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1.
Int. j. morphol ; 36(2): 551-556, jun. 2018. tab, graf
Article in Spanish | LILACS | ID: biblio-954153

ABSTRACT

Las patologías de la gestación como la hipertensión, diabetes mellitus gestacional, o restricción del crecimiento intrauterino, pueden determinar modificaciones en las características morfológicas macro y microscópicas de la placenta y sus vellosidades coriales libres, y en el feto se puede acompañar de manifestaciones patológicas, con riesgo para su calidad de vida futura, e incluso su viabilidad. El objetivo de este trabajo consistió en describir aspectos morfométricos e histológicos de las vellosidades coriales libres en gestas normales, con diabetes e hipertensión arterial. Se utilizaron 30 placentas humanas y fueron separadas, según presencia o ausencia de patologías en el embarazo, en tres grupos: Normal (N), Síndrome Hipertensivo del Embarazo (SHE), Diabetes (D) y Restricción del Crecimiento Intrauterino (RCIU). Se usó ficha para registrar peso placentario y del recién nacido Todas las muestras fueron fijadas en formalina tamponada al 10 %. De cada una fueron extraídas 5 muestras, obteniendo 25 cortes por cada placenta. Posteriormente, fueron teñidas con H&E, Azul Alcián y Tricrómico de Masson. Además, se efectuó el análisis histológico y morfométrico (ImageJ®) de las vellosidades coriales. El análisis estadístico fue realizado utilizando ANOVA. Entre los cambios morfológicos, se encontró una relación peso placentario/peso del recién nacido aumentada en la Diabetes Mellitus Gestacional asociada a cambios histológicos. No hubo cambios morfométricos significativos entre placentas N, SHE y D. Hubo un aumento en el número de vasos coriales en placentas del grupo D (P < 0,05) y de la superficie entre las vellosidades coriales. En el grupo SHE hubo aumento moderado de nudos sinciciales y presencia de fibrina en el estroma. Las placentas con Diabetes Mellitus Gestacional experimentan alteraciones histológicas, como consecuencia de cambios estructurales y funcionales. Además, el aumento de vasos sanguíneos en placentas con diabetes se produce por neoformación vascular y mayor penetración de vasos sanguíneos dentro de las vellosidades. En el caso del SHE las alteraciones placentarias se relacionan con la gravedad de la enfermedad.


Gestational pathologies such as hypertension, gestational diabetes mellitus and restriction of intrauterine growth can determine changes in the macro and microscopic morphological characteristics of the placenta and its free chorionic villi. In the fetus it can be accompanied by pathological manifestations with risk to its viability and future quality of life. The aim of this work was to describe morphometric and histological aspects of free chorionic villi in normal pregnancies associated with diabetes, hypertension and restriction of intrauterine growth. Thirty human placentas were used and were separated into three groups: Normal (N), Hypertensive Pregnancy Syndrome (SHE), Diabetes (D), and Restriction of Intrauterine Growth (RIG) according to evident pathologies or absence thereof during pregnancy. Tab was used to record placental and newborn weight. All samples were fixed in 10 % buffered formalin. From each, 5 samples were extracted, obtaining 25 cuts for each placenta. Subsequently, they were stained with H & E, Alcian Blue and Masson's Trichrome. In addition, histological and morphometric analysis (ImageJ®) of the chorion villus was carried out. Statistical analysis was performed using ANOVA. Among the morphological changes, an increased placental weight / weight ratio of the newborn was found in Gestational Diabetes Mellitus associated with histological changes. There were no significant morphometric changes between placentas N, SHE and D. There was an increase in the number of corial vessels in placentas of group D (P <0.05) and of the surface between the chorion villi. In the SHE group there was a moderate increase in syncytial nodes and presence of fibrin in the stroma. Placentas with Gestational Diabetes Mellitus experience histological alterations, as a consequence of structural and functional changes. In addition, the increase of blood vessels in placentas D is produced by vascular neoformation and increased penetration of blood vessels into the villi. In the case of SHE, placental alterations are related to the severity of the disease.


Subject(s)
Humans , Female , Pregnancy , Infant, Newborn , Adolescent , Adult , Chorionic Villi/pathology , Diabetes, Gestational/pathology , Fetal Growth Retardation/pathology , Hypertension/pathology , Placenta/pathology , Cross-Sectional Studies
2.
Rev. ANACEM (Impresa) ; 7(2): 64-66, ago. 2013. tab, graf
Article in Spanish | LILACS | ID: lil-716569

