Long-term safety and effectiveness of levodopa-carbidopa intestinal gel infusion.

INTRODUCTION: Levodopa-carbidopa intestinal gel (LCIG) infusion has demonstrated to improve motor fluctuations. The aim of this study is to assess the long-term safety and effectiveness of LCIG infusion in advanced Parkinson's disease (PD) patients with motor fluctuations and its effect in nonmotor symptoms. METHODS: Adverse events (AE) and their management, clinical motor, and nonmotor aspects were assessed up to 10 years. Thirty-seven patients were treated with LGIC; in three subsets of patients, specific batteries of tests were used to assess cognitive and behavior assessment for 6 months, quality of sleep for 6 months, and quality of life and caregiver burden for 1 year. RESULTS: There was a high number of AE, but manageable, most of mild and moderate severity. All patients experienced significant improvement in motor fluctuations with a reduction in mean daily off time of 4.87 hr after 3 months (n = 37) to 6.25 hr after 9 years (n = 2). Diskynesias remained stables in 28 patients (75.7%) and improved in 5 patients (13.5%). There was no neuropsychological deterioration, but an improvement in attentional functions, voluntary motor control, and semantic fluency. Quality of sleep did not worsen, and there was an improvement in the subjective parameters, although overnight polysomnography did not change. There was a significant sustained improvement of 37% in PD-Q39 after 3 months and to 1 year, and a significant reduction in caregiver burden of 10% after 3 months. CONCLUSION: LCIG infusion is a safe and efficacious treatment for the control of motor fluctuations, and for improvement or nonworsening of nonmotor aspects, long-term sustained, and feasible for use in routine care.

Indications, reconstructive techniques, and results for total glossectomy.

BACKGROUND: The best treatment for advanced tongue tumors remains controversial. Total glossectomy with laryngeal preservation is considered a feasible option, despite its morbidity. METHODS: A retrospective analysis of 12 total glossectomies with laryngeal preservation was performed in order to assess the available reconstruction techniques and analyze survival and functional outcomes. RESULTS: One-year overall survival (OS) and disease-free survival (DFS) rates were 58.3% and 33.3%, respectively, both dropping to 25% after 3 years. Permanent gastrostomy was necessary in 10 patients, although videofluoroscopy revealed adequate tolerance to liquids. Speech intelligibility was satisfactory in 50% of the patients and severely impaired in the remaining 50%. CONCLUSION: Laryngeal preservation in the context of advanced tumors of the tongue without supraglottic invasion carried similar oncologic results to total glossectomy with laryngectomy, but offers a better phonatory function. However, it is usually associated with a higher gastrostomy dependency ratio. A scrupulous selection of candidates is mandatory. © 2016 Wiley Periodicals, Inc. Head Neck 38: E2004-E2010, 2016.

Prospective study of catheter-related central vein thrombosis in home parenteral nutrition patients with benign disease using serial venous Doppler ultrasound.

BACKGROUND & AIMS: Catheter-related central vein thrombosis (CRVT) is a severe complication of home parenteral nutrition (HPN) that may be clinically manifest or subclinical. The aims of the study were to prospectively investigate the incidence of CRVT in patients on HPN with benign disease and determine the influence of different variables on this complication. METHODS: A prospective, multicentre, observational study in the Home Artificial Nutrition-Chronic Intestinal Failure ESPEN group was performed. Patients with benign disease starting HPN or already on HPN after the insertion of a new catheter, were recruited and followed up with Color Doppler Duplex Sonography (CDDS) evaluations at baseline, 1 week, 3, 6 and 12 months after catheter insertion. Fisher's exact test was used to calculate the association of different variables (related to the patient, type of catheter, vascular access, insertion method, catheter care and anticoagulant treatment) with CRVT events. RESULTS: Sixty-two patients (31 males, 31 females) aged 50 ± 19 (19-83) years were included and followed for a median 363 days, with an Inter Quartile Range of 180-365 days, and a total of 16,186 catheter-days. Six patients had previous CRVT and 16 had history of thromboembolic disease (pulmonary and mesenteric). Forty one patients were receiving anticoagulant treatment. Fifty two patients had tunneled catheters and 10 implanted ports. Two patients had symptomatic thrombosis at 3 and 12 months of follow-up (2 and 3 weeks after normal routine CDDS evaluation). The incidence of CRVT was 0.045/catheter/year. CRVT was not significantly associated with any of the variables analyzed. CONCLUSIONS: The incidence of CRVT in patients on HPN for benign disease followed by CDDS is low in the first year of catheterization. We did not observe any case of asymptomatic CRVT. Based on our data, CDDS seems to have low effectiveness as a screening tool for CRVT in asymptomatic patients on HPN with benign disease.

