Comparison between 200 mg generic celecoxib hard capsules and Celebra®: bioequivalence study in healthy male and female subjects under fasting conditions after a single dose / Comparação entre celecoxibe genérico de 200 mg em cápsulas duras e Celebra®: estudo de bioequivalência em indivíduos saudáveis do sexo masculino e feminino, em jejum, após uma dose única

ABSTRACT BACKGROUND AND OBJECTIVES: The objective of this study was to assess the bioequivalence between two 200 mg celecoxib hard capsule formulations administered to healthy male and female participants under fasting conditions with the aim of providing an alternative pharmaceutical product to the reference drug, Celebra®. METHODS: A randomized, open label, single dose, 2x2 crossover trial was conducted with 60 adult healthy subjects under fasting conditions comparing single doses of two celecoxib hard capsules formulation. Pharmacokinetic parameters were calculated following the determination of drugs concentrations in human plasma using a validated liquid chromatography with a tandem mass spectrometer detector method (LC-MS/MS). RESULTS: Statistical analysis provided geometric mean of test/reference ratio, confidence intervals, intra-subject variation coefficient and power of the test to the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞. Confidence intervals for the geometric mean (90% CI) of the test/reference drugs for celecoxib were 98.26 to 122.75% for Cmax, 100.27% to 110.78% for AUC0-t, and 96.87% to 110.29% for AUC0-∞. The power of the test found was 95.09% for Cmax, 100.00% for AUC0-t, and 99.99% for AUC0-∞. CONCLUSION: The formulations met the Brazilian standards for interchangeability, as the confidence intervals for Cmax and AUC0-t ratios are within the range of 80% to 125%, thus meeting the requirements of the legislation during market registration. The researched product was approved by the regulatory authorities and became a commercially competitive option to the reference product for the Brazilian population.

RESUMO JUSTIFICATIVA E OBJETIVOS: O objetivo deste estudo foi avaliar a bioequivalência entre duas formulações de cápsulas duras de celecoxibe de 200 mg administradas a participantes saudáveis do sexo masculino e feminino em condições de jejum com o objetivo de fornecer um produto farmacêutico alternativo ao fármaco de referência, Celebra®. MÉTODOS: Estudo randomizado, aberto, de dose única e cruzado 2x2. Foi conduzido com 60 indivíduos adultos saudáveis em condições de jejum, comparando doses únicas de duas formulações de cápsulas duras de celecoxibe. Os parâmetros farmacocinéticos foram calculados após a determinação das concentrações dos fármacos no plasma humano usando uma cromatografia líquida validada com um método detector de espectrômetro de massa em tandem (LC-MS/MS). RESULTADOS: A análise estatística forneceu a média geométrica da razão teste/referência, os intervalos de confiança, o coeficiente de variação intra-sujeito e o poder do teste para os parâmetros farmacocinéticos Cmáx, AUC0-t e AUC0-∞. Os intervalos de confiança para a média geométrica (IC 90%) dos fármacos teste/referência para o celecoxibe foram 98,26 a 122,75% para Cmáx, 100,27% a 110,78% para AUC0-t e 96,87% a 110,29% para AUC0-∞. O poder do teste encontrado foi de 95,09% para Cmáx, 100,00% para AUC0-t e 99,99% para AUC0-∞. CONCLUSÃO: As formulações atenderam aos padrões brasileiros de intercambialidade, pois os intervalos de confiança para as razões Cmáx e AUC0-t estão dentro da faixa de 80% a 125%, atendendo, assim, às exigências da legislação para o registro no mercado. O produto pesquisado foi aprovado pelas autoridades regulatórias e tornou-se uma opção comercialmente competitiva ao produto de referência para a população brasileira.

Brazilian version of the Pasero Opioid-Induced Sedation Scale: cross-cultural adaptation study / Versión brasileña de la escala Pasero Opioid-Induced Sedation Scale: estudio de adaptación transcultural / Versão brasileira da Pasero Opioid-Induced Sedation Scale: estudo de adaptação transcultural

ABSTRACT Objective: Perform a cross-cultural adaptation of the Pasero Opioid-induced Sedation Scale to the Brazilian setting. Method: This is a methodological study using Beaton's framework, which consists in six stages: translation, synthesis of translations, re-translation, expert committee, pre-test, and sending the adapted version of the instrument to the author of the original. The study was carried out from April to December 2021. The research was conducted in a private hospitalin the city of São Paulo, in the adult hospitalization and critical care units. It was approved by the research ethics committee. Results: After translation, translation synthesis and back-translation steps, the version was evaluated by the expert committee, requiring two rounds to obtain acceptable CVI values above 0.80. In the pre-test phase, the scale was well understood, with a CVI of 0.98. Conclusion: The scale was adapted for the Brazilian context; however, further studies will be needed to analyze validity and reliability evidence.

RESUMEN Objetivo: Realizar la adaptación transcultural de la escala de Pasero Opioid-induced Sedation Scale para el contexto brasileño. Método: Estudio metodológico, utilizando el marco de referencia de Beaton, que consta de seis fases: traducción, síntesis de traducciones, traducción inversa, comité de expertos, prueba previa, y envío del instrumento adaptado ala autora del instrumento original. El estudio se realizó de abril a diciembre de 2021, y a la investigación se condujo en un hospital privado, ubicado en la ciudad de São Paulo, en las unidades de hospitalización de adultos y cuidados críticos. Recibió la aprobación del comité de ética. Resultados: Después de las etapas de traducción, síntesis de traducción y traducción inversa, la versión fue evaluada por un comité de expertos, con dos rondas para obtener valores aceptables de índice de validez de contenido superiores a 0,80. En la fase previa a la prueba, la escala mostró una buena comprensión, con una puntuación de 0,98. Conclusión: La escala fue adaptada para el contexto brasileño, sin embargo, serán necesarios más estudios para analizar las evidencias de validez y confiabilidad.

RESUMO Objetivo: Realizar adaptação transcultural da escala Pasero Opioid-Induced Sedation para o cenário brasileiro. Método: Estudo metodológico, utilizado referencial de Beaton, composto por seis fases: tradução, síntese das traduções, retradução, comitê de especialistas, pré-teste e envio dos instrumentos adaptados ao autor do instrumento original. Estudo foi realizado de abril a dezembro de 2021. A pesquisa desenvolveu-se em um hospital privado, localizado no município de São Paulo, nas unidades de internação e críticas adultos. Recebeu aprovação do comitê de ética. Resultados: Após as etapas de tradução, síntese de tradução e retrotradução a versão foi avaliada pelo comitê de especialistas, com duas rodadas para obtenção de valores aceitáveis de índice de validade de conteúdo acima de 0,80. Na fase de pré-teste a escala apresentou boa compreensão com score de 0,98. Conclusão: A escala foi adaptada para o contexto brasileiro, no entanto, novos estudos serão necessários para análises de evidências de validade e confiabilidade.

