RESUMO
OBJECTIVE: To evaluate factors involved in spontaneous pregnancy rate after surgery for endometriosis in patients with endometriosis and infertility. METHODS: This retrospective study spanned from 2014 to 2020 and included a follow-up period of two years of patients with endometriosis-related infertility who underwent laparoscopic surgery. Women aged 25 to 43 years with patent tubes, no/mild male factor and no other infertility factors were selected and grouped according to fertility management as follows: patients immediately prescribed ART (16.5%, ART-p); patients who chose not to undergo ART (83.5%) and achieved spontaneous pregnancy (71.8% SP-p); and patients who first chose not to undergo ART but had it subsequently (28.2%, NSP-p). RESULTS: A total of 200 patients were analyzed. Of the 167 patients who waited for spontaneous pregnancy, 71.8% achieved it. We observed a tendency of higher endometriosis ASRM scores in the ART-p group compared with patients who waited for spontaneous pregnancy, and lower scores in individuals that achieved spontaneous pregnancy. When we looked at how long it took to achieve pregnancy, we found that individuals in the SP-p group achieved pregnancy in 5.7 months, while subjects in the NSP-p group took 1.8 times longer than their peers in the SP-p group (p<0.001). However, once prescribed ART, the individuals in the NSP-p group achieved pregnancy within a similar time when compared with subjects in the SP-p group. In order to identify individuals that might benefit from ART early on, we performed a multivariable analysis and developed a decision tree (81.3% accuracy and 53.3% sensitivity). CONCLUSIONS: The present results indicated that, after surgery, the majority of patients achieved spontaneous pregnancy. The decision tree proposed in this study allows the early identification of patients who might require ART, thus decreasing the time between surgery and pregnancy and improving overall outcomes.
Assuntos
Endometriose , Infertilidade Feminina , Laparoscopia , Taxa de Gravidez , Humanos , Feminino , Endometriose/cirurgia , Endometriose/complicações , Gravidez , Adulto , Laparoscopia/métodos , Estudos Retrospectivos , Infertilidade Feminina/cirurgia , Infertilidade Feminina/terapia , Infertilidade Feminina/etiologia , Técnicas de Reprodução AssistidaRESUMO
COVID-19 coronavirus disease is an often-severe illness caused by the SARS-CoV-2 virus. The pandemic has demanded a great organization and redistribution of infrastructure and medical resources for the care of patients with cancer. The Gynecology service of the Oncology Hospital of the City of Buenos Aires is a monovalent center dependent on the City of Buenos Aires. It is part of the network of 33 public hospitals in the City of Buenos Aires and receives referrals from other hospitals in the network and from hospitals in the Province of Buenos Aires. As of March 20, 2020, when decree 260/20 came into force, which established social, preventive and compulsory isolation, a new modality was started for the care and benefits of our hospital. In our Service of the Hospital de Oncología de la Ciudad de Buenos Aires we have developed recommendations for the management of gynecological tumors during the COVID-19. The guide we developed is based on up-to-date data and available resources and provides suggestions and tools for decision-making in order to reduce the morbidity and mortality of patients with gynecological cancer during the Coronavirus pandemic (COVID-19).
La enfermedad por coronavirus COVID-19 causada por el virus SARS-CoV-2 es en muchos casos grave. La pandemia ha demandado una gran organización y redistribución de infraestructura y recursos médicos para la atención de pacientes con cáncer. El servicio de Ginecología del Hospital de Oncología Marie Curie es un centro monovalente dependiente del Gobierno de la Ciudad de Buenos Aires. Forma parte de la red de 33 hospitales públicos de la Ciudad y recibe derivaciones de otros hospitales de la red y de hospitales de la Provincia de Buenos Aires. A partir del 20 de marzo de 2020, cuando entró en vigor el decreto 260/20 que dispuso el aislamiento social, preventivo y obligatorio, se inició una nueva modalidad para la atención y prestaciones de nuestro hospital. En el Servicio de Ginecología del Hospital Marie Curie hemos desarrollado recomendaciones para el manejo de los tumores ginecológicos durante la pandemia por COVID-19. Elaboramos una guía basada en los datos actualizados y recursos disponibles entre los que se encuentran la guía del International Journal of Gynecological Cancer, la guía de la Sociedad Británica del Cáncer Ginecológico, las recomendaciones de la Asociación Argentina de Ginecología Oncológica, y la Guía de la Sociedad de Ginecología Oncológica Americana que proveen sugerencias y herramientas para la toma de decisiones con el objeto de reducir la morbilidad y mortalidad de las pacientes con cáncer ginecológico durante la pandemia por Coronavirus (COVID-19).