ABSTRACT

INTRODUCCIÓN: La asfixia es responsable del 19 por ciento de las muertes neonatales que ocurren en el mundo. La reanimación neonatal disminuye la mortalidad en estos Recién Nacidos (RN). 10 por ciento de los RN requieren maniobras de reanimación, de éstos, 1 por ciento requiere reanimación avanzada. OBJETIVOS: Caracterizar los RN reanimados durante el año 2011 en un hospital público. Materiales y métodos: Estudio descriptivo retrospectivo, con historias clínicas correspondientes a la totalidad de RN durante el 2011 en el Hospital Clínico Regional de Concepción. Se seleccionaron RN que requirieron maniobras de reanimación desde ventilación a presión positiva. Se analizaron datos demográficos, Apgar, maniobras realizadas y antecedentes maternos. RESULTADOS: Del total de RN vivos (4095) fueron reanimados 130 (3,17 por ciento), de estos últimos un 57,69 por ciento de término. El 11,5 por ciento fue de muy bajo peso y el 11,5 por ciento de extremo bajo peso al nacer. Hubo parto vaginal en 49,6 por ciento y cesárea urgencia 40,8 por ciento. En relación al Apgar al (1’) resultó <7 en 93,18 por ciento de los RN. Se utilizó Ventilación a Presión Positiva (VPP) en 66,15 por ciento; reanimándose sólo con aire un 12,9 por ciento de RN de término y todos los RN Pretérmino fueron reanimados con oxígeno, regulado por oximetría de pulso. Se realizó intubación endotraqueal en 26,92 por ciento; 6,92 por ciento requirió masaje cardiaco y medicamentos. El 96,15 por ciento sobrevivió y 48,15 por ciento fueron hospitalizados en UCI. DISCUSIÓN: El porcentaje de RN reanimados fue bajo en comparación a lo señalado en la literatura, pese a ser un centro de referencia. La mayoría de los reanimados fue de término. La maniobra más utilizada fue la VPP.


INTRODUCTION: Asphyxia is responsible for 19 percent of neonatal deaths that occur worldwide. Neonatal resuscitation contributes to lower morbidity and mortality in newborns. 10 percent of newborns require some assistance to begin breathing at birth; of this group less than 1 percent require extensive resuscitative measures. OBJECTIVE: To characterize newborns resuscitated during2011 in a public hospital. Material and method: Descriptive retrospective study, including all infants born during 2011 in Regional Clinical Hospital of Concepción. Neonates that required resuscitation measures were selected from positive ventilation pressure. Demographic data, Apgar score, resuscitation measures and maternal history were analyzed. RESULTS: Out of the 4095 living newborns, 130 of them (3.17 percent) were resuscitated. Of this group, 57.69 percent were of term gestation, 11.5 percent of them were very low weight and 11.5 percent extremely low weight. Vaginal delivery ocurred in 49.6 percent and urgency cesarean section in 40.8 percent. Apgar score at (1’) resulted <7 in 93.18 percent of neonates. Positive-pressure ventilation was used in 66.15 percent; using air in 12.9 percent of term infants. All preterm infants were resuscitated with oxygen, regulated by pulse oximetry. Endotracheal intubation was used in 6.92 percent; whereas 6.92 percent required cardiac massage and drugs. 96.15 percent survived and 48.15 percent were admitted to ICU. DISCUSSION: The percentage of resuscitated neonates was low in comparison to the pointed out in literature, despite being a reference center. The majority of resuscitated infants had term gestation. The most used resuscitation measure was positive pressure ventilation.


Subject(s)
Humans , Male , Female , Infant, Newborn , Resuscitation/statistics & numerical data , Resuscitation/methods , Apgar Score , Birth Weight , Chile , Cesarean Section/statistics & numerical data , Epidemiology, Descriptive , Hospitals, Public , Infant Mortality , Intermittent Positive-Pressure Ventilation , Oximetry , Delivery, Obstetric/statistics & numerical data , Retrospective Studies
3.
Rev. chil. neuro-psiquiatr ; 50(4): 217-218, dic. 2012.
Article in Spanish | LILACS | ID: lil-671276
4.
Rev. méd. Chile ; 139(7): 902-908, jul. 2011. ilus, tab
Article in Spanish | LILACS | ID: lil-603143

ABSTRACT

Background: The bioequivalence of different formulations of a same pharmaceutical product must be tested empirically. Aim: To evaluate the relative bioavailability for an oralformulation of mycophenolate mofetil (MMF) (Linfonex™) compared to the reference formulation (Cellcept™) to determine the bioequivalence between both formulations. Material and Methods: A randomized, crossover, double-blind trial in 22 healthy male volunteers, who received a single oral dose of 1000 mg of Linfonex and Cellcept with a washout period of 10 days. Plasma levels of the drug were determined by high performance liquid chr ornatography. Plasma concentrations were plotted and maximum concentration, area under the plasma concentration versus time between 0 and 12 hours after administration and área under plasma concentration curve versus time after administration between 0 and infinity, were calculated for both products. Results: The active compound, mycophenolic acid, was similarly absorbed in both formulations. No statistically significant differences were found in calculated pharmacokinetic parameters between both formulations. Conclusions: Linfonex™ 500 mg is bioequivalent to Cellcept™ 500 mg.


Subject(s)
Adult , Humans , Male , Immunosuppressive Agents/pharmacokinetics , Mycophenolic Acid/analogs & derivatives , Administration, Oral , Area Under Curve , Biological Availability , Chromatography, High Pressure Liquid , Cross-Over Studies , Double-Blind Method , Immunosuppressive Agents/administration & dosage , Mycophenolic Acid/administration & dosage , Mycophenolic Acid/pharmacokinetics , Therapeutic Equivalency
5.
Cuad. méd.-soc. (Santiago de Chile) ; 51(2): 66-79, 2011. graf
Article in Spanish | LILACS | ID: lil-690994

ABSTRACT

En el presente trabajo se hace un análisis de los conceptos, normativas y propuestas sobre la equivalencia terapéutica de medicamentos similares con respecto a los innovadores, desde una perspectiva internacional y nacional, explicando las bases científicas de los estudios de bioexención in vitro para determinar la intercambiabilidad de aquellos medicamentos similares provenientes de diferentes fuentes que se han liberado de los estudios de bioequivalencia (in vivo). Además, se presentan algunos resultados de estudios de test de disolución para dar a conocer la metodología usada en la bioexención y se detallan los requisitos para aprobar un Centro de Bioequivalencia in vitro.