Mioclonías positivas y negativas en paciente con enfermedad renal crónica / Positive and negative myoclonus in a patient with end stage renal disease

Introducción: Las mioclonías son contracciones musculares paroxísticas de corta duración o pérdida abrupta del tono muscular, denominadas mioclonías positivas y negativas, respectivamente. Se presenta un caso clínico de mioclonías positivas y negativas generalizadas y se pretende describir los múltiples mecanismos fisiopatológicos y etiologías que lo desencadenan. Presentación del caso: Hombre de 35 años, con diabetes mellitus tipo 1 complicada con enfermedad renal diabética en hemodiálisis, desarrolló una bacteriemia asociada a catéter por Staphylococcus aureus y presentó mioclonías positivas y negativas. Se identificaron como posibles desencadenantes la uremia, la infección y los fármacos con potencial promioclónico; el hallazgo incidental de una lesión isquémica en núcleo caudado no explicaba la semiología encontrada en el paciente. Se hizo el control y retiro de todos los factores promioclónicos enunciados, junto a manejo farmacológico con levetiracetam, y con ello se logró el control de los síntomas. Discusión: Los pacientes con enfermedad renal crónica son susceptibles a la acumulación de productos tóxicos de tipo guanidinas, que tienen potencial para producir mioclonías. Además, las infecciones, el uso de fármacos con potencial promioclónico y lesiones estructurales como las isquemias corticales son etiologías que deben considerarse en el diagnóstico diferencial. El mayor impacto en los síntomas se observa con el control del factor desencadenante, y, en caso de persistir, la terapia farmacológica proporciona buenos resultados. Conclusión: Las mioclonías son trastornos del movimiento relativamente comunes en la enfermedad renal crónica. La identificación del desencadenante es crucial para su manejo junto al uso de fármacos con actividad antimioclónica.

Introduction: Myoclonus are paroxysmal muscle contractions of short duration or abrupt loss of muscle tone, called positive and negative myoclonus respectively. A clinical case of generalized positive and negative myoclonus is presented and the aim is to describe the multiple pathophysiological mechanisms and etiologies that trigger it. Case presentation: A 35-year-old man with type 1 diabetes mellitus complicated by diabetic kidney disease on hemodialysis developed catheter-associated bacteremia due to Staphylococcus aureus and presented positive and negative myoclonus. Uremia, infection, and drugs with pro-myoclonic potential were identified as possible triggers; The incidental finding of an ischemic lesion in the caudate nucleus did not explain the semiology found in the patient. The control and removal of all the pro-myoclonic factors mentioned was carried out, along with pharmacological management with levetiracetam, thus achieving control of the symptoms. Discussion: Patients with chronic kidney disease are susceptible to the accumulation of guanidine-type toxic products, which have the potential to produce myoclonus. Furthermore, infections, the use of drugs with pro-myoclonic potential and structural lesions such as cortical ischemia are etiologies that should be considered in the differential diagnosis. The greatest impact on symptoms is observed with the control of the triggering factor and if it persists, pharmacological therapy provides good results. Conclusion: Myoclonus are relatively common movement disorders in chronic kidney disease. Identification of the trigger is crucial for its management along with the use of drugs with anti-myoclonic activity.

Postoperative pain management in the elderly. Literature review

Timely post-operative pain management in elderly patients is critically important. Given their physiological changes and comorbidities, management in this group of patients is different from the rest of the population. Knowledge of potentially inappropriate medications (Beers criteria) is relevant because of the presence of comorbidities in this population. Although acetaminophen continues to be safe, non-steroidal anti-inflammatory agents produce several adverse effects which need to be considered before they are used. On the other hand, opioids continue to be one of the pillars in analgesia, with due consideration of their adverse affects and interactions, and the need for dose adjustments. Adequate postoperative pain management prevents adverse effects and the risk of developing chronic pain.

El manejo oportuno del dolor en la población anciana durante el periodo posoperatorio es de vital importancia. Este grupo de pacientes, dado sus cambios fisiológicos y comorbilidades, requieren un manejo diferente al resto de la población. Es relevante conocer cuáles medicamentos son potencialmente inapropiados para su uso (criterios de Beers) ante las comorbilidades de esta población. Si bien el acetaminofén continúa siendo seguro, los antiinflamatorios no esteroideos causan varios efectos adversos que ameritan consideración antes de su uso; por su parte, los opioides siguen siendo uno de los pilares analgésicos, teniendo en cuenta sus efectos adversos y valorando la necesidad de ajuste de dosis e interacciones. El adecuado manejo del dolor posoperatorio previene desenlaces adversos y el riesgo de cronificación.

Mapa de utilización de mezclas analgésicas por vía parenteral en España. Proyecto MEDPAIN / Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project

Objetivo: este estudio corresponde a la primera etapa del proyecto MEDPAIN «Actualización de mezclas analgésicas por vía parenteral: estudios de utilización, compatibilidad y estabilidad», y tiene por objetivo la elaboración de un mapa a nivel nacional del empleo de mezclas analgésicas en los hospitales y los centros sociosanitarios. Material y método estudio transversal, basado en una encuesta dirigida a farmacéuticos hospitalarios, durante el período diciembre 2020 - abril 2021. Se diseñó un cuestionario multirrespuesta en la plataforma RedCap® para su difusión a través de la lista de distribución de la Sociedad Española de Farmacia Hospitalaria. Se definió mezcla analgésica como la combinación de 2 o más principios activos, de los cuales al menos uno es analgésico. Una misma combinación de fármacos a distintas concentraciones, o administrada por diferentes vías, se consideró una misma mezcla a efectos de este estudio. Se registraron variables relacionadas con el centro participante y otras relacionadas con las mezclas analgésicas: composición farmacológica de la mezcla, vía de administración, frecuencia de uso, indicación, tipo de paciente (adulto/pediátrico), ámbito en el que se utiliza (hospitalario/domicilio) y lugar de preparación. Resultados se recibieron un total de 67 encuestas válidas (55,4%) procedentes de 13 comunidades autónomas. Los 67 centros sanitarios comunicaron un total de 462 mezclas analgésicas. La mediana de mezclas informadas por centro participante fue de 6 (RIC p25-p75 = 4,0-9,0). La mayoría de las mezclas notificadas se utilizan en adultos (93,9%) y en el ámbito hospitalario (91,8%); mayoritariamente se trata de mezclas protocolizadas y de uso frecuente. El 21,4% se preparan en el servicio de farmacia. En las mezclas descritas aparecen 26 fármacos distintos; predominan los analgésicos opioides, presentes en el 87,4% de las mezclas. El fármaco coadyuvante más frecuente es el midazolam. ... (AU)

Objetive: This study is the first part of the MEDPAIN project “Update of analgesic parenteral admixtures: studies of use, compatibility and stability”, and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. Methods Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020–April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. Results A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 =4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. ... (AU)

[Translated article] Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project.

