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1.
World Neurosurg ; 2019 Jul 19.
Artigo em Inglês | MEDLINE | ID: mdl-31330334

RESUMO

INTRODUCTION: The lateral transpsoas approach (LTPA) has gained popularity in thoracolumbar spine surgery procedures; however, there is an insufficient amount of data pertaining to motor and sensory complications that arise when a corpectomy is performed through the LTPA approach. METHODS: Patients who underwent a corpectomy through a LTPA at a single institution between 2006 and 2016 were analyzed. Demographics, neurological outcomes, and complications were recorded. The minimum follow-up was 6 months. Univariate analysis was performed to compare demographics, surgical characteristics, complications, and outcome scores. To compare categorical variables, the χ2 test was used. For continuous outcomes, simple linear regression was used. Statistical significance was set at P < 0.05. RESULTS: A total of 166 patients were included. The patients were divided into 2 groups; LTPA without corpectomy (n = 112) versus LTPA with corpectomy (n = 54). Patients without corpectomy showed a significantly lower rate of postoperative infections compared with patients with corpectomy (3.6% vs. 22.2%; P < 0.000). A higher percentage of postoperative complications was found in patients with corpectomy (31.5% vs. 13.4%; P = 0.006). The rate of neurologic complications at the 6-month follow-up and the reoperation rate (22.7% vs. 32.4%; P = 0.256) were higher in the corpectomy group (8.9% vs. 7.4%; P = 0.741), no significant difference was found between the groups. CONCLUSION: Patients who underwent an LTPA corpectomy have a higher risk to suffer from postoperative complications. The results at the 6-month follow-up did not significantly differ between the groups.

2.
Reumatol. clín. (Barc.) ; 15(3): 156-164, mayo-jun. 2019. tab
Artigo em Espanhol | LILACS-Express | ID: ibc-ET1-3382

RESUMO

Objetivo: El paradigma actual en el tratamiento de la artritis reumatoide (AR) contempla el diagnóstico temprano y el uso precoz de fármacos modificadores de enfermedad (FAME) para alcanzar la remisión o baja actividad inflamatoria, lo cual, se conoce como «treat to target» (T2T). El objetivo del trabajo es desarrollar un indicador compuesto (IC) para evaluar la calidad asistencial en el manejo de los pacientes con AR atendiendo a la estrategia T2T y a otras recomendaciones generales para la atención de estos pacientes. Material y método: La construcción del IC siguió las fases: 1) selección de los criterios de calidad mediante un juicio de expertos; 2) priorización de los criterios, a partir de un Delphi con 20 expertos; 3) diseño de los indicadores de calidad, y 4) cálculo del IC ponderado. La fuente de información para el cálculo del IC son las historias clínicas de los pacientes con AR. Resultados: De los 37 criterios seleccionados, 12 necesitaron una segunda ronda Delphi. Se priorizaron 31 criterios, los cuales presentaron una mediana en relevancia y factibilidad, en las rondas Delphi, mayor o igual a 7,5, con un rango intercuartílico inferior a 3,5, y un grado de acuerdo (puntuación mayor o igual a 8) igual o superior al 80%. Conclusiones: El IC construido, consensuado y ponderado, permite evaluar la calidad asistencial de los pacientes con AR, en las Unidades de Reumatología de hospitales españoles, ofreciendo una medida resumen válida y fácilmente interpretable


Objective: The current guidelines in the treatment of rheumatoid arthritis (RA) include the early diagnosis and early use of disease modifying drugs to achieve remission or low disease activity level, known as "Treat to Target" (T2T). The objective of this study is to develop a composite indicator (CI) to evaluate the quality of care in the management of patients with RA, according to the T2T strategy and other general recommendations concerning the management of these patients. Material and method: The phases of the construction of the CI were: 1) selection of quality criteria through expert judgment; 2) prioritization of the criteria, according to relevance and feasibility, applying the Delphi methodology (two rounds) involving 20 experts; 3) design of quality indicators; and 4) calculation of the weighted CI, using the mean value in relevance and feasibility granted by the experts. The source of information for the calculation of the CI are the medical records of patients with RA. Results: Twelve criteria out of 37 required a second Delphi round. Thirty-one criteria were prioritized. These criteria presented a median in relevance and feasibility greater than or equal to 7.5, with an interquartile range of less than 3.5, and a level of agreement (score greater than or equal to 8) greater than or equal to 80%. Conclusions: The constructed CI allows us to evaluate the quality of care of patients with RA following the T2T strategy in the rheumatology units of Spanish hospitals, offering a valid and easily interpretable summary measure

