediante las "tarjetas de valores". El objetivo del estudio fue, conocer los valores de las personas con Enfermedad Renal Crónica en la elección de modalidad de Tratamiento Sustitutivo Renal y analizar si existía relación entre los mensajes de las tarjetas y la modalidad de tratamiento. Estudio retrospectivo. Se incluyeron 281 pacientes que pasaron por el proceso de educación con HATD entre los años 2011-2016. Los datos se obtuvieron de los registros de enfermería de la historia clínica. Se estudiaron variables demográficas, tarjetas de valores y elección de tratamiento. La muestra fue de 281 pacientes. Las 3 tarjetas que obtuvieron un mayor porcentaje de elección fueron, Personal sanitario responsable del tratamiento (14,20%), Ser independiente (13,65%), Impacto para la familia (13,30%); según la modalidad de tratamiento elegida, HD: Impacto para la familia (15,94%), Personal sanitario responsable del tratamiento (15,58%), Ser independiente (13,04%). DP: Ser independiente (18,95%), Personal sanitario responsable del tratamiento (15,26%), Impacto para la familia (14,21%). Tratamiento médico conservador: Ser independiente (25,2%), Autonomía e Impacto para la familia (12,5%). Trasplante de donante vivo: Personal sanitario responsable tratamiento (30%), Ser independiente (30%), Autonomía (10%). Podemos concluir que la mayoría de los mensajes de las tarjetas, parecen estar en concordancia con la modalidad elegida. No hay valores propios de una modalidad de tratamiento sustitutivo renal sino personas con diferentes valores que marcan la toma de decisión (AU)

One of the activities carried out in the educational process with decision support tools (HATD) is to help patients explore their values through "value cards". The aim of the study was to know the personal values of Chronic Kidney Disease patients in the choice of Renal Replacement Treatment modality and to analyze if there was a relationship between the messages of the cards and the modality of treatment. Retrospective study. We included 281 patients who went through the education process with HATD between the years 2011-2016. Data were obtained from nursing records in the medical history. Demographic variables, stock cards and treatment choice were studied. The sample was 281 patients. The three cards that obtained a higher percentage of selection were: health personnel responsible for treatment (14.20%), independent (13.65%) and impact for the family (13.30%). According to the modality of treatment chosen, for hemodialysis patients were: impact for the family (15.94%), health personnel responsible for treatment (15.58%) and independent (13.04%); while for peritoneal dialysis patients, they were: independent (18.95%), health personnel responsible for treatment (15.26%) and impact for the family (14.21%). For those with conservative medical treatment, they were: independent (25.2%), autonomy and impact for the family (12.5%); and for those with live donor transplantation: health personnel responsible for treatment (30%), independent (30%) and autonomy (10%). We can conclude that most of the messages on the cards appear to be in accordance with the modality of treatment. There are no values of a modality of renal replacement therapy, but people with different values that influence in the decision making (AU)

Humanos , Diálise Renal/enfermagem , Tomada de Decisões , Enfermagem em Nefrologia/educação , Enfermagem em Nefrologia/organização & administração , Insuficiência Renal Crônica/epidemiologia , Insuficiência Renal Crônica/enfermagem , Técnicas de Apoio para a Decisão , Estudos Retrospectivos
J Clin Oncol ; 35(24): 2745-2753, 2017 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-28486043