OBJECTIVE: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. METHODS: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020 - April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. RESULTS: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 = 4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%). CONCLUSION: In conclusion, this study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country.

Effects of cannabinoids on pain control, quality of life and opioid-sparing in cancer patients: systematic review / Utilização de canabinoides no controle da dor, na qualidade de vida e no efeito poupador de opioides em pacientes com câncer: revisão sistemática

ABSTRACT BACKGROUND AND OBJECTIVES: Cannabinoids, such as delta-9-tetrahydrocannabinol and cannabidiol, have several therapeutic properties that may be useful in medicine. The objective of this study was to analyze the impact of cannabinoid use on pain control, quality of life and opioid-sparing in patients with advanced cancer. CONTENTS: A systematic review of the evidence for the use of cannabinoids in patients with advanced cancer was conducted on 1) Pain control; 2) Quality of life; and 3) Opioid-sparing effect. PubMed, Web of Science and Cochrane databases were searched for articles, written in English, published between January 1, 2011, and December 31, 2022, with the filters "randomized controlled trials" and "clinical trials". Using oral formulations of cannabinoids was accepted as "intervention" and placebo as "control". Risk of bias analysis was performed with Cochrane's RoB 2 and ROBINS-I tools. This review followed the 2020 PRISMA- statement. Ten studies were included, with 1169 participants, most with moderate risk of bias. The studies were from Australia (n=4), Canada (n=1), Israel (n=1), Mexico (n=1), The United Kingdom (n=1); two were multinationals. Eight were randomized, placebo-controlled trials; two were non-randomized studies. The most used formulation was nabiximols oral spray. Cannabinoids provide a clinical improvement in pain control. Evidence of improved quality of life with cannabinoids is inconclusive. Cannabinoids do not affect the daily dose of opioids in refractory cancer pain. Cannabinoid use cannot be said to have an opioid-sparing effect. CONCLUSION: It is necessary to expand research on the prescription of cannabinoids in individuals with cancer and other progressive diseases, with several comorbidities and multiple medications, in different health contexts.

RESUMO JUSTIFICATIVA E OBJETIVOS: Os canabinoides, como o delta-9-tetrahidrocanabinol e o canabidiol, possuem propriedades terapêuticas que podem ser úteis em pacientes oncológicos. O objetivo deste estudo foi avaliar o impacto do uso de canabinoides no controle da dor, na melhoria da qualidade de vida, e no efeito poupador de opioides em pacientes com câncer avançado. CONTEÚDO: Realizou-se uma revisão sistemática sobre a evidência da utilização de canabinoides em pacientes com câncer avançado, relativamente a: 1) Controle da dor; 2) Qualidade de vida; e 3) Efeito poupador de opioides. Foram buscados artigos na Pubmed, Web of Science e Cochrane, em inglês, publicados entre 2011 e 2022, com os filtros "randomized controlled trials" e "clinical trials". Aceitaram-se como "intervenção" qualquer uso de formulações orais de canabinoides e como "controle" o uso de placebo. Fez-se análise de viés com as ferramentas da Cochrane RoB 2 e ROBINS-I. Seguiu-se a Declaração PRISMA 2020. Foram incluídos 10 estudos, com 1169 participantes, a maioria com risco moderado de viés. Os estudos provinham de Austrália (n=4), Canadá (n=1), Israel (n=1), México (n=1), Reino Unido (n=1); dois eram multinacionais. Oito eram ensaios randomizados controlados com placebo; dois eram não randomizados. A formulação mais usada foi spray bucal de nabiximóis. Os canabinoides proporcionam uma melhoria clínica do controle da dor. A evidência da melhoria da qualidade de vida com canabinoides é inconclusiva. Os canabinoides não afetam a dose diária de opioides na dor oncológica refratária. Não se pode afirmar que o uso de canabinoides tem um efeito poupador de opioides. CONCLUSÃO: É necessário incrementar a investigação sobre a prescrição de canabinoides em indivíduos com câncer e outras doenças progressivas, com comorbilidades e polimedicação, em diferentes contextos de saúde.

Urinary retention after lipoabdominoplasty: case report / Retenção urinária após lipoabdominoplastia: relato de caso

Introduction: Postoperative urinary retention may predispose to permanent bladder damage. Risk factors include type of anesthesia, type of surgery, and use of anticholinergics, analgesics, and opioids. Once the lesion is established, complementary urodynamic tests are essential for etiological diagnosis and treatment. The objective of this study is to report a case of a patient with urinary retention in the postoperative period of lipoabdominoplasty. Case Report: 27-year-old female patient, without comorbidities or use of continuous medication. She underwent lipoabdominoplasty and evolved postoperatively with urinary retention and bladder distention, diagnosed as detrusor contractility and sensitivity deficit in the urodynamic study. She was maintained in outpatient follow-up with the surgical team and Urology, with a progressive reduction in urinary catheter use and complete removal in eight months of follow-up. Discussion: The objective of aesthetic plastic surgery is to improve the physical appearance of the body. It is subject to complications like other surgical procedures, and pain seems to be the most frequent. Urinary retention may be secondary to the use of opioids, and its diagnosis in the postoperative period of lipoabdominoplasty still has some obstacles. Plication of the rectus muscle diastasis, liposuction, and the use of a compressive abdominal belt make it difficult to identify a possible bladder distention. An episode of bladder overdistention can result in significant morbidity. Conclusion: The present report demonstrated the good evolution of a patient who developed urinary retention in the postoperative period of lipoabdominoplasty. The main diagnostic hypothesis was that it was secondary to the use of opioids.

Introdução: A retenção urinária pós-operatória pode predispor a danos permanentes à bexiga. Os fatores de risco incluem tipo de anestesia, tipo de cirurgia e uso anticolinérgicos, analgésicos e opioides. Uma vez que a lesão está estabelecida, os exames complementares urodinâmicos são fundamentais para diagnóstico etiológico e tratamento. O objetivo deste trabalho é relatar caso de paciente com quadro de retenção urinária no pós-operatório de lipoabdominoplastia. Relato de Caso: Paciente de 27 anos, sexo feminino, sem comorbidades ou uso de medicamentos contínuos. Foi submetida a lipoabdominoplastia, e evoluiu no pós-operatório com quadro de retenção urinária e bexigoma, diagnosticada como acontratilidade detrusora e déficit de sensibilidade no estudo urodinâmico. Manteve acompanhamento ambulatorial com a equipe cirúrgica e a Urologia, com redução progressiva do uso do cateter vesical e retirada completa em oito meses de seguimento. Discussão: O objetivo da cirurgia plástica estética é melhorar o aspecto físico do corpo. Como os demais procedimentos cirúrgicos, está sujeita a complicações e a dor parece ser a mais frequente. A retenção urinária pode ser secundária ao uso de opioides e seu diagnóstico no pós-operatório da lipoabdominoplastia ainda possui alguns obstáculos. A plicatura da diástase do músculo reto, a lipoaspiração e o uso de cinta abdominal compressiva dificultam a identificação do possível bexigoma. Um episódio de hiperdistensão da bexiga pode resultar em morbidade significativa. Conclusão: O presente relato demonstrou boa evolução de paciente que desenvolveu retenção urinária no pós-operatório de lipoabdominoplastia. A principal hipótese diagnóstica foi de ser secundária ao uso de opioide.

Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project. / Mapa de utilización de mezclas analgésicas por vía parenteral en España. Proyecto MEDPAIN.

OBJETIVE: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. METHODS: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020-April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. RESULTS: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 =4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%). CONCLUSION: This study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country.

Política pública en cuidados paliativos y sus implicaciones sobre servicios, opioides y educación en Colombia / Public policy on palliative care and its implications for services, opioids, and education in Colombia

Introducción: El desarrollo de cuidados paliativos exige la intervención de múltiples dimensiones de salud pública, incluyendo la disponibilidad de servicios de salud, medicamentos esenciales y programas educativos. En Colombia se han realizado diversos cambios en las políticas públicas para promover la atención de personas con necesidades paliativas. Objetivo: Evaluar empíricamente las políticas públicas, existentes en cuidados paliativos y sus implicaciones sobre disponibilidad de servicios, opioides y programas educativos en los años 2010 ­ 2019 en Colombia. Materiales y métodos: Se diseñó un estudio mixto exploratorio secuencial en tres fases: identificación de indicadores empíricos de políticas nacionales, diagnostico situacional de cuidados paliativos y evaluación cualitativa de los resultados de la implementación de políticas en siete nodos territoriales de Colombia. Resultados: Se revisaron siete normas obteniendo 12 indicadores empíricos para la evaluación, seis de ellos no contaban con fuentes de información. El diagnostico nacional evidencia un aumento gradual de servicios y consumo de opioides en los años hito del desarrollo de políticas. 44 profesionales de cuidados paliativos perciben un efecto positivo de las políticas públicas en el consumo de opioides y bajos resultados para el dominio de servicios y educación Conclusiones: Existe una relación positiva entre políticas públicas y consumo de opioides, una relación cuantitativa positiva para servicios de cuidados paliativos y una relación cuanticualitativa negativa para programas educativos, lo que denota un bajo estatus operativo de las políticas construidas para mejorar el dolor y sufrimiento asociado a la enfermedad crónica avanzada.

Introduction: Palliative care development requires the intervention of multiple dimensions of public health, including the availability of health services, essential medicines, and educational programs. In Colombia, several changes have been made in public policy to promote the care of people with palliative needs. Objective: To empirically evaluate existing public policies on palliative care and their implications for the availability of services, opioids, and educational programs during the years 2010 to 2019 in Colombia. Materials and methods: A mixed sequential exploratory study was designed in three phases: identification of empirical indicators of national policies, palliative care situational diagnosis, and qualitative assessment of the results of policy implementation in seven regional nodes in Colombia. Results: Seven standards were reviewed, yielding 12 empirical indicators for assessment, six of which had no sources of information. The national diagnosis shows a gradual increase in services and opioid use during the landmark years of policy development. Forty-four palliative care professionals perceive a positive effect of public policy on opioid use and low outcomes for service and education domains. Conclusions: There is a positive relationship between public policy and opioid use, a positive quantitative relationship with palliative care services, and a negative quantitative-qualitative relationship with educational programs. This indicates a low operational status of policies designed to alleviate the pain and suffering associated with advanced chronic diseases.

Introdução: O desenvolvimento dos cuidados paliativos requer a intervenção de múltiplas dimensões da saúde pública, incluindo a disponibilidade de serviços de saúde, medicamentos essenciais e programas educativos. Na Colômbia, várias mudanças foram feitas nas políticas públicas para promover o cuidado de pessoas com necessidades paliativas. Objetivo: Avaliar empiricamente as políticas públicas existentes em cuidados paliativos e suas implicações na disponibilidade de serviços, opioides e programas educacionais nos anos 2010 - 2019 na Colômbia. Materiais e métodos: Desenhou-se um estudo misto exploratório sequencial em três fases: identificação de indicadores empíricos de políticas nacionais, diagnóstico situacional de cuidados paliativos e avaliação qualitativa dos resultados da implementação de políticas em sete nodos territoriais da Colômbia. Resultados: Sete normas foram revisadas, obtendo-se 12 indicadores empíricos para avaliação, seis delas não possuíam fontes de informação. O diagnóstico nacional mostra um aumento gradual nos serviços e consumo de opioides nos anos marcantes do desenvolvimento de políticas. 44 profissionais de cuidados paliativos percebem efeito positivo das políticas públicas sobre o consumo de opioides e resultados baixos para o domínio serviços e educação Conclusões: Existe relação positiva entre políticas públicas e consumo de opioides, relação quantitativa positiva para serviços de cuidados paliativos e negativa relação quantitativo-qualitativa para programas educativos, o que denota um baixo status operacional das políticas destinadas a melhorar a dor e o sofrimento associados à doença crônica avançada.

Diferencias clínicas entre los pacientes con dolor crónico primario y secundario atendidos por una unidad multidisciplinar de dolor crónico infantil / Clinical differences in a multidisciplinary pediatric pain unit between primary and secondary chronic pain

Introducción: El dolor crónico afecta a un porcentaje significativo de la población pediátrica en los países desarrollados, y puede tener una causa médica bien definida en el dolor crónico secundario (DCS), o desconocida en el dolor crónico primario (DCP). En España, hasta el momento, no existe información acerca de las diferencias clínicas de los pacientes atendidos en unidades multidisciplinarias. Métodos: Análisis retrospectivo de las historias clínicas de los pacientes atendidos en 2018 por la Unidad de Dolor Crónico Infantil del Hospital Universitario La Paz. Resultados: Se incluyeron los 92 pacientes atendidos, con edades comprendidas entre 2 y 19 años, y una edad media de 12,4 (SD=4,1) años, mayoritariamente de sexo femenino (55%) y una duración media del dolor de 11,3 (SD=10,4) meses. Los resultados de comparar pacientes con DCP (n=31) y DCS (n=61) mostraron que ambos grupos presentaban dolor medio con una gran intensidad (x=5,9; SD=2,2; rango=0-10), con duración y repercusión funcional similares, aunque el DCP se asoció menos a descriptores de tipo neuropático que el DCS (p=0,040) y era más extenso en su localización (p<0,001). Ambos grupos recibieron similar tratamiento basado en rehabilitación, psicoterapia, técnicas invasivas y tratamiento con medicación analgésica, aunque los pacientes del grupo DCP recibieron menos medicaciones analgésicas (gabapentinoides y opiáceos) que el DCS (p=0,011). Conclusión: Los pacientes con DCP o DCS, aunque tengan un perfil clínico similar, presentan diferencias en el número y tipo de analgésicos empleados, lo que avalaría la importancia del diagnóstico de la causa para adecuar el tratamiento farmacológico subsiguiente.(AU)