3.
Arch Esp Urol ; 72(4): 360-366, 2019 May.
Artigo em Espanhol | MEDLINE | ID: mdl-31070131

RESUMO

OBJECTIVE: Following first-line treatment progression in metastatic renal carcinoma, different options for second-line treatment are available, with axitinib being one of them. The objective of this article is to evaluate the results of Axitinib in a real practice setting. METHODS: From December 2011 to October 2016, we treated 19 patients with CCRM with Axitinib, 3 patients in third line and 16 patients in second line after progression on Sunitinib or Pazopanib. We performed a retrospective study of the last 16 patients, analyzing the effectiveness and safety of the drug. RESULTS: The median progression-free survival (PFS) was 9 months and the median overall survival with 8 dead patients was 59 months. Overall, toxicity by Axitinib was very common, diarrhea 87.5%, asthenia 75%, dysphonia 56.25%, hypertension 37.5% and anorexia 37.5%, although most are grade 1-2 toxicities controlled with hygiene-diet measures and treatment recommendations. CONCLUSIONS: Axitinib is a drug that has been shown to increase PFS after 1st line progression, with a tolerable toxic profile. With the approval of nivolumab and cabozantinib, the place of Axitinib in sequential therapy is yet to be defined.


Assuntos
Antineoplásicos , Axitinibe , Carcinoma de Células Renais , Neoplasias Renais , Antineoplásicos/uso terapêutico , Axitinibe/uso terapêutico , Carcinoma de Células Renais/tratamento farmacológico , Humanos , Imidazóis , Indazóis , Neoplasias Renais/tratamento farmacológico , Estudos Retrospectivos , Resultado do Tratamento
4.
Artigo em Inglês | MEDLINE | ID: mdl-31033231

RESUMO

OBJECTIVE: To evaluate the impact of comorbidities on the physical function in patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA). METHODS: Cross-sectional analysis of the baseline visit from the CARMA study. Multivariate models with physical function as the dependent variable (BASFI and HAQ for AS and PsA, respectively) were performed. INDEPENDENT VARIABLES: A proxy for the Charlson Comorbidity Index (CCIp) (range: 0-27); sociodemographic data; disease activity (ESR and BASDAI in AS; DAS28-ESR in PsA); disease duration; radiographic damage and treatments. Results were reported as ß-coefficients, 95% confidence intervals [95%CI] and p-values. RESULTS: We included 738 patients with AS and 721 with PsA; 21% of them had more than one comorbidity. Comorbidity burden (CCIp) was independently associated with worse adjusted physical function in patients with PsA (ß: 0.11). Also, female sex (ß: 0.14), disease duration (ß: 0.01), disease activity (DAS28-ESR, ß: 0.19), NSAIDs (ß: 0.09), glucocorticoids (ß: 0.11) and biologics (ß: 0.15) were associated with worse function in patients with PsA. A higher educational level was associated with less disability (ß: -0.14). In patients with AS, age (ß: 0.03), disease activity (BASDAI; ß: 0.81), radiographic damage (ß: 0.61) and the use of biologics (ß: 0.51) were independently associated with worse function on multivariate analyses, but CCIp was not. CONCLUSION: The presence of comorbidities in patients with PsA is independently associated with worse physical function. The detection and control of the comorbidities may yield an integral management of the disease. This article is protected by copyright. All rights reserved.

5.
Clin Spine Surg ; 32(4): 170-174, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30807364

RESUMO

STUDY DESIGN: This is a retrospective cohort review. OBJECTIVE: To determine whether a correlation exists between facet cysts and lumbar instability. SUMMARY OF BACKGROUND DATA: Lumbar facet cysts are common degenerative entities observed in patients with low-grade spondylolisthesis at a rate of 10%-50%. Surgical management with partial facetectomy with or without fusion remains controversial. METHODS: Review of 86 patients with lumbar degenerative spondylolisthesis is performed. Preoperative magnetic resonance imagings were reviewed for the presence of lumbar facet cysts and Facet Fluid Indices (FFI)-calculated as the ratio of facet fluid width to facet width. Instability was defined as a difference of >3 mm in vertebral displacement between flexion and extension radiographs. T tests and the Pearson correlation analyses were used to determine statistical significance. RESULTS: In total, 26 patients had unstable and 60 had stable spondylolisthesis. Facet cysts were present at an overall prevalence of 30.1%-in 10/26 patients in the unstable group and in 18/60 patients in the stable group (P>0.05). The average FFIs for the unstable and stable groups were 0.13 and 0.09, respectively (P>0.05). FFI in patients with facet cysts was significantly higher than those without (P<0.05). In addition, the group with facet cysts had a significantly higher proportion of patients with FF effusions >3 mm. CONCLUSIONS: Lack of correlation with instability hints that the presence of facet cysts may not indicate instability in lumbar degenerative spondylolisthesis. Therefore, presence of facet cysts in static magnetic resonance imaging revealing spondylolisthesis should not preclude the physician from performing dynamic films to evaluate for instability. Significantly higher FFI in patients with facet cysts reaffirms the degenerative pathophysiology involved in their formation. Although this is not an outcomes study, it does spark interest into whether patients with stable spondylolisthesis and concurrent facet cysts are suitable for partial facetectomy alone with fusion.

