Underreporting and Triggering Factors for Reporting ADRs of Two Ophthalmic Drugs: A Comparison between Spontaneous Reports and Active Pharmacovigilance Databases.

(1) Aims of the study: calculating the underreporting ratio for two different medications, a fixed combination of 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide (antiglaucoma) and a fixed combination of sodium hyaluronate 0.1% + chondroitin sulfate 0.18% (artificial tears) for characterizing the features influencing the reporting of adverse drug reactions (ADRs) in spontaneous reporting. (2) Methods: The underreporting ratio was calculated by comparing the adverse drug reactions reported in the spontaneous reporting database for every 10,000 defined daily doses marketed and the adverse drug reactions from an active surveillance study for every 10,000 defined daily doses used for different drugs (antiglaucoma and artificial tears). The factors related to the report in spontaneous reporting through statistical tests were also determined. (3) Results: The underreporting ratio of spontaneous reporting was 0.006029% for antiglaucoma and 0.003552% for artificial tears. Additionally, statistically significant differences were found for severity, unexpected adverse drug reactions, and incidence of adverse drug reactions in females when compared with spontaneous reporting and active surveillance. (4) Conclusions: The underreporting ratio of ADRs related to ophthalmic medications indicates worry since the cornerstone of pharmacovigilance focuses on spontaneous reporting. Additionally, since underreporting seems to b selective, the role of certain aspects, such as gender, seriousness, severity, and unexpected ADRs, must be considered in future research.

Ophthalmic Solution Safety Profile: Active Surveillance of a Sodium Hyaluronate/Chondroitin Sulfate Combination in Peruvian Population.

BACKGROUND: Sodium hyaluronate/chondroitin sulfate fixed combination plays an essential role in the treatment of keratoconjunctivitis sicca, a multifactorial disease accompanied by ocular symptoms like alteration of the tear film. Despite low or no absorption of such drugs, these can cause secondary effects. An essential tool in the study of medication behavior is active pharmacovigilance. Unlike spontaneous reporting pharmacovigilance, this tool allows an appraisal of adverse drug reactions (ADRs)' real incidence, a higher capacity to identify safety signals, the relationship with concomitant drugs and pathologies prevalent in the study population. This study aimed to evaluate the safety profile and identify and/or assess adverse reactions in an uncontrolled population. METHODS: Active pharmacovigilance by Drug Event Monitoring was performed. A total of 3 follow-up calls were made for 30 days for the identification of the ADRs, tolerability (ADR severity, seriousness, long term sequelae, and duration) and the possible risks (safety signals, medical interactions) of sodium hyaluronate and chondroitin sulfate (HUM). RESULTS: Thirty-five ADRs were identified in the 212 patients included in the study (0.17 ADR/patient). The 35 ADRs were classified into 3 System Organ Class (SOC) groups: general disorders and administration site conditions (74.2%), eye disorders (22.9%), and nervous system disorders (2.9%); and 4 Preferred Term (PT) groups: burning sensation (74.2%), followed by blurred vision (20%), ocular pain (2.9%) and headache (2.9%). All the ADRs were categorized as mild and not serious. No statistically significant differences were found in concomitantly medications, posology and age groups. CONCLUSION: Good tolerability to the solution was identified, with a low incidence of ADRs. Just the same, all the associated ADRs were consistent with the information found in HUM's physicochemical profile and the physiopathology of DED. No unknown risks were identified, reinforcing HUM's safety profile.

A Drug Safety Surveillance Study of a Ciprofloxacin/Dexamethasone Ophthalmic Fixed Combination in Peruvian Population.

(1) Background: drugs provide a significant benefit for patients who require medical treatment; however, their use implies an intrinsic potential danger, with the possibility of causing unwanted effects. These effects are known as adverse drug reactions (ADRs). Post-marketing drug safety surveillance detects unknown risks that have not been identified in clinical trials, and it is necessary to monitor marketed medications under real-life practice. Due to the scarce information about fixed combination of ciprofloxacin 0.3%/dexamethasone 0.1% (SDO), we performed a drug safety surveillance study. (2) Methods: A prospective non-controlled drug safety surveillance study was conducted in Peruvian population. A total of 236 patients prescribed SDO were included derived from 12 sites. Patients' standardized information was collected through two phone calls, including demographics, medical history, prescribing patterns of SDO, concomitant medication, and ADRs in detail. The ADRs were classified by causality and severity, followed by outcome measures to identify new risk. (3) Results: 236 patients prescribed with SDO participated in the study and 220 were included. A total of 82 ADRs/220 patients were reported after the use of SDO, presenting a ratio 0.37 ADR/patient. The most frequent ADR with SDO administration was eye irritation (30%). All ADRs were classified as non-serious, and 97.5% (n = 80) were classified as mild while 2.5% as moderate (n = 2). No cases under the severe category were identified. (4) Conclusion: No new risks were found in the population where this study was conducted.

