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COVID-19 , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Vacunas , Humanos , Vacunas contra la COVID-19/efectos adversos , COVID-19/prevención & control , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Europa (Continente) , VacunaciónRESUMEN
Our aims were to provide updated information on placebo/nocebo effect and the potential use of placebo in clinical practice. This article can only provide a rough overview on the placebo and nocebo effect and is intended to serve as a starting point for the reader to go deeper into the corresponding literature. The placebo effect has been observed in multiple medical conditions, after oral administration, with manual therapies as well as with surgery and invasive procedures. The use of placebo in clinical trials is fundamental, although the ethics of its use is under discussion. The placebo may behave like a drug from the pharmacokinetic and pharmacodynamic point of view and can also be associated with adverse events (nocebo effect). Placebo can modify treatment by increasing or decreasing the effects of drugs. The factors associated with the occurrence of placebo effect are multiple, but in addition to those that depend on the placebo itself, the doctor-patient relationship would be the most important. As a result of findings that were published in the last two decades, the psycho-neurobiological basis of placebo is becoming better understood, although further studies are needed. In conclusion, the placebo effect in the clinic exhibits weak to moderate intensity. Placebo, in addition to its use in the clinical trial, should be considered another therapeutic remedy either as stand alone or in association with treatment, and could be useful in certain circumstances. The use of placebo should be regulated by the European health authorities through a guide in clinical practice that will improve patient care.
Asunto(s)
Efecto Nocebo , Relaciones Médico-Paciente , Humanos , Efecto PlaceboRESUMEN
PURPOSE: Our aim was to determine the impact of potentially inappropriate prescriptions (PIP), according to "Screening Tool of Older Persons' Prescriptions" criteria version 2 (STOPP-2), on mortality and hospital admissions. METHODS: Monocentric retrospective cohort study. Patients over 65 years of age and who were consecutively discharged from internal medicine at a Spanish university hospital in 2016 were included. The mortality and hospital admissions of the cohort of patients were analysed using their electronic health records within two years from the time of discharge. Analysis was done based on the type and number of STOPP-2 criteria as well as taking into account the total number of medications. The subdistribution hazard ratios (SHR) were estimated through a competing proportional hazards model. RESULTS: A total of 270 patients with a median age of 82 years (interquartile range/IQR 76-86 years), and 152 (56.3%) women were studied. It was found out that 28.3% of patients with PIP died compared to 17.2% of patients without it. Digoxin (B1 STOPP-2 criterion) with a subdistribution hazard ratio (SHR) 2.40 (95% CI 0.63-9.18), selective serotonin re-uptake inhibitors/SSRIs (D4) with a SHR 1.76 (95% CI 0.52-5.96) and neuroleptic drugs (K2) with a SHR 2.01 (95% CI 0.82-4.95) non-significantly increased the risk of death. Dementia (SHR 5.45; 95% CI 2.76-10.78) was then the only statistically significant risk factor for death. Sixty percent of patients with a PIP had shown at least one hospital admission compared to 51% of patients without it. The number of drugs at discharge (SHR 1.03; 95% CI 1.01-1.05) and having 1-2 STOPP-2 criteria (SHR 1.17; 95% CI 1.02-1.35) significantly increased the risk of hospital admission. CONCLUSION: The number of drugs at discharge and having any STOPP criteria significantly increased the risk of hospital admission in this cohort. PIP, only according to some specific STOPP-2 criteria involving digoxin, neuroleptics and SSRIs, might associate with a statistically non-significantly higher risk on mortality.
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Prescripción Inadecuada/estadística & datos numéricos , Mortalidad/tendencias , Readmisión del Paciente/estadística & datos numéricos , Factores de Edad , Anciano , Anciano de 80 o más Años , Registros Electrónicos de Salud , Femenino , Humanos , Masculino , Estudios Retrospectivos , Factores de RiesgoRESUMEN
Our aim was to compare adverse drug reactions (ADRs) associated with direct-acting oral anticoagulants and vitamin K antagonists from the European EudraVigilance (EV) database. The EV database is the system for the analysis of information on suspected ADRs that are authorised, or being evaluated in clinical trials, in the European Economic Area. Registered ADRs (from the groups "Gastrointestinal disorders", "General disorders and administration site conditions", "Injury, poisoning and procedural complications", "Nervous system (NS) disorders" and "Vascular disorders") for apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKA) were collected by age group (< 65 years; 65-85 years and > 85 years) and by sex. The proportional reporting ratio (PRR) was used to compare ADRs in relation to the anticoagulants tested. A total of 274,693 ADRs were analysed. For gastrointestinal ADRs, patients treated with rivaroxaban and dabigatran (PRR 2.17 and 2.51, respectively) were at significantly higher risks than those treated with apixaban and VKA (PRR 1.27 and 1.47, respectively), while risks for vascular disorders were increased by all anticoagulants that were tested. Lastly, none of the anticoagulants significantly increased the risk of ADRs within the NS group. Rivaroxaban and dabigatran were associated with a significantly higher risk of gastrointestinal ADR than apixaban or VKA. All anticoagulants increased the risk of vascular pathology while none of them demonstrated significant increased risk of ADR to NS.
