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1.
J Rheumatol ; 2019 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-30988123

RESUMO

OBJECTIVE: To describe the incidence of bacteremia in a large multicentric cohort of patients with systemic lupus erythematosus (SLE) and their clinical characteristics and to identify risk factors. METHODS: All bacteremic episodes from the Spanish RELESSER registry were included. Clinical and laboratory characteristics concerning bacteremia and SLE status, as well as comorbidities at the time of infection, were retrospectively collected. A comparison with sex- and age-matched SLE controls without bacteremia was made. A logistic regression was conducted. RESULTS: The study included 114 episodes of bacteremia in 83 patients. The incidence rate was 2.7/1000 patient-years. At the time of bacteremia, the median age was 40.5 (range: 8-90) years, and 88.6% of patients were female. The Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index was 4 [interquartile range (IQR) 8]; 41% had an SLE flare (66% severe); Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index was 3 (IQR 4). A comorbidity was recorded in 64% of cases. At the time of bacteremia, 88.6% received corticosteroids (68.6% > 10 mg/day) and 57% immunosuppressors. Gram-negative bacilli, most frequently Escherichia coli (29.8%), caused 52.6% of the episodes. The bacteremia-related mortality was 14% and bacteremia was recurrent in 27.2% of cases. A dose-response relationship was found between corticosteroids and bacteremia risk. In the multivariate analysis, these factors were associated with bacteremia: elevated creatinine (OR 1.31, 95% CI 1.01-1.70; p = 0.045), diabetes (OR 6.01, 95% CI 2.26-15.95; p < 0.001), cancer (OR 5.32, 95% CI 2.23-12.70; p < 0.001), immunosuppressors (OR 6.35, 95% CI 3.42-11.77; p < 0.001), and damage (OR 1.65, 95% CI 1.31-2.09; p < 0.001). CONCLUSION: Bacteremia occurred mostly in patients with active SLE and was frequently associated with severe flares and corticosteroid use. Recurrence and mortality were high. Immunosuppressors, comorbidities, and disease-related damage were associated with bacteremia.

2.
Reumatol. clín. (Barc.) ; 15(1): 34-42, ene.-feb. 2019. tab
Artigo em Inglês | IBECS | ID: ibc-176075

RESUMO

Objectives: The course and long-term outcome of pure membranous lupus nephritis (MLN) are little understood. The aims of this study are to evaluate the clinical features, course, outcome and prognostic indicators in pure MLN and to determine the impact of ethnicity and the type of health insurance on the course and prognosis of pure MLN. Methods: We conducted a retrospective review of medical records of 150 patients with pure MLN from Spain and the USA. Results: Mean age was 34.2±12.5 and 80% were women. Sixty-eight percent of patients had nephrotic syndrome at diagnosis. The average serum creatinine was 0.98±0.78mg/dl. Six percent of patients died and 5.3% developed end-stage renal disease (ESRD). ESRD was predicted by male sex, hypertension, dyslipidemia, high basal 24h-proteinuria, high basal serum creatinine and a low basal creatinine clearance. Age, cardiac insufficiency, peripheral artheriopathy, hemodialysis and not having received mycophenolate mofetil or antimalarials for MLN predicted death. Conclusions: Pure MLN frequently presents with nephrotic syndrome, high proteinuria and normal serum creatinine. Its prognosis is favourable in maintaining renal function although proteinuria usually persists over time. Baseline cardiovascular disease and not having a health insurance are related with poor prognosis


Objetivos: Los conocimientos sobre el curso y el desenlace a largo plazo de la nefritis lúpica membranosa (NLM) pura son todavía escasos. El objetivo de este estudio es evaluar las características clínicas, curso, desenlace e indicadores pronósticos de la NLM y determinar el impacto de la etnicidad y tipo de cobertura sanitaria en el curso y pronóstico de la NLM. Métodos: Se realizó una revisión retrospectiva de las historias de 150 pacientes con NLM de España y Estados Unidos. Resultados: La edad media fue 34,2±12,5 y el 80% eran mujeres. El 68% de los pacientes tenían síndrome nefrótico al diagnóstico. La creatinina sérica media fue 0,98±0,78mg/dl. El 6% de los pacientes fallecieron y el 5,3% desarrollaron insuficiencia renal terminal (IRT). El sexo masculino, la hipertensión, la dislipemia, la alta proteinuria basal, la alta creatininemia y un aclaramiento de creatinina reducido predijeron el desarrollo de IRT. La edad, la insuficiencia cardíaca, la arteriopatía periférica, la hemodiálisis y el no haber recibido micofenolato de mofetilo o antimaláricos predijeron el fallecimiento. Conclusiones: La NLM pura suele debutar con síndrome nefrótico, alta proteinuria y creatininemia normal. Su pronóstico es favourable en términos de mantenimiento de la función renal aunque la proteinuria habitualmente persiste durante el seguimiento. La enfermedad cardiovascular basal y no tener cobertura sanitaria se relacionan con mal pronóstico


Assuntos
Humanos , Masculino , Feminino , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Nefrite Lúpica/epidemiologia , Glomerulonefrite Membranosa/epidemiologia , Lúpus Eritematoso Sistêmico/complicações , Estudos Retrospectivos , Proteinúria/epidemiologia , Avaliação de Resultados da Assistência ao Paciente , Lúpus Eritematoso Sistêmico/etnologia , Creatinina/sangue
3.
Arthritis Res Ther ; 20(1): 100, 2018 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-29848360

