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1.
Health Sci Rep ; 6(3): e1034, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36875929

RESUMO

Background and Aims: A noninterventional prospective study was performed in Colombia and Peru. The aim was to describe the impact of access to treatment on Patient-reported outcomes (PRO) in patients with Rheumatoid arthritis (RA) after failure to conventional disease-modifying antirheumatic drugs (DMARDs) in real-life conditions. Methods: The impact of access to treatment was measured by access barriers, time to supply (TtS) and interruption evaluating their effect in changes of PROs between baseline and 6-month follow-up between February 2017 and November 2019. The association of access to care with disease activity, functional status, health-related quality of life was assessed using bivariate and multivariable analysis. Results are expressed in least mean difference; TtS in mean number of days for delivery of treatment at baseline. Variability measures were standard deviation and standard error. Results: One hundred seventy patients were recruited, 70 treated with tofacitinib and 100 with biological DMARDs. Thirty-nine patients reported access barriers. The mean of TtS was 23 ± 38.83 days. The difference from baseline to 6-month visit in PROs were affected by access barriers and interruptions. There was not statistically significant difference in the of PRO's score among visits in patients that reported delay of supply of more than 23 days compared to patients with less days of delay. Conclusion: This study suggested the access to treatment can affect the response to the treatment at 6 months of follow-up. There seems to be no effect in the PROs for delay of TtS during the studied period.

2.
Salud ment ; 43(5): 235-240, Sep.-Oct. 2020.
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1145105

RESUMO

Abstract Introduction The influx of new knowledge and scientific contributions into contemporary world psychiatry has counted on a vigorous dissemination through technology-inspired means. This process has led to the realities of Global Mental Health (GMH) inspired by "a new epistemology" of mostly positivistic roots. Objective To explore the basis of these realities and the resulting homogenization attempts of psychiatry as a medical, clinical, and research discipline. Discussion and conclusion The need for "a new architecture" of contemporary psychiatry is discussed as a reflection of a correct epistemological exercise and a renewed pact between professionals and communities, materialized in and enriched by the re-emerging Community Mental Health (CMH) movement. The essential bases of the movement are presented, and its mutually collaborative, multidisciplinary, integrated, and realistic nature, as reflected in national efforts like Peru's in Latin America, is described.


Resumen Introducción El flujo de nuevos conocimientos y contribuciones científicas surgido en la psiquiatría mundial contemporánea ha contado con una vigorosa diseminación mediada por recursos tecnológicos. Este proceso ha conducido a las realidades de la Salud Mental Global (SMG) inspiradas por una "nueva epistemología" de raíces fundamentalmente positivistas. Objetivo Explorar las bases de esta nueva realidad y los resultantes intentos de homogenización de la psiquiatría como disciplina médica, clínica y de investigación. Discusión y conclusión Se discute la necesidad de "una nueva arquitectura" de la psiquiatría contemporánea como reflejo de un correcto ejercicio epistemológico y de un pacto renovado entre profesionales y comunidades que se han materializado y enriquecido por el reemergente movimiento de la Salud Mental Comunitaria (SMC). Se presentan las bases esenciales del movimiento y su naturaleza de mutua colaboración multidisciplinaria, integrada y realista, reflejada en esfuerzos nacionales como es el caso del Perú en América Latina.

4.
Rev. neuro-psiquiatr. (Impr.) ; 83(2): 97-103, abr-jun 2020.
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1144873

RESUMO

Resumen En tanto que componente fundamental del quehacer médico a lo largo de la historia, la Ética es aún más prominente en situaciones de emergencia en salud pública. Luego de exponer los principios éticos esenciales y de enfatizar su valor en el cuidado médico de todo ser humano, se plantea la inevitable tensión que su aplicación genera en los diversos contextos de la relación médico-paciente. Se presta especial atención a las distinciones de la perspectiva ética en casos individuales y en el ámbito colectivo o de salud pública, particularmente en el curso de emergencias masivas como la desencadenada por COVID-19. A la luz de recientes documentos nacionales e internacionales, se discute el inevitable advenimiento de nuevas normas que deberán incluir aspectos socio-culturales, psicobiológicos y legales poseedores de un impacto clínico altamente significativo.


