Análisis descriptivo de los ensayos clínicos con subestudio farmacogenético presentados al Comité Autonómico de Andalucía (2005-2008) / Descriptive analysis of clinical trials with pharmacogenetics substudy submitted to the Ethics Committee of Andalusia, Spain (2005-2008)

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Análisis descriptivo de los ensayos clínicos con subestudio farmacogenético presentados al Comité Autonómico de Andalucía (2005-2008) / Descriptive analysis of clinical trials with pharmacogenetics substudy submitted to the Ethics Committee of Andalusia, Spain (2005-2008)

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Use of non-specific intravenous human immunoglobulins in Spanish hospitals; need for a hospital protocol.

UNLABELLED: Intravenous immunoglobulin (IVIG) use in non-approved indications, the increase in consumption and its high cost recommend rationalisation in its utilisation. AIMS: To assess the use of IVIG in Spanish hospitals. METHODS: An observational, prospective and multicentre drug utilisation study was conducted in 13 tertiary Spanish hospitals. Data were collected for 3 months in patients receiving any IVIG. Patient demographics, indication for IVIG use, dosage regimen and cost of treatment were collected. RESULTS: Five hundred and fifty-four patients (mean age of 52 years) were included in the study. A total of 1,287 prescriptions were administered, and the average number of prescriptions per patient was 2.3. The mean daily dose was 24 g (range 0.6-90 g). Overall, IVIG was prescribed for authorised indications in 335 patients (60%) with 953 prescriptions (74%), for non-authorised indications with scientific evidentiary support in 86 patients (16%) with 137 prescriptions (11%), and non-authorised and non-accepted indications in 133 patients (24%) with 197 prescriptions (15%). The most frequent authorised indications were primary and secondary immunodeficiencies, and the most frequent non-authorised and non-accepted indications were multiple sclerosis and bullous dermatosis. The mean cost of IVIG per patient for authorised indications was 2,636.2 , non-authorised indications with scientific support 5,262.1 and non-accepted indications 3,555.8 . CONCLUSIONS: IVIG is prescribed for a significant number of non-authorised and non-accepted indications with a notable cost. There is an important variability in IVIG prescriptions between hospitals, indicating room for improvement in IVIG use and the need for a consensus of protocol use.

Investigación en Terapéutica clínica: Ensayos clínicos con medicamentos / Research in Therapeutics. Clinical trials with drugs

La investigación biomédica mediante ensayos clínicos ofrece rasgos propios: finalidad concreta, aplicabilidad inmediata y efectuarse sobre seres humanos. Está sometida al ordenamiento jurídico, y en nuestro país específicamente al Real Decreto 223/2.004. Se puede definir al ensayo clínico como una prueba científica de un fármaco, aceptada por el enfermo y amparada por la ley. En cualquier caso, siempre deben respetárselos postulados éticos básicos: autonomía, justicia, beneficencia y no maleficencia. Los protagonistas den ensayo clínico son: promotor, monitor, investigador los sujetos del ensayo, todos ellos ensamblados porras autoridades sanitarias. Para su aprobación, el ensayo clínico necesita la existencia de un protocolo específico. El principal problema en la realización reensayos clínicos es conseguir la coordinación de todas las personas e instituciones participantes en el mismo (AU)

Biomedical research via clinical trials offers certain features: defined aim, immediate applicability, and implementation on human beings. It is subject to the legal system — in Spain, specifically to the Real Decreto 223/2.004. The clinical trial can be defined as the scientific testing of a drug, accepted by the patient and safeguarded by law. In all cases, the basic ethical postulates of independence, equity, virtue, and non-harmfulness must always be respected. The participants in a clinical trial are the promoter, the supervisor, the researcher, and the subjects under trial — all convened by the health authorities. The approval of a clinical trial requires the existence of a specific protocol. The main problem in carrying out clinical trials is to achieve the co-ordination of all the people and institutions taking part (AU)

Probable toxicidad hepática por clopidogrel / Clopidogrel probably induced hepatic toxicity

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