Evaluación positiva de medicamentos: noviembre y diciembre de 2022 y enero de 2023 / Positive assessment of drugs: from November and December of 2022 and January of 2023

Se reseñan los medicamentos evaluados y con dictamen positivo por comisión de expertos de la Agencia Española de Medicamentos y Productos Sanitarios o de la Agencia Europea del Medicamento hechos públicos de noviembre y diciembre de 2022 y enero de 2023, y considerados de mayor interés para el profesional sanitario. Se trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento. (AU)

The drugs assessed by the Spanish Agency for Medicines and Health Products or European Medicines Agency made public from November 2022 to January of 2023, and considered of interest to the healthcare professional, are reviewed. These are positive technical reports prior to the authorization and placing on the market of the product. (AU)

Inmunología y consumo de medicamentos: reacciones adversas de baja frecuencia tipo B / Immunology and drugs´ consumption: type B low-frequency adverse reactions

Introducción: para el Sistema Cubano de Farmacovigilancia, es importante la detección de efectos adversos ocasionales, raros o muy raros e incluso no descritos, este es el punto de partida para generar hipótesis de relaciones causales entre la administración de un fármaco y la aparición de un determinado efecto adverso. Objetivo: describir las reacciones adversas tipo B en Cuba notificadas al sistema de farmacovigilancia y las bases inmunológicas para su interpretación. Materiales y métodos: se realizó una investigación documental y análisis de contenido de las publicaciones identificadas en la literatura nacional e internacional que tratan el tema. Resultados: se presentan los elementos teóricos metodológicos para el abordaje de la seguridad del consumo de medicamentos, farmacovigilancia y reacciones adversas a medicamentos, así como su interpretación inmunológica y perfil de baja frecuencia tipo B. Conclusiones: el perfil de reacciones adversas tipo B en Cuba es alto por lo que el estudio de estas teniendo en cuanta su interpretación inmunológica resulta información valiosa para la caracterización de la seguridad de los medicamentos y para la toma de decisiones en salud (AU).

Introduction: for the Cuban System of Pharmacovigilance, the detection occasionally adverse, rare or very rare, and even non-described is important. This is the starting point to generate hypotheses of casual relations between drug administration and the emergency of a determinate adverse effect. Objective: to describe the type B adverse reactions in Cuba that have been notified to the pharmacovigilance system and the immunologic bases for their interpretation. Material and methods: it was carried out a documental research and a content analysis of the identified national and international publications dealing with the theme. Results: the theoretical and methodological elements for dealing with drug consumption security, pharmacovigilance and drug adverse reactions are given, and also their immunologic interpretation and type B low-frequency profile. Conclusions: the type B adverse reaction´s profile in Cuba is high; therefore their study, taking into account their immunologic interpretation is a valuable information for characterizing drugs security and for taking decisions in public health care (AU).

Inmunología y consumo de medicamentos: reacciones adversas de baja frecuencia tipo B / Immunology and drugs´ consumption: type B low-frequency adverse reactions

Introducción: para el Sistema Cubano de Farmacovigilancia, es importante la detección de efectos adversos ocasionales, raros o muy raros e incluso no descritos, este es el punto de partida para generar hipótesis de relaciones causales entre la administración de un fármaco y la aparición de un determinado efecto adverso.Objetivo: describir las reacciones adversas tipo B en Cuba notificadas al sistema de farmacovigilancia y las bases inmunológicas para su interpretación.Materiales y métodos: se realizó una investigación documental y análisis de contenido de las publicaciones identificadas en la literatura nacional e internacional que tratan el tema.Resultados: se presentan los elementos teóricos metodológicos para el abordaje de la seguridad del consumo de medicamentos, farmacovigilancia y reacciones adversas a medicamentos, así como su interpretación inmunológica y perfil de baja frecuencia tipo B.Conclusiones: el perfil de reacciones adversas tipo B en Cuba es alto por lo que el estudio de estas teniendo en cuanta su interpretación inmunológica resulta información valiosa para la caracterización de la seguridad de los medicamentos y para la toma de decisiones en salud (AU).