Summary As an essential component of medical work throughout history, Ethics becomes even more prominent in public health emergency situations. After presenting the fundamental ethical principles, and emphasizing their value in the medical care of every human being, the inevitable tensions that their application generates in the diverse contexts of the doctor-patient relationship, are examined. Particular attention must be paid to the distinctions between ethical perspectives of individual cases and those related to public health situations such as the massive emergency triggered by the COVID-1 pandemic. On the basis of recent national and international documents, the unavoidable upcoming of new ethical norms that must include socio-cultural, psychological and legal aspects of a highly significant clinical impact, is discussed.

7.
Immunotherapy ; 8(12): 1427-1436, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27737604

RESUMO

Biologics are increasingly being used to modify the course of immune-mediated inflammatory diseases. Some main agents are monoclonal antibodies and a fusion-protein that target TNF. This group includes adalimumab, infliximab, certolizumab pegol, golimumab and etanercept. Although the efficacy of anti-TNFs is supported by numerous randomized clinical trials, their pharmacokinetics depend on many factors, in particular immunogenicity, which can cause marked and rapid clearance and a consequent decrease in efficacy. Kinetics involve receptors that recognize the Fc fragment of the antibody and are responsible for various processes. Pharmacological advances permit optimizing the pharmacokinetics of anti-TNFs. In this review, we examine the kinetics of anti-TNF biologics, and consequent therapeutic implications, and overview some latest developments in the field. First draftsubmitted: 17 May 2016; Accepted for publication: 15 September2016; Published online: 14 October 2016.


Assuntos
Anti-Inflamatórios/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Produtos Biológicos/uso terapêutico , Doenças do Sistema Imunitário/terapia , Imunoterapia/métodos , Inflamação/terapia , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Animais , Ensaios Clínicos como Assunto , Humanos , Doenças do Sistema Imunitário/imunologia , Inflamação/imunologia
8.
Open Rheumatol J ; 10: 13-25, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27006728

RESUMO

BACKGROUND: Although long-term data are available from biologic studies in North American/European populations with rheumatoid arthritis (RA), long-term findings in Latin American RA populations are limited. OBJECTIVE: To examine long-term safety/efficacy of etanercept, methotrexate, and/or other disease-modifying anti-rheumatic drugs (DMARDs) in Latin American patients with moderate-to-severe active RA. METHODS: In the first phase of this open-label study, patients were randomized to etanercept 50 mg weekly plus methotrexate or conventional DMARD (hydroxychloroquine or sulfasalazine) plus methotrexate for 24 weeks. At the start of the second phase (week 24), investigators selected a treatment regimen that included any combination/dosage of etanercept, methotrexate, hydroxychloroquine, or sulfasalazine based on previous treatment response, preference, and local product labeling, and was continued for the 104-week extension. RESULTS: In the extension, in the group previously randomized to etanercept-plus-methotrexate therapy, etanercept was continued in 259/260 patients; methotrexate continued in 260/260; and hydroxychloroquine and sulfasalazine added in 8/260 and 3/260, respectively. In the group previously randomized to conventional DMARD-plus-methotrexate therapy, conventional DMARD was discontinued in 86/126 and etanercept added in 105/126. Among etanercept-exposed patients (total exposure, 798.1 patient-year [PY]), rates of adverse events, serious adverse events, and serious infections per PY were 1.7, 0.07, and 0.02 events per PY. In both groups, after treatment modification was permitted, clinical response rates and improvements in clinical/patient-reported outcomes from baseline were sustained to week 128. CONCLUSION: After investigators were permitted to modify treatment, etanercept was part of the treatment regimen in 95% of patients. Continuation or addition of etanercept in the 2-year extension resulted in a consistently good risk:benefit profile. TRIAL REGISTRATION: Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy; ClinicalTrials.gov, number NCT00848354; https://clinicaltrials.gov/ct2/show/NCT00848354.