6.
Clin Exp Rheumatol ; 2019 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-30789151

RESUMO

OBJECTIVES: Cardiovascular (CV) disease is one of the main causes of morbi-mortality in spondyloarthritis (SpA), partially explained by traditional CV risk factors. Information on lipoprotein(a) [Lp(a)], a non-conventional risk factor, in SpA is scarce. In this study we assessed the prevalence of hyperlipoproteinaemia(a) in SpA patients and analysed the possible related factors. METHODS: A baseline analysis was made of ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients and controls included in the CARMA project (CARdiovascular in RheuMAtology), a 10-year prospective study evaluating the risk of CV events in chronic inflammatory rheumatic diseases. A multivariate logistic regression model was performed using hyperlipoproteinaemia(a) (Lp(a) >50 mg/dl) as a dependent variable and adjusting for confounding factors. RESULTS: 19.2% (95% CI: 16.80-22.05) of the SpA patients [20.7% (95% CI: 16.91-24.82) of those with AS and 17.7% (95% CI: 14.15-21.75) of those with PsA] and 16.7% (95% CI: 13.23-20.86) of the controls had hyperlipoproteinaemia(a) (p=0.326). Adjusting for age and sex, SpA patients were more likely to have hyperlipoproteinaemia(a) than controls (OR: 1.43, 95%CI: 1.00-2.04; p=0.05), especially those with AS (OR: 1.81, 95%CI: 1.18-2.77; p=0.007). In the adjusted model, apolipoprotein B in all patients, non-steroidal anti-inflammatory drugs in AS, and female sex in PsA, were associated with hyperlipoproteinaemia(a). No disease-specific factors associated with hyperlipoproteinaemia(a) were identified. CONCLUSIONS: SpA patients show a moderately increased risk of hyperlipoproteinaemia(a) compared to controls, especially those with AS. Lp(a) determination may be of interest to improve the CV risk assessment in SpA patients.

7.
Arthritis Res Ther ; 21(1): 27, 2019 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-30658685

RESUMO

BACKGROUND: A high prevalence of periodontitis has been reported in rheumatoid arthritis (RA) patients, although the strength of this association, its temporal link and the possible relationship between the severity of periodontitis and RA disease activity remain unclear. The objective of this work was to investigate whether periodontitis is associated with RA and whether periodontitis severity is linked to RA disease activity. METHODS: This case-control study included 187 patients diagnosed with RA and 157 control patients without inflammatory joint disease. RA disease activity and severity were evaluated by the Disease Activity Score 28, the Simplified Disease Activity Index, the Clinical Disease Activity Index, rheumatoid factor, anti-citrullinated protein antibody titers, the erythrocyte sedimentation rate, C-reactive protein, presence of extra-articular manifestations and type of RA therapy. Exposure severity was assessed by the following periodontal parameters: plaque index, bleeding on probing, probing pocket depth and clinical attachment levels. Sociodemographic variables and comorbidities were evaluated as confounding variables. Outcome and exposure variables were compared by both parametric and nonparametric tests, and possible associations were assessed through regression analysis with a calculation for the adjusted odds ratio (OR). RESULTS: A significant association was demonstrated between periodontitis and RA with an adjusted OR of 20.57 (95% CI 6.02-70.27, p < 0.001). Compared with controls, all parameters related to periodontal status (plaque index, bleeding on probing, probing pocket depth and clinical attachment levels) were significantly worse in RA patients (p < 0.001). Periodontitis severity was significantly associated with RA disease activity (p < 0.001), showing in an ordinal logistic regression model an association between periodontal severity and disease activity with an adjusted OR of 2.66 (95% CI 1.24-5.74, p = 0.012). CONCLUSION: A significant association was demonstrated between periodontitis and RA, independent of other confounders. This association was more evident in patients with pronounced periodontal disease and higher RA disease activity.