Introduction: for the Cuban System of Pharmacovigilance, the detection occasionally adverse, rare or very rare, and even non-described is important. This is the starting point to generate hypotheses of casual relations between drug administration and the emergency of a determinate adverse effect.Objective: to describe the type B adverse reactions in Cuba that have been notified to the pharmacovigilance system and the immunologic bases for their interpretation.Material and methods: it was carried out a documental research and a content analysis of the identified national and international publications dealing with the theme.Results: the theoretical and methodological elements for dealing with drug consumption security, pharmacovigilance and drug adverse reactions are given, and also their immunologic interpretation and type B low-frequency profile.Conclusions: the type B adverse reaction´s profile in Cuba is high; therefore their study, taking into account their immunologic interpretation is a valuable information for characterizing drugs security and for taking decisions in public health care (AU).

Terapia clásica frente a terapia secuencial en la erradicación de la infección por Helicobacter pylori / Classical therapy versus sequential therapy in the eradication of Helicobacter pylori infection

Introducción: en el año 1983 se descubre el Helicobacter pylori, lo cual abrió un nuevo campo en la atención de las enfermedades que este causaba así como en el tratamiento para erradicar esta bacteria. Objetivo: comparar la eficacia de la terapia clásica respecto a la terapia secuencial en la erradicación de la infección por Helicobacter pylori.Método: se realizó un estudio analítico aleatorio en el Centro de Investigaciones Médico Quirúrgico, entre enero del 2013 y mayo del 2015. Se estudiaron 160 pacientes, según los criterios de inclusión, los que fueron ubicados en dos grupos: Grupo A, con 80 pacientes, para la terapia secuencial y Grupo B, con 80 pacientes, para la terapia clásica. Resultados: el promedio de edad de ambos grupos fue de 46,0 ± 14,3 años. El promedio de edad de los pacientes que recibieron terapia clásica fue de 46,9 ± 14,6 años mientras que el promedio en el grupo de la terapia secuencial fue de 45,2 ± 14,1 años; no hubo diferencias significativas entre ambos grupos (p= 0,770) en cuanto a la edad ni al sexo. La gastritis eritematosa antral fue el diagnóstico endoscópico más identificado (24,4 por ciento) mientras que en el histológico fue la gastritis crónica antral moderada (36,9 por ciento). El 93,7 por ciento de los pacientes que recibieron la terapia clásica erradicaron la infección por Helicobacter pylori lo que representó una diferencia de erradicación respecto a la terapia secuencial. Conclusiones: la terapia clásica fue más eficaz que la terapia secuencial en la erradicación del Helicobacter pylori(AU)

Introduction: Helicobacter pylori was discovered in 1983, opening a new field in the management of diseases it causes as well as the treatment for the eradication of this bacterium. Objective: compare the efficacy of classical treatment compared with sequential therapy in the eradication of Helicobacter pylori infection. Method: a randomized analytical study was conducted at the Center for Medical Surgical Research from January 2013 to May 2015. A hundred sixty (160) patients were studied according to the inclusion criteria and they were divided into two groups: Group A, with 80 patients for sequential therapy and group B with 80 patients to conventional therapy. Results: the average age of both groups was 46.0 ± 14.3 years. For patients who received conventional therapy the average age was 46.9 ± 14.6 years while the sequential therapy group was 45.2 ± 14.1 years with no significant differences in both groups (p = 0.770), nor were significant differences for sex. Erythematous antral gastritis was the most identified endoscopic diagnosis in 24.4 percent while moderate chronic gastritis antral was the most identified histologic diagnosis in 36.9 percent. 93.7 percent of patients who received conventional therapy eradicated Helicobacter pylori infection, representing a difference eradication regarding sequential therapy.Conclusions: classical therapy was more effective than sequential therapy in the eradication of Helicobacter pylori(AU)

Reacciones adversas en ensayos clínicos con nuevos fármacos conducidos en Brasil: años 2000 y 2012 / Adverse reactions in clinical trials carried out in Brazil with new drugs, years 2000-2012