In this review, the concepts, guidelines and proposals regarding the determination of therapeutic equivalence of similar drug products are analyzed from a national and international point of view. The scientific background of the in vitro biowaiver studies that may result in the interchange ability of multisource drug product that have been waived from the demonstration of in vivo bioequivalence studies is also explained. In order to explain the methods in biowaiver studies, results of dissolution kinetics are shown as well as the requirements to approve an in vitro biopharmaceutic center.


Subject(s)
Biological Availability , Pharmaceutical Preparations , Therapeutic Equivalency , Chile , Solubility
6.
Cuad. méd.-soc. (Santiago de Chile) ; 50(1): 11-23, mar. 2010. graf
Article in Spanish | LILACS | ID: lil-588419

ABSTRACT

Se hace un análisis de los conceptos, normativas y propuestas sobre la equivalencia terapéutica de los medicamentos similares, desde una perspectiva internacional y nacional, explicando las bases científicas de los estudios de biodisponibilidad y bioequivalencia para determinar la intercambiabilidad de los medicamentos provenientes de diferentes fuentes.


A concept, rules and proposals research about therapeutic bioequivalence of similar drugs, from an international and national perspective, explaining the scientific bases of bioavailability and bioequivalence studies to determine the drugs of different sources exchangeability.


Subject(s)
Humans , Biological Availability , Interchange of Drugs
7.
Rev. méd. Chile ; 138(2): 188-195, feb. 2010. ilus, tab
Article in Spanish | LILACS | ID: lil-546210

ABSTRACT

Background: Less favored social classes usually have more unhealthy life-styles and a more difficult access to Health Resources. Aim: To study the possible association between poverty and some common diseases, in a population of postmenopausal women. Material and Methods: Four hundred and forty nine poor women aged 56 ± 12 years and 776 consecutive women aged 53 ± 12 years, answered a personal interview about their lifestyles and medications used. Their medical records were reviewed and they were subjected to a complete physical examination, including weight and height measurement. A fasting blood sample was also obtained. Poverty was defined according to criteria of the Spanish National Institute of Statistics that is based on the income in Euros and the number of family members that share such income. Results: A higher proportion of poor women live in rural areas. They were shorter, had a higher weight and thus a higher body mass index, smoked less and drank less alcohol than their non-poor counterparts drink. The consumption of caffeine, the actual calcium intake and the physical activity during leisure time was similar in both groups. Compared with their counterparts, poor women had a higher prevalence of diabetes mellitus (15.9 and 10.1 percent respectively, p = < 0.01), obesity (44.2 and 24.3 percent respectively, p < 0.01) hypertension (24.3 and 16.4 percento respectively, p<0.01) and autoimmune rheumatic diseases (7.8 and 4.8 percent> respectively, p = 0.03). A multiple logistic regression model showed that obesity, hypertension, diabetes mellitus, smoking, alcohol consumption and living in rural areas, were independently associated to poverty. Conclusions: Poor postmenopausal women have a higher prevalence of diabetes mellitus, obesity, autoimmune rheumatic diseases and hypertension and lower frequency of smoking and alcohol consumption than their affluent counterparts do.


Subject(s)
Female , Humans , Middle Aged , Epidemiology , Life Style , Postmenopause , Poverty , Alcohol Drinking/epidemiology , Comorbidity , Diabetes Mellitus/epidemiology , Hypertension/epidemiology , Interviews as Topic , Obesity/epidemiology , Prevalence , Rheumatic Diseases/epidemiology , Smoking/epidemiology , Spain/epidemiology , Thyroid Diseases/epidemiology
8.
Bol. micol ; 24: 65-69, dic. 2009. tab, ilus
Article in Spanish | LILACS | ID: lil-585745

ABSTRACT

La finalidad de este trabajo fue la obtención de basidiocarpos (setas), por lo cual se diversificó el cultivo de hongos comestibles Basidiomycetes, siguiendo los objetivos del proyecto FONDEF D05I10196. Para ello, se utilizaron diferentes sustratos agronómicos y forestales sin valor comercial (paja de trigo, aserrines, astillas de maderas, etc.). Partidas del respectivo sustrato fueron pasteurizadas por 3 horas, luego en forma independiente se depositaron en bolsas de nylon (7 K) y se sembraron con la ®semilla¼ del hongo a ensayar, las bolsas fueron incubadas hasta la obtención de basidiocarpos. Se obtuvieron fructificaciones de: Agrocybe aegerita en aserrín de álamo (pero no el de pino), Flammulina velutipes y Hericium erinaceum en aserrín de Nothofagus spp. y paja de trigo y Pholiota nameko en aserrín de pino y astillas de pino.