9.
Acta herediana ; 56: 7-16, 2015.
Artigo em Espanhol | LIPECS | ID: biblio-1105150

RESUMO

El autor formula una serie de reflexiones en torno a la trayectoria de la tercera promoción egresada de la Facultad de Medicina de la Universidad Peruana Cayetano Heredia y que celebra este año sus Bodas de Oro. Examina horizontes inspirados por maestros ilustres y principios irrevocables; solsticios que a la manera de acmés y nadires iluminaron rutas de éxitos y satisfacciones o las ensombrecieron con dudas o dificultades; y penumbras o retraimientos de soledad e impotencia frente a lo inevitable. En su actual encrucijada existencial, la Promoción Alberto Hurtado de 1965 reafirma convicciones de inmenso valor ético, de servicio auténtico, de ciencia profunda y de vocación duradera.


The author formulates a series of reflections about the trajectory of the third class graduated from the School of Medicine of the Universidad Peruana Cayetano Heredia and celebrating this year itÆs Golden Anniversary. Horizons, inspired by illustrious teachers and irrevocable principles; solstices that in the manner of acmes and nadirs illuminated routes of success and satisfactions, or darkened them with doubts and difficulties; and somber moments of retractions, solitude or impotence in the face of the inevitable, are all examined. In its current existential crossroads, the Alberto Hurtado Class of 1965 reaffirms convictions of enormous ethical value, authentic service, profound science and enduring vocation.


Assuntos
Aniversários e Eventos Especiais , Médicos
10.
Rev. neuro-psiquiatr. (Impr.) ; 77(4): 201-206, oct. 2014. ilus
Artigo em Espanhol | LILACS, LIPECS | ID: lil-735457

RESUMO

Tributo in memoriam a Don Oscar Pino Galarza (1926-2014), secretario y asistente administrativo de la Revista de Neuro-Psiquiatría por espacio de más de sesenta años, colaborador cercano de los Profesores Honorio Delgado, primero, y Javier Mariátegui, después. Luego de breves anotaciones biográficas, obtenidas mediante una entrevista con la esposa e hijos de Don Oscar, se describen rasgos fundamentales de su personalidad y su trabajo. En la Revista, su labor fue multidimensional al haber estado envuelto en tareas secretariales, administrativas, logísticas y editoriales que desempeñó con singular eficiencia, devoción, lealtad y modestia. Estas cualidades y su nobleza espiritual fueron evidentes en momentos decisivos de la trayectoria académica y editorial de los dos primeros Directores de nuestra publicación. Se reconocen así la vida y la obra de un auténtico orfebre, de alguien que reflejó lo mejor y más alto de una genuina calidad humana, más allá de orígenes sociales, documentos burocráticos o formalidades institucionales.


A tribute to Don Oscar Pino Galarza (1926-2014), secretary and administrative assistant of the Revista de Neuro-Psiquiatría for over 60 years, closely working with Professors Honorio Delgado, first, and Javier Mariátegui, later. After brief biographic notes obtained from an interview with Don Oscar’s wife and children, fundamental features of his personality and his work are described. At the Revista, his activity was multidimensional as he was involved in secretarial, administrative, logistic and editorial tasks which he conducted with unique efficiency, devotion, loyalty and modesty. These qualities and his spiritual nobility were evident during decisive moments in the academic and editorial careers of the first two Directors of our journal. Thus, due recognition is given to life and the work of a genuine goldsmith, one who reflected the best and the highest of a true human quality, beyond social origins, bureaucratic documents or institutional formalities.