Purpose Azacitidine is standard, first-line therapy in higher-risk myelodysplastic syndromes (MDS). Whether azacitidine-based combinations with lenalidomide or vorinostat produce superior overall response rates (ORRs) to azacitidine is not known. Patients and Methods North American Intergroup Study S1117 is a phase II/III trial that randomly assigned patients with higher-risk MDS and chronic myelomonocytic leukemia (CMML) 1:1:1 to azacitidine (75 mg/m2/day on days 1 to 7 of a 28-day cycle); azacitidine plus lenalidomide (10 mg/day on days 1 to 21); or azacitidine plus vorinostat (300 mg twice daily on days 3 to 9). The primary phase II end point was improved ORR. Results Of 277 patients from 90 centers, 92 received azacitidine, 93 received azacitidine plus lenalidomide, and 92 received azacitidine plus vorinostat. Median age was 70 years (range, 28 to 93 years), 85 patients (31%) were female, and 53 patients (19%) had CMML. Serious adverse events were similar across arms, although combination-arm patients were more likely to undergo nonprotocol-defined dose modifications ( P < .001).With a median follow-up of 23 months (range, 1 to 43 months), the ORR was 38% for patients receiving azacitidine, 49% for azacitidine plus lenalidomide ( P = .14 v azacitidine), and 27% for azacitidine plus vorinostat ( P = .16 v azacitidine). For patients with CMML, ORR was higher for azacitidine plus lenalidomide versus azacitidine (68% v 28%, P = .02) but similar for all arms across cytogenetic subgroups, as was remission duration and overall survival. ORR was higher with mutations in DNMT3A and lower for SRSF2, whereas ORR duration improved with fewer mutations. Lenalidomide dose reduction was associated with worse overall survival (hazard ratio, 1.30; P = .05). Conclusion Patients with higher-risk MDS treated with azacitidine-based combinations had similar ORR to azacitidine monotherapy, although patients with CMML benefitted from azacitidine plus lenalidomide. The efficacy of combination regimens may have been affected by dose modifications.

Antimetabólitos Antineoplásicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Azacitidina/uso terapêutico , Leucemia Mielomonocítica Crônica/tratamento farmacológico , Síndromes Mielodisplásicas/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Azacitidina/administração & dosagem , Humanos , Ácidos Hidroxâmicos/administração & dosagem , Lenalidomida , Pessoa de Meia-Idade , Talidomida/administração & dosagem , Talidomida/análogos & derivados , Vorinostat
Appl Health Econ Health Policy ; 15(6): 755-762, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28265820


Healthcare reforms aim to change certain parts of the health system to improve quality of care, access, or financial sustainability. Traditionally, healthcare reform is understood as an action undertaken by a government at a national or local level. However, bottom-up changes can also lead to improvements in the health system. This paper describes the efforts of a coordinated multi-stakeholder advocacy group in Spain to promote a more cost-effective and patient-centred treatment for people receiving renal replacement therapy and assesses the outcomes of their advocacy for health system financing and patient satisfaction. It concludes that bottom-up initiatives do indeed have the power to change health policy and that policy makers should pay attention to their arguments.

Assistência à Saúde/economia , Reforma dos Serviços de Saúde/economia , Política de Saúde/economia , Programas Nacionais de Saúde/economia , Assistência Centrada no Paciente/economia , Qualidade da Assistência à Saúde/economia , Terapia de Substituição Renal/economia , Humanos , Espanha
JAMA ; 317(1): 48-58, 2017 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-28030702