RESUMO

BACKGROUND: Systemic lupus erythematosus (SLE) is a common systemic autoimmune disease with a complex genetic inheritance. Genome-wide association studies (GWAS) have significantly increased the number of significant loci associated with SLE risk. To date, however, established loci account for less than 30% of the disease heritability and additional risk variants have yet to be identified. Here we performed a GWAS followed by a meta-analysis to identify new genome-wide significant loci for SLE. METHODS: We genotyped a cohort of 907 patients with SLE (cases) and 1524 healthy controls from Spain and performed imputation using the 1000 Genomes reference data. We tested for association using logistic regression with correction for the principal components of variation. Meta-analysis of the association results was subsequently performed on 7,110,321 variants using genetic data from a large cohort of 4036 patients with SLE and 6959 controls of Northern European ancestry. Genetic association was also tested at the pathway level after removing the effect of known risk loci using PASCAL software. RESULTS: We identified five new loci associated with SLE at the genome-wide level of significance (p < 5 × 10- 8): GRB2, SMYD3, ST8SIA4, LAT2 and ARHGAP27. Pathway analysis revealed several biological processes significantly associated with SLE risk: B cell receptor signaling (p = 5.28 × 10- 6), CTLA4 co-stimulation during T cell activation (p = 3.06 × 10- 5), interleukin-4 signaling (p = 3.97 × 10- 5) and cell surface interactions at the vascular wall (p = 4.63 × 10- 5). CONCLUSIONS: Our results identify five novel loci for SLE susceptibility, and biologic pathways associated via multiple low-effect-size loci.

4.
Reumatol. clín. (Barc.) ; 13(5): 264-281, sept.-oct. 2017. tab
Artigo em Espanhol | IBECS | ID: ibc-165224

RESUMO

Objetivo. Desarrollar recomendaciones basadas en la mejor evidencia y experiencia sobre el manejo de pacientes con enfermedades reumáticas inflamatorias y autoinmunes durante la edad fértil, el embarazo, posparto y lactancia. Métodos. Se siguió la metodología de grupos nominales. Se seleccionó un grupo nominal de expertos (12 reumatólogos). Se realizó una actualización de una revisión sistemática de la literatura, una revisión literaria, así como una encuesta a nivel nacional sobre el manejo de estos pacientes. El grupo de expertos se encargó de definir el alcance, usuarios, apartados del manuscrito y posibles recomendaciones. El GA con las recomendaciones se votó siguiendo la metodología Delphi según una escala de 1 (total desacuerdo) a 10 (total acuerdo), definiéndose el acuerdo como una puntuación ≥ 7 por al menos el 70% de los participantes. El NE y GR se clasificaron según el modelo del Center for Evidence Based Medicine de Oxford. El documento completo inicial fue revisado por los expertos y el proyecto estuvo coordinado, en todo momento, por un metodólogo experto. Resultados. Se generaron 14 recomendaciones sobre el periodo preconcepcional (anticoncepción, reproducción asistida), el embarazo (planificación, manejo farmacológico y seguimiento) y lactancia (manejo farmacológico y seguimiento). Incluye recomendaciones específicas sobre situaciones de especial riesgo como el lupus eritematoso sistémico y el síndrome antifosfolípido. Existió acuerdo > 90% con todas las recomendaciones menos en una de ellas. Conclusiones. En los pacientes con enfermedades inflamatorias y autoinmunes estas actuaciones pueden mejorar los resultados y el pronóstico de los mismos (AU)


Objective. To develop recommendations on the evaluation and management of patients with rheumatic autoimmune and inflammatory diseases during the reproductive age, pregnancy, post-partum and breastfeeding based on the best evidence and experience. Methods. Recommendations were generated using nominal group and Delphi techniques. An expert panel of 12 rheumatologists was established. A systematic literature review and a narrative review (websites, clinical guidelines and other relevant documentation) were performed and presented to the panel in its 1st meeting to be discussed and to help define recommendations. A first draft of recommendations was generated and circulated for comments and wording refinement. A national survey analyzing different aspects of this topic was undertaken separately, followed by a Delphi process (2 rounds). Agreement with each recommendation was ranked on a scale of 1 (total disagreement) to 10 (total agreement), and was considered to be achieved if at least 70% voted ≥ 7. The level of evidence and grade of recommendation were assessed using the Oxford Centre for Evidence-based Medicine Levels of Evidence. Results. A total of 14 recommendations were generated for the preconception period (oral and hormonal contraception, reproductive techniques), pregnancy (planning, treatment and follow-up), and breastfeeding (treatment and follow-up). High-risk situations such as lupus or antiphospholipid syndrome were included. A consensus > 90% was reached for all but one recommendation. Conclusions. These recommendations are intended to provide rheumatologists, patients, families and other stakeholders with a consensus on the evaluation and management of patients with autoimmune and inflammatory diseases during the reproductive age, pregnancy, postpartum and breastfeeding (AU)


Assuntos
Humanos , Feminino , Gravidez , Adulto , Doenças Reumáticas/epidemiologia , Doenças Reumáticas/terapia , Doenças Autoimunes/complicações , Doenças Autoimunes/epidemiologia , Antirreumáticos/uso terapêutico , Terapia Biológica/métodos , Fertilidade , Prognóstico , Anticoncepção/normas , Técnicas de Reprodução Assistida/normas , Técnica Delfos , Complicações na Gravidez/fisiopatologia , Comorbidade , Fatores de Risco
5.
Arthritis Res Ther ; 19(1): 138, 2017 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-28619073