Anticuerpos Antifosfolípidos en Enfermedad Periodontal / Antiphospholipid Antibodies in Periodontal Disease

INTRODUCCIÓN Las complicaciones obstétricas observadas en la enfermedad periodontal (EP) son similares a las del síndrome antifosfolípido (SAF). Se desconoce la prevalencia de los anticuerpos antifosfolípidos (aPL) en mujeres con EP y su relación con complicaciones obstétricas. Objetivo/s: Investigar la prevalencia de aPL, criterio y no criterio, en mujeres en edad fértil con EP; y su asociación con antecedentes obstétricos adversos. MÉTODOS El estudio se llevó a cabo en el Hospital Odontológico Universitario de la Facultad de Odontología de la Universidad de Buenos Aires (UBA); las determinaciones de laboratorio se realizaron en el Laboratorio de Hemostasia del Departamento de Bioquímica Clínica de la Facultad de Farmacia y Bioquímica, UBA. Se realizó un estudio de casos y controles. Se definió como caso a pacientes con EP. Se incluyeron mujeres entre 30 y 45 años, que hubieran tenido embarazos en los últimos 5 años. RESULTADOS El estudio no alcanzó el tamaño muestral calculado. Se incluyeron 50 pacientes; se informan los datos 28 casos (edad: 34.8±2.2) y 21 controles (edad: 31±1.8) con resultados de laboratorio completos. El 75% de los casos y el 62% de los controles tuvieron partos normales en los últimos 5 años. Sólo los casos tuvieron positividad de aPL criterio (28%, 8/28 pacientes); únicamente se constataron AL y títulos altos de aCL y aB2GPI en 2 pacientes con enfermedad periodontal (frecuencia: 7.1%). Se observó positividad de Ac. "no criterio" en 4 pacientes (1 caso y 3 controles). Ninguna paciente con EP y aPL criterio positivos tuvo antecedentes obstétricos adversos. Un caso con EP y Ac. Anti Anexina V IgM había tenido un parto prematuro un año antes. DISCUSIÓN Sólo se observaron aPL en pacientes con EP; no se observó asociación con antecedentes obstétricos adversos. Se requiere mayor número de pacientes para confirmar estas observaciones así como para valorar su asociación con complicaciones bstétricas.

[Prevalence of anti-Toxoplasma gondii antibodies in blood donors in Buenos Aires city, from 1967 to 2017]. / Prevalencia de anticuerpos anti-Toxoplasma gondii en hemodonantes en la ciudad de Buenos Aires, desde 1967 a 2017.

A prevalence study of antibodies anti Toxoplasma gondii in voluntary blood donors who attended the hemotherapy service at the Hospital Alemán during the first four months of the years 1997, 2007 and 2017 was carried out and the results were compared to the study carried out in 1967. The sera where processed with the Sabin Feldman Dye Test. The global average seroprevalence in 1967 was 67.0% (CI95%, 64.4%-69.6%); in 1997, 35.0% (CI95%, 33.3%-38.3%); in 2007, 31.9% (CI95%, 29.6%-34.2%) and in 2017, 21.2% (CI95%, 19.0%-23.3%). In the fifty years covered by the study the decline in prevalence was 45.8%, which represents an average annual decline of 0.9%.The decline was statistically significant between 1967 and 1997, and between 2007 and 2017. The four studies demonstrate that infection prevalence increased depending on age. The infection rate for 1967 was 1.0% per year and declined in the next studies to 0.8% in 1997, 0.8% in 2007, and 0.5% in 2017. Donors from the last study responded to a survey that showed a statistically significant correlation between seroprevalence of Toxoplasma gondii antibodies and lack of tap water, unfinished secondary studies or residence in the western or southern part of the Buenos Aires metropolitan area. No significant association was found with having a cat as a pet, the consumption of undercooked meat or the practice of gardening.