8.
Clin Exp Rheumatol ; 2019 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-30620291

RESUMO

OBJECTIVES: To determine the incidence and risk factors of first cardiovascular event (CVE) in patients with chronic inflammatory rheumatic diseases (CIRD). METHODS: Analysis of data after 2.5 years of follow-up from the prospective study CARMA project, that includes patients with CIRD [rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA)] and matched individuals without CIRD from 67 hospitals in Spain. CVE cumulative incidence per 1000 patients was calculated after 2.5 years from the start of the project. Weibull proportional hazard model was used to calculate hazard ratio (HR) and 95% confidence interval (95% CI) of the risk factors. RESULTS: 2595 (89.1%) patients completed the 2.5 years of follow-up visit. Cumulative incidence of CVE in patients with CIRD was 15.30 cases per 1000 patients (95% CI: 12.93-17.67), being higher in the subgroup with AS; 22.03 (95% CI: 11.01-33.04). Patients with AS (HR: 4.11; 95% CI: 1.07-15.79), those with older age (HR: 1.09; 95% CI: 1.05-1.13), systolic hypertension (HR: 1.02; 95% CI: 1.00-1.04) and long duration of the disease (HR: 1.07; 95% CI: 1.03-1.12) were at higher risk of first CVE during the 2.5 years of follow-up. In contrast, female gender was a protective factor (HR: 0.43; 95% CI: 0.18-1.00). CONCLUSIONS: Among CIRD patients prospectively followed-up at rheumatology outpatient clinics, those with AS show higher risk of first CVE. Besides cardiovascular risk factors, such as hypertension, being a man and older as well as having a long disease duration increase the risk of CVE in patients with CIRD.

9.
Arthritis Res Ther ; 20(1): 280, 2018 12 19.
Artigo em Inglês | MEDLINE | ID: mdl-30567600

RESUMO

BACKGROUND: The purpose of this study was to assess the prevalence, associated factors, and impact on mortality of primary respiratory disease in a large systemic lupus erythematosus (SLE) retrospective cohort. METHODS: All adult patients in the RELESSER-TRANS (Registry of Systemic Lupus Erythematosus Patients of the Spanish Society of Rheumatology [SER], cross-sectional phase) registry were retrospectively investigated for the presence of primary pleuropulmonary manifestations. RESULTS: In total 3215 patients were included. At least one pleuropulmonary manifestation was present in 31% of patients. The most common manifestation was pleural disease (21%), followed by lupus pneumonitis (3.6%), pulmonary thromboembolism (2.9%), primary pulmonary hypertension (2.4%), diffuse interstitial lung disease (2%), alveolar hemorrhage (0.8%), and shrinking lung syndrome (0.8%). In the multivariable analysis, the variables associated with the development of pleuropulmonary manifestation were older age at disease onset (odds ratio (OR) 1.03, 95% confidence interval (CI) 1.02-1.04), higher SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) scores (OR 1.03, 95% CI 1.00-1.07), the presence of Raynaud's phenomenon (OR 1.41, 95% CI 1.09-1.84), secondary antiphospholipid syndrome (OR 2.20, 95% CI 1.63-2.97), and the previous or concomitant occurrence of severe lupus nephritis, (OR 1.48, 95% CI 1.12-1.95) neuropsychiatric manifestations (OR 1.49, 95% CI 1.11-2.02), non-ischemic cardiac disease (OR 2.91, 95% CI 1.90-4.15), vasculitis (OR 1.81, 95% CI 1.25-2.62), hematological manifestations (OR 1.31, 95% CI 1.00-1.71), and gastrointestinal manifestations, excluding hepatitis (OR 2.05, 95% CI 1.14-3.66). Anti-RNP positivity had a clear tendency to significance (OR 1.32, 95% CI 1.00-1.75; P = 0.054). The development of pleuropulmonary manifestations independently contributes to a diminished survival (hazard ratio of 3.13). However, not all complications will influence the prognosis in the same way. Whereas the occurrence of pleural disease or pulmonary thromboembolism has a minimal impact on the survival of these patients, the remaining manifestations have a major impact on mortality. CONCLUSION: Except for pleural disease, the remaining respiratory manifestations are very uncommon in SLE (<4%). Pleuropulmonary manifestations independently contributed to a decreased survival in these patients.

10.
Arch Esp Urol ; 71(8): 685-695, 2018 Sep.
Artigo em Espanhol | MEDLINE | ID: mdl-30319128

RESUMO

We review the role of immunotherapy in castration resistant prostate cancer. Two immunotherapeutic strategies have been applied, isolated or in combination, either with each other or with other agents with demonstrated efficacy in this scenario that would play a role as immunomodulators: vaccines or monoclonal antibodies aimed to block immune response checkpoint inhibitors. Although CRPC presents, a priori, characteristics suggesting that immunotherapy may play a relevant role as a therapeutic strategy, its clinical application has demonstrated a limited and heterogeneous activity, in terms of proportion of responders and response intensity. Generally, the objective response rate is very low, although, in patients who have response it is possible to detect a clear, long-lasting benefit. Only the autologous vaccine Sipuleucel T has demonstrated an overall survival increase in patients with good prognosis criteria. In these treatments, it is characteristic that no progression free survival increase is visible due to its action mechanism. PSA evolution may not be considered a surrogate variable of radiological response or clinical benefit in this environment either. It is necessary to identify what patient's or tumor's characteristics are able to maximize the response. An important limitation is the absence of response predictive biomarkers that serve for patient preselection. As a general rule, the best responses with isolated immunotherapeutic treatments have been observed in patients with low tumor load, which may suggest that their optimal application could be in earlier phases of the disease (high risk localized, biochemical failure, etc) Combination strategy, without doubt the one with best future, is based on additional treatments increasing cell lysis with the subsequent antigen exposure and/ or producing an immunomodulatory effect that can surmount tumor induced immunologic tolerance. The results obtained suggest that immunotherapy may be more effective in combined therapy with other active therapies (abiraterone, enzalutamide, Radium 223, docetaxel) in a fight to achieve disease chronification.