RESUMO

BACKGROUND: Systemic lupus erythematosus (SLE) is a genetically complex rheumatic disease characterized by heterogeneous clinical manifestations of unknown etiology. Recent studies have suggested the existence of a genetic basis for SLE heterogeneity. The objective of the present study was to identify new genetic variation associated with the clinically relevant phenotypes in SLE. METHODS: A two-stage pathway-based approach was used to identify the genetic variation associated with the main clinical phenotypes in SLE. In the discovery stage, 482 SLE patients were genotyped using Illumina Human Quad610 microarrays. Association between 798 reference genetic pathways from the Molecular Signatures Database and 11 SLE phenotypes was tested using the set-based method implemented in PLINK software. Pathways significantly associated after multiple test correction were subsequently tested for replication in an independent cohort of 425 SLE patients. Using an in silico approach, we analyzed the functional effects of common SLE therapies on the replicated genetic pathways. The association of known SLE risk variants with the development of the clinical phenotypes was also analyzed. RESULTS: In the discovery stage, we found a significant association between the vascular endothelial growth factor (VEGF) pathway and oral ulceration (P value for false discovery rate (P FDR) < 0.05), and between the negative regulation signaling pathway of retinoic acid inducible gene-I/melanoma differentiation associated gene 5 and the production of antinuclear antibodies (P FDR < 0.05). In the replication stage, we validated the association between the VEGF pathway and oral ulceration. Therapies commonly used to treat mucocutaneous phenotypes in SLE were found to strongly influence VEGF pathway gene expression (P = 4.60e-4 to 5.38e-14). Analysis of known SLE risk loci identified a strong association between PTPN22 and the risk of hematologic disorder and with the development of antinuclear antibodies. CONCLUSIONS: The present study has identified VEGF genetic pathway association with the risk of oral ulceration in SLE. New therapies targeting the VEGF pathway could be more effective in reducing the severity of this phenotype. These findings represent a first step towards the understanding of the genetic basis of phenotype heterogeneity in SLE.


Assuntos
Lúpus Eritematoso Sistêmico/genética , Lúpus Eritematoso Sistêmico/patologia , Úlceras Orais/genética , Fator A de Crescimento do Endotélio Vascular/genética , Adulto , Feminino , Predisposição Genética para Doença/genética , Variação Genética , Estudo de Associação Genômica Ampla , Genótipo , Humanos , Lúpus Eritematoso Sistêmico/complicações , Masculino , Fenótipo
6.
Reumatol Clin ; 2017 May 18.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-28528869

RESUMO

OBJECTIVES: The course and long-term outcome of pure membranous lupus nephritis (MLN) are little understood. The aims of this study are to evaluate the clinical features, course, outcome and prognostic indicators in pure MLN and to determine the impact of ethnicity and the type of health insurance on the course and prognosis of pure MLN. METHODS: We conducted a retrospective review of medical records of 150 patients with pure MLN from Spain and the USA. RESULTS: Mean age was 34.2±12.5 and 80% were women. Sixty-eight percent of patients had nephrotic syndrome at diagnosis. The average serum creatinine was 0.98±0.78mg/dl. Six percent of patients died and 5.3% developed end-stage renal disease (ESRD). ESRD was predicted by male sex, hypertension, dyslipidemia, high basal 24h-proteinuria, high basal serum creatinine and a low basal creatinine clearance. Age, cardiac insufficiency, peripheral artheriopathy, hemodialysis and not having received mycophenolate mofetil or antimalarials for MLN predicted death. CONCLUSIONS: Pure MLN frequently presents with nephrotic syndrome, high proteinuria and normal serum creatinine. Its prognosis is favourable in maintaining renal function although proteinuria usually persists over time. Baseline cardiovascular disease and not having a health insurance are related with poor prognosis.

7.
Semin Arthritis Rheum ; 47(1): 38-45, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28259425

RESUMO

OBJECTIVES: To estimate the incidence of severe infection and investigate the associated factors and clinical impact in a large systemic lupus erythematosus (SLE) retrospective cohort. METHODS: All patients in the Spanish Rheumatology Society Lupus Registry (RELESSER) who meet ≥4 ACR-97 SLE criteria were retrospectively investigated for severe infections. Patients with and without infections were compared in terms of SLE severity, damage, comorbidities, and demographic characteristics. A multivariable Cox regression model was built to calculate hazard ratios (HRs) for the first infection. RESULTS: A total of 3658 SLE patients were included: 90% female, median age 32.9 years (DQ 9.7), and mean follow-up (months) 120.2 (±87.6). A total of 705 (19.3%) patients suffered ≥1 severe infection. Total severe infections recorded in these patients numbered 1227. The incidence rate was 29.2 (95% CI: 27.6-30.9) infections per 1000 patient years. Time from first infection to second infection was significantly shorter than time from diagnosis to first infection (p < 0.000). Although respiratory infections were the most common (35.5%), bloodstream infections were the most frequent cause of mortality by infection (42.0%). In the Cox regression analysis, the following were all associated with infection: age at diagnosis (HR = 1.016, 95% CI: 1.009-1.023), Latin-American (Amerindian-Mestizo) ethnicity (HR = 2.151, 95% CI: 1.539-3.005), corticosteroids (≥10mg/day) (HR = 1.271, 95% CI: 1.034-1.561), immunosuppressors (HR = 1.348, 95% CI: 1.079-1.684), hospitalization by SLE (HR = 2.567, 95% CI: 1.905-3.459), Katz severity index (HR = 1.160, 95% CI: 1.105-1.217), SLICC/ACR damage index (HR = 1.069, 95% CI: 1.031-1.108), and smoking (HR = 1.332, 95% CI: 1.121-1.583). Duration of antimalarial use (months) proved protective (HR = 0.998, 95% CI: 0.997-0.999). CONCLUSIONS: Severe infection constitutes a predictor of poor prognosis in SLE patients, is more common in Latin-Americans and is associated with age, previous infection, and smoking. Antimalarials exerted a protective effect.