Introduction: Chronic pain affects an important part of the pediatric population in developed countries. secondary chronic pain (SCP) can have a well-defined medical cause, but primary chronic pain (PCP) can have an unknown etiology. In Spain, there is as yet no information on the clinical differences between patients treated in multidisciplinary units. Methods: Retrospective analysis of the clinical records of patients seen in 2018 at the Children's Chronic Pain Unit in University La Paz Hospital. Results: A total of 92 patients were included (age between 3 and 19 years), with a mean age of 12.4 (SD=4.1) years, mostly female (55%), with a mean duration of pain of 11.3 (SD=10.4) months. A comparison of patients with PCP (n=31) and SCP (n=61) showed that both groups, on average, presented intense pain (X=5.9; SD=2.2; range=0-10), with similar duration and functional repercussions, although PCP was less likely to be associated with neuropathic descriptors than SCP (p=.040), and was more extensive (p<.001). Both groups received similar treatment, based on rehabilitation, psychotherapy, invasive techniques and analgesic medication, although patients in the PCP group received less analgesic medication (gabapentinoids and opioids) than the SCP (p=.011). Conclusion: Patients treated in a multidisciplinary Child Pain Unit for PCP or SCP present a very similar clinical profile, though with differences in the number and type of analgesic drugs used. This shows the importance of etiologic diagnosis for adequate pharmacological treatment.(AU)

Diagnosis of a Case of Hepatotoxicity Due to Drugs and Herbal Supplements in a Hospital in Pasto, Colombia

The liver is a crucial organ in metabolism, and some substances can induce toxic hepatitis with high morbidity and mortality. Chemical and drug-induced liver disease is a diagnostic and therapeutic challenge since it requires extension studies to rule out other entities. We present the case of a 51-year-old female patient without underlying comorbidities, admitted due to symptoms of two-day evolution consisting of progressive jaundice, diarrheal episodes without acholia, or any other additional manifestation. Her condition was caused by the intake of nimesulide, two tablets a day for two days, for pain secondary to a mandibular cyst diagnosed in previous days. During her admission to the emergency room, the patient described chronic consumption of Herbalife® products daily for four years. She presented with elevated transaminases, prolonged prothrombin time (PT), and direct hyperbilirubinemia. Infectious and immunological diseases were ruled out. We decided to start antibiotic and vitamin K coverage. Finally, and by exclusion, a liver biopsy suggested an inflammatory process compatible with drug-induced hepatitis. The woman evolved favorably when the medication and dietary supplement were discontinued. In conclusion, this case constitutes an initial point in advancing research into hepatotoxicity by shared mechanisms of various substances simultaneously, such as what happened to the patient with the parallel use of Herbalife® and nimesulide.

El hígado es un órgano crucial en el metabolismo y algunas sustancias pueden inducir hepatitis toxica con alta morbimortalidad. La enfermedad hepática inducida por sustancias químicas y medicamentos es un desafío tanto diagnostico como terapéutico, puesto que requiere la realización de estudios de extensión para descartar otras entidades. A continuación se presenta el caso de una paciente femenina de 51 años sin comorbilidades de base, ingresada por clínica de 2 días de evolución consistente en ictericia progresiva, episodios diarreicos sin acolia ni otra manifestación adicional. Aparentemente, su cuadro fue provocado por la administración de nimesulida, 2 tabletas al día por 2 días, contra el dolor secundario a un quiste mandibular diagnosticado en días anteriores. Durante su ingreso a urgencias la paciente describió consumo crónico, a diario desde hace 4 años, de productos de Herbalife®. Cursa con elevación de transaminasas, prolongación del tiempo de protrombina (TP) e hiperbilirrubinemia directa. Se descartan enfermedades infecciosas e inmunológicas. Se decidió iniciar el cubrimiento antibiótico y vitamina K. Finalmente y por exclusión, se realizó una biopsia hepática que sugirió un proceso inflamatorio compatible con hepatitis inducida por fármacos. La mujer evolucionó favorablemente al suspender la medicación y el suplemento dietético referido. En conclusión, el caso expuesto constituye un punto inicial en el avance hacia la investigación en hepatotoxicidad por mecanismos compartidos de diversas sustancias simultáneamente, como lo sucedido a la paciente con el uso paralelo de Herbalife® y de nimesulida.

Clinical differences in a multidisciplinary pediatric pain unit between primary and secondary chronic pain.

INTRODUCTION: Chronic pain affects an important part of the pediatric population in developed countries. secondary chronic pain (SCP) can have a well-defined medical cause, but primary chronic pain (PCP) can have an unknown etiology. In Spain, there is as yet no information on the clinical differences between patients treated in multidisciplinary units. METHODS: Retrospective analysis of the clinical records of patients seen in 2018 at the Children's Chronic Pain Unit in University La Paz Hospital. RESULTS: A total of 92 patients were included, (age between 3 and 19 years), with a mean age of 12.4 (SD = 4.1) years, mostly female (55%), with a mean duration of pain of 11.3 (SD = 10.4) months. A comparison of patients with PCP (n = 31) and SCP (n = 61) showed that both groups, on average, presented intense pain (X = 5.9; SD = 2.2; range = 0-10), with similar duration and functional repercussions, although PCP was less likely to be associated with neuropathic descriptors than SCP (p = 0.040), and was more extensive (p < 0.001). Both groups received similar treatment, based on rehabilitation, psychotherapy, invasive techniques and analgesic medication, although patients in the PCP group received less analgesic medication (gabapentinoids and opioids) than the SCP (p = 0.011). CONCLUSION: Patients treated in a multidisciplinary Child Pain Unit for PCP or SCP present a very similar clinical profile, though with differences in the number and type of analgesic drugs used. This shows the importance of etiologic diagnosis for adequate pharmacological treatment.