Importance: Zoledronic acid, a third-generation aminobisphosphonate, reduces the incidence of skeletal-related events and pain in patients with bone metastases. The optimal dosing interval for zoledronic acid is uncertain. Objective: To determine whether zoledronic acid administered every 12 weeks is noninferior to zoledronic acid administered every 4 weeks. Design, Setting, Participants: Randomized, open-label clinical trial conducted at 269 academic and community sites in the United States. Patients (n = 1822) with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma who had at least 1 site of bone involvement were enrolled between May 2009 and April 2012; follow-up concluded in April 2014. Interventions: Patients were randomized to receive zoledronic acid administered intravenously every 4 weeks (n = 911) vs every 12 weeks (n = 911) for 2 years. Main Outcomes and Measures: The primary end point was the proportion of patients having at least 1 skeletal-related event (defined as clinical fracture, spinal cord compression, radiation to bone, or surgery involving bone) within 2 years after randomization and a between-group absolute difference of 7% as the noninferiority margin. Secondary end points included the proportion of patients with at least 1 skeletal-related event by disease type, pain as assessed by the Brief Pain Inventory (range, 0-10; higher scores indicate worse pain), Eastern Cooperative Oncology Group performance status (range, 0-4; higher scores indicate worse disability), incidence of osteonecrosis of the jaw, kidney dysfunction, skeletal morbidity rate (mean number of skeletal-related events per year), and, in a subset of 553 patients, suppression of bone turnover (assessed by C-terminal telopeptide levels). Results: Among 1822 patients who were randomized (median age, 65 years; 980 [53.8%] women; 855 with breast cancer, 689 with prostate cancer, and 278 with multiple myeloma), 795 completed the study at 2 years. A total of 260 patients (29.5%) in the zoledronic acid every 4-week dosing group and 253 patients (28.6%) in the every 12-week dosing group experienced at least 1 skeletal-related event within 2 years of randomization (risk difference of -0.3% [1-sided 95% CI, -4% to ∞]; P < .001 for noninferiority). The proportions of skeletal-related events did not differ significantly between the every 4-week dosing group vs the every 12-week dosing group for patients with breast cancer, prostate cancer, or multiple myeloma. Pain scores, performance status scores, incidence of jaw osteonecrosis, and kidney dysfunction did not differ significantly between the treatment groups. Skeletal morbidity rates were numerically identical in both groups, but bone turnover was greater (C-terminal telopeptide levels were higher) among patients who received zoledronic acid every 12 weeks. Conclusions and Relevance: Among patients with bone metastases due to breast cancer, prostate cancer, or multiple myeloma, the use of zoledronic acid every 12 weeks compared with the standard dosing interval of every 4 weeks did not result in an increased risk of skeletal events over 2 years. This longer interval may be an acceptable treatment option. Trial Registration: Identifier: NCT00869206.

Conservadores da Densidade Óssea/administração & dosagem , Neoplasias Ósseas/secundário , Neoplasias da Mama/patologia , Difosfonatos/administração & dosagem , Imidazóis/administração & dosagem , Mieloma Múltiplo/patologia , Neoplasias da Próstata/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Osso e Ossos/efeitos da radiação , Osso e Ossos/cirurgia , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Tamanho da Amostra , Compressão da Medula Espinal/cirurgia , Fraturas da Coluna Vertebral/cirurgia , Ácido Zoledrônico
Acta neurol. colomb ; 32(4): 337-346, oct.-dic. 2016. ilus, tab
Artigo em Espanhol | LILACS | ID: biblio-949599


Resumen Introducción: la enfermedad de Alzheimer (EA), una condición neurodegenerativa irreversible y progresiva, es la causa más frecuente de demencia y genera una gran carga económica anual. El objetivo de este estudio fue realizar una revisión sistemática de la literatura para determinar la seguridad y eficacia de rivastigmina parche, sola o en combinación con memantina, comparadas con la memantina en monoterapia para el tratamiento de la EA moderada y severa. Métodos: se realizó una búsqueda sistemática de la literatura. Se incluyeron estudios clínicos controlados aleatorizados de pacientes con diagnóstico de EA moderada a severa, evaluando los desenlaces de eficacia y seguridad. Resultados: los resultados de los estudios experimentales que comparan dosis de rivastigmina en parche, indican una posible diferencia en algunos desenlaces de eficacia, tales como desempeño de las actividades diarias, actividades instrumentales y funcionamiento general en pacientes con EA moderada y severa, sin diferencia significativa en los desenlaces de seguridad. Se observó una tendencia a favor de la terapia combinada en algunos desenlaces como cambio en puntuación de MMSE y actividades diarias instrumentales. Discusión: la evidencia disponible apoya el uso de rivastigmina, y la combinación con memantina parece una opción terapéutica apropiada en casos seleccionados.