Assuntos
Corticosteroides/uso terapêutico , Antimaláricos/uso terapêutico , Antirreumáticos/uso terapêutico , Imunossupressores/uso terapêutico , Infecção/epidemiologia , Lúpus Eritematoso Sistêmico/epidemiologia , Adulto , Feminino , Humanos , Incidência , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Masculino , Ácido Micofenólico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença
8.
Arthritis Care Res (Hoboken) ; 69(1): 38-45, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27564390

RESUMO

OBJECTIVE: To compare the prevalence of the main comorbidities in 2 large cohorts of patients with primary Sjögren's syndrome (SS) and systemic lupus erythematosus (SLE), with a focus on cardiovascular (CV) diseases. METHODS: This was a cross-sectional multicenter study where the prevalence of more relevant comorbidities in 2 cohorts was compared. Patients under followup from SJOGRENSER (Spanish Rheumatology Society Registry of Primary SS) and RELESSER (Spanish Rheumatology Society Registry of SLE), and who fulfilled the 2002 American-European Consensus Group and 1997 American College of Rheumatology classification criteria, respectively, were included. A binomial logistic regression analysis was carried out to explore potential differences, making general adjustments for age, sex, and disease duration and specific adjustments for each variable, including CV risk factors and treatments, when appropriate. RESULTS: A total of 437 primary SS patients (95% female) and 2,926 SLE patients (89% female) were included. The mean age was 58.6 years (interquartile range [IQR] 50.0-69.9 years) for primary SS patients and 45.1 years (IQR 36.4-56.3 years) for SLE patients (P < 0.001), and disease duration was 10.4 years (IQR 6.0-16.7 years) and 13.0 years (IQR 7.45-19.76 years), respectively (P < 0.001). Smoking, dyslipidemia, and arterial hypertension were associated less frequently with primary SS (odds ratio [OR] 0.36 [95% confidence interval (95% CI) 0.28-0.48], 0.74 [95% CI 0.58-0.94], and 0.50 [95% CI 0.38-0.66], respectively) as were life-threatening CV events (i.e., stroke or myocardial infarction; OR 0.57 [95% CI 0.35-0.92]). Conversely, lymphoma was associated more frequently with primary SS (OR 4.41 [95% CI 1.35-14.43]). The prevalence of severe infection was lower in primary SS than in SLE (10.1% versus 16.9%; OR 0.54 [95% CI 0.39-0.76]; P < 0.001). CONCLUSION: Primary SS patients have a consistently less serious CV comorbidity burden and a lower prevalence of severe infection than those with SLE. In contrast, their risk of lymphoma is greater.


Assuntos
Lúpus Eritematoso Sistêmico/epidemiologia , Síndrome de Sjogren/epidemiologia , Adulto , Idoso , Doenças Cardiovasculares/epidemiologia , Estudos de Coortes , Comorbidade , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Sistema de Registros
9.
Reumatol Clin ; 13(5): 264-281, 2017 Sep - Oct.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-27321859

RESUMO

OBJECTIVE: To develop recommendations on the evaluation and management of patients with rheumatic autoimmune and inflammatory diseases during the reproductive age, pregnancy, post-partum and breastfeeding based on the best evidence and experience. METHODS: Recommendations were generated using nominal group and Delphi techniques. An expert panel of 12 rheumatologists was established. A systematic literature review and a narrative review (websites, clinical guidelines and other relevant documentation) were performed and presented to the panel in its 1st meeting to be discussed and to help define recommendations. A first draft of recommendations was generated and circulated for comments and wording refinement. A national survey analyzing different aspects of this topic was undertaken separately, followed by a Delphi process (2 rounds). Agreement with each recommendation was ranked on a scale of 1 (total disagreement) to 10 (total agreement), and was considered to be achieved if at least 70% voted≥7. The level of evidence and grade of recommendation were assessed using the Oxford Centre for Evidence-based Medicine Levels of Evidence. RESULTS: A total of 14 recommendations were generated for the preconception period (oral and hormonal contraception, reproductive techniques), pregnancy (planning, treatment and follow-up), and breastfeeding (treatment and follow-up). High-risk situations such as lupus or antiphospholipid syndrome were included. A consensus>90% was reached for all but one recommendation. CONCLUSIONS: These recommendations are intended to provide rheumatologists, patients, families and other stakeholders with a consensus on the evaluation and management of patients with autoimmune and inflammatory diseases during the reproductive age, pregnancy, postpartum and breastfeeding.


Assuntos
Doenças Autoimunes , Aleitamento Materno , Cuidado Pós-Natal/métodos , Complicações na Gravidez , Cuidado Pré-Natal/métodos , Doenças Reumáticas , Doenças Autoimunes/diagnóstico , Doenças Autoimunes/terapia , Técnica Delfos , Feminino , Humanos , Gravidez , Complicações na Gravidez/diagnóstico , Complicações na Gravidez/terapia , Doenças Reumáticas/diagnóstico , Doenças Reumáticas/terapia , Espanha
10.
Farm. hosp ; 40(3): 209-218, mayo-jun. 2016.
Artigo em Inglês | IBECS | ID: ibc-152841

RESUMO

Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial (AU)