The purpose of this paper was to get basidiocarps (mushrooms) that is why the culture of edible Basidiomycete mushrooms became diversified according to the objectives of FONDEF D05110196 project. To achieve this, different agronomic and forest substrate lacking any commercial value (wheat straw, wood sawdusts, chips etc. were used. Pieces of the corresponding substratum were pasteurized for 3h, then they were deposited separatedly (independently) in 7-kg polyethylene bags and they were later on sowed with the ®seed¼ of the fungi under test; bags were incubated until the basidiocarp appearance. Fructifications of Agrocybe aegerita in poplar sawdust (yet not in pine chips), Flammulina velutipes and Hericium erinaceum in Nothofagus spp. sawdust and wheat straw as well as Pholiota nameko in pine sawdust and pine chips were obtained.


Subject(s)
Crop Production , Agaricales/classification , Agaricales/growth & development , Culture Techniques , Chile
9.
Rev. méd. Chile ; 136(10): 1327-1335, Oct. 2008. ilus, tab
Article in Spanish | LILACS | ID: lil-503903

ABSTRACT

Cytochrome P450 enzymes are very important to metabolize anti-carcinogenic agents. Therefore, understanding the role of these enzymes and their allele variants in the bioactivation or detoxification of drugs could greatiy benefit antineoplastic pharmacotherapy. The aim of thís manuscrípt is to give information about metabohzing enzymes for antineoplastic agents and to relate the current situation in antitumoral pharmacotherapy with recent knowledge about cytochrome P450 enzymes. This is crucial for the future perspectives towards personalized pharmacotherapy. We summarize the role of cytochrome P450 enzymes in the resistance and bioactivation of several antitumor agents, their induction and repression mechanisms and the effect of genetic polymorphisms on variability of drug metabolization. The understanding of genetic variability will help to develop new research Unes on innovative therapeutic possibilities.


Subject(s)
Humans , Antineoplastic Agents/metabolism , /physiology , Neoplasms/metabolism , Polymorphism, Genetic , Antineoplastic Agents/therapeutic use , /antagonists & inhibitors , /genetics , Drug Interactions , Enzyme Induction/physiology , Enzyme Inhibitors/pharmacology , Neoplasms/drug therapy
10.
Int. j. odontostomatol. (Print) ; 2(1): 71-76, jul. 2008. ilus
Article in Spanish | LILACS | ID: lil-545856

ABSTRACT

El Síndrome de Sjõgren es una patología sistémica crónica autoinmune, cuyos síntomas principales son la xerolftalmia y la xerostomía. Por esta última el tratamiento con prótesis removible total convencional no es bien tolerado en estos pacientes. Se presenta un caso de un paciente género femenino, de 64 años, con síndrome de Sjõgren secundario, rehabilitada con prótesis removibles totales mucosoportada superior e implantorretenida inferior mediante dos implantes con fijaciones tipo O´ring. El presente caso se documenta para demostrar que no hay contraindicación en la atención de un paciente con este síndrome tanto para la rehabilitación protésica removible como para la colocación y pronóstico favorable de un tratamiento con implantes óseointegrados.


The Sjõgren syndrome is a chronic autoimmune systemic disease, which main symptoms are xerophtalmia and. xerostomy. Due to the latter treatment with total conventional removable prosthesis is not well tolerated in these patients. We report a case of a female patient, 64 years old, with secondary Sjõgren syndrome, treated with full archupper denture and lower implant-retained denture. O'ring type fixings. This case show that these is not contraindication to treat a patient with this syndrome with a conventional dentures or implant support denture.


Subject(s)
Humans , Female , Middle Aged , Dental Prosthesis, Implant-Supported , Denture, Complete , Dental Implantation, Endosseous , Mandible/surgery , Orthodontic Appliances, Removable , Sjogren's Syndrome , Osseointegration , Treatment Outcome
11.
Rev. chil. pediatr ; 79(3): 249-258, jun. 2008. graf, tab
Article in Spanish | LILACS | ID: lil-517508

ABSTRACT

Pharmacokinetics corresponds to the branch of pharmacology that studies the absorption, distribution, biotransformation and excretion of drugs in the body, in order to proportionate a reference line for interpretation of drug concentration in biological fluids, fundamental for clinical therapy. While adult pharmacology has increase greatly, advances in pediatric pharmacology have been poor. Therefore, drug prescription in children is essentially empirical on the basis of an inmature organism. An effective, secure and rational pediatric pharmacology requires exhaustive knowledgement of the developmental changes in relation to absorption, distribution, metabolism and excretion affecting pharmacokinetics parameters; therefore, the effective dose. This review describes fundamental differences between adult and pediatric pharmacokinetics. These differences must be considered when therapeutic strategies develop for newborns and children.