Assuntos
Humanos , Masculino , Biografias como Assunto , Publicações Periódicas como Assunto
12.
Joint Bone Spine ; 81(6): 471-7, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24956990

RESUMO

A biosimilar is a biopharmaceutical product intended to be comparable to a previously licensed biopharmaceutical agent. The goal of such products is to increase the accessibility of biopharmaceutical therapy for rheumatoid arthritis by reducing costs. They are not like generic drugs, in that they may differ from the reference products in manufacturing, composition, and formulation. Regulatory authorities strive to ensure the absence of clinically meaningful differences between biosimilars and their reference drugs. However, small molecular differences may potentially affect pharmacodynamics (including affinity), pharmacokinetics, and immunogenicity. Intended copies are non-innovator biopharmaceutical products that, unlike biosimilars, do not have enough clinical evidence to demonstrate biosimilarity. For approval of a biosimilar, most countries require preclinical and clinical studies demonstrating comparability with the reference drug. The margin for determining equivalence or non-inferiority is determined on a case-by-case basis in each country, as there are no general criteria. The European Medicines Agency and US Food and Drug Administration have stringent regulatory processes to ensure comparability of biosimilars with their reference drugs. There are also post-marketing surveillance requirements to monitor safety. Only one biosimilar, CT-P13, has been approved for rheumatoid arthritis. However, in countries with less stringent regulation, intended copies are being commercialized and safety problems have been documented. Consequently, in such countries, there is an urgent need for appropriate regulatory processes to be established. Attempts to close the affordability gap of biopharmaceuticals should not open another gap between patients treated with an innovator drug and an intended copy.


Assuntos
Biofarmácia , Doenças Reumáticas/tratamento farmacológico , Medicamentos Biossimilares , Medicamentos Genéricos , Europa (Continente) , Humanos , Índia , América Latina , Federação Russa
13.
J Clin Rheumatol ; 20(1): 25-33, 2014 01.
Artigo em Inglês | MEDLINE | ID: mdl-24356474

RESUMO

BACKGROUND: Previous global studies examined etanercept (ETN) + methotrexate (MTX) for treatment of rheumatoid arthritis (RA), but included few subjects from Latin America. OBJECTIVE: The objective of this study was to compare the safety and efficacy of ETN + MTX versus a standard-of-care disease-modifying antirheumatic drug (DMARD) + MTX in Latin American subjects with moderate to severe active RA despite MTX therapy. METHODS: This open-label, active-comparator study (NCT00848354) randomized subjects 2:1 to ETN 50 mg/wk + MTX or investigator-selected DMARD (sulfasalazine or hydroxychloroquine) + MTX (ETN + MTX, n = 281; DMARD + MTX, n = 142). The primary end point was the proportion achieving American College of Rheumatology (ACR) 50 at week 24. Secondary end points included ACR20/70, disease activity score (DAS) 28 measures, and mean change in modified total Sharp score. Patient-reported outcomes were the Health Assessment Questionnaire, 36-item Short-Form, Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment: RA (WPAI:RA), and Caregiver Burden and Resource Utilization. Statistical analyses were stratified by country; χ test and analysis of covariance were used. Adverse events were monitored. RESULTS: More subjects achieved ACR50 at week 24 with ETN + MTX versus DMARD + MTX (62% vs 23%, respectively), in addition to secondary end points (P < 0.0001 for all); mean change in modified total Sharp score was lower for the ETN + MTX group (0.4 vs 1.4, respectively; P = 0.0270). Improvements in patient-reported outcomes favored ETN + MTX for Health Assessment Questionnaire, 36-item Short-Form, Hospital Anxiety and Depression Scale for depression, WPAI:RA, and Caregiver Burden and Resource Utilization emergency department visits for RA (P < 0.01). Overall, adverse events were similar between the groups (69% vs 68%,); serious adverse events were also similar (4% vs 1%). The rate of overall infections was higher with ETN + MTX (38%) than DMARD + MTX (22%, P ≤ 0.001). CONCLUSIONS: Consistent with published global data among RA patients with inadequate response to MTX, adding ETN to MTX demonstrated better efficacy than adding one other conventional DMARD to MTX. No new safety issues were observed. ETN + MTX provided favorable benefit-risk profile among RA patients from LA region.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Imunoglobulina G/uso terapêutico , Metotrexato/uso terapêutico , Receptores do Fator de Necrose Tumoral/uso terapêutico , Adulto , Antirreumáticos/efeitos adversos , Artrite Reumatoide/epidemiologia , Artrite Reumatoide/etnologia , Quimioterapia Combinada , Etanercepte , Feminino , Humanos , Imunoglobulina G/efeitos adversos , América Latina/epidemiologia , Masculino , Metotrexato/efeitos adversos , Pessoa de Meia-Idade , Medição de Risco , Índice de Gravidade de Doença , Resultado do Tratamento
15.
Arthritis Rheum ; 65(9): 2368-79, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23740801