El consentimiento informado es una parte esencial de la investigación y su firma es imprescindible para llevar a cabo la mayor parte de los estudios clínicos. Su fin es poner en conocimiento del paciente lo que implica su participación en el estudio que se le propone. Sin embargo, cada vez más, su complejidad y extensión los hacen difícilmente comprensibles, por lo que se corre el riesgo de que el paciente dé su autorización sin haberlo leído previamente o sin haber entendido lo que en él se le expone. En este sentido, los comités éticos de investigación clínica y los farmacéuticos, especialistas en farmacia hospitalaria y atención primaria como parte integrante de los mismos, cumplen un importante y difícil papel en la defensa de los derechos de los pacientes. En ellos se revisan exhaustivamente estos documentos para garantizar que todos los requisitos que exige la normativa estén contemplados y, al mismo tiempo, que sean de fácil comprensión para los potenciales participantes en un estudio (AU)


Assuntos
Humanos , Consentimento Livre e Esclarecido/estatística & dados numéricos , Pesquisa Biomédica/organização & administração , Compreensão , Conhecimentos, Atitudes e Prática em Saúde , Ensaios Clínicos como Assunto , Participação do Paciente
11.
Farm Hosp ; 40(3): 209-18, 2016 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-27145389

RESUMO

Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial.


Assuntos
Pesquisa Biomédica , Consentimento Livre e Esclarecido , Humanos , Atenção Primária à Saúde
12.
Clin Exp Rheumatol ; 34(3 Suppl 97): S44-53, 2016 May-Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27050507

RESUMO

OBJECTIVES: To assess the efficacy of tocilizumab (TCZ) in patients with Takayasu arteritis (TA). METHODS: Multicentre open-label retrospective study. RESULTS: Eight patients (all women) with a mean age of 34±16 years, median 36 years (range: 7-57) were assessed. The main clinical features at TCZ therapy onset were: constitutional symptoms (n=4), fever (n=3), headache (n=2), chest pain (n=1), abdominal pain (n=1), mesenteric ischaemia (n=1), myalgia involving the lower limbs (n=1), cerebral vascular insufficiency (n=1), malaise (n=1), upper limb claudication (n=1) and nodular scleritis (n=1). Besides corticosteroids and before TCZ treatment onset, 7 of 8 patients had also received several conventional immunosuppressive and/or biologic agents. Seven patients experienced marked clinical improvement in the first 3 months after the onset of TCZ therapy. After a median follow-up of 15.5 [interquartile range-IQR: 12-24] months, 7 patients were asymptomatic. The median C-reactive protein decreased from 3.09 [IQR: 0.5-12] to 0.15 [IQR: 0.1-0.5] mg/dL (p=0.018), and median erythrocyte sedimentation rate from 40 [IQ range: 28-72] to 3 [IQR: 2-5] mm/1st hour (p=0.012). The median dose of prednisone was also tapered from 42.5 [IQR: 25-50] to 2.5 [IQR: 0-7.5] mg/day (p=0.011). However, TCZ had to be discontinued in 1 patient because she developed a systemic lupus erythematosus, and in another patient due to inefficiency. TCZ dose was reduced in a patient because of mild thrombocytopenia. CONCLUSIONS: TCZ appears to be effective in the management of patients with TA, in particular in patients refractory to corticosteroids and/or conventional immunosuppressive drugs.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Arterite de Takayasu/tratamento farmacológico , Adolescente , Adulto , Criança , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos
13.
Medicine (Baltimore) ; 95(9): e2891, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26945378

RESUMO

The aim of the study was to profile those patients included in the RELESSER registry with histologically proven renal involvement in order to better understand the current state of lupus nephritis (LN) in Spain. RELESSER-TRANS is a multicenter cross-sectional registry with an analytical component. Information was collected from the medical records of patients with systemic lupus erythematosus who were followed at participating rheumatology units. A total of 359 variables including demographic data, clinical manifestations, disease activity, severity, comorbidities, LN outcome, treatments, and mortality were recorded. Only patients with a histological confirmation of LN were included. We performed a descriptive analysis, chi-square or Student's t tests according to the type of variable and its relationship with LN. Odds ratio and confidence intervals were calculated by using simple logistic regression. LN was histologically confirmed in 1092/3575 patients (30.5%). Most patients were female (85.7%), Caucasian (90.2%), and the mean age at LN diagnosis was 28.4 ±â€Š12.7 years. The risk for LN development was higher in men (M/F:47.85/30.91%, P < 0.001), in younger individuals (P < 0.001), and in Hispanics (P = 0.03). Complete response to treatment was achieved in 68.3% of patients; 10.35% developed ESRD, which required a kidney transplant in 45% of such cases. The older the patient, the greater was the likelihood of complete response (P < 0.001). Recurrences were associated with persistent lupus activity at the time of the last visit (P < 0.001) and with ESRD (P < 0.001). Thrombotic microangiopathy was a risk factor for ESRD (P = 0.04), as for the necessity of dialysis (P = 0.01) or renal transplantation (P = 0.03). LN itself was a poor prognostic risk factor of mortality (OR 2.4 [1.81-3.22], P < 0.001). Patients receiving antimalarials had a significantly lower risk of developing LN (P < 0.001) and ESRD (P < 0.001), and responded better to specific treatments for LN (P = 0.014). More than two-thirds of the patients with LN from a wide European cohort achieved a complete response to treatment. The presence of positive anti-Sm antibodies was associated with a higher frequency of LN and a decreased rate of complete response to treatment. The use of antimalarials reduced both the risk of developing renal disease and its severity, and contributed to attaining a complete renal response.


