RESUMEN

OBJECTIVES: Underreporting of adverse drug reactions (ADRs) limits and delays the detection of signs. The aim of this systematic review with meta-analyses was to synthesize the evidence of educational interventions (EIs) efficacy in health professionals to increase ADR reporting, attitudes, and knowledge of pharmacovigilance. EVIDENCE ACQUISITION: A systematic literature review was carried out to identify randomized clinical trials evaluating the efficacy of EI in pharmacovigilance in health professionals to improve ADR reports, knowledge, and attitude toward pharmacovigilance. ADR reports were pooled by calculating Odds Ratio (OR) with a 95% confidence interval (95%CI), while pharmacovigilance knowledge and attitude were pooled by calculating a mean difference (MD) with 95%CI. In addition, the subanalysis was performed by EI type. Meta-analysis was performed with RevMan 5.4 software. PROSPERO registry CRD42021254270. RESULTS: Eight hundred seventy-five articles were identified as potentially relevant, and 11 were included in the systematic review. Metanalysis showed that EI increased ADR reporting in comparison with control group (OR = 4.74, [95%CI, 2.46 to 9.12], I2 = 93%, 5 studies). In subgroup analysis, the workshops (OR = 6.26, [95%CI, 4.03 to 9.73], I2 = 57%, 3 studies) increased ADR reporting more than telephone-based interventions (OR = 2.59, [95%CI, 0.77 to 8.73], I2 = 29%, 2 studies) or combined interventions (OR = 5.14, [95%CI, 0.97 to 27.26], I2 = 93%, 3 studies). No difference was observed in pharmacovigilance knowledge. However, the subanalysis revealed that workshops increase pharmacovigilance knowledge (SMD = 1.85 [95%CI, 1.44 to 2.27], 1 study). Only one study evaluated ADR reporting attitude among participants and showed a positive effect after the intervention. CONCLUSION: EI improves ADR reports and increases pharmacovigilance knowledge. Workshops are the most effective EI to increase ADR reporting.

Asunto(s)

RESUMEN

INTRODUCTION: Midazolam is a benzodiazepine used for sedation, however, can cause respiratory depression and increases morbidity in patients. Melatonin is an effective alternative to manage anxiety in the perioperative period and could help to reduce the use of benzodiazepines during surgery. The aim of this clinical trial was to determine the efficacy of pre-operative sedation with a single-dose melatonin to reduce intraoperative use of midazolam in women under total abdominal hysterectomy (TAH). MATERIALS AND METHODS: This is a double-blind randomized clinical trial conducted in women over 25 years, scheduled for TAH, with American Society of Anesthesiologists Grade I or II. Each patient was randomly assigned to receive 5 mg of melatonin prolonged-release oral capsules or placebo. Midazolam use for anesthetic management was the decision of the treating anesthesiologist and sedation status was determined using the observer's assessment of alertness/sedation scale. RESULTS: In patients receiving melatonin, the use of midazolam during surgery was less than in patients receiving placebo. In addition, melatonin produces sedation 30 min after administration, the sedative effect was maintained at 60- and 90-min. Furthermore, hospital stay was shorter in patients who received melatonin (p = 0.006). CONCLUSION: Melatonin is effective for reduces intraoperative midazolam consumption and hospital stay in women undergoing TAH.