RESUMO

OBJECTIVE: To investigate the efficacy and safety of ocrelizumab in patients with class III/IV lupus nephritis (LN). METHODS: Patients were randomized 1:1:1 to receive placebo, 400 mg ocrelizumab, or 1,000 mg ocrelizumab given as an intravenous infusion on days 1 and 15, followed by a single infusion at week 16 and every 16 weeks thereafter, accompanied by background glucocorticoids plus either mycophenolate mofetil (MMF) or the Euro-Lupus Nephritis Trial (ELNT) regimen (cyclophosphamide followed by azathioprine). The study was terminated early due to an imbalance in serious infections in ocrelizumab-treated patients versus placebo-treated patients. We report week 48 efficacy data for patients receiving ≥32 weeks of treatment (n = 223) and safety results for all treated patients (n = 378). RESULTS: The overall renal response rate was 54.7%, 66.7%, 67.1%, and 66.9% in the placebo-treated, 400 mg ocrelizumab-treated, 1,000 mg ocrelizumab-treated, and combined ocrelizumab-treated groups, respectively. The associated treatment difference versus placebo for the combined ocrelizumab-treated groups was 12.7% (95% confidence interval [95% CI] -0.8, 26.1) (P = 0.065), with similar differences observed for both ocrelizumab-treated groups. Ocrelizumab versus placebo treatment differences were apparent in patients receiving the background ELNT regimen, but not in those receiving background MMF. A numerically greater proportion of ocrelizumab-treated patients had a ≥50% reduction in the urinary protein:urinary creatinine ratio at 48 weeks compared with placebo-treated patients (placebo-treated patients, 58.7%; 400 mg ocrelizumab-treated patients, 70.7%; 1,000 mg ocrelizumab-treated patients, 68.5%). Serious adverse events occurred in 27.2% of placebo-treated patients, 35.7% of 400 mg ocrelizumab-treated patients, and 22.0% of 1,000 mg ocrelizumab-treated patients. Corresponding serious infection rates (events/100 patient-years) were 18.7 (95% CI 12.2, 28.7), 28.8 (95% CI 20.6, 40.3), and 25.1 (95% CI 17.4, 36.1), respectively. The imbalance in serious infections with ocrelizumab occurred with background MMF but not with the background ELNT regimen. CONCLUSION: In patients with active LN, overall renal response rates with ocrelizumab were numerically but not statistically significantly superior to those with placebo. Ocrelizumab treatment was associated with a higher rate of serious infections in the subgroup receiving background MMF.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Imunossupressores/uso terapêutico , Nefrite Lúpica/tratamento farmacológico , Adolescente , Adulto , Idoso , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Azatioprina/administração & dosagem , Azatioprina/uso terapêutico , Ciclofosfamida/administração & dosagem , Ciclofosfamida/uso terapêutico , Método Duplo-Cego , Esquema de Medicação , Quimioterapia Combinada , Feminino , Humanos , Imunossupressores/administração & dosagem , Imunossupressores/efeitos adversos , Masculino , Pessoa de Meia-Idade , Ácido Micofenólico/administração & dosagem , Ácido Micofenólico/análogos & derivados , Ácido Micofenólico/uso terapêutico , Resultado do Tratamento
17.
Rheumatology (Oxford) ; 51(7): 1293-8, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22389125