Prevalencia de dolor y su abordaje terapéutico en niños pasibles de cuidados paliativos asistidos en un centro de referencia de Uruguay / Prevalence of pain and its therapeutic approach in children eligible for assisted palliative care in a reference hospital center in Uruguay / Prevalência de dor e sua abordagem terapêutica em crianças submetidas a cuidados paliativos atendidas em um centro hospitalar de referência no Uruguai

Introducción: el tratamiento del dolor es un derecho humano y constituye un pilar de los cuidados paliativos (CP). Este síntoma en niños suele ser subestimado e insuficientemente tratado. Objetivo: conocer la prevalencia del dolor y describir el perfil de uso de fármacos analgésicos, coadyuvantes y procedimientos invasivos en niños asistidos en la Unidad de Cuidados Paliativos Pediátricos del Centro Hospitalario Pereira Rossell (UCPP-CHPR) durante el período 2019-2021. Metodología: se realizó un estudio observacional, descriptivo y retrospectivo mediante revisión de historias clínicas. Resultados: se incluyeron 317 niños, 58% de sexo masculino, con una mediana de edad 6,9 años. Eran portadores de enfermedades neurológicas severas no evolutivas 64%, utilizaban prótesis o tecnología médica 51%. Se encontró registro de presencia de dolor en 35%, de tipo crónico 87%, mixto 55% y de fuentes múltiples 54%. Se detectó uso de escala para evaluación del dolor en 61%, la más utilizada fue r-FLACC. En el grupo de niños con dolor se encontró prescripción de analgésicos en 43% (48/111) y de coadyuvantes 87% (97/111), gabapentina en 78. En todos la vía de administración fue la oral/enteral. Se encontró uso off label de fármacos en 79% y polifarmacia en 82%. Se registraron efectos adversos en 10%. Conclusión: un tercio de los niños asistidos por la UCPP-CHPR, presentaba registros de presencia dolor. La mayoría de tipo crónico, mixto y de fuentes múltiples. Se encontró amplio uso de escalas validadas para evaluación del dolor y alta prescripción de coadyuvantes en relación a la de analgésicos.

Introduction: pain treatment is a human right and a pillar of palliative care (PC). This symptom in children is often underestimated and insufficiently treated. Objective: learn about the prevalence of pain and describe the analgesic drugs' usage profile, adjuvants and invasive procedures in children assisted in the Pediatric Palliative Care Unit of the Pereira Rossell Hospital Center (UCPP-CHPR) during the period 2019-2021. Methodology: observational, descriptive and retrospective study based on the review of medical records. Results: 317 children were included, 58% male, with a median age of 6.9 years. 64% were carriers of severe non-progressive neurological diseases, 51% used prosthetics or medical technology. A record of the presence of pain was found in 35%, chronic type 87%, mixed 55% and multiple sources 54%. The use of a pain assessment scale was detected in 61%, the most used was r-FLACC. In the group of children with pain, analgesics were prescribed in 43% (48/111) and adjuvants in 87% (97/111), gabapentin in 78. In all of them, the administration route was oral/enteral. Off-label use of drugs was found in 79% and polypharmacy in 82%. Adverse effects were recorded in 10%. Conclusion: a third of the children assisted by the UCPP-CHPR showed records of pain presence. Most chronic type, mixed and multiple sources. We found a vast use of validated scales for pain assessment and high prescription of adjuvants in relation to analgesics.

Introdução: o tratamento da dor é um direito humano e constitui um pilar dos Cuidados Paliativos (CP). Este sintoma em crianças é geralmente subestimado e insuficientemente tratado. Objetivo: conhecer a prevalência da dor e descrever o perfil do uso de medicamentos analgésicos, adjuvantes e procedimentos invasivos em crianças atendidas na Unidade de Cuidados Paliativos Pediátricos do Centro Hospitalar Pereira Rossell (UCPP-CHPR) durante o período de 2019-2021. Metodologia: foi realizado um estudo observacional, descritivo e retrospectivo por meio de revisão de prontuários. Resultados: foram incluídas 317 crianças, 58% do sexo masculino, com idade mediana de 6,9 anos. 64% eram portadores de doenças neurológicas graves não evolutivas, 51% usavam próteses ou tecnologia médica. Registro da presença de dor foi encontrado em 35%, do tipo crônica 87%, mista 55% e de origem múltipla 54%. A utilização de escala para avaliação da dor foi detectada em 61%, sendo a mais utilizada a r-FLACC. No grupo de crianças com dor, a prescrição de analgésicos foi encontrada em 43% (48/111) e adjuvantes em 87% (97/111), gabapentina em 78. Ao todo, a via de administração foi oral/enteral. Uso off-label de medicamentos foi encontrado em 79% e polifarmácia em 82%. Efeitos adversos foram registrados em 10%. Conclusão: um terço das crianças atendidas pela UCPP-CHPR apresentou registro da presença de dor. A maioria do tipo crônica, mista e de fontes múltiplas. Encontrou-se ampla utilização de escalas validadas para avaliação da dor e elevada prescrição de coadjuvantes em relação aos analgésicos.

Estratégias para manejo e prevenção da síndrome de abstinência em pacientes pediátricos críticos: revisão sistemática / Strategies for the management and prevention of withdrawal syndrome in critically ill pediatric patients: a systematic review

RESUMO Objetivo: Verificar as estratégias de prevenção e tratamento da síndrome de abstinência em unidade de terapia intensiva pediátrica. Métodos: Trata-se de revisão sistemática nas bases de dados PubMed®, Lilacs, Embase, Web of Science, Cochrane, Cinahl, Cochrane Database Systematic Review e CENTRAL. Uma estratégia de busca em três etapas foi utilizada para esta revisão. O protocolo da revisão foi aprovado no PROSPERO (CRD42021274670). Resultados: Foram incluídos na análise 12 artigos. Observou-se grande heterogeneidade entre os estudos incluídos, principalmente em se tratando de esquemas terapêuticos utilizados na sedação e na analgesia. As doses de midazolam variaram de 0,05mg/kg/hora a 0,3mg/kg/hora. A morfina também variou consideravelmente, de 10mcg/kg/hora a 30mcg/kg/hora entre os estudos. A escala mais utilizada para identificação da síndrome de abstinência, entre os 12 estudos selecionados, foi a Sophia Observational Widrawal Symptoms Scale. Em três estudos, houve diferença estatística relevante na prevenção e no manejo da síndrome de abstinência com a implantação de protocolos (p < 0,01 e p < 0,001). Conclusão: Observou-se grande variação entre o regime de sedoanalgesia utilizado entre os estudos e o método de desmame e avaliação de síndrome de abstinência. São necessários mais estudos para fornecer evidências mais robustas acerca do tratamento mais indicado para prevenção e redução dos sinais e sintomas de abstinência em crianças criticamente doentes. Registro PROSPERO:CRD 42021274670