Summary Introduction: Alzheimer's disease (AD), an irreversible, progressive neurodegenerative condition, is the most common cause of dementia and generates a high economic burden. The aim of this study was to conduct a systematic review of the literature to determine the safety and efficacy of rivastigmine patch, alone or in combination with memantine, compared with memantine monotherapy for the treatment of moderate to severe AD. Methods: A systematic search of the literature was conducted. Including randomized controlled trials of patients diagnosed with moderate to severe AD, evaluating outcomes of effectiveness and safety. Results: The results of experimental studies comparing doses of rivastigmine patches indicate a possible difference in some of the outcomes of effectiveness such as performance in activities of daily living, instrumental activities, and overall functioning, in patients with moderate and severe AD, without significant difference in safety outcomes. A trend in favor of combination therapy in some of the outcomes, as change in MMSE score and instrumental daily activities, was observed. Discussion: The available evidence supports the use of rivastigmine, and the association with memantine seems an appropriate therapeutic option in selected cases.

Memantina , Inibidores da Colinesterase , Doença de Alzheimer
Cancer ; 122(15): 2371-8, 2016 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-27163943


BACKGROUND: Preclinical targeting of the hedgehog pathway by vismodegib and of insulin-like growth factor 1 receptor by cixutumumab enhances the efficacy of chemotherapy and also demonstrates activity against the tumor cell fraction responsible for disease recurrence in small cell lung cancer. METHODS: Patients with newly diagnosed extensive-stage small cell lung cancer (SCLC-ED) were randomized to receive four 21-day cycles of cisplatin and etoposide alone (cisplatin at 75 mg/m(2) on day 1 and etoposide at 100 mg/m(2) on days 1-3; arm A) or in combination with either vismodegib (150 mg/d by mouth; arm B) or cixutumumab (6 mg/kg/wk intravenously on day 1; arm C). The primary endpoint was progression-free survival (PFS). Circulating tumor cells (CTCs) were isolated/enumerated with the Veridex CellSearch platform at the baseline. RESULTS: One hundred fifty-two eligible patients were treated. Patient demographics and disease characteristics were well balanced between the 3 arms except for the higher rate with a performance status of 0 in arm B (P = .03). The median PFS times in arms A, B, and C were 4.4, 4.4, and 4.6 months, respectively; the median overall survival (OS) times were 8.8, 9.8, and 10.1 months, respectively; and the response rates were 48%, 56%, and 50%, respectively. None of the comparisons of these outcomes were statistically significant. The median OS was 10.5 months for those with low CTC counts (≤100/7.5 mL) at baseline and 7.2 months for those with high CTC counts (hazard ratio, 1.74; P = .006). CONCLUSIONS: There was no significant improvement in PFS or OS with the addition of either vismodegib or cixutumumab to chemotherapy in patients with SCLC-ED. A low baseline CTC count was associated with a favorable prognosis. Cancer 2016;122:2371-2378. © 2016 American Cancer Society.

Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/patologia , Carcinoma de Pequenas Células do Pulmão/tratamento farmacológico , Carcinoma de Pequenas Células do Pulmão/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Anilidas/administração & dosagem , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais Humanizados , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Biomarcadores , Cisplatino/administração & dosagem , Etoposídeo/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Células Neoplásicas Circulantes , Piridinas/administração & dosagem , Carcinoma de Pequenas Células do Pulmão/metabolismo , Resultado do Tratamento
Enferm. nefrol ; 18(4): 321-325, oct.-dic. 2015. ilus
Artigo em Espanhol | IBECS | ID: ibc-147453