Experience in Bedside Placement, Clinical Validity, and Cost-Efficacy of a Self-Propelled Nasojejunal Feeding Tube.

BACKGROUND: The procedures needed to insert nasojejunal tubes (NJTs) are often invasive or uncomfortable for the patient and require hospital resources. The objectives of this study were to describe our experience in inserting a self-propelling NJT with distal pigtail end and evaluate clinical validity and cost efficacy of this enteral nutrition (EN) approach compared with parenteral nutrition (PN). MATERIALS AND METHODS: Prospective study from July 2009 to December 2010, including hospitalized noncritical patients who required short-term jejunal EN. The tubes were inserted at bedside, using intravenous erythromycin as a prokinetic drug. Positioning was considered correct when the distal end was beyond the ligament of Treitz. Migration failure was considered when the tube was not positioned into the jejunum within 48 hours postinsertion. RESULTS: Fifty-six insertions were recorded in 47 patients, most frequently in severe acute pancreatitis (69.6%). The migration rates at 18 and 48 hours postinsertion were 73.2% and 82.1%, respectively. There was migration failure in 8.9% of cases, and 8.9% were classified null (the tube was no longer in the gastrointestinal tract at 18 hours). There were no reported or observed complications. The mean duration of the EN was 12 ± 10.8 days. Five different types of EN formula were used. The total study cost was 53.9% lower compared with using PN in all patients. CONCLUSIONS: Our study demonstrated that bedside insertion of a self-propelling NJT is a safe, cost-effective, and successful technique for postpyloric enteral feeding in at least 73% of the patients, and only 18% of patients could eventually need other placement techniques. It can avoid the need for more aggressive or expensive placement techniques or even PN if we cannot achieve enteral access.

Impact of parenteral nutrition standardization on costs and quality in adult patients.

BACKGROUND: Parenteral nutrition (PN) is a costly therapy that can also be associated with serious complications. Therefore, efforts are focusing on reducing rate of complications, and costs related to PN. OBJECTIVE: The aim was to analyze the effect of the implementation of PN standardization on costs and quality criteria. Secondary aim was to assess the use of individualized PN based on patient's clinical condition. METHODS: We compare the use of PN before and after the implementation of PN standardization. Demographic, clinical and PN characteristics were collected. Costs analysis was performed to study the costs associated to the two different periods. Quality criteria included were: 1) PN administration; 2) nutrition assessment (energy intake between 20-35 kcal/kg/day; protein contribution according to nitrogen balance); 3) safety and complications (hyperglycemia, hypertriglyceridemia, hepatic complications, catheter-related infection); 4) global efficacy (as serum albumin increase). Chi-square test was used to compare percentages; logistic regression analysis was performed to evaluate the use of customized PN. RESULTS: 296 patients were included with a total of 3,167 PN compounded. During the first period standardized PN use was 47.5% vs 85.7% within the second period (p < 0.05). No differences were found in the quality criteria tested. Use of individualized PN was related to critical care patients, hypertriglyceridemia, renal damage, and long-term PN. Mean costs of the PN decreased a 19.5%. Annual costs savings would be € 86,700. CONCLUSIONS: The use of customized or standard PN has shown to be efficient and flexible to specific demands; however customized PN was significantly more expensive.