ABSTRACT Objective: To verify strategies for the prevention and treatment of abstinence syndrome in a pediatric intensive care unit. Methods: This is a systematic review in the PubMed database®, Lilacs, Embase, Web of Science, Cochrane, Cinahl, Cochrane Database Systematic Review and CENTRAL. A three-step search strategy was used for this review, and the protocol was approved in PROSPERO (CRD42021274670). Results: Twelve articles were included in the analysis. There was great heterogeneity among the studies included, especially regarding the therapeutic regimens used for sedation and analgesia. Midazolam doses ranged from 0.05mg/kg/hour to 0.3mg/kg/hour. Morphine also varied considerably, from 10mcg/kg/hour to 30mcg/kg/hour, between studies. Among the 12 selected studies, the most commonly used scale for the identification of withdrawal symptoms was the Sophia Observational Withdrawal Symptoms Scale. In three studies, there was a statistically significant difference in the prevention and management of the withdrawal syndrome due to the implementation of different protocols (p < 0.01 and p < 0.001). Conclusion: There was great variation in the sedoanalgesia regimen used by the studies and the method of weaning and evaluation of withdrawal syndrome. More studies are needed to provide more robust evidence about the most appropriate treatment for the prevention and reduction of withdrawal signs and symptoms in critically ill children. PROSPERO register: CRD 42021274670

Evaluación del dolor en pacientes con patologías reumáticas entratamiento con terapias biológicas / Assessment of pain in patients with rheumatic disease under biological therapy treatment

Fundamento: El objetivo fue evaluar el dolor en pacientes con patologías reumáticas en tratamiento con terapias biológicas. Material y métodos: Estudio observacional, retrospectivo, de pacientes con enfermedad reumatológica tratada con terapias biológicas, atendidos en consulta externa en febrero/agosto de 2020. Se recogieron variables demográficas (sexo y edad), clínicas (diagnóstico, presencia de dolor, intensidad y localización) y farmacológicas (terapia biológica, tratamiento concomitante con FAME tradicionales, y tratamiento analgésico). Las fuentes de información utilizadas fueron la historia clínica electrónica y Farmatools Dominion®. Resultados: Se incluyeron 138 pacientes, con edad media 56 años, 71% mujeres. El diagnóstico más frecuente fue espondilitis anquilosante (47%). El fármaco biológico más utilizado fue anti TNF-α (64%) y el 60,1% recibían fármacos tradicionales, especialmente metotrexato y leflunomida (51,8 y 28,9%). El 81% de los pacientes presentaban dolor, especialmente en manos (73,2%) y rodillas (69,6%), de intensidad media 6,5 en la escala EVA. El 84,8% de los pacientes no tenía el dolor controlado (EVA >4) y era severo o muy severo en el 67,9% de los pacientes, a pesar de que el 83,3% tenían pautado tratamiento antiálgico, el 52,2% con más de un fármaco, con antiinflamatorios no esteroideos (AINE) (60%), paracetamol (52,2%) y opioides (56,5%). El dolor se controló mejor con AINE (14,5%) que con opioides (8,3%); en un 29,6% el dolor no mejoraba con el tratamiento. El número de fármacos aumentó con la intensidad del dolor (rho = 0,264; p = 0,006). Conclusiones: Más del 69% de los pacientes presentaba dolor no controlado y severo, reflejando el desafío que supone instaurar un tratamiento efectivo para el dolor.(AU)

Background: To assess pain in patients with rheumatic disease under biological therapy treatment. Methods. Observational retrospective study of patients with rheumatic disease under biological therapy treatment who visited the health care center as outpatients in February/August 2020. We collected demographic (sex and age), clinical (diagnosis, pain presence, intensity, and location), and pharmacological (biological therapy, concomitant treatment with traditional DMARDs, and analgesic treatment) variables from the electronic medical records and Farmatools Dominion®. Results: We included 138 patients; mean age was 56 years and 71% were female. The most frequent diagnosis (47%) was ankylosing spondylitis. Anti-TNF-α was the most prescribed biological drug (64%); 60.1% of study patients received traditional drugs, particularly methotrexate and leflunomide (51.8 and 28.9%, respectively). Pain was reported in 81% of the cases, particularly in hands (73.2%) and knees (69.6%); mean pain intensity was 6.5 (VAS). Although 83.3% of the patients had been prescribed analgesics, pain persisted in 84.8% of the cases (VAS >4), being severe or very severe in 67.9%. Over half of the patients (52.2%) used more than one analgesic. The most frequently prescribed medications were non-steroidal anti-inflammatory drugs (NSAIDs) (60%), paracetamol (52.2%), and opioids (56.5%). NSAIDs controlled pain (14.5%) better than opioids (8.3%); there was no post-treatment improvement of pain in 29.6% of the patients. The number of prescribed drugs increased with pain intensity (rho = 0.264; p = 0.006). Conclusion. Almost 70% of study patients had uncontrolled severe rheumatic-related pain. This implies a challenge for establishing effective treatments for this type of pain.(AU)

Factors associated with all-cause mortality at 90 days in hospitalized adult patients who received parenteral nutrition / Factores asociados a mortalidad a los 90 días en pacientes adultos hospitalizados que recibieron nutrición parenteral

Objective: this study aimed to assess the main factors related to mortality in a cohort of hospitalized adult patients who required parenteral nutrition (PN) considering their characteristics, type of admission, procedures, nutritional data, and adverse events. Methods: a retrospective study was performed in a 400-bed university hospital. All adult inpatients that had received ≥ 4 days as first course of PN within 24 months were included. Patients with long-term (> 90 days) or home PN were excluded. The main variable was all-cause mortality at 90 days after the end of PN. Initial independent variables were anthropometric and demographic data, admission characteristics, severity, comorbidity, surgical/medical procedures, baseline biochemical parameters, nutritional risk, and other nutritional data, medications, and adverse events during PN. A Cox proportional hazards regression model was planned to analyze time-to-event data. Results: a total of 634 patients entered the study and 140 (22.1 %) died. Patients were mainly: surgical 471 (74.3 %), male 393 (62.0 %), and age 69.0 (67.8-70.1) years old. The survival time for the entire cohort was 74.0 (95 % CI: 71.6-76.6) days. The final model included 14 variables, with severity and comorbidity being the main ones, but including also anastomotic suture dehiscence, sepsis during PN, days with hyperglycemic events, use of potent opioids, failed attempts at enteral nutrition, and, as a protective one, energy provided in PN. Conclusions: the factors related to mortality in hospitalized adult patients who required PN were mainly severity and comorbidities, but several other important factors were also relevant and could be modified to maximize outcomes in these patients (AU)