11.
Arch Esp Urol ; 71(8): 704-710, 2018 Sep.
Artigo em Espanhol | MEDLINE | ID: mdl-30319130

RESUMO

Prostate cancer is a health problem in many Countries worldwide. Understanding the essential function of androgens in the prostate physiology led to the development of hormonal blockade as a therapeutic option in advanced disease, with limited response with time and development of resistance. In this stage, where castration resistant prostate cancer (CRPC) is defined, it is associated with poor prognosis because survival varies between 18 and 24 months. Even with castration levels, tumors are dependent on the functional androgen receptor (AR). In this paper, we analyze pretreatment clinical parameters such as prognostic or progression-predictive biomarkers, castration resistance mechanisms, the development of new technologies for the use of the so called liquid biopsies from biological ayufluids and the identification of circulating tumor cells as CRPC response and progression biomarkers. Currently ongoing clinical trials are partially oriented to the search of new prognostic and predictive biomarkers, that will enable to open up precision medicine and so to improve oncological patient's quality of life with it.

12.
Arch Esp Urol ; 71(8): 735-742, 2018 Sep.
Artigo em Espanhol | MEDLINE | ID: mdl-30319133

RESUMO

OBJECTIVES: There is no broad consensus about what diagnostic tests use for CRPC follow up as well as their frequency. Our objective is to review and analyze the most important CRPC follow up patterns described in the literature to date. METHODS: We performed a critical analysis of the recommendations for follow up most universally employed (PCWG3, RADAR, St Gallen consensus, NCCN guidelines, EAU guidelines) RESULTS: CT scan and bone scan are the routine recommended diagnostic tests, in front of other techniques such as PET/CT or MRI, that may improve the diagnostic efficacy but they have the problem of availability and lack of internal validity for follow up. CONCLUSIONS: Follow up is different for non metastatic and metastatic CRPC. For nm CRPC, it is recommended to perform monitoring that includes PSA and imaging tests, without consensus about periodicity. For mCRPC, it is recommendable to do follow up with periodic PSA and imaging tests, since it is possible to have radiological progression without PSA progression.

13.
Rheumatol Int ; 2018 Oct 24.
Artigo em Inglês | MEDLINE | ID: mdl-30353269

RESUMO

The retention rate of a biological drug (percentage of patients remaining on treatment over time) provides an index of a drug's overall effectiveness. The golimumab retention rate as first-line biological therapy was high in clinical trial extensions lasting 5 years. Real-world studies also indicate good retention rates but have been of shorter duration. The probability of retention with golimumab treatment was assessed, as any line of anti-tumor necrosis factor-alpha therapy, for up to 5 years in patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) or psoriatic arthritis (PsA), associated factors were analyzed. A retrospective database analysis of the Spanish registry of patients with rheumatic disorders receiving biological drugs (BIOBADASER) was performed. Among 353 patients, 29.8% had RA, 41.6% SpA and 28.6% PsA. Golimumab was the first biological drug in 40.1% of patients, second in 30.1% and third/later in 29.8%. The overall probability of retention of golimumab at years 1, 2, 3, 4 and 5 was 85.9% (95% confidence interval 81.4-89.5%), 73.7% (67.1-79.1%), 68.5% (60.5-75.1%), 60.6% (50.2-69.5%) and 57.1% (44.9-67.5%), respectively. Retention was similar across indications (p = 0.070) but was greater when golimumab was used as the first biological agent compared with later therapy lines (p < 0.001). Factors associated with higher retention of golimumab treatment (Cox regression) were use as a first-line biological and concomitant methotrexate treatment; corticosteroid need was associated with lower retention. The long-term probability of golimumab retention was high in this real-world study of patients with rheumatic diseases, especially when used as the first biological drug.