Introducción: La nutrición parenteral (NP) es una terapia costosa asociada a serias complicaciones. De manera que muchos de los esfuerzos se centran en reducir éstas complicaciones, así como los costes asociados. Objetivos: Analizar el efecto de la estandarización de la NP en los costes y en indicadores de calidad. El objetivo secundario es estudiar la utilización de NP individualizadas en función de las condiciones clínicas de los pacientes. Métodos: Se compara la utilización de NP antes y después de la estandarización de la NP. Se recogen los datos demográficos, clínicos y características de la NP. Se realiza un análisis de costes asociados a los dos periodos de estudio. Se incluyen los siguientes indicadores de calidad: 1) Administración de NP; 2) Valoración nutricional (aporte calórico 20-35 kcal/kg/día; aporte proteico en función del balance nitrogenado); 3) seguridad y complicaciones (hiperglicemia, hipertrigliceridemia, complicaciones hepáticas, infección de catéter); eficacia global (aumento albúmina sérica). Se utiliza test de chi-cuadrado para comparación de porcentajes, y regresión logística para evaluar la utilización de NP individualizada. Resultados: Se incluyeron 296 pacientes para un total de 3,167 NP. Durante el primer período el uso de NP estandarizada fue del 47,5% frente 85,7% en el segundo (p < 0,05). No se encontraron diferencias en los indicadores de calidad estudiados. La utilización de NP individualizada fue relacionada con pacientes críticos, hipertrigliceridemia y NP de larga duración. El coste medio de NP disminuyó en un 19,5%; pudiendo resultar un ahorro anual de 86,700 . Conclusiones: La utilización de NP individualizadas o estándar ha mostrado ser eficiente y flexible; aunque el coste de la individualizada fue significativamente mayor.

Impact of parenteral nutrition standardization on costs and quality in adult patients / Impacto de la estandarización de la nutrición parenteral en costes y calidad en pacientes adultos

Background: Parenteral nutrition (PN) is a costly therapy that can also be associated with serious complications. Therefore, efforts are focusing on reducing rate of complications, and costs related to PN. Objective: The aim was to analyze the effect of the implementation of PN standardization on costs and quality criteria. Secondary aim was to assess the use of individualized PN based on patient’s clinical condition. Methods: We compare the use of PN before and after the implementation of PN standardization. Demographic, clinical and PN characteristics were collected. Costs analysis was performed to study the costs associated to the two different periods. Quality criteria included were: 1) PN administration; 2) nutrition assessment (energy intake between 20-35 kcal/kg/day; protein contribution according to nitrogen balance); 3) safety and complications (hyperglycemia, hypertriglyceridemia, hepatic complications, catheter-related infection); 4) global efficacy (as serum albumin increase). Chi-square test was used to compare percentages; logistic regression analysis was performed to evaluate the use of customized PN. Results: 296 patients were included with a total of 3,167 PN compounded. During the first period standardized PN use was 47.5% vs 85.7% within the second period (p < 0.05). No differences were found in the quality criteria tested. Use of individualized PN was related to critical care patients, hypertriglyceridemia, renal damage, and long-term PN. Mean costs of the PN decreased a 19.5%. Annual costs savings would be Euros 86,700. Conclusions: The use of customized or standard PN has shown to be efficient and flexible to specific demands; however customized PN was significantly more expensive (AU)

Introducción: La nutrición parenteral (NP) es una terapia costosa asociada a serias complicaciones. De manera que muchos de los esfuerzos se centran en reducir éstas complicaciones, así como los costes asociados. Objetivos: Analizar el efecto de la estandarización de la NP en los costes y en indicadores de calidad. El objetivo secundario es estudiar la utilización de NP individualizadas en función de las condiciones clínicas de los pacientes. Métodos: Se compara la utilización de NP antes y después de la estandarización de la NP. Se recogen los datos demográficos, clínicos y características de la NP. Se realiza un análisis de costes asociados a los dos periodos de estudio. Se incluyen los siguientes indicadores de calidad: 1) Administración de NP; 2) Valoración nutricional (aporte calórico 20-35 kcal/kg/día; aporte proteico en función del balance nitrogenado); 3) seguridad y complicaciones (hiperglicemia, hipertrigliceridemia, complicaciones hepáticas, infección de catéter); eficacia global (aumento albúmina sérica). Se utiliza test de chi-cuadrado para comparación de porcentajes, y regresión logística para evaluar la utilización de NP individualizada. Resultados: Se incluyeron 296 pacientes para un total de 3,167 NP. Durante el primer período el uso de NP estandarizada fue del 47,5% frente 85,7% en el segundo (p < 0,05). No se encontraron diferencias en los indicadores de calidad estudiados. La utilización de NP individualizada fue relacionada con pacientes críticos, hipertrigliceridemia y NP de larga duración. El coste medio de NP disminuyó en un 19,5%; pudiendo resultar un ahorro anual de 86,700 Euros. Conclusiones: La utilización de NP individualizadas o estándar ha mostrado ser eficiente y flexible; aunque el coste de la individualizada fue significativamente mayor (AU)

Cellular transplants in amyotrophic lateral sclerosis patients: an observational study.