Introducción: los ensayos clínicos constituyen un diseño de tipo experimental utilizado para evaluar cualquier actuación diagnóstica y terapéutica aplicada a humanos.Objetivo: evaluar los relatos de reacciones adversas a medicamentos, en cuanto a causalidad, gravedad, edad y grupos vulnerables en protocolos de ensayos clínicos con nuevos fármacos analizados en el Comité de Ética de la Investigación de la Secretaria de Salud de Brasilia. Distrito Federal, Brasil.Método: estudio observacional, descriptivo y transversal, en la modalidad de estudio de caso, se consideró como universo de trabajo los proyectos evaluados por el Comité de Ética en Investigación-CEI/SES/DF en el período comprendido entre los años 2000 y 2012. Resultados: el 59 por ciento de las investigaciones se correspondieron con estudios nacionales y el 41 por ciento con estudios internacionales. La industria farmacéutica fue la fuente financiadora en el 65 por ciento de los casos y en el 41 por ciento de ellos existió participación extranjera. De los medicamentos estudiados el 19 por ciento no poseían registro en la Agencia Nacional de Vigilancia Sanitaria-ANVISA y solo en el 9,5 por ciento de los ensayos se utilizó grupo control. Las reacciones adversas fueron consideradas como relacionadas a los medicamentos, posibles o improbables en el 15,7 por ciento, 19,8 por ciento y 63,6 por ciento, respectivamente.Conclusiones: la mayor parte de las investigaciones en las que se evaluaron nuevos medicamentos fueron conducidas por instituciones brasileñas y en la mayoría se recibió financiación internacional. La falta de registro de algunos de los nuevos productos en la agencia nacional reguladora y la no existencia de grupo control, en diferentes ensayos clínicos, fueron limitaciones identificadas en el proceso de evaluación. Se identificó la no existencia de modelos únicos legalmente validados para la evaluación de los eventos adversos a los medicamentos(AU)

Background: clinical trials are an experimental kind design used to assess any diagnostic and therapeutic performance applied to human beings.Aim: to assess the reports of adverse reactions to drugs, according to causality, seriousness, age and vulnerable groups in protocols of new drugs clinical trials analyzed in the Research Ethic Committee of Brasilia Health Secretariat, Federal District, Brazil. Method: cross-sectional, descriptive, observational study of case study kind. As universe of work, we took into account the projects assessed by the Research Ethic Committee of Brasilia Health Secretariat, Federal District (CEI/SES/DF in Portuguese) in the period from 2000 to 2012.Outcomes: 59 percent of the research corresponded to national studies and 41 percent to international ones. The pharmaceutical industry was the financeable source in 65 percent of the cases and there it was foreign participation in 41 percent of them. 19 percent of the studied drugs were not registered in the National Agency of Sanitary Surveillance (ANVISA in Portuguese) and control group was used in only 9,5 percent of the trials. The adverse reactions were considered as related to drugs, possible or improbable in 15,7 percent, 19,8 percent and 63,6 percent, respectively.Conclusions: most of the research where new drugs were assessed was carried out by Brazilian institutions and most of them received international financial support. The lack of registration of several new products in the national regulatory agency and not using control groups were limitations identified during the assessing process in several clinical trials. We identified the inexistence of unique models legally validated for the evaluation of adverse events to drugs(AU)

Intoxicação de ovinos que receberam duas aplicações de closantel, na dosagem terapêutica (7,5mg/kg), com intervalo de 28 dias / Poisoning of sheep that received two treatments of closantel in a therapeutic dose (7.5mg/kg), with an interval of 28 days

This study reports poisoning in sheep wich have received two applications of closantel in therapeutic dosage (7.5mg/kg) within a preestablished 28-day period for effectiveness formulation. A high percentage of efficiency was observed after the first and second treatment, but around 72 hours after the second administration of closantel (D30), three sheep have showed mild apathy, anorexia, diarrhea, bilateral blindness, and dilated pupils without reaction. These three animals, were observed in the following 250 days, and the bilateral blindness remained. Numerous reports of animals poisoned by closantel emphasize that overdose and/or nutritional status of the animals are key factors to occur poisoning due closantel administration. However, in this experiment the signs of poisoning (mild apathy, anorexia, diarrhea and ophthalmic disturbance), observed in the three clinically healthy sheep, occurred when they received two applications of closantel (7.5mg/kg), in a interval of 28 days, highlighting the fact of obtaining a cumulative residual effect of closantel in the animal organism, caused by two consecutive applications, may also be a predisposing factor for sheep to demonstrate irreversible signs of intoxication.