El hidrotórax como complicación en Diálisis Peritoneal (DP) puede producirse por el paso de líquido de diálisis, de peritoneo a pleura cuando existe una comunicación congénita o adquirida en la barrera diafragmática. Puede ser asintomático o manifestarse con disnea, tos, dolor torácico, disminución del volumen de drenaje o simular un déficit de ultrafiltración. Existe una relación entre el aumento de la Presión Intraperitoneal (PIP) y la aparición de hidrotórax. El diagnóstico se realiza por radiografía de tórax, toracentesis y gammagrafía. Es una complicación seria y poco frecuente que generalmente ocasiona el abandono de la técnica, aunque la realización de pleurodesis química con sustancias esclerosantes (talco, tetraciclinas, sangre) puede ser un tratamiento eficaz para resolver la comunicación pleuroperitoneal. Describimos dos casos de hidrotórax que aparecieron después de tres meses de inicio de la DP, cursaron con derrame pleural derecho, tos, disnea y disminución del volumen de drenaje, el diagnostico se realizo mediante radiografía de tórax, toracentesis y gammagrafía con infusión intraperitoneal del radioisótopo. Los dos casos se resolvieron con la suspensión de la diálisis peritoneal. En base a la relación existente entre la PIP y la aparición de fugas de líquido hacia diferentes cavidades entre ellas la cavidad pleural, podría ser interesante medir y monitorizar los resultados de la Presión Intraperitoneal como parte de la rutina de las actividades enfermeras. Para realizar la gammagrafía, la colaboración entre la Enfermería de DP y Medicina Nuclear permite la administración del radioisótopo de forma segura e indolora (AU)

Hydrothorax as complication in Peritoneal Dialysis (PD) can be produced by the passage of dialysis fluid from the peritoneum to pleura when there is a communication congenital or acquired diaphragmatic wall. It may be asymptomatic or manifest with dyspnea, cough, chest pain, decreased amount of drainage or simulate a deficit of ultrafiltration. There is a relationship between increased intraperitoneal pressure (IP) and the appearance of hydrothorax. The diagnosis is made by chest X-ray, thoracentesis and gammagraphy. It is a serious and rare complication that usually causes the abandonment of techniques while the realization of chemical pleurodesis with sclerosing agents (talc, tetracyclines, blood) can be an effective treatment to solve the pleuroperitoneal communication. We describe two cases of hydrothorax that appeared after three months of start of PD, coursing with right pleural effusion, cough, dyspnea and decreased volume of drainage, the diagnosis was made by chest X-ray, thoracentesis and gammagraphy with intraperitoneal radioisotope infusion. The two cases were resolved with the suspension of peritoneal dialysis. Based on the relationship between the IP and the occurrence of leakage of fluid into different chambers including pleural cavity, it may be interesting to measure and monitor the results of the intraperitoneal pressure as part of the routine activities of nurses. To carry out the gammagraphy, the collaboration between DP nurse and Medicine Nuclear allow the safe and painless administration of the radioisotope (AU)

Humanos , Masculino , Feminino , Hidrotórax/metabolismo , Hidrotórax/patologia , Diálise Peritoneal/instrumentação , Diálise Peritoneal/métodos , Derrame Pleural/complicações , Derrame Pleural/metabolismo , Cateteres/normas , Cateteres , Preparações Farmacêuticas/administração & dosagem , Preparações Farmacêuticas/metabolismo , Hidrotórax/complicações , Hidrotórax/diagnóstico , Diálise Peritoneal/normas , Diálise Peritoneal , Derrame Pleural/congênito , Derrame Pleural/diagnóstico , Cateteres/classificação , Cateteres/provisão & distribução , Preparações Farmacêuticas/análise , Preparações Farmacêuticas/provisão & distribução
PLoS One ; 10(10): e0138811, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26466387


INTRODUCTION: It is desirable for patients to play active roles in the choice of renal replacement therapy (RRT). Patient decision aid tools (PDAs) have been developed to allow the patients to choose the option best suited to their individual needs. MATERIAL AND METHODS: An observational, prospective registry was conducted in 26 Spanish hospitals between September 2010 and May 2012. The results of the patients' choice and the definitive RRT modality were registered through the progressive implementation of an Education Process (EP) with PDAs designed to help Chronic Kidney Disease (CKD) patients choose RRT. RESULTS: Patients included in this study: 1044. Of these, 569 patients used PDAs and had made a definitive choice by the end of registration. A total of 88.4% of patients chose dialysis [43% hemodialysis (HD) and 45% peritoneal dialysis (PD)] 3.2% preemptive living-donor transplant (TX), and 8.4% conservative treatment (CT). A total of 399 patients began RRT during this period. The distribution was 93.4% dialysis (53.6% HD; 40% PD), 1.3% preemptive TX and 5.3% CT. The patients who followed the EP changed their mind significantly less often [kappa value of 0.91 (95% CI, 0.86-0.95)] than those who did not follow it, despite starting unplanned treatment [kappa value of 0.85 (95% CI, 0.75-0.95]. A higher agreement between the final choice and a definitive treatment was achieved by the EP and planned patients [kappa value of 0.93 (95% CI, 0.89-0.98)]. Those who did not go through the EP had a much lower index of choosing PD and changed their decision more frequently when starting definitive treatment [kappa value of 0.73 (95% CI, 0.55-0.91)]. CONCLUSIONS: Free choice, assisted by PDAs, leads to a 50/50 distribution of PD and HD choice and an increase in TX choice. The use of PDAs, even with an unplanned start, achieved a high level of concordance between the chosen and definitive modality.