Assuntos
COVID-19 , Ginecologia , Neoplasias , Humanos , Pandemias/prevenção & controle , SARS-CoV-2RESUMO
Resumen La enfermedad por coronavirus COVID-19 causada por el virus SARS-CoV-2 es en muchos casos grave. La pandemia ha demandado una gran organización y redistribución de infraestructura y recur sos médicos para la atención de pacientes con cáncer. El servicio de Ginecología del Hospital de Oncología Marie Curie es un centro monovalente dependiente del Gobierno de la Ciudad de Buenos Aires. Forma parte de la red de 33 hospitales públicos de la Ciudad y recibe derivaciones de otros hospitales de la red y de hospitales de la Provincia de Buenos Aires. A partir del 20 de marzo de 2020, cuando entró en vigor el decreto 260/20 que dispuso el aislamiento social, preventivo y obligatorio, se inició una nueva modalidad para la atención y prestaciones de nuestro hospital. En el Servicio de Ginecología del Hospital Marie Curie hemos desarrollado recomendaciones para el manejo de los tumores ginecológicos durante la pandemia por COVID-19. Elaboramos una guía basada en los datos actualizados y recursos disponibles entre los que se encuentran la guía del International Journal of Gynecological Cancer, la guía de la Sociedad Británica del Cáncer Ginecológico, las recomendaciones de la Asociación Argentina de Ginecología Oncológica, y la Guía de la Sociedad de Ginecología Oncológica Americana que proveen sugerencias y herramientas para la toma de decisiones con el objeto de reducir la morbilidad y mortalidad de las pacientes con cáncer ginecológico durante la pandemia por Coronavirus (COVID-19).
Abstract COVID-19 coronavirus disease is an often-severe illness caused by the SARS-CoV-2 virus. The pandemic has demanded a great organization and redistribution of infrastructure and medical resources for the care of patients with cancer. The Gynecology service of the Oncology Hospital of the City of Buenos Aires is a monovalent center dependent on the City of Buenos Aires. It is part of the network of 33 public hospitals in the City of Buenos Aires and receives referrals from other hospitals in the network and from hospitals in the Province of Buenos Aires. As of March 20, 2020, when decree 260/20 came into force, which established social, preventive and compulsory isolation, a new modality was started for the care and benefits of our hospital. In our Service of the Hospital de Oncología de la Ciudad de Buenos Aires we have developed recommendations for the management of gynecological tumors during the COVID-19. The guide we developed is based on up-to-date data and available resources and provides suggestions and tools for decision-making in order to reduce the morbidity and mortality of patients with gynecological cancer during the Coronavirus pandemic (COVID-19).
RESUMO
The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharmaceutics classification system and the BCS regulatory guidelines in Latin America and analyzes the current BCS regulatory requirements and the perspective of the harmonization in the region to develop safe and effective multisource products. Differences and similarities between the official and publicly available BCS guidelines of several Latin American regulatory authorities and the new ICH harmonization guideline were identified and compared. Only Chile, Brazil, Colombia, and Argentina have a more comprehensive BCS guideline, which includes solubility, permeability, and dissolution requirements. Although their regulatory documents have many similarities with the ICH guidelines, there are still major differences in their interpretation and application. This situation is an obstacle to the successful development of safe and effective multisource products in the Latin American region, not only to improve their access to patients at a reasonable cost, but also to develop BCS biowaiver studies that fulfill the quality standards of regulators in developed and emerging markets.
RESUMO
En el marco de la pandemia de COVID-19, las agencias reguladoras del mundo, junto a la Organización Mundial de la Salud, recomendaron el uso de sanitizantes de manos para disminuir la transmisión viral. El repentino incremento del uso de estos productos por parte de la población derivó, entre otras cosas, en la aparición de vías de comercialización no autorizadas. Como consecuencia, y por intervención de la justicia, el Laboratorio Nacional de Control del Instituto Nacional de Medicamentos recibió numerosas muestras a fin de conocer la composición cuali-cuantitativa dado que, por la apariencia de los envases y rótulos, denotaban ilegitimidad. Para ello, se llevaron a cabo diversos análisis físico-químicos por picnometría, cromatografía gaseosa y espectrofotometría de infrarrojo medio. Los resultados indicaron que, si bien las muestras analizadas contenían etanol y/o isopropanol, en la mayoría de los casos su concentración no se hallaba en los valores recomendados y casi todos los envases no cumplían con la normativa vigente de rotulado
In the context of COVID-19 pandemic, the use of hand sanitizers was recommended to reduce viral transmission by the global regulatory agencies together with the World Health Organization. The sudden increase in the use of these products by the population led, among other things, to the emergence of unauthorized marketing channels. As a result, and due to judicial intervention, numerous samples were received by the National Control Laboratory of the National Institute of Medicines in order to determine the qualitative-quantitative composition, since the appearance of the containers and labels denoted illegitimacy. To that end, various physicochemical analyses were carried out by pycnometry, gas chromatography and mid-infrared spectrophotometry. Although the analyzed samples contained ethanol and/or isopropanol, the results showed that in most cases the concentration was not within the recommended values and almost all the containers did not comply with the current labeling regulations.