La farmacocinética, rama de la farmacología que estudia el paso de las drogas a través del organismo en función del tiempo y la dosis tiene por finalidad el proporcionar un marco de referencia para interpretar la concentración de los fármacos en los líquidos biológicos por el bien del paciente, lo que es fundamental para una correcta terapéutica clínica. Mientras los avances en farmacología clínica del adulto en las últimas décadas tuvieron un gran adelanto, no ha ocurrido lo mismo en farmacología pediátrica donde la mayoría de las veces la prescripción de medicamentos se realiza sobre una base empírica en un organismo inmaduro. Una terapéutica farmacológica efectiva, segura y racional en neonatos, lactantes y niños requiere el exhaustivo conocimiento de las diferencias en la absorción, distribución, metabolismo y excreción, las que aparecen durante el crecimiento y desarrollo, debido a que virtualmente, todos los parámetros farmacocinéticos se modifican con la edad. Esta revisión describe las diferencias fundamentales en la farmacocinética de los medicamentos en el niño cuando se compara con el adulto. Estas diferencias y los cambios en estos procesos deben ser cuidadosamente considerados cuando se desarrollan estrategias terapéuticas en recién nacidos y niños pequeños.


Subject(s)
Humans , Child , Drug Therapy , Child Development/physiology , Pediatrics , Pharmacokinetics
12.
Rev. gastroenterol. Perú ; 27(2): 172-176, abr.-jun. 2007. tab
Article in Spanish | LILACS, LIPECS | ID: lil-533774

ABSTRACT

Objetivo: Determinar la utilidad del test de la ureasa o test del aliento con carbono 14 en la detección de la infección por Helicobacter pilory (Hp) en pacientes dispépticos del Hospital Nacional Cayetano Heredia. Material y Método: Se incluyó a 31 pacientes dispépticos que acudieron a la consulta externa del Servicio de Gastroenterología del HNCH en el mes de setiembre de 2004 y que aceptaron voluntariamente participar en este estudio y a los cuales se les indicó endoscopía alta y biopsia gástrica. A todos ellos se les realizó igualmente el TA, que se realizó con cápsulas de urea marcada con carbono 14 (C14) comercializadas por el Instituto Peruano de Energía Nuclear (IPEN) y con reactivos producidos por el mismo instituto. El diagnóstico de Hp se basó en el análisis histológico con coloración de hematoxilina-eosina. Resultados: De los 31 Test del aliento, hubo un falso negativo y 30 estudios correlacionaron de las biopsias, de los cuales 23 estudios fueron positivos y 7 negativos. Conclusiones: El test del aliento realizado en el IPEN con C14 demuestra en este estudio una sensibilidad de 96.6 por ciento y una especificidad del 100 por ciento, que lo hace una herramienta diagnóstica para la infección por Hp muy confiable.


Objective: To establish the utility of the IPEN ureasa test or breath test with C14, in the detection of Helicobacter pylori infection in dyspeptic patients at the HNCH. MATERIAL AND METHODS: 31 dyspeptic patients that attended the outpatient GI clinic during September2004 were included. All of them had an upper endoscopy , gastricbiopsies, and a Breath Test with C14, done at the IPEN (Peruvian Institute of Nuclear Energy) . The diagnosis of HP infection was based on the histopathology report. RESULTS: Of the 31 Breath Test , one was a false negative and in 30 there was a good correlation with the biopsies results , 23 demonstrated the HP infection and in 7 this was not present. CONCLUSION: The IPEN Breath Test showed in this study a sensibility of 96.6 per centand a specificity of 100 per cent , demonstrating that is a very useful diagnostic tool for HP infection.


Subject(s)
Humans , Male , Adult , Middle Aged , Female , /methods , Helicobacter pylori/pathogenicity , Helicobacter Infections/diagnosis , Stomach Ulcer/diagnosis
13.
Rev. méd. Chile ; 134(12): 1583-1588, dic. 2006. tab
Article in Spanish | LILACS | ID: lil-441439

ABSTRACT

Once drug patents expire, the health authorities can approve the registry of similar products. They must request to the manufacturer, the bibliographic background of the original product and the analytical results that certify drug quality. An inspection of the premises of the manufacturer is also required. The main goal of this approval is to decrease cost, considering that the original product is usually more expensive. This is a current situation due to the imminent expiration of the patents of many biopharmaceutical products. Therefore, in Chile, the Public Health (ISP) and the Ministry of Health should consider that for this kind of products, until now, there are no interchangeable generic drugs, and that the similar drugs that are offered have a different chemical composition, since they have been manufactured through different processes. In the case of biological drugs (e.g. erythropoietir, somatotropin, heparin) the quality and homogeneity depend from the manufacture process. Its complete composition can not be absolutely elucidated; therefore small impurities or conformational variants can elicit an altered immune response or unexpected adverse reactions. This indicates that the approval of a biogeneric drug requires in addition to pharmacokinetic studies, preclinical and clinical analytical studies such as physicochemical assays, biological and immunological test. This issues have been established by WHO and have been incorporated for the main drug registry entities all over the world (FDA, EMEA, ANVISA) to approve biogeneric products.