Prevalencia de anticuerpos anti Toxoplasma gondii en hemodonantes en la ciudad de Buenos Aires, desde 1967 a 2017 / Prevalence of anti-Toxoplasma gondii antibodies in blood donors in Buenos Aires city, from 1967 to 2017

Se estudió la prevalencia de anticuerpos anti Toxoplasma gondii a los dadores voluntarios de sangre que concurrieron durante el primer cuatrimestre de los años 1997, 2007 y 2017 al Servicio de Hemoterapia del Hospital Alemán de Buenos Aires y se compararon los resultados con el estudio efectuado en el año 1967. Los sueros fueron procesados con el Sabin Feldman Dye Test. La seroprevalencia promedio en 1967 fue 67.0% (IC95%, 64.4%-69.6%), en 1997, 35% (IC95%, 33.3%-38.3%), en 2007, 31.9 % (IC95%, 29.6%-34.2%) y en 2017, 21.2% (IC95%, 19.0%-23.3%). En los cincuenta años que abarca el estudio la disminución de la prevalencia fue de 45.8%, que representa una declinación anual promedio del 0.9%. El descenso fue estadísticamente significativo entre los años 1967 y 1997 y entre 2007 y 2017. En los cuatro estudios se observó un incremento de la prevalencia de infección en función de la edad. La tasa de infección calculada para el año 1967 fue 1.0% y disminuyó en los estudios posteriores, a 0.8% en 1997, 0.7% en 2007 y 0.5% en 2017. Los donantes del último estudio respondieron una encuesta que mostró una correlación estadísticamente significativa entre seroprevalencia de anticuerpos anti-Toxoplasma gondii y la carencia de agua corriente, estudios secundarios no concluidos o la residencia en zona oeste o sur del conurbano bonaerense. No se encontró una asociación significativa con tener un gato como mascota, consumo de carne poco cocida o práctica de jardinería.

A prevalence study of antibodies anti Toxoplasma gondii in voluntary blood donors who attended the hemotherapy service at the Hospital Alemán during the first four months of the years 1997, 2007 and 2017 was carried out and the results were compared to the study carried out in 1967. The sera where processed with the Sabin Feldman Dye Test. The global average seroprevalence in 1967 was 67.0% (CI95%, 64.4%-69.6%); in 1997, 35.0% (CI95%, 33.3%-38.3%); in 2007, 31.9% (CI95%, 29.6%-34.2%) and in 2017, 21.2% (CI95%, 19.0%-23.3%). In the fifty years covered by the study the decline in prevalence was 45.8%, which represents an average annual decline of 0.9%.The decline was statistically significant between 1967 and 1997, and between 2007 and 2017. The four studies demonstrate that infection prevalence increased depending on age. The infection rate for 1967 was 1.0% per year and declined in the next studies to 0.8% in 1997, 0.8% in 2007, and 0.5% in 2017. Donors from the last study responded to a survey that showed a statistically significant correlation between seroprevalence of Toxoplasma gondii antibodies and lack of tap water, unfinished secondary studies or residence in the western or southern part of the Buenos Aires metropolitan area. No significant association was found with having a cat as a pet, the consumption of undercooked meat or the practice of gardening.

Statins but not aspirin reduce thrombotic risk assessed by thrombin generation in diabetic patients without cardiovascular events: the RATIONAL trial.