Assuntos
Etanol , Higienizadores de Mão , COVID-19RESUMO
Los métodos clásicos o tradicionales utilizados para el control microbiológico de medicamentos fueron desarrollados hace más de un siglo y se continúan utilizando ya que cumplen con su función de enumerar e identificar microorganismos, contribuyendo a controlar la seguridad microbiológica de los productos farmacéuticos. Estos métodos, tienen la principal desventaja de requerir prolongados tiempos de incubación por lo que, con la intención de resolver este punto y otras limitaciones, se desarrollaron nuevas tecnologías con distintas estrategias para la detección microbiana. El objetivo del presente trabajo fue analizar y discutir acerca de los procesos de validación de métodos microbiológicos alternativos y su implementación en el control de calidad de productos farmacéuticos. Las tecnologías utilizadas en los métodos microbiológicos alternativos pueden clasificarse en detección temprana basada en la actividad metabólica, medición directa de células, o basados en la medición de biomoléculas. Los parámetros críticos a evaluar son exactitud, precisión, especificidad, límite de detección y cuantificación, linealidad y rango, robustez y equivalencia; su determinación dependerá de la categoría del ensayo: cualitativo/cuantitativo. Las guías analizadas presentan lineamientos generales sobre el análisis de estos atributos, evidenciándose leves diferencias en la terminología, procedimientos de validación, interpretación de datos, criterios de aceptación y uso de métodos estadísticos. Según surge de la revisión realizada, se destaca el requisito de contar con procedimientos de ensayo detallados, con el fin de establecer los atributos de validación para productos farmacéuticos
The traditional methods used for the microbiological quality control of medicines were developed more than a century ago and they continue being used since they fulfill the role to enumerate and identify microorganisms, providing microbiological safety of pharmaceutical products. These methods have the main disadvantage of requiring long incubation times, therefore, with the intention of solving this point and other limitations, new technologies were developed. The objective of this work was to analyze and discuss the validation processes of alternative microbiological methods and their implementation in the quality control of pharmaceutical products. The technologies used in alternative microbiological methods can be classified as: early detection based on metabolic activity, direct measurement of cells, or based on the measurement of biomolecules. The critical parameters to evaluate are accuracy, precision, specificity, limit of detection and quantification, linearity and range, robustness and equivalence; its determination will depend on the category of the assay: qualitative / quantitative. The consulted bibliography presents general guidelines on the analysis of these attributes, showing slight differences in terminology, validation procedures, data interpretation, acceptance criteria and use of statistical methods. To summarize, this review highlights the importance of using detailed test procedures, in order to establish the validation attributes for pharmaceutical products.
Assuntos
Medição de Risco , Estudo de Validação , Indústria Farmacêutica , Fenômenos MicrobiológicosRESUMO
We explored the association between excess body fat and academic performance in high school students from Santiago, Chile. In 632 16-year-olds (51% males) from low-to-middle socioeconomic status (SES), height, weight, and waist circumference were measured. Body-mass index (BMI) and BMI for age and sex were calculated. Weight status was evaluated with 2007 World Health Organization (WHO) references. Abdominal obesity was diagnosed with International Diabetes Federation (IDF) references. Total fat mass (TFM) was measured with dual-energy X-ray absorptiometry (DXA). TFM values ≥25% in males and ≥35% in females were considered high adiposity. School grades were obtained from administrative records. Analysis of covariance examined the association of fatness measures with academic performance, accounting for the effect of diet and physical activity, and controlling SES background and educational confounders. We found that: (1) having obesity, abdominal obesity, or high adiposity was associated with lower school performance alone or in combination with unhealthy dietary habits or reduced time allocation for exercise; (2) high adiposity and abdominal obesity were more clearly related with lower school grades compared to obesity; (3) the association of increased fatness with lower school grades was more salient in males compared to females.