BACKGROUND AIMS: Cytotherapy is a promising option for neurodegenerative disease treatment. Because of the fatal prognosis and imperative need for effective treatment, amyotrophic lateral sclerosis (ALS) patients request this therapy before its effectiveness has been verified. The increase in clinics offering cytotherapies but providing little scientific information has prompted considerable medical tourism. We present an observational study of Spanish ALS patients receiving cytotherapy, analyzing the experiences arising from the treatment (TX) and considering two progression markers, FVC and ALSFRS-R. METHODS: Twelve ALS patients with a mean age of 48.6 years (SD 12.8) received cytotherapy 26.9 months (SD 15.8) after clinical onset. ALSFRS-R and FVC at TX were 32.3 (SD 6.8) and 63.4% (SD 15.3), respectively. TX involved transplants of olfactory ensheathing cells in three patients, and autologous mesenchymal stromal cells in the remainder. RESULTS: One patient died 33 months post-TX after surviving for 49 months. Five required mechanical non-invasive home ventilation 7.4 months post-TX. Two required invasive ventilation 13 months post-TX. Five patients needed gastrostomy feeding 23.3 months post-TX. Survival between clinical onset and the study end date was 50 months (SD 17.2). No significant adverse events or changes in the decline of FVC and ALSFRS-R compared with the disease's natural history were observed. CONCLUSIONS: Our observations suggest that these therapies do not halt the course of the disease. Cytotherapy cannot yet be considered a curative treatment for ALS.

Improvements in subcutaneous fat, lipid profile, and parameters of mitochondrial toxicity in patients with peripheral lipoatrophy when stavudine is switched to tenofovir (LIPOTEST study).

BACKGROUND: Lipoatrophy is the most stigmatizing side effect of stavudine therapy. We assessed the long-term effects of replacing stavudine with tenofovir in HIV-infected patients with lipoatrophy. METHOD: Prospective switch study. Sixty-two clinically stable patients with antiretroviral therapy (ART) containing stavudine, HIV-1 RNA <50 copies/mL, and lipoatrophy at least in the face on physical examination were included. All patients switched from stavudine to tenofovir without changing any other drug. Objective (malar ultasonography, bioelectrical impedance analysis) and subjective measures of lipoatrophy were assessed. RESULTS: Median age at baseline was 40 years, 44 patients (71%) were male, and median time on stavudine was 4.8 years. Median malar fat thickness increased 0.8 mm (25%) 24 months after switching. Total fat mass increased 3.9 kg (21%). Plasma lactate levels decreased significantly, mainly in patients with baseline hyperlactatemia (from 3.05 to 1.19 mmol/L). Significant improvement in total cholesterol (-12%), triglycerides (-31%), and total cholesterol/HDL cholesterol ratio (-11%) was observed at Month 24. CONCLUSIONS: In this study, switching from stavudine to tenofovir maintained durable virologic suppression when the HAART regimen included a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor, led to a slow improvement of lipoatrophy, and improved the lipid profile and lactate levels with excellent tolerability. These results support the proactive change of stavudine to tenofovir.

Effect of oral administration of a whole formula diet on nutritional and cognitive status in patients with Alzheimer's disease.

AIMS: To evaluate the effect of a whole formula diet on nutritional and cognitive status in Alzheimer's disease patients. METHODS: Patients were randomly assigned to two interventions: a whole formula diet based on lyophilised foods (Treatment Group, n=24) or nutritional advice (Control Group, n=29). Energy intake, body weight, biochemistry, Mini Nutritional Assessment (MNA) and Pfeiffer's tests were determined at baseline and at 3 months of treatment. RESULTS: No differences were observed between groups at baseline. Energy intake tended to increase in the Treatment Group and to decrease in the Control Group, although differences were not significant. The improvement in MNA and Pfeiffer test scores was not significantly different between groups. Body weight increased by 2.06+/-1.9 kg in the Treatment Group and by 0.32+/-3.04 kg in the Control Group (P=0.007). The increases in albumin (P=0.007), haemoglobin (P=0.002) and serum ferritin (P=0.009) were higher in the Treatment Group than in controls. A similar rate of serious adverse events (hospitalisation or death) was observed in both groups. CONCLUSIONS: Administration of this whole formula has a positive impact on nutritional status. The great diversity in textures and tastes enable these formulations to be administered to a wide range of patients with or without liquid dysphagia.