O presente estudo notifica a intoxicação de ovinos que receberam duas aplicações de closantel, na dosagem terapêutica (7,5mg/kg), com intervalo de 28 dias pré-estabelecido pela eficácia da formulação. Referente aos resultados de eficácia foi possível observar elevado percentual após o primeiro e o segundo tratamento. Cerca de 72 horas após a administração do segundo tratamento (D+30), três animais que receberam closantel demonstraram leve apatia, anorexia, diarréia e cegueira bilateral com ausência de reflexo e midríase bilateral. Estes três ovinos foram observados por cerca de 250 dias após o segundo tratamento, e a cegueira bilateral não regrediu. Os inúmeros casos de animais intoxicados por closantel descritos na literatura enfatizam que a sobredosagem e/ou qualidade nutricional dos animais, são fatores determinantes para que ocorra intoxicação destes animais pelo closantel. Entretanto, no presente trabalho, os sinais de intoxicação (leve apatia, anorexia, diarréia e a alteração oftálmica) observada nos três ovinos clinicamente sadios, ocorreram quando estes receberam duas aplicações de closantel (7,5mg/kg) com o intervalo de 28 dias, evidenciando que o possível efeito residual cumulativo de closantel no organismo animal, desencadeado por duas aplicações consecutivas, também pode ser um fator predisponente para que ovinos demonstrem sinais irreversíveis de intoxicação pelo princípio ativo em questão.

Evaluación positiva de medicamentos: junio y julio 2014 / Positive assessment of drugs: June and July of 2014

Se reseñan los medicamentos ya evaluados por la Agencia Española de Medicamentos y Productos Sanitarios hechos públicos en junio, julio y agosto de 2014, y considerados de mayor interés para el profesional sanitario. Se trata de opiniones técnicas positivas que son previas a la autorización y comercialización del medicamento

The drugs assessed by the Spanish Agency for Medicines and Health Products made public in June, July and August of 2014, and considered of interest to the healthcare professional, are reviewed. These are positive technical reports prior to the autho-rization and placing on the market of the product

Avaliação da qualidade de vida em um grupo de portadores de HIV / Evaluation of quality of life in a HIV carriers' group

Introdução: atualmente, a qualidade de vida teve os seus conceitos ainda mais ampliados, devido especialmente às doenças crônicas. A Organização Mundial da Saúde desenvolveu então um instrumento universal para a avaliação da qualidade de vida, o WHOQOL-abreviado, um instrumento na versão abreviada do WHOQOL-100. Objetivo: avaliar a qualidade de vida dos portadores de HIV. Métodos: trata-se de uma pesquisa transversal exploratória sobre qualidade de vida de 40 pacientes portadores de HIV, utilizando como instrumento de pesquisa o WHOQOL-abreviado. Resultados: a avaliação geral da qualidade de vida foi de 65,0%. Houve signifi cância entre QV2 com o grupo que possuía reações adversas aos antirretrovirais (0,0391) em relação àquele que não manifestava, com o grupo que apresentava doenças oportunistas pregressas (0,0272) e também com o grupo que apresentava doenças oportunistas atuais (0,0086). Conclusão: verifi cou-se que as reações adversas aos medicamentos e as doenças oportunistas infl uenciam negativamente a qualidade de vida, o que pode ser modifi cado com o uso racional dos medicamentos e com o acompanhamento multiprofi ssional a estes pacientes.

Introduction: nowadays the quality life had its concepts enlarged especially because of the chronic diseases. The World Health Organization organized a universal quality of life instrument, the WHOQOL-bref, this instrument was developed by WHOQOL-100. Objetives: the objective was to evaluate the HIV carriers? quality of life group. Methods: it is a transversal study based on interview technique using WHOQOL-bref instrument. Forty HIV carriers? were interviewed. Results: the quality of life average was of 65.0%. There is signifi cance between QV2 and the group presents adverse reactions by antiretrovirals (0.0391), the regress opportunistic diseases group (0.0272) and the actual opportunistic diseases (0.0086). Conclusion: it was verifi ed that the adverse reactions to the medicine and to the opportunistic diseases have infl uenced negatively in the quality of life, this situation can be different whenexisting the rational use drugs and the following of patient by health equip.