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Anticoagulantes/efectos adversos , Bases de Datos Factuales/estadística & datos numéricos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Farmacovigilancia , Vitamina K/antagonistas & inhibidores , Administración Oral , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Anticoagulantes/administración & dosificación , Dabigatrán/administración & dosificación , Dabigatrán/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/diagnóstico , Femenino , Enfermedades Gastrointestinales/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Pirazoles/administración & dosificación , Pirazoles/efectos adversos , Piridonas/administración & dosificación , Piridonas/efectos adversos , Rivaroxabán/administración & dosificación , Rivaroxabán/efectos adversos , Adulto JovenAsunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/diagnóstico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/mortalidad , Hospitalización/tendencias , Hospitales de Enseñanza/tendencias , Factores de Edad , Anciano , Anciano de 80 o más Años , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Curva ROC , Estudios Retrospectivos , Factores de Riesgo , Factores Sexuales , España/epidemiologíaAsunto(s)
Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/metabolismo , Polipéptido alfa Relacionado con Calcitonina/metabolismo , Carcinoma Pulmonar de Células Pequeñas/diagnóstico , Carcinoma Pulmonar de Células Pequeñas/metabolismo , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Biomarcadores , Biopsia , Humanos , Infecciones/etiología , Neoplasias Pulmonares/complicaciones , Neoplasias Pulmonares/terapia , Masculino , Polipéptido alfa Relacionado con Calcitonina/sangre , Carcinoma Pulmonar de Células Pequeñas/complicaciones , Carcinoma Pulmonar de Células Pequeñas/terapia , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
AIM: To determine if there are ethnic differences in the prevalence of antiphospholipid syndrome (APS), clinical presentation and autoantibody profile between Roma and Caucasian patients with systemic lupus erythematosus (SLE). METHOD: A cross-sectional study was conducted including data from Roma and Caucasian SLE patients consecutively attending six hospitals in Spain. Socio-demographic characteristics, prevalence of APS, clinical and analytical features of SLE and APS were compared between ethnic groups. RESULTS: Data from 52 Roma and 98 Caucasian SLE patients were included. Roma SLE patients had a higher risk (odds ratio 2.56, 95% CI 1.02-6.39) and prevalence of APS (28.8% vs. 13.3%, P = 0.027). Furthermore, Roma SLE patients had a statistically significant higher prevalence of abortions (23.5% vs. 10.2%, P = 0.049). In relation to other APS diagnostic criteria, Roma SLE patients had a non-statistically significant higher prevalence of fetal deaths (14.3% vs. 5.1%, P = 0.106) and thrombotic events (21.1% vs. 12.2%, P = 0.160). In relation to SLE clinical features, Roma patients had a significantly higher prevalence of arthritis (75% vs. 57.1%, P = 0.034) and non-significant higher prevalence of serositis (44.2% vs. 29.6%, P = 0.104), discoid lesions (11.5% vs. 5.1%, P = 0.191), oral ulcers (46.1% vs. 34.7%, P = 0.218) and livedo reticularis (21.1% vs. 15.3%, P = 0.374). No statistically significant differences were found in the Systemic Lupus International Collaborating Clinics Damage Index or the autoimmune serological profile. CONCLUSION: Prevalence and risk of APS were significantly higher in Roma SLE patients. Furthermore, Roma patients had a significantly higher prevalence of abortions and a non-significant higher prevalence of fetal deaths and thrombotic events.
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Síndrome Antifosfolípido/etnología , Lupus Eritematoso Sistémico/etnología , Romaní , Población Blanca , Aborto Espontáneo/etnología , Adolescente , Adulto , Anticuerpos Antifosfolípidos/sangre , Síndrome Antifosfolípido/sangre , Síndrome Antifosfolípido/diagnóstico , Síndrome Antifosfolípido/inmunología , Biomarcadores/sangre , Comorbilidad , Estudios Transversales , Femenino , Muerte Fetal , Humanos , Lupus Eritematoso Sistémico/sangre , Lupus Eritematoso Sistémico/diagnóstico , Lupus Eritematoso Sistémico/inmunología , Masculino , Persona de Mediana Edad , Embarazo , Prevalencia , Medición de Riesgo , Factores de Riesgo , España/epidemiología , Trombosis/etnología , Adulto JovenRESUMEN
AIM: This study aims to determine the prevalence of potentially inappropriate prescribing (PIP) among patients discharged from Internal Medicine, the drugs and factors associated and economic cost of PIP. METHODS: This retrospective cross-sectional, single-center study included participants aged ≥65 years consecutively discharged from the Internal Medicine Unit in a tertiary hospital of Southern Spain. PIP was defined by the Screening Tool for Older Persons Prescriptions (STOPP-2) criteria version 2 (2015 update). The association of PIP with chronic conditions was analyzed using multilevel logistic regression model. Data on economic cost associated to PIP were determined according to the computerized prescribing database of Andalusia ("Receta XXI"). RESULTS: Out of the 275 patients studied, a total of 249 PIPs were detected in 114 (41.5%) patients of whom 79 (28.7%) had one or two STOPP-2 criteria and 35 (12.7%) 3 or more criteria. The most involved drugs were benzodiazepines (45.5%); antithrombotics (14.5%), including anticoagulants or antiplatelets, and opioids (11.4%). The multivariate logistic regression analysis identified polypharmacy (OR=11.00; 95% CI 1.41-85.52) and extreme polypharmacy (OR=26.25; 95% CI 3.34-206.07) as independent risk factors for PIP. The mean cost of PIP was 18.75±4.24 per patient and month. Opioids accounted for the highest percentage expenditure of PIP (39.02%), followed by inhaled bronchodilator drugs (30.30%), antithrombotics (12.20%) and benzodiazepines (7.92%). CONCLUSIONS: PIP is frequent among patients discharged from Internal Medicine. The number of prescribed drugs was independently associated to PIP and benzodiazepines were the most involved drugs. PIP was associated to a significant economic cost.