Assuntos
Nefrite Lúpica/epidemiologia , Sistema de Registros , Adolescente , Adulto , Feminino , Humanos , Nefrite Lúpica/terapia , Masculino , Recidiva , Estudos Retrospectivos , Reumatologia , Espanha/epidemiologia , Adulto Jovem
14.
Rheumatology (Oxford) ; 55(7): 1243-50, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27018057

RESUMO

OBJECTIVES: To identify patterns (clusters) of damage manifestations within a large cohort of SLE patients and evaluate the potential association of these clusters with a higher risk of mortality. METHODS: This is a multicentre, descriptive, cross-sectional study of a cohort of 3656 SLE patients from the Spanish Society of Rheumatology Lupus Registry. Organ damage was ascertained using the Systemic Lupus International Collaborating Clinics Damage Index. Using cluster analysis, groups of patients with similar patterns of damage manifestations were identified. Then, overall clusters were compared as well as the subgroup of patients within every cluster with disease duration shorter than 5 years. RESULTS: Three damage clusters were identified. Cluster 1 (80.6% of patients) presented a lower amount of individuals with damage (23.2 vs 100% in clusters 2 and 3, P < 0.001). Cluster 2 (11.4% of patients) was characterized by musculoskeletal damage in all patients. Cluster 3 (8.0% of patients) was the only group with cardiovascular damage, and this was present in all patients. The overall mortality rate of patients in clusters 2 and 3 was higher than that in cluster 1 (P < 0.001 for both comparisons) and in patients with disease duration shorter than 5 years as well. CONCLUSION: In a large cohort of SLE patients, cardiovascular and musculoskeletal damage manifestations were the two dominant forms of damage to sort patients into clinically meaningful clusters. Both in early and late stages of the disease, there was a significant association of these clusters with an increased risk of mortality. Physicians should pay special attention to the early prevention of damage in these two systems.


Assuntos
Doenças Cardiovasculares/mortalidade , Lúpus Eritematoso Sistêmico/complicações , Lúpus Eritematoso Sistêmico/mortalidade , Doenças Musculoesqueléticas/mortalidade , Índice de Gravidade de Doença , Adulto , Doenças Cardiovasculares/etiologia , Análise por Conglomerados , Estudos Transversais , Feminino , Humanos , Lúpus Eritematoso Sistêmico/patologia , Masculino , Pessoa de Meia-Idade , Doenças Musculoesqueléticas/etiologia , Sistema de Registros , Espanha , Fatores de Tempo
15.
Medicine (Baltimore) ; 94(1): e267, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25569641

RESUMO

Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by multiple organ involvement and pronounced racial and ethnic heterogeneity. The aims of the present work were (1) to describe the cumulative clinical characteristics of those patients included in the Spanish Rheumatology Society SLE Registry (RELESSER), focusing on the differences between patients who fulfilled the 1997 ACR-SLE criteria versus those with less than 4 criteria (hereafter designated as incomplete SLE (iSLE)) and (2) to compare SLE patient characteristics with those documented in other multicentric SLE registries.RELESSER is a multicenter hospital-based registry, with a collection of data from a large, representative sample of adult patients with SLE (1997 ACR criteria) seen at Spanish rheumatology departments. The registry includes demographic data, comprehensive descriptions of clinical manifestations, as well as information about disease activity and severity, cumulative damage, comorbidities, treatments and mortality, using variables with highly standardized definitions.A total of 4.024 SLE patients (91% with ≥4 ACR criteria) were included. Ninety percent were women with a mean age at diagnosis of 35.4 years and a median duration of disease of 11.0 years. As expected, most SLE manifestations were more frequent in SLE patients than in iSLE ones and every one of the ACR criteria was also associated with SLE condition; this was particularly true of malar rash, oral ulcers and renal disorder. The analysis-adjusted by gender, age at diagnosis, and disease duration-revealed that higher disease activity, damage and SLE severity index are associated with SLE [OR: 1.14; 95% CI: 1.08-1.20 (P < 0.001); 1.29; 95% CI: 1.15-1.44 (P < 0.001); and 2.10; 95% CI: 1.83-2.42 (P < 0.001), respectively]. These results support the hypothesis that iSLE behaves as a relative stable and mild disease. SLE patients from the RELESSER register do not appear to differ substantially from other Caucasian populations and although activity [median SELENA-SLEDA: 2 (IQ: 0-4)], damage [median SLICC/ACR/DI: 1 (IQ: 0-2)], and severity [median KATZ index: 2 (IQ: 1-3)] scores were low, 1 of every 4 deaths was due to SLE activity.RELESSER represents the largest European SLE registry established to date, providing comprehensive, reliable and updated information on SLE in the southern European population.


Assuntos
Lúpus Eritematoso Sistêmico/epidemiologia , Sistema de Registros , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Espanha/epidemiologia
16.
Clin Exp Rheumatol ; 32(3 Suppl 82): S79-89, 2014 May-Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24854377

RESUMO

OBJECTIVES: Non-infectious aortitis is often refractory to standard immunosuppressive therapy. Since IL-6 has been implicated in the pathogenesis of aortitis, we assessed the efficacy of the anti-IL6 receptor monoconal antibody tocilizumab (TCZ) in a series of patients with refractory non-infectious aortitis. METHODS: Review of 16 patients (14 women/2 men) with refractory aortitis diagnosed by imaging (CT angiography, MR angiography, and/or PET) that were treated with TCZ. RESULTS: The mean age±SD was 51.4±20.1 years. The underlying conditions were: Takayasu arteritis (TakA) (n=7 cases), giant cell arteritis (GCA) (n=7), relapsing polychondritis (RP) (n=1), and aortitis associated with retroperitoneal fibrosis (n=1). TCZ was the first biologic drug used in all patients with GCA and in the patient with aortitis associated with retroperitoneal fibrosis but in only 2 of 7 TakA patients. In the remaining cases anti-TNF inhibitors were prescribed before TCZ (standard dose was 8 mg/kg/iv/4 weeks). After a mean±SD follow-up of 11.8±6.6 months most patients experienced clinical improvement, showing reduction of erythrocyte sedimentation rate from 43±36 mm/1st h to 5±4 mm/1st h at last visit. At TCZ onset, 25% of patients had fever and 19% polymyalgia rheumatica. These manifestations disappeared after 3 months of TCZ therapy. A corticosteroid sparing effect was also achieved (from 27.3±17.6 mg/day of prednisone at TCZ onset to 4.2±3.8 mg/day at last visit). TCZ had to be discontinued in a patient because of severe neutropenia. CONCLUSIONS: TCZ appears to be effective and relatively safe in patients with inflammatory aortitis refractory to corticosteroids or to other biologic immunosuppressive drugs.