14.
BMJ Open ; 8(10): e020242, 2018 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-30282677

RESUMO

INTRODUCTION: There is a need for fast-acting, non-injection antiagitation treatments that are well tolerated and can be used outside of healthcare facilities. In phase II/III trials, an inhaled formulation of loxapine (ADASUVE®), a well-established, first-generation antipsychotic agent, provided rapid control of mild to moderate agitation in the hospital setting. The present study was designed to investigate the safety and efficacy of inhaled loxapine when self-administered outside the hospital setting. METHODS AND ANALYSIS: This phase IV, multicentre, single-arm, open-label clinical trial is being conducted in five countries in Europe: Spain, Germany, Norway, Romania and Austria. The aim is to include approximately 500 patients with schizophrenia or bipolar disorder who previously received and responded well to inhaled loxapine in the hospital setting. Eligible patients will be followed up for 6 months from baseline. They will be given a 10 mg dose of inhaled loxapine to self-administer outside the hospital setting to treat an agitation episode, should one occur. Patients will also be given a short-acting beta-agonist bronchodilator for treatment of possible severe respiratory side effects. The primary endpoint is incidence of serious adverse events (AEs) and respiratory AEs of special interest related to use of inhaled loxapine outside the hospital setting. Secondary endpoints include incidence of other AEs, Clinical Global Impression-Improvement scores up to 2 hours after self-administration of inhaled loxapine, time to improvement of agitation, patient satisfaction with treatment, treatment outcomes according to agitation severity and concordance between the patient (or a family member/caregiver) and the physician in scoring of agitation severity and the decision to self-administer inhaled loxapine. ETHICS AND DISSEMINATION: The protocol received ethics committee approval in the participating countries between January and August 2016. The results of this study will be disseminated through one or more scientific papers. TRIAL REGISTRATION NUMBER: EudraCT2015-003331-36; NCT02525991; Pre-results.

15.
Arthritis Res Ther ; 20(1): 227, 2018 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-30305158

RESUMO

BACKGROUND: Biologic therapy has changed the prognosis of patients with juvenile idiopathic arthritis (JIA). The aim of this study was to examine the pattern of use, drug survival, and adverse events of biologics in patients with JIA during the period from diagnosis to adulthood. METHODS: All patients included in BIOBADASER (Spanish Registry for Adverse Events of Biological Therapy in Rheumatic Diseases), a multicenter prospective registry, diagnosed with JIA between 2000 and 2015 were analyzed. Proportions, means, and SDs were used to describe the population. Incidence rates and 95% CIs were calculated to assess adverse events. Kaplan-Meier analysis was used to compare the drug survival rates. RESULTS: A total of 469 patients (46.1% women) were included. Their mean age at diagnosis was 9.4 ± 5.3 years. Their mean age at biologic treatment initiation was 23.9 ± 13.9 years. The pattern of use of biologics during their pediatric years showed a linear increase from 24% in 2000 to 65% in 2014. Biologic withdrawal for disease remission was higher in patients who initiated use biologics prior to 16 years of age than in those who were older (25.7% vs 7.9%, p < 0.0001). Serious adverse events had a total incidence rate of 41.4 (35.2-48.7) of 1000 patient-years. Patients younger than 16 years old showed significantly increased infections (p < 0.001). CONCLUSIONS: Survival and suspension by remission of biologics were higher when these compounds were initiated in patients with JIA who had not yet reached 16 years of age. The incidence rate of serious adverse events in pediatric vs adult patients with JIA treated with biologics was similar; however, a significant increase of infection was observed in patients under 16 years old.

16.
Arch. esp. urol. (Ed. impr.) ; 71(8): 735-743, oct. 2018. tab
Artigo em Espanhol | IBECS | ID: ibc-178739

RESUMO

Objetivo: No existe un consenso amplio sobre qué pruebas diagnósticas emplear en el seguimiento del CPRC, así como la periodicidad de las mismas. Nuestro objetivo es revisar y analizar las pautas de seguimiento en el CPRC más importantes descritas hasta la fecha en la literatura. Métodos: Se realiza un análisis crítico de las recomendaciones de seguimiento más universalmente empleadas (PCWG3, RADAR, consenso de St Gallen, guías NCCN, Guías Europeas de Urología). Resultado: El TC y la gammagrafía ósea son las técnicas diagnósticas recomendadas rutinariamente, por delante de otras técnicas como el PET/TC o la RM, las cuales pueden mejorar la eficacia diagnóstica pero tienen el problema de la disponibilidad y la falta de validez interna para el seguimiento. Conclusiones: El seguimiento es diferente entre CPRC no metastásico (nm) y metastásico(m). En el CPRCnm, se recomienda realizar una monitorización que incluya PSA y pruebas de imagen, no existiendo consenso en la periodicidad. En el CPRCm, es recomendable realizar el seguimiento con PSA y con pruebas de imagen periódicas, pues se puede dar una progresión radiológica sin progresión por PSA


Objectives: There is no broad consensus about what diagnostic tests use for CRPC follow up as well as their frequency. Our objective is to review and analyze the most important CRPC follow up patterns described in the literature to date. Methods: We performed a critical analysis of the recommendations for follow up most universally employed (PCWG3, RADAR, St Gallen consensus, NCCN guidelines, EAU guidelines) Results: CT scan and bone scan are the routine recommended diagnostic tests, in front of other techniques such as PET/CT or MRI, that may improve the diagnostic efficacy but they have the problem of availability and lack of internal validity for follow up. Conclusions: Follow up is different for non metastatic and metastatic CRPC. For nm CRPC, it is recommended to perform monitoring that includes PSA and imaging tests, without consensus about periodicity. For mCRPC, it is recommendable to do follow up with periodic PSA and imaging tests, since it is possible to have radiological progression without PSA progression