Impacto de las recomendaciones del Sistema Español de Farmacovigilancia en la publicación de casos de reacciones adversas a medicamentos / Impact of the spanish pharmacovigilance system recommendation son the publication of cases of adverse drug reactions

Objetivo. Evaluar el impacto de lasrecomendaciones que el Comité Técnico delSistema Español de Farmacovigilancia envióa los editores de revistas médicas españolasen el año 2004 sobre la información mínimaque deberían contener los casos publicadosde reacciones adversas a medicamentos.Diseño. Estudio observacional.Emplazamiento. Base de datos nacional desospechas de reacciones adversas (FEDRA).Participantes. Notificaciones de publicacionesde sospechas de reacciones adversasregistradas en FEDRA y publicadas enlos años previo (2003) y posterior (2005)al envío de las recomendaciones.Mediciones principales. Información en losapartados: sexo, edad, dosis, motivo de laprescripción, duraciones del tratamiento y dela reacción, secuencia temporal, efecto de laretirada y causas alternativas de laspublicaciones de sospechas de reaccionesadversas registradas en FEDRA. Secompararon los resultados de los 2 años.Resultados. No se observaron diferenciassignificativas en la información contenidaen las publicaciones de casos de reaccionesadversas entre los años 2003 y 2005.Los apartados que con mayor frecuenciapresentaban información incompleta eranlas dosis y duraciones de los tratamientosy de la reacción adversa. Sólo un tercio,aproximadamente, de las publicacionescontenían información completa.Conclusiones. Es necesario mejorarel contenido de la información de laspublicaciones de casos de reacciones adversasa medicamentos para que esta mejordocumentación contribuya a mejorarla evaluación de las señales de alerta

Objective. To assess the impact of therecommendations that, the TechnicalCommittee of the SpanishPharmacovigilance System sent, in 2004,to the editors of Spanish medical journalson the minimum information required forpublication of adverse drug reaction casereports.Design. Observational study.Setting. National suspected adverse drugreactions database (FEDRA).Participants. Published adverse drug reactionreports registered in FEDRA, publishedin the years before (2003) and after (2005)the recommendations were issued.Main measurements. The following dataelements were analysed: sex, age, dose,disease treated with the suspecteddrug, length of treatment and adverse drugreaction, temporal sequence, withdrawaleffect, and alternative causes. The resultsof the 2 years were compared.Results. The information in the case reportspublished between years 2003 and 2005was not significantly different. The dataelements more often incomplete were dose,length of treatment, as well as length ofadverse reaction. Approximately one thirdof the published case reports included fullinformation.Conclusions. There seems to be a needto improve the data elements contentof published adverse drug reactions casereports, so that such documentation can contribute to improve the assessment of alert signals (AU)

Estudio del consumo de fármacos inadecuados o no indicados en el anciano que ingresa en un Servicio de Medicina Interna / Study of the consumption of innapropiate medicaments in elder hospitalized in the internal medicine service

Introducción: Los pacientes ancianos se caracterizan por el alto grado de polimedicación. Este factor se ha mostrado el más importante en la aparición de efectos adversos (EAF). El estudio de los fármacos ayuda a establecer cuales son inapropiados y por lo tanto se deben retirar, disminuyendo de esta forma la posibilidad de EAF. Material y Métodos: Estudio prospectivo y observacional. Criterio de inclusión: pacientes de > 64 años que ingresan en Medicina Interna. Se definió como fármaco inapropiado los medicamentos de baja utilidad terapéutica (UTB), los no indicados, y los inadecuados para el anciano. Mediante el programa informático SPSS 11.5 se analizaron las posibles variables relacionadas con el consumo. Resultados: Se incluyeron en el estudio 172 ancianos. La media de medicamentos por persona y día fue de 5,34 (0-15). El 52,5% consumían un fármaco inapropiado (36,6% inadecuado para el anciano, 15% noindicado y 12% UTBs). El análisis multivariante asocia el consumo de estos fármacos a un mayor número de patologías (p < 0,012), a un mayor consumo de medicamentos (p < 0,001) y a la procedencia de residencias de ancianos (p < 0,001). Sólo el consumo de fármacos no adecuados para el anciano se asocia a aumento de EAF. Conclusión: La mitad de los ancianos toma al menos un fármaco deforma innecesaria, y la mayoría de estos fármacos favorece la aparición de EAF