Assuntos
Anticorpos Monoclonais Humanizados , Aortite , Interleucina-6/sangue , Prednisona , Receptores de Interleucina-6/antagonistas & inibidores , Adulto , Idoso , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Aortite/classificação , Aortite/diagnóstico , Aortite/tratamento farmacológico , Aortite/imunologia , Monitoramento de Medicamentos , Resistência a Medicamentos , Feminino , Glucocorticoides/administração & dosagem , Glucocorticoides/efeitos adversos , Humanos , Imunossupressores/administração & dosagem , Imunossupressores/efeitos adversos , Angiografia por Ressonância Magnética/métodos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados (Cuidados de Saúde) , Tomografia por Emissão de Pósitrons/métodos , Prednisona/administração & dosagem , Prednisona/efeitos adversos , Indução de Remissão/métodos , Espanha
17.
Arthritis Rheumatol ; 66(6): 1659-65, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24515813

RESUMO

OBJECTIVE: Adult-onset Still's disease (AOSD) is frequently refractory to standard therapy. Tocilizumab (TCZ) has demonstrated efficacy in single cases and in small series of patients with AOSD. The aim of this multicenter study was to assess the efficacy of TCZ in patients with AOSD refractory to conventional treatment. METHODS: This was a retrospective open-label study of TCZ treatment in 34 patients with AOSD who had experienced an inadequate response to corticosteroids and at least 1 standard synthetic immunosuppressive drug and also, in many cases, biologic agents. RESULTS: The mean ± SD age of the patients (8 men and 26 women) was 38.7 ± 16.1 years. The median duration of AOSD before TCZ was initiated was 4.2 years (interquartile range [IQR] 1-9 years). The initial dosages of intravenous TCZ were 8 mg/kg every 4 weeks in 22 patients, 4 mg/kg every 4 weeks in 2 patients, and 8 mg/kg every 2 weeks in 10 patients. TCZ treatment resulted in rapid and maintained improvement in both clinical and laboratory parameters. After 1 year of TCZ therapy, the incidence of joint manifestations had decreased from 97.1% at baseline to 32.4%, the incidence of both cutaneous manifestations and fever had decreased from 58.8% to 5.9%, and the incidence of lymphadenopathy had decreased from 29.4% to 0%. A dramatic reduction in laboratory markers of inflammation, including the C-reactive protein level, the erythrocyte sedimentation rate, and the ferritin level, was achieved. The median dosage of prednisone was also reduced, from 13.8 mg/day (IQR 5-45) at the initiation of TCZ to 2.5 mg/day (IQR 0-30) at 12 months. After a median followup of 19 months (IQR 12-31 months), only 2 patients required permanent discontinuation of TCZ therapy because of severe infections. CONCLUSION: TCZ treatment was associated with rapid and maintained clinical and laboratory improvement in patients with AOSD refractory to standard treatment. However, joint manifestations seem to be more refractory to treatment compared with systemic manifestations.


Assuntos
Anticorpos Monoclonais Humanizados/efeitos adversos , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Doença de Still de Início Tardio/tratamento farmacológico , Adolescente , Corticosteroides/uso terapêutico , Adulto , Idoso , Anticorpos Monoclonais/imunologia , Feminino , Humanos , Imunossupressores/uso terapêutico , Masculino , Pessoa de Meia-Idade , Receptores de Interleucina-6/imunologia , Estudos Retrospectivos , Falha de Tratamento , Resultado do Tratamento , Adulto Jovem
18.
Reumatol Clin ; 7(1): 20-6, 2011 Jan-Feb.
Artigo em Espanhol | MEDLINE | ID: mdl-21794775

RESUMO

UNLABELLED: FUNDAMENTAL AND OBJECTIVE: Psychological impairment is frequent in patients with rheumatic diseases. The aim of the study was to assess the prevalence of symptoms of anxiety and depression in patients with psoriatic arthritis attending rheumatology clinics. PATIENTS AND METHOD: Multicentre cross-sectional study conducted in rheumatology clinics. Patients with psoriatic arthritis were recruited; variables retrieved were sociodemographic, clinical and patient centered (Hospital Anxiety and Depression scale o HADs, EQ-5D questionnaire, etc.). Prevalence in the study population was calculated as anxiety or depression symptoms by an HADs score ≥11 or those receiving pharmacological treatment. A logistics regression model was used to know which variables were related to symptoms of anxiety or depression. RESULTS: A total of 495 patients were included, 42.8% were women and median (SD) age was 50.4 (12.7) years. Prevalence of symptoms of anxiety were 29.7% and prevalence of symptoms of depression was 17,6%. Patients with anxiety or depression symptoms had all EQ-5D dimensions affected (p<0.01). Higher prevalence of anxiety was related to being a woman, a mixed onset pattern with respect to peripheral joints and those treated with DMARD alone with respect to DMARD+NSAID or biologic alone. A higher depression prevalence was related to being a woman and a mixed onset pattern with respect to peripheral joints. CONCLUSION: The prevalence of anxiety symptoms and the prevalence of depression symptoms are high among patients suffering psoriatic arthritis in the studied population.