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Adhesión a Directriz/estadística & datos numéricos , Prescripción Inadecuada/estadística & datos numéricos , Lista de Medicamentos Potencialmente Inapropiados , Pautas de la Práctica en Medicina/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Estudios Transversales , Costos de los Medicamentos/estadística & datos numéricos , Femenino , Adhesión a Directriz/economía , Unidades Hospitalarias , Humanos , Prescripción Inadecuada/economía , Medicina Interna , Masculino , Alta del Paciente , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en Medicina/economía , Estudios Retrospectivos , EspañaRESUMEN
No disponible
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Humanos , Masculino , Femenino , Anciano , Anciano de 80 o más Años , Prescripción Inadecuada/efectos adversos , Prescripción Inadecuada/prevención & control , Polifarmacia , Deprescripciones , Algoritmos , Receptores de GABA-A/uso terapéutico , Consentimiento Informado/normas , Diuréticos/uso terapéutico , Indicadores de MorbimortalidadRESUMEN
PURPOSE: Hospital mortality related to adverse drug reactions (ADRs) is a relevant clinical problem with major health and economic consequences. We conducted a study to assess hospital mortality related to ADRs, the drugs most frequently involved, and the possible risk factors associated with fatal ADRs. METHODS: A retrospective observational study was conducted, reviewing the clinical records of 1388 consecutive adult patients (18-101 years) who died during a 22-month period in a tertiary hospital in Southern Europe (Granada, Spain). The main outcome was the prevalence of hospital death suspected to be related to administered drugs. RESULTS: Out of the 1388 adult deaths studied, 256 (18.4 %) were suspected of being related to drugs. Drugs were suspected of causing death in 146 inpatients (10.5 %) and contributing to death in 110 (7.9 %). Drugs related to death were administered during the hospital stay in 161 cases (11.5 %) and before hospital admission in 95 (6.84 %). The most frequent fatal ADRs were cardiac arrhythmia, gastrointestinal bleeding, and respiratory failure. The drugs most frequently involved in fatal ADRs were antithrombotics (anticoagulants or antiplatelets) (23 %), psychotropic drugs (21.2 %), and digoxin (11.3 %). Independent risk factors for ADR-related death were the presence of ≥4 diseases (OR = 1.43) and the receipt of ≥10 drugs (OR = 3.24), but no significant association with gender or age was found. CONCLUSIONS: A high percentage of hospital deaths were suspected of being associated with ADRs, especially in patients with comorbidity and/or polypharmacy. Antithrombotics, psychotropics, and digoxin were the drugs most frequently associated with in-hospital drug-related deaths.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/mortalidad , Mortalidad Hospitalaria , Pacientes Internos/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Digoxina/efectos adversos , Femenino , Fibrinolíticos/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Psicotrópicos/efectos adversos , España/epidemiología , Adulto JovenRESUMEN
Adult Still's Disease has been reported as cause of Fever of Unknown Origin. Leukocytosis has been described as a common haematological abnormality in Adult Still's Disease. In some rare cases, leukemoid reaction has been reported associated to Still's Disease. We report the case of Adult Still's Disease presenting as Fever of Unknown Origin and leukemoid reaction in a patient with Down Syndrome. The patient needed high dosage of corticosteroids to control the disease and haematological findings.
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Fiebre de Origen Desconocido/etiología , Reacción Leucemoide/etiología , Enfermedad de Still del Adulto/complicaciones , Enfermedad de Still del Adulto/diagnóstico , Adulto , Humanos , MasculinoRESUMEN
No disponible
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Humanos , Masculino , Persona de Mediana Edad , Mielinólisis Pontino Central/tratamiento farmacológico , Inmunoglobulinas/uso terapéutico , Inyecciones IntravenosasRESUMEN
TITLE: Respuesta favorable al uso de inmunoglobulinas intravenosas en la mielinolisis central pontina.