Drug utilisation study in patients receiving antiepileptic drugs in Colombia.

INTRODUCTION: This study examines the indications according to which antiepileptic drugs are prescribed and used in a population of patients enrolled in the Colombian national health system (SGSSS). METHODS: Retrospective cross-sectional study. From the pool of individuals in 34 Colombian cities who used antiepileptic drugs between 18 July, 2013 and 31 August, 2014 during a period of no less than 12 months, we obtained a random sample stratified by city. Socio-demographic, pharmacological and comorbidity variables were analysed. Continuous and categorical variables were compared, and logistic regression models were used. RESULTS: Our patient total was 373 patients, with 197 women (52.1%) and a mean age of 41.9 ± 21.7 years; 65.4% of the patients were treated with monotherapy. The most frequently used drugs were valproic acid (53.1%) and carbamazepine (33.2%). Epilepsy was the most frequent indication (n=178; 47.7%); however, 52.3% of the patients were prescribed antiepileptics for different indications, especially neuropathic pain (26.8%), affective disorders (14.2%) and migraine prophylaxis (12.3%). A total of 81 patients with epilepsy (46.6%) displayed good seizure control while another 25 (14.4%) had drug-resistant epilepsy. In the multivariate analysis, medication adherence was associated with a lower risk of treatment failure in patients with epilepsy (OR: 0.27; 95%CI, 0.11-0.67). CONCLUSIONS: In Colombia, antiepileptic drugs are being used for indications other than those originally intended. Monotherapy is the most commonly used treatment approach, together with the use of classic antiepileptic drugs.

Sexual, ontogenetic, temporal and spatial effects on the diet of Urotrygon rogersi (Elasmobranchii:Myliobatiformes).

The food habits and trophic ecology of Urotrygon rogersi were analysed to ascertain sexual, ontogenetic, temporal and spatial effects on the diet. These effects were examined with contingency tables, simple correspondence analysis and MANOVA. The trophic relationships of the species were determined with Levin's niche amplitude index and Pianka's diet overlap index. Urotrygon rogersi is a predator of benthic organisms, especially shrimp and polychaetes. Analysis of sex and time showed no significant differences, but differences among class sizes were found. A strong trend towards diet specialization and a strong overlap between sexes and between class sizes were found. Finally, fishing activity on shrimps in the study area could force U. rogersi to change its trophic spectrum over time as an adaptation to the considerable reduction in its principal prey.

Método Dáder de seguimiento farmacoterapéutico y farmacovigilancia en instituciones de salud de Colombia / Drug therapy follow-up of patient by Dader method and pharmacovigilance in health institutions of Colombia

La farmacovigilancia pretende satisfacer la necesidad de disponer de información relacionada con los resultados del uso de medicamentos, al tiempo que se convierte en una estrategia para prevenir riesgos y minimizar costos causados por efectos no deseados de la farmacoterapia. La realización de seguimiento farmacoterapéutico, utilizando el método Dáder, ha evidenciado que posibilita el cumplimiento de los objetivos de la farmacovigilancia. Sin embargo, se requiere de mayores soportes de la utilidad y beneficios alcanzados con su implementación en más instituciones. Por ello, se realiza un estudio descriptivo retrospectivo de los resultados del seguimiento farmacoterapéutico, utilizando el método Dáder, en instituciones de salud hospitalarias o ambulatorias, realizado por estudiantes matriculados en las asignaturas prácticas en farmacia clínica o prácticas profesionales, del programa de Química Farmacéutica de la Universidad de Antioquia, entre agosto de 2003 y noviembre de 2004. Durante este período se realizó el seguimiento a 4556 pacientes, se detectaron 660 problemas relacionados con medicamentos y 3581 problemas relacionados con la utilización. Resultados que respaldan la utilidad y los beneficios adicionales de los programas de seguimiento farmacoterapéutico, utilizando el método Dáder, en la satisfacción de la necesidad de estructurar y desarrollar programas de farmacovigilancia en el sistema de salud de Colombia

Prueba de tolerancia in vitro con eritrocitos para medir el potencial de irritabiilidad de los surfactantes / In vitro tolerance trial with rbcs for measure the irritancy potencial of surfactants

Los tensoactivos utilizados como materia activa de productos cosméticos, de higiene, aseo y limpieza, pueden llegar a producir irritación dérmica y lesión en la membrana ocular. En éste trabajo se estudia una prueba asequible, económica y sencilla que permita evaluar la concentración a la cual los tensoactivos pueden producir irritación ocular. La prueba consiste en medir la hemólisis y la desnaturalización de proteínas causada por una concentración de surfactante, en una muestra de eritrocitos previamente caracterizada, empleando como indicador para ambos procesos la liberación de oxihemoglobina, la cual se detecta espectofotométricamente. Los resultados obtenidos en esta prueba, muestran la viabilidad del método, y hacen de este una herramienta alternativa para la evaluación del potencial de irritación ocular que poseen los tensoactivos.