RESUMO

OBJECTIVE: To examine the role of ethnicity and the use of anti-malarials (protective) on lupus renal disease. METHODS: A nested case-control study (1:2 proportion, n = 265 and 530) within GLADEL's (Grupo Latino Americano De Estudio de Lupus) longitudinal inception cohort was carried out. The end-point was ACR renal criterion development after diagnosis. Cases and controls were matched for follow-up time (end-point or a comparable time, respectively). Renal disease predictors were examined by univariable and multivariable analyses. Additional analyses were done to determine if the protective effect of anti-malarials persisted after adjusting for intake-associated confounders. RESULTS: Of the cases, 233 (87.9%) were women; their mean (s.d.) age at diagnosis was 28.0 (11.9) years and their median (Q3-Q1 interquartile range) follow-up time for cases and controls was 8.3 months (Q3-Q1: 23.5); 56.6% of the cases and 74.3% of the controls were anti-malarial users. Mestizo ethnicity [odds ratio (OR) 1.72, 95% CI 1.19, 2.48] and hypertension (OR 2.26, 95% CI 1.38, 3.70) were independently associated with a higher risk of renal disease, whereas anti-malarial use (OR 0.39, 95% CI 0.26, 0.58), older age at disease onset (OR 0.98, 95% CI 0.96, 0.99) and female gender (OR 0.56, 95% CI 0.32, 0.99) were negatively associated with such occurrence. After adjusting for variables associated with their intake, the protective effect of anti-malarials on renal disease occurrence persisted (OR 0.38, 95% CI 0.25, 0.58). CONCLUSION: Mestizo patients are at increased risk of developing renal disease, whereas anti-malarial use protects patients from such an occurrence.


Assuntos
Antimaláricos/uso terapêutico , Nefrite Lúpica/prevenção & controle , Medição de Risco , Adulto , Idade de Início , Argentina/epidemiologia , Progressão da Doença , Feminino , Seguimentos , Humanos , Incidência , Nefrite Lúpica/diagnóstico , Nefrite Lúpica/etnologia , Masculino , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
18.
Lancet ; 377(9767): 721-31, 2011 Feb 26.
Artigo em Inglês | MEDLINE | ID: mdl-21296403

RESUMO

BACKGROUND: Systemic lupus erythematosus is a heterogeneous autoimmune disease that is associated with B-cell hyperactivity, autoantibodies, and increased concentrations of B-lymphocyte stimulator (BLyS). The efficacy and safety of the fully human monoclonal antibody belimumab (BLyS-specific inhibitor) was assessed in patients with active systemic lupus erythematosus. METHODS: Patients (aged ≥18 years) who were seropositive with scores of at least 6 on the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) were enrolled in a multicentre phase 3 study, which was done in Latin America, Asia-Pacific, and eastern Europe. Patients were randomly assigned by use of a central interactive voice response system in a 1:1:1 ratio to belimumab 1 mg/kg or 10 mg/kg, or placebo by intravenous infusion in 1 h on days 0, 14, and 28, and then every 28 days until 48 weeks, with standard of care. Patients, investigators, study coordinators, and sponsors were masked to treatment assignment. Primary efficacy endpoint was improvement in the Systemic Lupus Erythematosus Responder Index (SRI) at week 52 (reduction ≥4 points in SELENA-SLEDAI score; no new British Isles Lupus Assessment Group [BILAG] A organ domain score and no more than 1 new B organ domain score; and no worsening [<0·3 increase] in Physician's Global Assessment [PGA] score) versus baseline. Method of analysis was by modified intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00424476. FINDINGS: 867 patients were randomly assigned to belimumab 1 mg/kg (n=289) or 10 mg/kg (n=290), or placebo (n=288). 865 were treated and analysed in the belimumab (1 mg/kg, n=288; 10 mg/kg, n=290) and placebo groups (n=287). Significantly higher SRI rates were noted with belimumab 1 mg/kg (148 [51%], odds ratio 1·55 [95% CI 1·10-2·19]; p=0·0129) and 10 mg/kg (167 [58%], 1·83 [1·30-2·59]; p=0·0006) than with placebo (125 [44%]) at week 52. More patients had their SELENA-SLEDAI score reduced by at least 4 points during 52 weeks with belimumab 1 mg/kg (153 [53%], 1·51 [1·07-2·14]; p=0·0189) and 10 mg/kg (169 [58%], 1·71 [1·21-2·41]; p=0·0024) than with placebo (132 [46%]). More patients given belimumab 1 mg/kg (226 [78%], 1·38 [0·93-2·04]; p=0·1064) and 10 mg/kg (236 [81%], 1·62 [1·09-2·42]; p=0·0181) had no new BILAG A or no more than 1 new B flare than did those in the placebo group (210 [73%]). No worsening in PGA score was noted in more patients with belimumab 1 mg/kg (227 [79%], 1·68 [1·15-2·47]; p=0·0078) and 10 mg/kg (231 [80%], 1·74 [1·18-2·55]; p=0·0048) than with placebo (199 [69%]). Rates of adverse events were similar in the groups given belimumab 1 mg/kg and 10 mg/kg, and placebo: serious infection was reported in 22 (8%), 13 (4%), and 17 (6%) patients, respectively, and severe or serious hypersensitivity reactions on an infusion day were reported in two (<1%), two (<1%), and no patients, respectively. No malignant diseases were reported. INTERPRETATION: Belimumab has the potential to be the first targeted biological treatment that is approved specifically for systemic lupus erythematosus, providing a new option for the management of this important prototypic autoimmune disease. FUNDING: Human Genome Sciences and GlaxoSmithKline.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Fatores Imunológicos/uso terapêutico , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Doença Aguda , Adulto , Idoso , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados , Esquema de Medicação , Feminino , Humanos , Fatores Imunológicos/administração & dosagem , Fatores Imunológicos/efeitos adversos , Modelos Logísticos , Lúpus Eritematoso Sistêmico/diagnóstico , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Inquéritos e Questionários , Resultado do Tratamento
19.
Artigo em Espanhol | LIPECS | ID: biblio-1110811