Background: The elderly patients are characterized by the high degree of polymedication. This factor is the most important in the appearance of adverse effects (EAD). The study of the medicaments helps to establish which are inappropriate and therefore they must move back, diminishing of this form EAD’s possibility. Patients and Method: Prospective and observacional Study. Criterion of incorporation: patients of > 64 years old, hospitalized in an Internal Medicine Service. There were defined as inappropriate medicament the medicines of low therapeutic utility, them not indicated, and the inadequate ones for the elder. By means of the SPSS 11.5 program the possible variables related with the consumption were analyzed. Results: 172 elders were included in the study. The average of medicines for person and day belonged to 5.34 (0-15). 52.5% was consuming an inappropriate medicament (36.6% inadequate for the elder, 15% not indicated, and 12% UTBs). The analysis multivariant associates the consumption of these medicaments with a major number of diseases (p <0.012), to a major consumption of medicines (p < 0.001) and to the origin of the nursing residences (p < 0.001). Only the consumption of medicaments not adapted for the elder is associated with increase of EAD. Conclusion: The half of the elders takes at least a medicament of unnecessary form, and the majority of these medicaments favors appearance of EAD

Ayudas a la prescripción: interacciones de medicamentos / Computerized prescriber order entry with decision support: drug interactions

Introducción: La complejidad del proceso de utilización de los medicamentos es tal, que los errores asociados a su empleo pueden aparecer en uno, varios o incluso todos los pasos desde su prescripción a su dispensación. Con la introducción de ayudas sencillas en los programas de prescripción se puede mejorar de forma significativa la eficacia y la seguridad global de este proceso, y las ayudas sobre interacciones de los fármacos son lasque más pueden influir en la calidad de la prescripción médica. Objetivo: Desarrollar un programa de ayuda a la prescripción médica sobre interacciones de fármacos. Método: Se seleccionan los medicamentos más utilizados en el área de cardiología pediátrica, revisándose para cada principio activo las interacciones fármaco-fármaco, alimento y producto medicinal. Resultados: Se elabora una tabla con un total de 30 principios activos que recoge toda la información. Discusión: Se estima que las interacciones pueden representar aproximadamente un 7% de todas las reacciones adversasen pacientes hospitalizados y el 1% del total de hospitalizaciones. Son muchas las posibles interacciones que pueden plantearse en la práctica clínica diaria, por lo que sólo hemos elegido las interacciones que se consideran más importantes por su potencial trascendencia clínica. La integración de esta información en el programa de prescripción electrónica constituye una ayuda a la prescripción médica, y puede contribuir a la disminución de la aparición de errores de medicación y problemas relacionados con los medicamentos (AU)

Background: The use of drugs is so complex that errors can arise at any step of the way from prescription to dispensation. The introduction of decision support systems into the computerized prescriber order entry may enhance both efficacy and safety of this process. Thus, information on drug interactions is one of the most useful aids for improving the overall quality of drug prescription. Objective: To develop a decision support application focusing on drug interactions. Method: We selected the drugs most widely used in the pediatric cardiology ward, reviewing the drug-drug, drug-food and drug-medicinal product interactions associated with each active ingredient. Results: We provide a table with all the information on the30 active ingredients reviewed. Discussion: Interactions are responsible for approximately7% of all the adverse events in hospitalized patients and 1% of all hospital admissions. There are so many possible interactions that we have chosen only those considered most important because of their potential clinical consequences. The integration of this information into the computerized prescriber order entry system may constitute a very helpful tool, contributing to a reduction in adverse drug events and the overall medication errors (AU)

Identificação de eventos adversos a medicamentos em pacientes idosos atendidos na Unidade de Saúde Parque dos Maias do Serviço de Saúde Comunitária do Grupo Hospitalar Conceição

O trabalho visa apresentar um levantamento dos casos de eventos adversos e identificar reações adversas a medicamentos em pacientes idosos na atenção primária à saúde. Objetiva mensurar o número e a classe farmacológica de fármacos utilizados pelos pacientes, bem como mensurar a prevalência de de eventos adversos relacionados.

