RESUMO
En el año 2009 se conoce el caso de un niño afectado de leucemia aguda linfoblástica. Es tratado con buen resultado y se obtiene la remisión completa, pero más tarde aparece una recidiva. Los padres no otorgan su consentimiento para el tratamiento, generando un conflicto que llega al mundo judicial y da lugar a dos fallos de gran interés para los profesionales de la salud. Por una parte se señala qué signfica en la práctica clínica el derecho a la vida. Por otra, se desarrolla el proceso de toma de decisiones sobre los menores con base en la teoría del menor maduro, un hito jurispridencial en Chile. Con el propósito de contribuir a esclarecer el significado de la sentencia de la Corte de Apelaciones de Valdivia, se expone su contenido en términos clínicos y se concluye con las aportaciones más significativas.
In 2009, the case of a child affected by acute lymphoblastic leukemia took place. He is treated with good results resulting in complete remission, but relapse occurred later. The parents did not consent to the new treatment, creating a conflict that reaches the legal world and leads to two court rulings of great interest to health professionals. One explained the meaning of the right to life in the clinical practice, and the other dealt with the decision-making process regarding minors based on the theory of the mature minor doctrine, a jurisprudential milestone in Chile. In order to help clarify the meaning of the ruling of the Corte de Apelaciones of Valdivia, its content is presented in clinical terms and ended with the most significant contributions.
Assuntos
Humanos , Masculino , Criança , Bioética , Recusa do Paciente ao Tratamento/legislação & jurisprudência , Suspensão de Tratamento/legislação & jurisprudência , Tomada de Decisões/ética , Valor da Vida , Ética Médica , Consentimento Livre e Esclarecido , Decisões Judiciais , Menores de Idade/legislação & jurisprudência , Recusa do Paciente ao Tratamento/ética , Direitos do Paciente , Suspensão de Tratamento/éticaRESUMO
Treatment with neurotrophic agents might enhance and/or prolong the effects of cholinesterase inhibitors (ChEIs) in Alzheimer's disease (AD). We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial. Primary endpoints were global outcome (Clinician's Interview-Based Impression of Change plus caregiver input; CIBIC+) and cognition (change from baseline in AD Assessment Scale-cognitive subscale+; ADAS-cog+) at week 28. Changes in functioning (AD Cooperative Study-Activities of Daily Living scale, ADCS-ADL) and behaviour (Neuropsychiatric Inventory, NPI) were secondary endpoints. Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy. Cognitive performance improved in all treatment groups (mean±SD for Cerebrolysin: -1.7±7.5; donepezil: -1.2±6.1; combination: -2.3±6.0) with best scores in the combined therapy group at all study visits. Cerebrolysin was as effective as donepezil, and the combination of neurotrophic (Cerebrolysin) and cholinergic (donepezil) treatment was safe in mild-to-moderate AD. The convenience of exploring long-term synergistic effects of this combined therapy is suggested.
Assuntos
Doença de Alzheimer/tratamento farmacológico , Aminoácidos/administração & dosagem , Indanos/administração & dosagem , Fármacos Neuroprotetores/administração & dosagem , Piperidinas/administração & dosagem , Atividades Cotidianas , Idoso , Donepezila , Método Duplo-Cego , Feminino , Humanos , Masculino , Testes Neuropsicológicos , Resultado do TratamentoRESUMO
Clinical Ethics Committees and Research Ethics Committees have their own specific roles. The Clinical Ethics Committee's pronouncements have an advisory function, whereas Research Ethics Committees' decisions are binding. This article analyzes the legal impact of the Clinical Ethics Committees' reports. Legal and medical reasoning share the same practical nature. Both can have several correct answers to the same situation. Clinical Ethics Committees deliberate about these alternatives and analyze the involved values. Their conclusions are non-compulsory recommendations. They do not replace nor diminish the doctor's personal responsibility. Even though the Clinical Ethics Committees' reports are not binding, they constitute a sort of "expert's opinion", expressed by qualified professionals, who assume their own professional responsibility as advisors. The members' behavior is necessarily subject to constitutional and legal regulations. When judges review the Clinical Ethics Committee's reports, they must realize that their nature is advisory, and also consider them an essential element to reduce the gap between the medical and legal fields. In this way, the problem of increasingly transforming medicine into a legal issue can be prevented.
Assuntos
Comitês de Ética Clínica/legislação & jurisprudência , Prática Profissional/legislação & jurisprudência , Comitês de Ética Clínica/normas , Comitês de Ética em Pesquisa/legislação & jurisprudência , Humanos , Responsabilidade Legal , Papel do Médico , Prática Profissional/normasRESUMO
Clinical Ethics Committees and Research Ethics Committees have their own specific roles. The Clinical Ethics Committee's pronouncements have an advisory function, whereas Research Ethics Committees' decisions are binding. This article analyzes the legal impact of the Clinical Ethics Committees' reports. Legal and medical reasoning share the same practical nature. Both can have several correct answers to the same situation. Clinical Ethics Committees deliberate about these alternatives and analyze the involved values. Their conclusions are non-compulsory recommendations. They do not replace nor diminish the doctor's personal responsibility. Even though the Clinical Ethics Committees' reports are not binding, they constitute a sort of "expert's opinion", expressed by qualified professionals, who assume their own professional responsibility as advisors. The members' behavior is necessarily subject to constitutional and legal regulations. When judges review the Clinical Ethics Committee's reports, they must realize that their nature is advisory, and also consider them an essential element to reduce the gap between the medical and legal fields. In this way, the problem of increasingly transforming medicine into a legal issue can be prevented.
Assuntos
Humanos , Comitês de Ética Clínica/legislação & jurisprudência , Prática Profissional/legislação & jurisprudência , Comitês de Ética Clínica/normas , Comitês de Ética em Pesquisa/legislação & jurisprudência , Responsabilidade Legal , Papel do Médico , Prática Profissional/normasRESUMO
Cerebrolysin (Cere) is a compound with neurotrophic activity shown to be effective in Alzheimer's disease in earlier trials. The efficacy and safety of three dosages of Cere were investigated in this randomized, double-blind, placebo-controlled, study. Two hundred and seventy-nine patients were enrolled (69 Cere 10 ml; 70 Cere 30 ml; 71 Cere 60 ml and 69 placebo). Patients received iv infusions of 10, 30, 60 ml Cere or placebo 5 days/week for the first 4 weeks and thereafter, two iv infusions per week for 8 weeks. Effects on cognition and clinical global impressions were evaluated 4, 12 and 24 weeks after the beginning of the infusions using the CIBIC+ and the modified Alzheimer's Disease Assessment Scale (ADAS)-cog. At week 24, significant improvement of cognitive performance on the ADAS-cog (P=0.038) and global function (CIBIC+; P>0.001) was observed for the 10 ml dose. The 30 and 60 ml doses showed significant improvement of the global outcome but failed to show significant improvement of cognition. The results are consistent with a reversed U-shaped dose-response relationship for Cere. The percentage of patients reporting adverse events was similar across all study groups. Cere treatment was well tolerated and led to significant, dose-dependent improvement of cognition and global clinical impression.