Subject(s)
Humans , Biological Products/adverse effects , Chile , Product Surveillance, Postmarketing
14.
Cuad. méd.-soc. (Santiago de Chile) ; 46(3): 205-211, sept. 2006. tab, graf
Article in Spanish | LILACS, MINSALCHILE | ID: lil-460459

ABSTRACT

Se analiza la actual definición de la Organización Mundial de la Salud (OMS) para medicamento genéricobioequivalente, la adopción de este concepto por parte de los países de mayor desarrollo sanitario y la situación de Chile al respecto. A través de ejemplos de estudios de biodisponibilidad y bioequivalencia (BD/BE) hechos en Chile, se discuten los conceptos de equivalencia terapéutica, calidad, seguridad y eficacia del medicamento y se da a conocer el listado de drogas que, de acuerdo a la legislación chilena, deberán ser sometidos a este tipo de estudios para probar equivalencia terapéutica y aquellos de la bioexención que podrán optar al estudio in vitro o test de disolución.También se discute la situación de los medicamentos a los cuales no es necesario hacerles estudios de BD/BE para demostrar equivalencia, como los inyectables endovenosos, jarabes y otros y también qué se recomienda hacer con los productos de origen biotecnológico para demostrar su intercambiabilidad con el original.


The present definition of the World Health Organization (WHO) for generic bioequivalent drug, the adoption of this concept by the countries of best sanitary development and the situation of Chile on the matter, are analyzed. Through examples of studies of bioavailability and bioequivalence (BD/BE) done in Chile we discuss the concepts of therapeutic equivalence, quality, safety and effectiveness of the drugs. We also list drugs that according to Chilean legislation must be submitted to this kind of studies and those will be able to choose in vitro studies (for example dissolution tests) in order to prove therapeutic equivalence. Also the situation ofthe drugs which do not require BD/BE studies, as for example intravenous injections, syrups and others is discussed. Finally, we recommended what to do with products of biotechnological origin.


Subject(s)
Therapeutic Equivalency , Drugs, Generic/pharmacokinetics , Drugs, Generic/supply & distribution , Chile
15.
Rev. Hosp. Clin. Univ. Chile ; 17(2): 148-157, 2006. tab, graf
Article in Spanish | LILACS | ID: lil-532929

ABSTRACT

El pie diabético es la principal causa de amputación y mortalidad en pacientes diabéticos. Objetivo: establecer la frecuencia de amputaciones y característica clínicas en pacientes con el diagnóstico de pie diabético hospitalizados en el Hospital Clínico de la Universidad de Chile entre 1985-2000. Evaluar posibles factores de riesgo y la mortalidad posterior al egreso. Pacientes y método: análisis de ficha clínica, obtención de la fecha y causa de muerte del Servicio de Registro Civil e Identificación. Resultados: De 278 pacientes a 193 (69.4 por ciento) se les realizó una amputación. El nivel anatómico se distribuyó de la siguiente manera: 46 por ciento ortejo, 20 por ciento transmetatarsiana, 17 por ciento infracondílea y 17 por ciento supracondílea. Resultaron factores de riesgo para amputación: antecedente de amputación anterior (odds ratio [OR] 1.95, 95 por ciento IC 1.1-3.4); linfopenia ([OR] 0.96, 0.93-0.98); VHS aumentada ([OR] 1.012, 1.0044-1.02) y la presencia de retinopatía ([OR] 4.4, 2.2-9.1). La hospitalización fue más prolongada en los amputados (25 +/-22 vs 15 +/-13 días). El porcentaje de amputaciones en los períodos 1985 - 1994 y 1995 - 2000 fue similar (67 por ciento vs 70 por ciento). Un 35 por ciento de los pacientes amputados y un 52 por ciento de los no amputados fallecieron en un promedio de 3.38 años (rango 0-15.5 y 0-11.8 respectivamente). La primera causa de muerte en el grupo no amputado fue la cardiovascular y en el grupo amputado, fue la causa séptica. Conclusiones: aún existe una elevada frecuencia de amputaciones por pie diabético en nuestro medio lo que se asocia a hospitalizaciones prolongadas. El pie diabético complicado determina una elevada mortalidad antes de los 5 años del egreso.


The diabetic foot is the main cause of amputation and mortality in diabetic patients. Aim: To determine the frequency of lower extremity amputations and clinical features in patients with the diagnosis of diabetic foot assisted at the University of Chile Clinical Hospital between 1985-2000 to determine risks factors and mortality after the discharge. Patients and Method: Analysis of patient records and obtainment of the date and cause of death from the National Register of Citizens. Results: Of 278 patients 193 patients (69.4 percent) underwent an amputation. The anatomic level was: 46 percent toe; 20 percent transmetatharsal; 17 percent under the knee and 17 percent over the knee. Risk factors for amputation were: history of amputation (odds ratio [OR] 1.95, 95 percent IC 1.1-3.4); low lymphocytes count ([OR] 0.96, 0.93-0.98); high eritro sedimentation rate ([OR] 1.012, 1.0044-1.02) and retinopathy ([OR] 4.4, 2.2-9.1). Longer hospitalizations were observed in amputee patients (25 +/- 22 vs 15 +/- 13 days). A similar frequency of amputations was observed between 1985-1994 and 1995-2000 periods. A 35 percent of amputee patients and 52 percent of non amputee patients died in a mean of 3.34 years after the event (range 0-15.5 y 0-11.8 respectively). Among non amputee patients the main cause of death was cardiovascular disease and infectious processes were the main cause in amputee patients. Conclusions: A high frequency of amputations because diabetic foot is still observed in our diabetic patients that is associated to longer hospitalizations. The complicated diabetic foot determines a high mortality before 5 years of the event.