Comportamento de Escolha , Tomada de Decisões , Falência Renal Crônica/psicologia , Sistema de Registros , Diálise Renal/psicologia , Idoso , Técnicas de Apoio para a Decisão , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Falência Renal Crônica/patologia , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Participação do Paciente/psicologia , Participação do Paciente/estatística & dados numéricos , Estudos Prospectivos , Diálise Renal/métodos , Espanha
J Ren Care ; 41(1): 62-75, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25597792


BACKGROUND: Patients with progressive chronic kidney disease face a series of treatment decisions that will impact the quality of life of themselves and their family. Renal replacement therapy option education (RRTOE), generally provided by nurses, is recommended by international guidelines OBJECTIVES: To provide nurses with advice and guidance on running RRTOE. DESIGN: A consensus conference. PARTICIPANTS: Four nurses, 5 nephrologists and 1 clinical psychologist (9 renal units; 6 European countries) from units that had extensive experience in RRTOE or were performing research in this field. APPROACH: Experts brainstormed and discussed quality standards for the education team, processes, content/topics, media/material/funding and quality measurements for RRTOE. RESULTS: Conclusions and recommendations from these discussions that are particularly pertinent to nurses are presented in this paper. CONCLUSIONS: Through careful planning and smooth interdisciplinary cooperation, it is possible to implement an education and support programme that helps patients choose a form of RRT that is most suited to their needs. This may result in benefits in quality of life and clinical outcomes. APPLICATION TO PRACTICE: There are large differences between renal units in terms of resources available and the demographics of the catchment area. Therefore, nurses should carefully consider how best to adapt the advice offered here to their own situation. Throughout this process, it is crucial to keep in mind the ultimate goal - providing patients with the knowledge and skill to make a modality choice that will enhance their quality of life to the greatest degree.

Comportamento de Escolha , Educação Continuada em Enfermagem , Relações Enfermeiro-Paciente , Educação de Pacientes como Assunto/métodos , Terapia de Substituição Renal/enfermagem , Bélgica , Conferências de Consenso como Assunto , Humanos , Comunicação Interdisciplinar , Colaboração Intersetorial , Garantia da Qualidade dos Cuidados de Saúde
Nephrol Dial Transplant ; 30(7): 1058-66, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24957808


This position statement was compiled following an expert meeting in March 2013, Zurich, Switzerland. Attendees were invited from a spread of European renal units with established and respected renal replacement therapy option education programmes. Discussions centred around optimal ways of creating an education team, setting realistic and meaningful objectives for patient education, and assessing the quality of education delivered.