INTRODUCCIÓN: El midazolam es una benzodiazepina utilizada para la sedación, sin embargo, puede causar depresión respiratoria y aumentar la morbilidad en los pacientes. La melatonina es una alternativa eficaz para controlar la ansiedad en el período perioperatorio y podría ayudar a reducir el uso de benzodiazepinas durante la cirugía. El objetivo de este ensayo clínico fue determinar la eficacia de la sedación preoperatoria con una dosis única de melatonina para reducir el uso intraoperatorio de midazolam en mujeres sometidas a histerectomía abdominal total (HTA). MATERIAL Y MÉTODOS: Se trata de un ensayo clínico aleatorizado doble ciego realizado en mujeres mayores de 25 años, programadas para TAH, con American Society of Anesthesiologists Grado I o II. Cada paciente fue asignado al azar para recibir 5 mg de cápsulas orales de liberación prolongada de melatonina o placebo. El uso de midazolam para el manejo anestésico fue decisión del anestesiólogo tratante y el estado de sedación se determinó mediante la escala OAA/S. RESULTADOS: En las pacientes que recibieron melatonina, el uso de midazolam durante la cirugía fue menor que en las pacientes que recibieron placebo. Además, la melatonina produce sedación 30 min después de la administración, el efecto sedante se mantuvo a los 60 y 90 min. Además, la estancia hospitalaria fue más corta en los pacientes que recibieron melatonina (p = 0.006). CONCLUSIÓN: La melatonina es eficaz para reducir el consumo de midazolam intraoperatorio y la estancia hospitalaria en mujeres sometidas a HTA.

Asunto(s)

RESUMEN

The anti-acetylcholinesterase, larvicidal, antifeedant activities and general toxicity of 15 semisynthetic eugenol derivatives based on clove oil (including the own oil), were evaluated against the maize armyworm, Spodoptera frugiperda (J.E. Smith). Therefore, promising eugenol molecules were classified with larvicidal, anti-acetylcholinesterase and antifeedant activities for controlling this pest. During structure-activity relationship studies and physicochemical profile analysis, it was found that among tested molecules 1-15, eugenol 1, prenyl eugenol 4, isoeugenol 8 and isoeugenol acetate 11 exhibited lethal effects LD50 at concentrations <1 mg/g of insect. On the other hand, eugenol 1, metallyl eugenol 3, isoeugenol 8 and isoeugenol acetate 11 showed a good antifeedant activity (CE50 = 158-209 µg/mL) with a high antifeedant index (70-78%) at concentration 1000 µg/mL, possessing a weak anti-acetylcholinesterase activity (IC50 = 21-31 µg/mL). According to their ecotoxicological profiles (LC50 = 2033.1-6303.8 µg/mL on Artemia salina larvae), isoeugenol 8 and its acetate derivative 11 could be potential used in control of the growth, feeding, or reproduction of S. frugiperda larvae, acting as moderate insecticidal acetylcholinesterase inhibitors and/or antifeedant molecules. Such structure-activity relationship studies could stimulate the identification of lead structures from natural sources for the development of larvicidal and deterrent products against S. frugiperda and related insect pests.

RESUMEN

The development of effective vaccines against neglected diseases, especially those associated with poverty and social deprivation, is urgently needed. Modern vaccine technologies and a better understanding of the immune response have provided scientists with the tools for rational and safer design of subunit vaccines. Often, however, subunit vaccines do not elicit strong immune responses, highlighting the need to incorporate better adjuvants; this step therefore becomes a key factor for vaccine development. In this review we outline some key features of modern vaccinology that are linked with the development of better adjuvants. In line with the increased desire to obtain novel adjuvants for future vaccines, the Finlay Adjuvant Platform offers a novel approach for the development of new and effective adjuvants. The Finlay Adjuvants (AFs), AFPL (proteoliposome), and AFCo (cochleate), were initially designed for parenteral and mucosal applications, and constitute potent adjuvants for the induction of Th1 responses against several antigens. This review summarizes the status of the Finlay technology in producing promising adjuvants for unsolved-vaccine diseases including mucosal approaches and therapeutic vaccines. Ideas related to adjuvant classification, adjuvant selection, and their possible influence on innate recognition via multiple toll-like receptors are also discussed.

