Asunto(s)
Comités de Ética en Investigación , Comités de Ética/normas , Regulación Gubernamental , Investigación , Compensación y Reparación , Confidencialidad , Revelación , Revisión Ética , Unión Europea , Humanos , Internacionalidad , Responsabilidad Legal , Registros Médicos , Sujetos de Investigación , Seguridad , Medicina Estatal , Reino UnidoAsunto(s)
Ética Médica , Farmacología Clínica , Consentimiento Informado , Investigación , Reino UnidoAsunto(s)
Industria Farmacéutica , Farmacología Clínica , Médicos , Ética Médica , Londres , Mala Conducta Profesional , Sociedades MédicasRESUMEN
KIE: Two professors, one of law and the other of pharmacology, trace the development of English law on compensation for injuries caused by defective drugs and examine the Vaccine Damage Payments Act of 1980, which established a no-fault system of compensation for vaccine injuries for a limited number of diseases. They discuss two possible approaches to handling compensation for drug-induced injuries in the future--use of the law of "strict liability" or creation of a no-fault system. The authors propose a model no-fault scheme and urge that the principal interested parties develop such a no-fault system without waiting for government action.^ieng
Asunto(s)
Seguridad de Productos para el Consumidor , Legislación de Medicamentos , Adulto , Niño , Industria Farmacéutica , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Inglaterra , Femenino , Humanos , Seguro de Responsabilidad Civil , Masculino , Vacunas/efectos adversosRESUMEN
KIE: The Association of the British Pharmaceutical Industry's guidelines on compensating patients for injuries incurred in clinical trials of drugs are published here, followed by a commentary co-authored by two ethics committee members who have reviewed such trials. Among the issues covered by the guidelines and clarified by the commentary are provision for compensation without proof of negligence; payment only for injuries caused by the drug under investigation and not by other factors; payment to patients involved in trials, but not to healthy volunteers; and the amount of compensation.^ieng
Asunto(s)
Ensayos Clínicos como Asunto , Evaluación de Medicamentos , Ética Médica , Industria Farmacéutica , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , Reino UnidoRESUMEN
A trial has been conducted of the efficacy of human tetanus immunoglobulin (250 I U) administered intrathecally (intracisternally) in addition to standard treatment (equine antitoxin intravenously, penicillin, anticonvulsants). The trial was analysed sequentially and was stopped for 120 patients when there was no longer any chance of achieving a statistically significant difference in favour of intrathecal administration. The sequential plan was modified during the trial. A prognostic correlation was found between onset of the first symptom and admission to hospital.
Asunto(s)
Ensayos Clínicos como Asunto , Antitoxina Tetánica/uso terapéutico , Tétanos/terapia , Adulto , Femenino , Humanos , Inmunoglobulinas/administración & dosificación , Inmunoglobulinas/uso terapéutico , Inyecciones Espinales , Tiempo de Internación , Masculino , Pronóstico , Tétanos/inmunología , Tétanos/mortalidad , Antitoxina Tetánica/administración & dosificaciónRESUMEN
Recommendations for the prevention of tetanus in the wounded have been revised to incorporate the use of human tetanus immunoglobulin, which is now available in the United Kingdom. Surgical toilet is of prime importance for all wounds, and is usually sufficient for tetanus prophylaxis in patients with wounds that are less than six hours old, clean, non-penetrating, and with negligible tissue damage. Human tetanus immunoglobulin should be given to patients with more serious wounds sho have had toxoid injections over 10 years earlier, had an incomplete course, or do not know their immunity status. The importance of active immunization is emphasized. The recommendations should be regarded as guidelines as the circumstances in individual cases will differ.
Asunto(s)
Inmunización , Antitoxina Tetánica/uso terapéutico , Toxoide Tetánico , Tétanos/prevención & control , Infección de Heridas/prevención & control , Humanos , Higiene , Inmunización SecundariaAsunto(s)
Dihidroxifenilalanina/uso terapéutico , Enfermedad de Parkinson/tratamiento farmacológico , Actividades Cotidianas , Anciano , Trastornos del Conocimiento/inducido químicamente , Dihidroxifenilalanina/administración & dosificación , Dihidroxifenilalanina/efectos adversos , Evaluación de Medicamentos , Expresión Facial , Femenino , Estudios de Seguimiento , Marcha , Alucinaciones/inducido químicamente , Humanos , Hipotensión Ortostática/inducido químicamente , Masculino , Persona de Mediana Edad , Trastornos del Movimiento/inducido químicamente , Náusea/inducido químicamente , Trastornos Paranoides/inducido químicamente , Postura , Habla , Síndrome de Abstinencia a Sustancias , Sudoración , Factores de TiempoRESUMEN
Intravenous infusions of phenylephrine, noradrenaline, adrenaline, and isoprenaline were given to healthy human volunteers after five to seven days on phenelzine, tranylcypromine, or imipramine, and cardiovascular responses were compared with those observed under control conditions. With monoamine oxidase inhibitors there was a 2-2(1/2) fold potentiation of the pressor effect of phenylephrine, but no clinically significant potentiation of cardiovascular effects of noradrenaline, adrenaline, or isoprenaline. With imipramine there was potentiation of the pressor effects of phenylephrine (2-3 fold), noradrenaline (4-8 fold), and adrenaline (2-4 fold); there were dysrhythmias during adrenaline infusions, but no noticeable or consistent changes in response to isoprenaline.Noradrenaline and adrenaline in amounts contained in local anaesthetics used in dentistry are not likely to be significantly potentiated in otherwise healthy patients receiving monoamine oxidase inhibitors. Hazardous potentiation of their cardiovascular effects might occur in patients receiving tricyclic antidepressants.Our observations do not indicate that the hazards associated with isoprenaline inhalation by bronchial asthmatics would be increased by coincident therapy with a monoamine oxidase inhibitor or tricyclic antidepressant.