Obtención de la enzima ligninoperxodidasa por fermentación en estado sólido del PHANEROCHAETE CRYSOSPORIUM sobre capacho y tusa de maíz / Solid state fermentation with PHANEROCHAETE CHRYSOSPORIUM on cornhusk and cocncob to produce ligninoperoxidase

Con el fin de optimizar las condiciones para obtener la enzima ligninoperoxidasa -LiP-, se evalúa por medio de la fermentación en fase sólida (FES), la utilización de capacho sólo y de la mezcla capacho y tusa de maíz, como soporte y como sustrato para el crecimiento del Phanerocahete chrysosporium. Se estudian tres sistemas de inoculación del microorganismo y se determina en ellos el cambio del porcentaje de humedad (bajo las mismas condiciones de humedad relativa) y la actividad de la LiP durante el tiempo de fermentación. Los resultados muestran que el Phanerochaete chysosporium encuentra en éstos sustratos (capacho y tusa de maíz) una fuente de carbono y nitrógeno que requiere para su metabolismo, ya que éstos no fueron suministrados de ninguna otra manera. De los sistemas estudiados, con el que se se obtuvo mayor actividad de la LiP en el menor tiempo, es en el que se añaden las esporas en un medio líquido basal con una humedad inicial del 70 por cietno, indicando que el metabolismo primario del hongo cesa rápidamente en éstas condiciones. Este sistema favorece por lo tanto el metabolismo secundario y una mayor producción

Soybean leghemoglobin targeted to potato chloroplasts influences growth and development of transgenic plants.

Potato tubers were transformed with a chimeric gene made by the fusion of the soybean leghemoglobin encoding gene (lba) with the chloroplastic targeting sequence from Rubisco. This construct was placed under the control of the strong constitutive 35S promoter and the 3' nontranslated region of Rubisco from pea. Leghemoglobin expression on kanamycin-resistant plants was monitored by RT-PCR. Furthermore, immunodetection of subcellular fractions of transgenic plants revealed that leghemoglobin was imported and correctively processed inside the organelle. In addition, analysis of transgenic plants revealed reduced growth and decreased tuber production compared with the untransformed plants. It is suggested that leghemoglobin expression in potato chloroplasts interferes with aerobic metabolism, leading to physiological and morphological changes.

Thalidomide, a current teratogen in South America.

Thalidomide, mainly used for the treatment of leprosy, is a current teratogen in South America, and it is reasonable to assume that at present this situation is affecting many births in underdeveloped countries. Moreover, the potential re-marketing of thalidomide for the treatment of a large variety of diseases may extend the problem to the developed world. When the drug is available, the control of its intake during early pregnancy is very difficult since most pregnancies are unintended. The ongoing occurrence of thalidomide embryopathy cases went undetected by the ECLAMC, due to several factors: (1) low populational coverage through this monitoring system; (2) pre-existence of the teratogen with its effects present in both baseline (expected) and monitored (observed) materials; and (3) lack of a defined phenotype to be monitored. Thus, if thalidomide re-enters the market throughout the world, due to the wide range of new applications, occurrence of phocomelia alone might not be sufficient to detect its effects. By a case-reference approach, the ECLAMC registered 34 thalidomide embryopathy cases born in South America after 1965 whose birthplaces correspond to endemic areas for leprosy. Phocomelia was found in five of eleven fully described cases. Thus, phocomelia alone is neither specific nor sufficient to serve as a suitable phenotype to survey the teratogenic effects of thalidomide. Therefore, a thalidomide-like phenotype, defined as any bilateral upper and/or lower limb reduction defect of the preaxial and/or phocomelia types, should be included in the routine surveillance of birth defects in all programmes.

Safety and immunogenicity of oral killed whole cell recombinant B subunit cholera vaccine in Barranquilla, Colombia.

In January and February 1992, an assessment was conducted of the safety and immunogenicity of two doses of a new oral cholera vaccine prepared from the recombinant B subunit of the toxin and from killed whole cells (rBS/WC) in 1,165 individuals between the ages of 12 months and 64 years in Barranquilla, Colombia. This was a randomized, double-blind placebo-controlled study. Participants received two doses of either the vaccine or a placebo (killed Escherichia coli K12) over a two-week interval. Few symptoms were detected during the three days following administration of the initial dose and even fewer following the second. Sera obtained upon administration of the first dose and two weeks after administration of the second were tested for Vibrio cholerae 01 Inaba vibriocidal antibodies and antitoxins. Geometric mean titers (GMT) of vibriocidal antibodies were found to increase two-fold in subjects receiving the vaccine. In the paired samples taken from vaccinated subjects, two-fold or greater increases were observed in 44% and four-fold or greater increases were observed in 34%, as compared to similar increases in 9.2% and 2.2% of the sera taken from those receiving the placebo (P < 0.05). The GMTs of IgG and IgA antitoxins, as determined by ELISA, increased by factors of 4 and 3.2, respectively, in those receiving the vaccine, as compared to factors of 1.1 and 1.1 in those given the placebo (P < 0.001 for IgG, P < 0.01 for IgA). Approximately 80% of the paired samples from the vaccinated group showed an increase of both IgG and IgA antitoxins > or = 1.5, as compared to only about 20% of those in the placebo group (P < 0.000001). Belonging to the O blood group did not significantly affect the immune response. Children under age four tended to show a weaker vibriocidal antibody response and a stronger antitoxin response than older subjects. The two doses of oral vaccine were found to be safe and without attributable side-effects. The vibriocidal antibody and antitoxin responses were similar to those obtained previously with the conventional oral killed whole cell B subunit cholera vaccine.