Assuntos
Transtornos de Ansiedade/epidemiologia , Ansiedade/epidemiologia , Artrite Psoriásica/psicologia , Depressão/epidemiologia , Transtorno Depressivo/epidemiologia , Ambulatório Hospitalar/estatística & dados numéricos , Reumatologia/estatística & dados numéricos , Adulto , Idoso , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Artrite Psoriásica/epidemiologia , Estudos Transversais , Escolaridade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ocupações , Prevalência , Índice de Gravidade de Doença , Fatores Socioeconômicos , Espanha/epidemiologia
19.
Reumatol. clín. (Barc.) ; 7(1): 20-26, ene.-feb. 2011. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-84608

RESUMO

Fundamento y objetivo. Las alteraciones psicológicas son frecuentes entre pacientes con enfermedades reumáticas. El objetivo del estudio fue conocer la prevalencia de los síntomas de ansiedad y depresión en pacientes con artritis psoriásica que acuden a consultas de reumatología. Pacientes y método. Estudio transversal multicéntrico en consultas de reumatología. Se seleccionaron pacientes con artritis psoriásica; se recogieron variables sociodemográficas, clínicas y centradas en el paciente (Escala Hospitalaria de Ansiedad y Depresión o HADs, cuestionario EQ-5D, etc.). Se calculó la prevalencia de síntomas de ansiedad y depresión en esta población según una puntuación ≥11 en HADs o estar recibiendo tratamiento farmacológico. Se utilizó un modelo de regresión logística para conocer las variables relacionadas con la presencia de síntomas de ansiedad o depresión. Resultados. Se incluyeron 495 pacientes, 42,8% mujeres y edad media (DE) de 50,4 (12,7) años. La prevalencia de síntomas de ansiedad fue 29,7% y 17,6% de depresión. Los pacientes con síntomas de ansiedad o depresión presentaron mayor afectación en todas las dimensiones del EQ-5D (p<0,01). La mayor prevalencia en la población de estudio de ansiedad se relacionó con ser mujeres, patrón de debut mixto respecto al periférico y en tratamiento con FAME en monoterapia respecto a FAME+AINES o biológico en monoterapia. La mayor prevalencia de depresión se relacionó con ser mujeres y patrón de debut mixto respecto al periférico. Conclusión. La prevalencia de síntomas de ansiedad y de depresión es elevada en pacientes con artritis psoriásica en la población de este estudio (AU)


Fundamental and Objective. Psychological impairment is frequent in patients with rheumatic diseases. The aim of the study was to assess the prevalence of symptoms of anxiety and depression in patients with psoriatic arthritis attending rheumatology clinics. Patients and method. Multicentre cross-sectional study conducted in rheumatology clinics. Patients with psoriatic arthritis were recruited; variables retrieved were sociodemographic, clinical and patient centered (Hospital Anxiety and Depression scale o HADs, EQ-5D questionnaire, etc.). Prevalence in the study population was calculated as anxiety or depression symptoms by an HADs score ≥11 or those receiving pharmacological treatment. A logistics regression model was used to know which variables were related to symptoms of anxiety or depression. Results. A total of 495 patients were included, 42.8% were women and median (SD) age was 50.4 (12.7) years. Prevalence of symptoms of anxiety were 29.7% and prevalence of symptoms of depression was 17,6%. Patients with anxiety or depression symptoms had all EQ-5D dimensions affected (p<0.01). Higher prevalence of anxiety was related to being a woman, a mixed onset pattern with respect to peripheral joints and those treated with DMARD alone with respect to DMARD+NSAID or biologic alone. A higher depression prevalence was related to being a woman and a mixed onset pattern with respect to peripheral joints. Conclusion. The prevalence of anxiety symptoms and the prevalence of depression symptoms are high among patients suffering psoriatic arthritis in the studied population (AU)


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Ansiedade/complicações , Ansiedade/psicologia , Transtornos de Ansiedade/complicações , Artrite Psoriásica/complicações , Artrite Psoriásica/diagnóstico , Depressão/epidemiologia , Antirreumáticos/uso terapêutico , Artrite/complicações , Artrite/diagnóstico , Artrite/psicologia , Estudos Transversais , Inquéritos e Questionários , Modelos Logísticos , Acontecimentos que Mudam a Vida , Análise Estatística
20.
Pediatr Blood Cancer ; 55(3): 557-9, 2010 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-20533520

RESUMO

Anaphylactic/anaphylactoid reaction to methotrexate (MTX) is uncommon. It may occur with the first dose (non-allergic reactions) or after a previous exposure to the drug (allergic or specific reactions). Desensitization has been shown effective in children with allergic-type reactions permitting the continuation of high-dose methotrexate (HDMTX) therapy. We report the case of a child with localized osteosarcoma who developed an anaphylactoid reaction after a first HDMTX course. A desensitization protocol was successfully applied allowing the administration of four additional courses. In our experience, desensitization can be a safe and effective procedure in children with anaphylactoid reactions to HDMTX.


Assuntos
Anafilaxia/etiologia , Antimetabólitos Antineoplásicos/efeitos adversos , Dessensibilização Imunológica , Metotrexato/efeitos adversos , Anafilaxia/prevenção & controle , Antimetabólitos Antineoplásicos/administração & dosagem , Neoplasias Ósseas/tratamento farmacológico , Criança , Dessensibilização Imunológica/métodos , Feminino , Humanos , Metotrexato/administração & dosagem , Osteossarcoma/tratamento farmacológico , Tíbia
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