Assuntos
Humanos , Masculino , Neoplasias de Próstata Resistentes à Castração/diagnóstico , Neoplasias de Próstata Resistentes à Castração/terapia , Seguimentos , Guias de Prática Clínica como Assunto , Antígeno Prostático Específico
17.
Arch. esp. urol. (Ed. impr.) ; 71(8): 685-695, oct. 2018. graf, ilus
Artigo em Espanhol | IBECS | ID: ibc-178746

RESUMO

Revisamos el papel de la inmunoterapia en el cáncer de próstata resistente a castración. Se han aplicado dos estrategias inmunoterápicas, de forma aislada o en combinación, bien entre ellas o bien con otros agentes de eficacia demostrada en este escenario y que ejercerían un papel inmunomodulador: vacunas o anticuerpos monoclonales destinados al bloqueo de puntos de control inhibidores de la respuesta inmune. Aunque a priori el CPRC presenta características que sugieren que la inmunoterapia podría jugar un papel relevante como estrategia terapéutica, su aplicación clínica ha demostrado una actividad limitada y heterogénea, en cuanto a la proporción de respondedores e intensidad de respuesta. En términos generales, la tasa de respuestas objetivas es muy baja, aunque, en los pacientes que responden, es posible detectar un beneficio claro y duradero. Sólo la vacuna autóloga Sipuleucel T ha demostrado un aumento de la supervivencia global en pacientes con criterios de buen pronóstico. Es característico en estos tratamientos que no se observe un incremento en la supervivencia libre de progresión debido a su propio mecanismo de acción. Tampoco la evolución del PSA puede considerarse una variante subrogada de respuesta radiológica o beneficio clínico en este entorno. Se hace necesario identificar qué características de los pacientes o del tumor son capaces de maximizar la respuesta. Una limitación importante es la ausencia de biomarcadores predictores de respuesta que sirvan para la preselección de pacientes. Como norma general, las mejores respuestas con tratamientos inmunoterápicos aislados se han observado en pacientes con baja carga tumoral, lo cual puede sugerir que su aplicación óptima podría ser en fases más precoces de la enfermedad (localizado de alto riesgo, fracaso bioquímico, etc.). La estrategia de combinación, sin lugar a dudas la de más futuro, se fundamenta en que los tratamientos adicionales incrementan la lisis celular con la consiguiente exposición antigénica y/o ejercen un efecto inmunomodulador capaz de vencer la tolerancia inmunológica inducida por el tumor. Los resultados obtenidos sugieren que la inmunoterapia puede ser más efectiva en modo tratamiento combinado con otros tratamientos activos (abiraterona, enzalutamida, Radio 223, docetaxel) en la lucha por lograr cronificar la enfermedad


We review the role of immunotherapy in castration resistant prostate cancer. Two immunotherapeutic strategies have been applied, isolated or in combination, either with each other or with other agents with demonstrated efficacy in this scenario that would play a role as immunomodulators: vaccines or monoclonal antibodies aimed to block immune response checkpoint inhibitors. Although CRPC presents, a priori, characteristics suggesting that immunotherapy may play a relevant role as a therapeutic strategy, its clinical application has demonstrated a limited and heterogeneous activity, in terms of proportion of responders and response intensity. Generally, the objective response rate is very low, although, in patients who have response it is possible to detect a clear, long-lasting benefit. Only the autologous vaccine Sipuleucel T has demonstrated an overall survival increase in patients with good prognosis criteria. In these treatments, it is characteristic that no progression free survival increase is visible due to its action mechanism. PSA evolution may not be considered a surrogate variable of radiological response or clinical benefit in this environment either. It is necessary to identify what patient`s or tumor's characteristics are able to maximize the response. An important limitation is the absence of response predictive biomarkers that serve for patient preselection. As a general rule, the best responses with isolated immunotherapeutic treatments have been observed in patients with low tumor load, which may suggest that their optimal application could be in earlier phases of the disease (high risk localized, biochemical failure, etc) Combination strategy, without doubt the one with best future, is based on additional treatments increasing cell lysis with the subsequent antigen exposure and/ or producing an immunomodulatory effect that can surmount tumor induced immunologic tolerance. The results obtained suggest that immunotherapy may be more effective in combined therapy with other active therapies (abiraterone, enzalutamide, Radium 223, docetaxel) in a fight to achieve disease chronification


Assuntos
Humanos , Masculino , Imunoterapia , Neoplasias de Próstata Resistentes à Castração/terapia , Neoplasias de Próstata Resistentes à Castração/imunologia , Vacinas Anticâncer/uso terapêutico
18.
J Voice ; 2018 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-30072204