Objetivo: valorar los factores relacionados con la mortalidad en una cohorte de pacientes adultos hospitalizados que recibieron nutrición parenteral (NP) atendiendo a sus características, procedimientos, parámetros nutricionales y complicaciones. Métodos estudio retrospectivo realizado en un hospital universitario de 400 camas. Se incluyeron todos los pacientes adultos que recibieron ≥ 4 días de NP en un periodo de 24 meses. Se excluyeron los pacientes con NP de largo plazo (> 90 días) o NP domiciliaria. La variable principal fue la mortalidad por cualquier causa en los 90 días posteriores al fin de la NP. Las variables independientes iniciales fueron los datos antropométricos y demográficos, el tipo de ingreso, la gravedad, la comorbilidad, los procedimientos médicos/quirúrgicos, los parámetros bioquímicos, el riesgo nutricional, otros parámetros nutricionales, las medicaciones y los eventos adversos durante la NP. Se realizó un análisis de supervivencia por el modelo de los riesgos proporcionales de Cox. esultados en total, 634 pacientes entraron en el estudio, de los cuales 140 (22,1 %) murieron. Los pacientes fueron principalmente: quirúrgicos 471 (74,3 %), hombres 393 (62,0 %) y de 69,0 (67,8-70,1) años de edad. La supervivencia de toda la cohorte fue de 74,0 (IC 95 %: 71,6-76,6) días. El modelo final incluyó 14 variables. La gravedad y la comorbilidad fueron las principales, pero también resultaron incluidas la dehiscencia de la sutura, la sepsis, los días con hiperglucemia, los intentos fallidos de nutrición enteral, el uso de opiáceos potentes y, como protector, la energía administrada en la NP. Conclusión:los factores relacionados con la mortalidad en estos pacientes con NP fueron principalmente la gravedad y la comorbilidad, pero otros factores también fueron relevantes y podrían ser modificados para maximizar los resultados en salud (AU)

Factors associated with all-cause mortality at 90 days in hospitalized adult patients who received parenteral nutrition.

Introduction: Objective: this study aimed to assess the main factors related to mortality in a cohort of hospitalized adult patients who required parenteral nutrition (PN) considering their characteristics, type of admission, procedures, nutritional data, and adverse events. Methods: a retrospective study was performed in a 400-bed university hospital. All adult inpatients that had received ≥ 4 days as first course of PN within 24 months were included. Patients with long-term (> 90 days) or home PN were excluded. The main variable was all-cause mortality at 90 days after the end of PN. Initial independent variables were anthropometric and demographic data, admission characteristics, severity, comorbidity, surgical/medical procedures, baseline biochemical parameters, nutritional risk, and other nutritional data, medications, and adverse events during PN. A Cox proportional hazards regression model was planned to analyze time-to-event data. Results: a total of 634 patients entered the study and 140 (22.1 %) died. Patients were mainly: surgical 471 (74.3 %), male 393 (62.0 %), and age 69.0 (67.8-70.1) years old. The survival time for the entire cohort was 74.0 (95 % CI: 71.6-76.6) days. The final model included 14 variables, with severity and comorbidity being the main ones, but including also anastomotic suture dehiscence, sepsis during PN, days with hyperglycemic events, use of potent opioids, failed attempts at enteral nutrition, and, as a protective one, energy provided in PN. Conclusions: the factors related to mortality in hospitalized adult patients who required PN were mainly severity and comorbidities, but several other important factors were also relevant and could be modified to maximize outcomes in these patients.

Introducción: Objetivo: valorar los factores relacionados con la mortalidad en una cohorte de pacientes adultos hospitalizados que recibieron nutrición parenteral (NP) atendiendo a sus características, procedimientos, parámetros nutricionales y complicaciones. Métodos: estudio retrospectivo realizado en un hospital universitario de 400 camas. Se incluyeron todos los pacientes adultos que recibieron ≥ 4 días de NP en un periodo de 24 meses. Se excluyeron los pacientes con NP de largo plazo (> 90 días) o NP domiciliaria. La variable principal fue la mortalidad por cualquier causa en los 90 días posteriores al fin de la NP. Las variables independientes iniciales fueron los datos antropométricos y demográficos, el tipo de ingreso, la gravedad, la comorbilidad, los procedimientos médicos/quirúrgicos, los parámetros bioquímicos, el riesgo nutricional, otros parámetros nutricionales, las medicaciones y los eventos adversos durante la NP. Se realizó un análisis de supervivencia por el modelo de los riesgos proporcionales de Cox. Resultados: en total, 634 pacientes entraron en el estudio, de los cuales 140 (22,1 %) murieron. Los pacientes fueron principalmente: quirúrgicos 471 (74,3 %), hombres 393 (62,0 %) y de 69,0 (67,8-70,1) años de edad. La supervivencia de toda la cohorte fue de 74,0 (IC 95 %: 71,6-76,6) días. El modelo final incluyó 14 variables. La gravedad y la comorbilidad fueron las principales, pero también resultaron incluidas la dehiscencia de la sutura, la sepsis, los días con hiperglucemia, los intentos fallidos de nutrición enteral, el uso de opiáceos potentes y, como protector, la energía administrada en la NP. Conclusión: los factores relacionados con la mortalidad en estos pacientes con NP fueron principalmente la gravedad y la comorbilidad, pero otros factores también fueron relevantes y podrían ser modificados para maximizar los resultados en salud.

Evaluación del conocimiento del paciente sobre fármacos para el dolor en farmacia comunitaria / Assessment of patient knowledge of pain medication in community pharmacies

JUSTIFICACIÓN: el dolor es la causa más frecuente de consulta médica. Los fármacos más utilizados por la población son analgésicos y antiinflamatorios no esteroideos (AINES). Sin embargo, también está aumentando el uso de analgésicos opioides para este fin. Es importante un buen uso de estos fármacos para conseguir una mayor efectividad y seguridad de los mismos. Desde la farmacia comunitaria en el momento de la dispensación podemos valorar el conocimiento que el paciente tiene de todos estos fármacos.OBJETIVOS: Principal: Evaluar el conocimiento que el paciente tiene del fármaco que se le dispensa en la farmacia comunitaria para reducir el dolor. Secundarios: -Conocer el correcto uso de estos fármacos-Registrar el conocimiento del paciente sobre las reacciones adversas de estos medicamentos.MATERIAL Y MÉTODO: estudio observacional transversal realizado en 8 farmacias de las provincias de Valencia y Alicante, por 11 farmacéuticos. Población diana:>18 años, durante la semana del 28 de febrero al 7 de marzo, que llegan a la farmacia comunitaria solicitando un fármaco, para sí mismo, para reducir o cese del dolor, análgésicos, AINEs, opiodes, ya sea por demanda o prescripción médica. Se elabora un cuaderno de recogida de datos mediante una encuesta de google, registrando las respuestas del paciente a las preguntas realizadas en la dispensación ¿para quién? ¿Para qué?, ¿cómo?, ¿cuándo?, ¿conoce las reacciones adversas?, tiempo de uso del fármaco y si la dispensación es con receta de prescripción. Además, se recogen las variables sociodemográficas del paciente. Análisis estadístico con MSExcel® Resultados Respondieron 164, de los cuales 105 eran mujeres, edad media 54 años. El fármaco más dispensado fue el paracetamol seguido de ibuprofeno, dexketoprofeno, metamizol y naproxeno. El 92 % de los fármacos dispensados era para la persona que lo retiraba. (AU)