PIP: In a randomized, double-blind, placebo-controlled study in January and February 1992, the safety and immunogenicity of two doses of a new oral cholera vaccine was assessed. The vaccine was prepared from the recombinant B subunit of the toxin and from killed whole cells (rBS/WC) in 1165 individuals between the ages of 12 months and 64 years in Barranquilla, Colombia. Participants received two doses of either the vaccine or a placebo (killed Escherichia coli K12) over a 2-week interval. Few symptoms were detected during the 3 days following administration of the initial dose and even fewer following the second one. Sera obtained upon administration of the first dose and 2 weeks after administration of the second dose were tested for Vibrio cholera 01 Inaba vibriocidal antibodies and antitoxins. Geometric mean titers (GMTs) of vibriocidal antibodies were found to increase two-fold in subjects receiving the vaccine. In the paired samples taken from vaccinated subjects, two-fold or greater increases were observed in 44% and four-fold or greater increases were observed in 34%. In comparison, similar increases were found only in 9.2% and 2.2% of the sera taken from those receiving placebo (p .05). The GMTs of IgG and IgA antitoxins, as determined by ELISA, increased by factors of 4 and 3.2, respectively, in those receiving the vaccine as compared with factors of 1.1 and 1.1, respectively, in those given the placebo (p .001 for IgG and p .01 for IgA). Approximately 80% of the paired samples from the vaccinated group showed an increase of both IgG and IgA antitoxins or= 1.5 as compared with only about 20% of those in the placebo group (p .000001). Belonging to the O blood group did not significantly affect the immune response. Children under the age of 4 years tended to show a weaker vibriocidal antibody response and stronger antitoxin response than did older subjects. The two doses of oral vaccine were found to be safe and without attributable side effects.

Vitamin D dependent rickets type II and normal vitamin D receptor cDNA sequence. A cluster in a rural area of Cauca, Colombia, with more than 200 affected children.

Vitamin D dependent rickets type II is an autosomal recessive disease caused by the vitamin D defective receptor. More than 200 patients with different types of lower limb deformities were detected in a rural area of the Cauca department in the southwest part of Colombia. Patients were well nourished and in good physical condition in spite of their deformities. None of them presented alopecia, myopathy, seizures or aminoaciduria. Serum analysis showed significantly lower serum calcium as compared to normal relatives, though in the normal low range, normal phosphorus, high alkaline phosphatase, normal 25-hydroxyvitamin D3 and high 1,25-dihydroxyvitamin D3, indicating target organ resistance. The cDNA analysis showed normal nucleotide sequence. We suggest that our patients represent a distinct form of receptor-positive resistance to vitamin D. This report is the first extensive study on this class of patients.

Estudio de inmunogenicidad para dos vacunas recombinantes contra hepatitis B comparando dos esquemas / Study of the immunogenicity of two recombinant hepatitis B vaccine comparating schedules

Este estudio compara la inmunogenicidad (seroconversión, seroprotección e hiperrespuesta), producida por dos vacunas recombinantes contra la hepatitis B (Engerix-B de Bélgica y Cubana), en dos esquemas (012 y 016 meses), empleando los métodos de cuantificación para anti-HBsAg (Abbott y Organón), los cuales fueron también comparados. En el estudio participaron 257 voluntarios, divididos al azar en 4 grupos (dos vacunas, dos esquemas). Resultados: los dos métodos de Abbott y Organon, no presentan diferencias estadísticas significativas. La vacuna cubana muestra una mayor respuesta inmunogénica para dos dosis de vacuna y para el esquema 012. No hay diferencia entre los esquemas 012 y 016 y en el esquema 016 no se ven diferencias estadísticamente significativas con la vacuna Engerix-B. En esta última el esquema 016 muestra mejores resultados que el 012

Birth defects among children born to a population occupationally exposed to pesticides in Colombia.

A case-referent study of birth defects was nested in a prevalence survey of adverse reproductive outcomes carried out among 8867 floriculture workers in Bogotá, Colombia. A total of 535 children born to these workers and reported by their parents as malformed and 1070 children selected at random as referents were invited to a medical examination including consultation with a geneticist and a clinical teratologist and a review of the medical records. Seventy-six percent of both groups attended the examination. Of 403 children reported as malformed, a birth defect was confirmed for only 154 (38%). On the other hand, of the 817 children reported as normal, 735 (90%) were normal, but 68 had a birth defect and 14 had other conditions. A case-referent analysis was then carried out including 222 children with birth defects and 443 referents. An increased risk was found only for birthmarks, and specifically for hemangiomas, for children with parents exposed to pesticides in the floriculture industry.