RESUMO

INTRODUCTION: Professional activities of university lecturers involve continued and sustained use of the voice, leading in many cases to increased risk of developing voice disorders. Risk identification followed by the fast application of preventive or corrective measures is a key issue in this context. OBJECTIVE: Define and implement a preventive program for the vocal health of university lecturers by using acoustic features automatically extracted from voice recordings to identify risk groups and manage preventive or corrective actions MATERIAL AND METHODS: A total of 170 subjects, aged between 18 and 65, were recruited at the San Pedro de Alcántara Hospital and at the University of Extremadura in Cáceres (Spain). They formed three groups-one of 25 people suffering from vocal fold nodules, another of 25 healthy people, and the third of 120 university lecturers. Medical history and voice status assessment was performed, and voice recordings were made following a research protocol. A feature extraction, selection, and classification procedure was applied to the voice recordings to provide the best predictors for discriminating between pathological and healthy voices. The model parameters were then used to determine the lecturers' probability of suffering vocal fold nodules or other pathologies with similar dysphonic speech. These probabilities were used to classify the lecturers into three risk groups-low, medium, and high. These groups were taken as the basis to assign the lecturers to a primary, secondary, or tertiary prevention level. Different preventive or corrective actions were applied for each prevention level. RESULTS: The best set of predictors comprised sample entropy, correlation dimension, pitch period entropy, glottal noise excitation, and sex, achieving an overall accuracy of 92% with a random forest classifier. They all showed statistically significant differences between vocal fold nodules and healthy groups (P < 0.05). Three out of the four best acoustic features were nonlinear, showing the importance of nonlinear dynamics for clinical practice. The model parameters were applied to the predictors of the lecturers so as to assign them to the different risk groups, leading to 60.8% (73 out of 120) of the lecturers in the low-risk group, 29.2% (35 out of 120) in the medium-risk group, and 10% (12 out of 120) in the high-risk group. The prevention levels were assigned on the basis of this classification and the medical history and laryngological evaluation of some specific subjects. A statistically significant association was found between the voice status and the assigned prevention level (P < 0.001), with there being a clear dependence relationship (Cramér's V = 0.630). CONCLUSION: It is feasible to develop and apply a preventive voice program for university lecturers that is aided by features automatically extracted from voice recordings. As the program progresses, it is expected that the information automatically provided for the assignment to prevention levels will become ever more precise. The method proposed can be extended to other voice professionals and other voice disorders.

19.
Neurosurgery ; 2018 Jul 12.
Artigo em Inglês | MEDLINE | ID: mdl-30010935

RESUMO

BACKGROUND: The authors present cystic epithelial masses in the suprasellar region which on histopathology revealed 4 mixed tumors having simple cuboidal epithelium of Rathke's Cleft Cyst (RCC) elements trapped within pituitary adenoma, epidermoid cyst, dermoid cyst, and papillary craniopharyngioma respectively. OBJECTIVE: To highlight the developmental theory of ectodermal continuum in the realm of suprasellar epithelial cystic lesions and examines the cardinal aspects that distinguish RCC from its confounder, ciliary craniopharyngioma. METHODS: The authors performed a medical chart review on 4 patients who had coexisting RCC with craniopharyngioma, pituitary adenoma, suprasellar dermoid, and epidermoid cysts. RESULTS: This series of unique suprasellar lesions elucidate the spectrum of cases from Rathke's cyst to other suprasellar epithelial cysts including a recently identified clinical entity called ciliary craniopharyngioma, which authors feel is a misnomer. The authors also report the first case of ruptured dermoid cyst admixed with elements of Rathke's cyst elements and xanthogranuloma in neurosurgical literature. CONCLUSION: We propose that the new entity of ciliary craniopharyngioma could be just another variant of RCC elements nested within a typical papillary or adamantinomatous lesion. Further study is warranted to understand the implications of natural history with tumors containing RCC elements.

20.
Artigo em Inglês | MEDLINE | ID: mdl-30010956

RESUMO

This 3-dimensional operative video illustrates resection of a thoracic hemangioblastoma in a 30-year-old female with a history of Von Hippel-Lindau disease. The patient presented with right lower extremity numbness and flank pain. Magnetic resonance imaging (MRI) demonstrated an enhancing intradural intramedullary lesion at T 7 consistent with a hemangioblastoma. The patient underwent a thoracic laminectomy with a midline dural opening for tumor resection. This case demonstrates the principles of intradural intramedullary spinal cord tumor resection. In this particular case, internal debulking was untenable owing to the vascular nature of hemangioblastomas. The operative video demonstrates en bloc tumor removal. Postoperative MRI demonstrated gross total resection. The postoperative course was uneventful. The natural history of this disease, treatment options, and potential complications are discussed.

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