RESUMEN

BACKGROUND: Preeclampsia (PE) is a multi-causal disease characterized by the development of hypertension and proteinuria in the second half of pregnancy. Multiple risk factors have been associated with the development of PE. Moreover, it is known that these risk factors vary between populations from developed and developing countries. The aim of this study is to identify which risk factors are associated with the development of preeclampsia (PE) among Colombian women. METHODS: A multi-centre case-control study was conducted between September 2006 and July 2009 in six Colombian cities. Cases included women with PE (n = 201); controls were aged-matched pregnant women (n = 201) without cardiovascular or endocrine diseases for a case-control ratio of 1:1. A complete medical chart, physical examination and biochemical analysis were completed before delivery. Multivariable logistic regression was used to calculate odds ratios (OR) and 95% confidence intervals (CI) of potential risk factors associated with PE. RESULTS: The presence of factors present in the metabolic syndrome cluster such as body mass index >31 Kg/m2 (OR = 2.18; 1.14-4.14 95% CI), high-density lipoprotein <1.24 mmol/L (OR = 2.42; 1.53-3.84 95% CI), triglycerides >3.24 mmol/L (OR = 1.60; 1.04-2.48 95% CI) and glycemia >4.9 mmol/L (OR = 2.66; 1.47-4.81 95%CI) as well as being primigravidae (OR = 1.71; 1.07-2.73 95% CI) were associated with the development of PE, after adjusting for other variables. CONCLUSION: Factors present in the cluster of metabolic syndrome and primigravidity were associated with a greater risk of PE among Colombian women. Understanding the role of this cluster of risk factors in the development of PE is of crucial importance to prevent PE and remains to be determined.

Asunto(s)

RESUMEN

BACKGROUND: Acute Myocardial Infarction (AMI) is one of the main causes of mortality and disability in Colombia. The factors associated to a new event in surviving subjects to a first AMI in our population have not yet been fully identified. METHODS: Two hundred and ninety five surviving subjects to a first AMI (58.8±12.6 years) were included in a prospective cohort study between 2000 and 2006. Lipid profile, glycemia and plasma insulin levels were measured. Deaths of cardiovascular origin, a new AMI, unstable angina, heart failure, stroke, new myocardial revascularization or angioplasty were considered new cardiovascular events. RESULTS: The study included 61 (20.6%) women and 234 (79.4%) men. The mean follow up time was 50±30 months with a 38.9% incidence of new events. Fifty five patients (18.6%) were diabetic. Bi-varied analysis identified as risk factors for a new cardiovascular event the presence of: hypertension, anterior descending coronary artery stenosis, intrahospital cardiac failure, age over 55, low income, lack of education, Killip III-IV, heart rate over 76 bpm, pulse pressure over 80 mmHg, total cholesterol over 200 mg/dl and insulin over 10 IU/ml. After logistic regression analysis, the log values of insulin remained as the only significant predictor for new cardiovascular events. CONCLUSIONS: Hyperinsulinism was the most important factor associated to the occurrence of new cardiovascular events in Colombian patients with AMI, which emphasizes the pivotal role of insulin resistance in the physiopathologic mechanisms of atherosclerosis, especially in undeveloped countries.

Asunto(s)

RESUMEN

BACKGROUND: Preeclampsia (PE) is a common maternal disease that complicates 5 to 10% of pregnancies and remains as the major cause of maternal and neonatal mortality. Cost-effective interventions aimed at preventing the development of preeclampsia are urgently needed. However, the pathogenesis of PE is not well known. Multiple mechanisms such as oxidative stress, endothelial dysfunction and insulin resistance may contribute to its development. Regular aerobic exercise recovers endothelial function; improves insulin resistance and decreases oxidative stress. Therefore the purpose of this clinical trial is to determine the effect of regular aerobic exercise on endothelial function, on insulin resistance and on pregnancy outcome. METHODS AND DESIGN: 64 pregnant women will be included in a blind, randomized clinical trial, and parallel assignment. The exercise group will do regular aerobic physical exercise: walking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes) in three sessions per week. Control group will do the activities of daily living (bathing, dressing, eating, and walking) without counselling from a physical therapist. TRIAL REGISTRATION: NCT00741312.

Asunto(s)