RESUMO

La Psiquiatría, como cualquier otra disciplina social o científica, ha reflejado a través de su historia la dinámica cultural de cada época. En Latinoamérica, su trayectoria experimentó primero el aporte característico de las sociedades precolombinas que la poblaron antes del intenso choque intercultural de la conquista, base de un mestizaje plural que a la larga se convirtió en una de sus características distintivas. El presente artículo examina la naturaleza esencial del mestizaje en la psiquiatría latinoamericana. Utilizando como referencia la vida, obra y legado del antropólogo peruano José María Arguedas, se establecen bases conceptuales que enmarcan la travesía histórica y el enriquecimiento mutuo teórico y práctico de la psiquiatría latinoamericana. La productividad mestiza de nuestra psiquiatría es evidente en los campos epidemiológico, clínico, farmacológico, terapéutico, asistencial y de formulación de políticas de Salud Mental. A la manera arguediana, este proceso debe ser objetivo, sostenido, constructivo y siempre en busca de una deseable armonía. El mestizaje se convierte así en piedra angular de una identidad que fomente auténtica textura social y crítica en el desarrollo futuro de la psiquiatría latinoamericana.


Psychiatry, like other social or scientific discipline, has reflected, throughout its history the cultural dynamics of each period. In Latin America, it experienced, first, the unique approach of pre-Columbian societies before the intense intercultural clash of the European conquest. This encounter was the basis of a plural process of mestization (mestizaje) that became one of its most distinctive characteristics. This article examines the essential nature of mestizaje in Latin American Psychiatry. Using the life, work and legacy of the Peruvian anthropologist José María Arguedas, as a frame of reference, the conceptual bases, historical journey and mutual theoretical and practical enrichment of Latin American Psychiatry are established. The mestizo productivity of our psychiatry is evident in the epidemiological, clinical, pharmacological, therapeutic, patient care, and policy making fields. In an Aguedian fashion, this process must be objective, consistent, constructive and harmony û seeking. Mestizaje would then be the stepping stone of an identity that must foster an authentic social and critical texture for the future of Latin America Psychiatry.


Assuntos
Humanos , América Latina , Antropologia , Cultura , Psiquiatria
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