Subject(s)
Humans , Male , Female , Amputation, Surgical , Diabetes Complications/mortality , Diabetic Foot/complications , Diabetic Foot/mortality , Diabetic Foot/pathology , Survival Analysis , Chile
16.
Bol. Asoc. Méd. P. R ; 97(3,Pt.2): 209-213, Jul.-Sept. 2005.
Article in English | LILACS | ID: lil-442766

ABSTRACT

Actinomycosis is an unusual, chronic granulomatous disease. Actinomyces israelli has been found to be related to infectious processes in those patients with affected skin integrity leading to abscess formation, fistulae or mass lesions. Actinomycosis mainly presents in three forms cervicofacial (50%), abdominal (20%) and thoracic (15%). Pelvic cases have been rarely reported and are usually associated with the use of intrauterine devices. We describe a case of a 23 y/o female without history of intrauterine device use, who was admitted with an ovarian cyst following an appendectomy. An ovarian abscess was drained. The pathology showed a granuloma and focal sulfur granules like particles compatible with Actinomyces. This is a case of pelvic Actinomyces, not related to the use of an intrauterine device


Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Abdominal Abscess/diagnosis , Abscess/microbiology , Actinomycosis/diagnosis , Ovarian Cysts/complications , Postoperative Complications/diagnosis , Ovarian Diseases/microbiology , Appendectomy , Abdominal Abscess/etiology , Abdominal Abscess/microbiology , Abscess/drug therapy , Abscess/surgery , Actinomycosis/drug therapy , Actinomycosis/surgery , Actinomyces/isolation & purification , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Amoxicillin/administration & dosage , Amoxicillin/therapeutic use , Ovarian Cysts/diagnosis , Ovarian Cysts/microbiology , Diagnosis, Differential , Drainage , Ovarian Diseases/drug therapy , Ovarian Diseases/surgery , Intrauterine Devices , Penicillin G/administration & dosage , Penicillin G/therapeutic use , Risk Factors , Time Factors , Treatment Outcome
17.
Rev. chil. radiol ; 11(1): 32-35, 2005. ilus
Article in Spanish | LILACS | ID: lil-449899

ABSTRACT

Se presenta el caso de una lactante con enfermedad de Hirschsprung que requirió alimentación parenteral permanente y que presentó complicaciones de las vías venosas centrales incluyendo trombosis, septicemia y tromboembolismo pulmonar. El diagnóstico de las complicaciones trombóticas mediante Doppler y cintigrafía de ventilación perfusión permitió un tratamiento oportuno y seguimiento adecuado.


Subject(s)
Humans , Female , Infant , Pulmonary Embolism , Pulmonary Embolism/drug therapy , Pulmonary Embolism , Hirschsprung Disease/complications , Ventilation-Perfusion Ratio , Anticoagulants/therapeutic use , Pulmonary Embolism/etiology , Heparin, Low-Molecular-Weight/therapeutic use , Treatment Outcome , Ultrasonography, Doppler
18.
P. R. health sci. j ; 23(3): 207-215, Sept. 2004.
Article in English | LILACS | ID: lil-406541

ABSTRACT

Extended-spectrum Beta (beta)-lactamases (ESBLs) have emerged as an important mechanism of resistance to B-lactam antibiotics in gram-negative bacteria (GNB). They are enzymes that hydrolyze older B-lactam antibiotics as well as broad-spectrum cephalosporins and monobactams. ESBL producers have been reported in many bacteria but special attention has been paid to the ones in E.coli and Klebsiella spp. Detection of the ESBLs by the clinical laboratory is a special challenge. Surveillance to monitor resistance is important to decide when detection of ESBLs must be started. This study determined the prevalence of ESBL producers in the strains E.coli and K.pneumoniae at the San Juan VA Medical Center, and characterized their phenotypes to evaluate the importance to identify these bacteria as a standard routine procedure in the institution. All E.coli and K.pneumoniae isolated from Jan 1 to Mar 31, 2003 were evaluated according to National Committee for Clinical Laboratory Standards (NCCLS) screening criteria for suspected ESBL producers. Phenotypic confirmation of the ESBL production was performed using the Etest method. A total of 112/253 (44%) E.coli and 72/137 (53%) K.pneumoniae were identified as suspected ESBL producers. Etest was performed in 60% of the E.coli and 57% of the K.pneumoniae suspected to be ESBL producers. The overall ESBL prevalence for E.coli was 25% and in K.pneumoniae was 26%. Most E.coli ESBL-producers were from urine while the K.pneumoniae were from sputum. ESBL-producers were isolated from different sources including pleural and synovial fluids, blood, and skin besides urine and sputum. According to susceptibility results, the most reliable antibiotic in predicting a negative ESBL was cefpodoxime (CPD), and in the strains studied, the ESBL producers were consistently resistant to aztreonam (ATM). A large proportion (95%) of ESBL producing K.pneumoniae were susceptible to cefepime (CEP). Of the ESBL producing E.coli, 24% were susceptible. In the case of E.coli ESBLproducers, Cefepime can be considered as a therapeutic option if susceptibilities are available. Automated identification and sensitivity systems are valid alternatives for routine evaluation of B-lactam resistance but when increased resistance is documented in GNB and/or ESBL prevalence is high, ESBL detection should be performed. All confirmed ESBL producers should be reported resistant to all penicillins, cephalosporins, and aztreonam in spite of having susceptible ra


