The safety and efficacy of the tetanus vaccine intramuscularly versus subcutaneously in anticoagulated patients: a randomized clinical trial

BACKGROUND: In patients treated with oral anticoagulants, subcutaneous injections of anti-tetanus vaccine are usually recommended to reduce the risk of bleeding, although the effectiveness of the vaccine has only been proven for intramuscular injection. The objective of this study was to compare the safety and efficacy of intramuscular and subcutaneous injections of tetanus-diphtheria vaccine in patients treated with oral anticoagulants. METHODS/DESIGN: We present a prospective, double blinded, clinical trial comparing two groups of patients with oral anticoagulants: one group was administered tetanus-diphtheria vaccine by intramuscular injection, while the other was administered the same vaccine by subcutaneous injection. Allocation to each group was randomized and the duration of the study was six years. STUDY POPULATION: all patients treated with oral anticoagulants, who had been administered with at least one dose of vaccine, at 15 Health Centres in Vigo (Spain), and who agreed to participate in the study. The sample size was 115 patients in each group. The main variables for the safety analysis were the measurement of the brachial diameter, the appearance of basic injuries at the vaccine administration site, the appearance of pain and systemic reactions. The variable used for the efficacy analysis was a significant increase in the titres of anti-tetanus toxoid antibodies.An Intention-to-treat analysis will be performed. Details will be classified according to the administration route, while within each group a 3-tiered stratification will be defined by the administered number of doses. As a measure of association, relative risk will be estimated; the reduction of relative risk will also measured. For safety and to control the confounder effect, a logistic regression analysis will be carried out. As a measure of impact the reduction of absolute risk in relation to the total number of patients to be treated and the Number Needed to Treat will be estimated.CONSORT 2010 guidelines were applied for reporting parallel group randomised trials. DISCUSSION: The most significant difficulties on the project are related to the large number of participating centres, required to obtain a viable study population sample size, and the coordination given the scattering of the centres and researchers. TRIAL REGISTRATION: ISRCTN69942081

Galician multidisciplinary consensus about the use of lipid-lowering drugs

Se desarrolla un consenso multidisciplinar sobre el uso de hipolipemiantes, pues las cifras de consumo de hipolipemiantes han aumentado considerablemente en los ultimos años, Las últimas guías publicadas han levantado bastante polémica y se considera necesario la realización de este consenso e identificar los niveles de riesgo de los pacientes, para tratar las dislipemias y normalizar el uso de hipolipemientes. Se realiza una mención especial al tratamiento de la dislipemia en la enfermedad renal crónica

Utilidad diagnóstica del cuestionario STOP-Bang en la apnea del sueño moderada en atención primaria

Objetivo: Validar el cuestionario STOP-Bang para la apnea moderada frente al método de referencia (polisomnografía de tipo I) en atención primaria. Método: Estudio de utilidad diagnóstica en atención primaria con una muestra estimada de 85 casos y 85 controles sanos. Con muestreo por conveniencia, 203 pacientes fueron reclutados por sus médicos en seis centros de salud. Se excluyeron 25 y se analizaron 57 mujeres y 121 hombres, de los cuales 74 tenían un índice de hipopnea-apnea (IHA) ≥15. Se evaluaron el STOP-Bang y el IHA observado en la polisomnografía en cada paciente. El tamano˜ de la muestra, el análisis de la curva ROC y los puntos de corte óptimos se identificaron con los paquetes easyROC, pROC y OptimalCutpoints del software libre R. Resultados: El área bajo la curva en la apnea moderada (IHA ≥15) del STOP-Bang fue 0,737 (0,667-0,808), con puntos de corte óptimos diferentes por sexo (4 en mujeres y 6 en hombres). En la validación cruzada con k = 10, el área bajo la curva para el STOP-Bang fue 0,678. Conclusiones: El STOP-Bang tiene una utilidad diagnóstica moderada para un IHA ≥15, pero superior a la de otras escalas, en una población comunitaria. Su desempeno˜ es más adecuado en las mujeres