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1.
Rev Med Chil ; 150(4): 549-553, 2022 Apr.
Artigo em Espanhol | MEDLINE | ID: mdl-36155764

RESUMO

Evidence-Based Medicine (EBM) is the methodological paradigm of Western medicine today. EBM is expected to reduce the use of intuition and to promote the use of scientific evidence, in the clinical decision-making process. Benefits of EBM in clinical practice are thoroughly documented, however, there are also critics. Among other issues, EBM is thought to contribute to an excessive reductionism, to neglect context variables and individual attributes involved in the physician-patient relationship. All the above could lead to several bioethical conflicts. This work consists in a literature review that examines the interaction between EBM and Bioethics in a reciprocity frame, in order to approach possible ethical conflicts that emerge with the use of EBM, and later analyze them from the perspective of the Narrative Ethics model, proposed by the philosopher Paul Ricoeur.


Assuntos
Bioética , Narração , Tomada de Decisões , Medicina Baseada em Evidências , Humanos , Princípios Morais
2.
Rev. méd. Chile ; 150(4): 549-553, abr. 2022.
Artigo em Espanhol | LILACS | ID: biblio-1409826

RESUMO

Evidence-Based Medicine (EBM) is the methodological paradigm of Western medicine today. EBM is expected to reduce the use of intuition and to promote the use of scientific evidence, in the clinical decision-making process. Benefits of EBM in clinical practice are thoroughly documented, however, there are also critics. Among other issues, EBM is thought to contribute to an excessive reductionism, to neglect context variables and individual attributes involved in the physician-patient relationship. All the above could lead to several bioethical conflicts. This work consists in a literature review that examines the interaction between EBM and Bioethics in a reciprocity frame, in order to approach possible ethical conflicts that emerge with the use of EBM, and later analyze them from the perspective of the Narrative Ethics model, proposed by the philosopher Paul Ricoeur.


Assuntos
Humanos , Bioética , Narração , Medicina Baseada em Evidências , Tomada de Decisões , Princípios Morais
4.
Eur Respir J ; 54(6)2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31601711

RESUMO

The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1-2) and 57 (11.3%) as serious (grade 3-5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.


Assuntos
Antituberculosos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Farmacovigilância , Estudos Prospectivos
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