Subject(s)
Humans , Escherichia coli/enzymology , Escherichia coli Infections/microbiology , Klebsiella Infections/microbiology , Klebsiella pneumoniae/enzymology , beta-Lactamases/analysis , Anti-Bacterial Agents/therapeutic use , Bacterial Typing Techniques , beta-Lactam Resistance , Escherichia coli/isolation & purification , Hospitals, Veterans/statistics & numerical data , Escherichia coli Infections/drug therapy , Klebsiella Infections/drug therapy , Klebsiella pneumoniae/isolation & purification , Microbial Sensitivity Tests , Phenotype , Puerto Rico
19.
Rev. colomb. obstet. ginecol ; 55(1): 71-82, mar. 2004. tab
Article in Spanish | LILACS | ID: lil-385472

ABSTRACT

La controversia alrededor del papel de la laparoscopia diagnóstica de rutina se origina de la comprensión incompleta de varios temas médicos en discusión. No obstante, existe consenso en varios puntos; primero, hay varios medios confiables no invasivos para confirmar la permeabilidad tubárica existente. Por tanto, el costo y los riesgos de la laparoscopia excluyen su uso para confirmar únicamente la permeabilidad tubárica, la cual puede ser documentada por imágenes radiológicas o sonográficas. En contraposición, la inspección visual directa del peritoneo pélvico otorga una gran sensibilidad para el diagnóstico de endometriosis y adherencias que comprometen los órganos reproductivos. Además, esta modalidad permite un tratamiento inmediato de la mayoría de estas condiciones. La infertilidad inexplicada es un diagnóstico que requiere de la apariencia normal de los órganos pélvicos a la inspección visual. El valor pronóstico de la laparoscopia diagnóstica y tratamiento permanecen en el área de lo controversial. La prevalencia real de la no clinicamente detectada pero importante enfermedad adherencial está entre un 20 a un 42 por ciento y los beneficios del tratamiento laparoscópico en cuanto a tasas de embarazo intrauterino se encuentran entre un 58 y un 62 por ciento. Las tasas de embarazo en la adhesiolisis laparoscópica de fimbria tubárica o fimbrioplastia están alrededor del 35 por ciento, con una tasa de embarazo ectópico entre el 9,7 y el 14 por ciento. Aunque parece que las tasas de embarazo se incrementan después de la reparación de la enfermedad adherencial, la tasa de reformación adherencial no se debe subestimar. Un estudio multicéntrico en 1991 mostró una reformación de adherencias en el 97 por ciento de las pacientes en el 66 por ciento de los sitios donde se realizó la adhesiolisis. Por tanto, en consonancia con la reformación de adherencias, la laparoscopia no ofrece un beneficio sustancial comparado con la laparotomía. Con relación a la endometriosis, se ha observado que esta patología se encuentra en gran porcentaje de pacientes infértiles, asintomáticas, las cuales no se embarazan después de un periodo expectante de manejo; estudios aleatorizados han demostrado que el manejo laparoscópico de la endometriosis mínima y leve mejora las tasas de embarazo en un 30,7 por ciento versus el manejo expectante con una tasa de embarazo del 17,7 por ciento...


Subject(s)
Humans , Female , Infertility, Female , Laparoscopy , Colombia
20.
P. R. health sci. j ; 23(1): 25-33, Mar. 2004.
Article in English | LILACS | ID: lil-359652

ABSTRACT

Antibiotics are frequently prescribed in the older person, the dosification needs special care, since the pharmacokinetic parameters changes with aging and the side effects can be different in the older person. The creatinine clearance changes and we must modify the way we prescribe such antibiotics to the elderly, calculating. The variety of antibiotics now available led us to consider this paper in which we have presented the antimicrobial agents that can be considered in the treatment of the older person. We present several groups: the penicillins, cephalosporins, monobactams, carbapenems and betalactamase inhibitors or the great betalactam group. Other trimetroprin-sulfame-thoxazole, the newer macrolides (azithromycin and clarithromycin) as well as the aminoglycosides, vancomycin, clindamycin, metroridazole. The indications and contraindications are presented and reviewed.


Subject(s)
Humans , Aged , Anti-Bacterial Agents/therapeutic use , Age Factors , Anti-Infective Agents , Anti-Infective Agents, Urinary , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/pharmacokinetics , Anti-Bacterial Agents/pharmacology , Aminoglycosides/administration & dosage , Aminoglycosides/therapeutic use , Carbapenems/administration & dosage , Carbapenems/therapeutic use , Cephalosporins/administration & dosage , Cephalosporins/therapeutic use , Drug Interactions , Fluoroquinolones/administration & dosage , Fluoroquinolones/therapeutic use , Monobactams , Macrolides/administration & dosage , Macrolides/therapeutic use , Penicillins/administration & dosage , Penicillins/therapeutic use , Trimethoprim, Sulfamethoxazole Drug Combination/administration & dosage , Trimethoprim, Sulfamethoxazole Drug Combination/therapeutic use , beta-Lactamases/antagonists & inhibitors
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