Impacto das intoxicações por antidepressivos tricíclicos comparados aos depressores do “sistema nervoso central” / Poisoning impact by tryciclic antidepressants compared to Central Nervous System depressants

Os antidepressivos tricíclicos (ADT) constituem uma classe de drogas de alta importância toxicológica,porque o uso abusivo dessa substância acarreta alguma sintomatologia ou mesmo risco de vida, pelo fácil acesso, em razão do baixo custo, da distribuição pelo sistema público de saúde e pela prescrição indiscriminada.Este trabalho teve por objetivos avaliar o impacto das intoxicações por ADT atendidos em um hospital terciário comparando com as intoxicações ocasionadas por outras drogas depressoras do “sistema nervoso central”. Para a realização deste trabalho foram avaliados os atendimentos realizados pelo Centro de Assistência Toxicológica (CEATOX) de São José do Rio Preto, entre o período de 01 de janeiro de 2001 até 31 de dezembrode 2003, através da Ficha de Notificação do CEATOX. Nesse estudo, de um total de 2950 atendimentos, 123 eram casos de intoxicação por antidepressivos tricíclicos (ADT) e 275 de outras drogas depressoras do“sistema nervoso central” (DSNC) atendidos neste hospital. O ADT mais utilizado foi a Amitriptilina; já entre os DSNC temos os Benzodiazepínicos (BZD). Houve uma maior internação por parte dos ADT, com maior tempo de internação em relação aos DSNC. Com isso, observamos o significativo impacto que as intoxicações pelos ADT causam em termos de atendimento e internação para o nosso hospital. Concluímos que os benefícios e os riscos da prescrição de ADT, hoje largamente utilizados em várias patologias, precisam ser bem avaliados, e sempre que possível, a opção por outros medicamentos com potencial toxicológico menos intenso deve ser feita.

A considerably important toxicological class of drugs is the Tryciclic antidepressants (TCA) because thedrug abuse can trigger some complex combined symptoms of a disease or even risk of death; it is easilyattainable; owing to his low cost; it is available at the health public system; and it is widely prescribed. Thisstudy directly aimed at to estimate the poisoning impact by TCA of patients treated at a tertiary hospitalcompared to poisoning caused by other central nervous system depressant drugs. To the completion of thisessay the exams performed by the Center for Toxicological Assistance (CEATOX) of São José do Rio Preto,from January 1st 2001 to December 31st 2003, were estimated by the Center for Toxicological Assistance(CEATOX) Notification Form. In this study, from a total of 2,950 treated in-hospital patients, 123 werepoisoning cases caused by tryciclic antidepressants (TCA), and 275 from other central nervous systemdepressant drugs. Amytriptiline was the most used Tryciclic antidepressant while among the central nervoussystem depressant drugs the benzodiazepine compounds were the mostly used ones. There was a higherhospitalization rate with tryciclic antidepressants but a higher length of hospitalization related to the centralnervous system depressant drugs. The hospitalization costs to the Unified Health System (SUS) werefurther analyzed indicating that the poisoning costs by tryciclic antidepressants were the same when comparedto central nervous system depressant drugs. And therewith we could see the significant impact that thepoisonings by tryciclic antidepressants caused in relation to medical attendance and hospitalization to ourhospital. It was inferred that the benefits and risks of tryciclic antidepressant prescription, nowadaysextensively used in several pathologies, need to be estimated and whenever is possible, the choice for amedication with a much less intense toxicological potential should be made.

A utilização dos antiinflamatórios seletivos para COX-2 em Odontologia / The use of antiinflamatory selective to COX-2 in Dentistry

Os antiinflamatórios não-esteróides representam a classe de medicamentos mais amplamente utilizada na área da saúde. Porém, sabe-se que eles podem desencadear efeitos colaterais com relação ao trato gastrointestinal, à função renal e hemostática, dentre outros. Em razão disso, um novo grupo de antiinflamatórios foi criado na tentativa de minimizar esses problemas: os antiinflamatórios (AINEs) seletivos para a COX-2. Sendo assim, o presente trabalho visa, através de uma ampla revisão da literatura, destacar e alertar os profissionais da área da saúde quanto às reais indicações, contra-indicações e efeitos colaterais que os AINEs seletivos para a COX-2 podem causar