BACKGROUND: The systematic use of aspirin and statins in patients with diabetes and no previous cardiovascular events is controversial. We sought to assess the effects of aspirin and statins on the thrombotic risk assessed by thrombin generation (TG) among patients with type II diabetes mellitus and no previous cardiovascular events. METHODOLOGY/PRINCIPAL FINDINGS: Prospective, randomized, open, blinded to events evaluation, controlled, 2×2 factorial clinical trial including 30 patients randomly allocated to aspirin 100 mg/d, atorvastatin 40 mg/d, both or none. Outcome measurements included changes in TG levels after treatment (8 to 10 weeks), assessed by a calibrated automated thrombogram. At baseline all groups had similar clinical and biochemical profiles, including TG levels. There was no interaction between aspirin and atorvastatin. Atorvastatin significantly reduced TG measured as peak TG with saline (85.09±55.34 nmol vs 153.26±75.55 nmol for atorvastatin and control groups, respectively; p = 0.018). On the other hand, aspirin had no effect on TG (121.51±81.83 nmol vs 116.85±67.66 nmol, for aspirin and control groups, respectively; p = 0.716). The effects of treatments on measurements of TG using other agonists were consistent. CONCLUSIONS/SIGNIFICANCE: While waiting for data from ongoing large clinical randomized trials to definitively outline the role of aspirin in primary prevention, our study shows that among diabetic patients without previous vascular events, statins but not aspirin reduce thrombotic risk assessed by TG. TRIAL REGISTRATION: ClinicalTrials.gov NCT00793754.

Los tiempos difíciles y la inteligencia emocional en el ejercicio odontológico

El odontólogo contemporáneo esta sometido a infinidad de situaciones personales, académicas y de trabajo que afectan directamente su comportamiento, esto se evidencia en el manejo de las emociones que le corresponde experimentar en su día a día. Las últimas teorías acerca de la inteligencia emocional marcan una nueva tendencia cognitiva, unida a ellos los hallazgos de la programación neurolinguística y los descubrimientos relacionados con el desarrollo del cerebro, la motivación y las relaciones interpersonales vitales en el campo odontológico, fundamentan la importancia de este tema.

Contemporaneous odontologist is professional is submitted to infiniteness personal, academics and work situations that affects directly his behavior; this make clear in the driven of emotions that he does correspond experiment in his day to day. Last theories about emotional intelligence mark a new cognitive tendency, besides, the new searching about neurolinguist programmes and discoveries engaged with the development of brain, motivation, and interpersonal relationships, which are vital in odontological field, the bases of the importance of this theme.

Influencia de un programa educativo brindado por la enfermera sobre hipertensión arterial, complicaciones y medidas higiénico - dietéticas a pacientes de la consulta externa de cardiología del Hospital Nacional Arzobispo Loayza febrero - abril 1997 / Influence of an educative program offered by the nurse on arterial hypertension, complications and measures hygienic - dietetic to patients of the external consultation of cardiology of the Hospital Nacional Arzobispo Loayza February - April 1997

El presente trabajo de investigación es un estudio cuasi - experimental, prospectivo y de corte longitudinal, que tuvo como finalidad mostrar el valor de la función educativa, asistencial y científica de la enfermera sobre todo en el nivel preventivo - promocional de la salud al medir la influencia de un programa educativo brindado por la enfermera sobre hipertensión arterial, complicaciones y medidas higiénico dietéticas a pacientes hipertensos, realizados en la consulta externa de Cardiología del Hospital Nacional Arzobispo Loayza. Se tomó una población de 29 personas, utilizando como instrumento un cuestionario de preguntas que se aplicó en tres oportunidades, uno antes de impartir el contenido educativo y los otros dos después del mismo. El estudio se llevó a cabo entre los meses de febrero - abril de 1997. El estudio establece que la enfermera profesional aplicando un programa educativo de salud con costos mínimos y dedicación exclusiva, interviene directamente en el nivel de prevención y control de la hipertensión arterial, lográndose un nivel de conocimientos aceptables de los pacientes sobre su enfermedad, complicaciones y medidas higiénico - dietéticas que se refleja en los resultados óptimos obtenidos, comprobándose así la hipótesis alterna. No se encontró influencia de los factores edad, sexo y estado laboral en el nivel de conocimientos alcanzados por el paciente hipertenso. Se sugiere realizar seguimiento a los pacientes que recibieron para medir el cambio de hábitos y la mejora de su calidad de vida.

Integración docente asistencial: la experiencia de enfermería en República Dominicana / Health care and teaching integration: the nursing experience en the Dominican Republic

Indica que el trabajo es producto de los resultados del diagnóstico de las necesidades de los mecanismos de integración docente asistencial de las escuelas de enfermería de las universidades dominicanas; que los resultados de las investigaciones, constituyen el eje integrador entre la docencia y el servicio de salud de la comunidad. Propone la participación activa para el desarrollo de facultades creativas y críticas para el conocimiento de la realidad