Educação de Pacientes como Assunto/normas , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica/normas , Qualidade da Assistência à Saúde/normas , Diálise Renal/normas , Humanos , Suíça
BMC Res Notes ; 7: 730, 2014 Oct 17.
Artigo em Inglês | MEDLINE | ID: mdl-25326141


BACKGROUND: There is growing evidence that renal replacement therapy option education (RRTOE) can result in enhanced quality of life, improved clinical outcomes, and reduced health care costs. However, there is still no detailed guidance on the optimal way to run such programmes. To help address this knowledge gap, an expert meeting was held in March 2013 to formulate a position statement on optimal ways to run RRTOE. Experts were selected from units that had extensive experience in RRTOE or were performing research in this field. Before the meeting, experts completed a pilot questionnaire on RRTOE in their own units. They also prepared feedback on how to modify this questionnaire for a large-scale study. METHODS: A pilot, web-based questionnaire was used to obtain information on: the renal unit and patients, the education team, RRTOE processes and content, how quality is assessed, and funding. RESULTS: Four nurses, 5 nephrologists and 1 clinical psychologist (9 renal units; 6 EU countries) participated. Nurses were almost always responsible for organising RRTOE. Nephrologists spent 7.5% (median) of their time on RRTOE. Education for the patient and family began several months before dialysis or according to disease progression. Key topics such as the 'impact of the disease' were covered by every unit, but only a few units described all dialysis modalities. Visits to the unit were almost always arranged. Materials came in a wide variety of forms and from a wide range of sources. Group education sessions were used in 3/9 centres. Expectations on the timing of patients' decisions on modality and permanent access differed substantially between centres. Common quality assurance measures were: patient satisfaction, course attendance, updated materials. Only 1 unit had a dedicated budget. CONCLUSIONS: There were substantial variations in how RRTOE is run between the units. A modified version of this questionnaire will be used to assess RRTOE at a European level.

Conhecimentos, Atitudes e Prática em Saúde , Nefrologia/educação , Equipe de Assistência ao Paciente , Educação de Pacientes como Assunto , Diálise Renal , Insuficiência Renal Crônica/terapia , Europa (Continente)/epidemiologia , Pesquisas sobre Serviços de Saúde , Disparidades em Assistência à Saúde , Humanos , Nefrologia/tendências , Equipe de Assistência ao Paciente/tendências , Educação de Pacientes como Assunto/tendências , Satisfação do Paciente , Projetos Piloto , Padrões de Prática Médica , Desenvolvimento de Programas , Garantia da Qualidade dos Cuidados de Saúde , Indicadores de Qualidade em Assistência à Saúde , Diálise Renal/tendências , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/epidemiologia , Inquéritos e Questionários , Resultado do Tratamento
Cir. Esp. (Ed. impr.) ; 92(3): 149-156, mar. 2014. tab
Artigo em Espanhol | IBECS | ID: ibc-119542


El objetivo es realizar una revisión del estado actual de la prevención y tratamiento de las complicaciones de los estomas. Se ha realizado una búsqueda de la literatura en Medline-PubMed, EMBASE y Cochrane Library hasta diciembre de 2012.Las complicaciones de los estomas son frecuentes e implican una peor calidad de vida y un aumento del costo para el sistema sanitario. Muchas están en relación con la técnica quirúrgica y son susceptibles de prevención con una correcta cirugía realizada por cirujanos con experiencia. El uso de mallas reduce el riesgo de hernia paraestomal y la tasa de recurrencia después de su reparación. Es fundamental el papel de la enfermera estomaterapeuta para elegir la localización del estoma en la fase preoperatoria, y en la fase de seguimiento, para conseguir una mejor adaptación e independencia de los pacientes ostomizados, lo que redundará en una mayor calidad de vida

The aim of our study was to perform a review of the literature to assess the results of prevention and treatment of stoma complications. Medline, EMBASE medical database and the Cochrane Library were searched up to December 2012.Stomal complications are prevalent and associated with a worse quality of life and increased health-economic burdens. The most common complications are attributed to stoma construction. Attention to the finer technical points performed by experienced surgeons reduces morbidity. The use of mesh reduces the risk of parastomal hernia and recurrence rates in hernia repair. Preoperative stoma site marking and postoperative care by a stomatherapist are crucial for the patients’ successful adaption, improving quality of life, promoting their independence and reducing the rates of complications

Humanos , Estomas Cirúrgicos/efeitos adversos , Colostomia/efeitos adversos , Ileostomia/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle