[Translated article] Characteristics, clinical benefit, and reimbursement of new authorisations for oncohaematology drugs in Spain between 2017 and 2020.

OBJECTIVE: To describe the authorisations and funding resolutions for new onco-haematological drugs in Spain between 2017 and 2020, as well as the results of their main trials. METHODS: Observational, cross-sectional, descriptive study conducted between October and December 2022. Onco-haematology drugs approved by the European Medicines Agency between 2017 and 2020 were included, according to EFPIA patients W.A.I.T Indicator 2021 Survey. Authorisation information was obtained from the main study of the European Public Assessment Report. Data were collected on medicines, their authorisation and main study, benefit shown, cost, and status and time to reimbursement. RESULTS: Forty-one new drugs authorised for 49 indications were identified. More than half (58.5%) were targeted therapies, and 61.2% were for the treatment of solid tumours (61.2%). Most had palliative intent (71.4%) and were indicated in relapsed or refractory disease (55.1%). Of the clinical trials, 57.1% were phase III and 63.3% were randomised. The primary endpoint was overall survival in 16.3%, increasing to 25.8% among randomised clinical trials. Regarding licensed drugs based on response rate, the median response rate was 56.4% [IQI 40-66.3]. In those authorised on the basis of surrogate time-to-event endpoints, the median hazard ratio was 0.54 [IQI 0.38-0.57], and among those using overall survival was 0.71 [IQI 0.59-0.77]. Globally, 22.4% had shown benefit in overall survival, with a median gain of 4 months [IQI 3.6-16.7]. One-third (33.3%) of the indications evaluable according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale showed substantial clinical benefit. Of the indications, 75.5% were funded, half (48.6%; 36.7% of the total) with restrictions. The median time to funding was 19.5 months [IQI 11.4-29.3]. CONCLUSIONS: Most main clinical trials of new onco-haematology drugs approved in Spain used surrogate primary endpoint and, at the time of authorisation, few had shown to prolong overall survival. More than a third were uncontrolled clinical trials.

Characteristics, clinical benefit and reimbursement of new authorisations for oncohaematology drugs in Spain between 2017 and 2020. / Características, beneficio clínico y financiación de las nuevas autorizaciones de fármacos oncohematológicos en España entre 2017 y 2020.

OBJECTIVE: To describe the authorisations and funding resolutions for new onco-hematological drugs in Spain between 2017 and 2020, as well as the results of their main trials. METHODS: Observational, cross-sectional, descriptive study conducted between October and December 2022. Onco-hematology drugs approved by the European Medicines Agency between 2017 and 2020 were included, according to EFPIA patients W.A.I.T Indicator 2021 Survey. Authorisation information was obtained from the main study of the European Public Assessment Report (EPAR). Data were collected on medicines, their authorisation and main study, benefit shown, cost, and status and time to reimbursement. RESULTS: Forty-one new drugs authorised for 49 indications were identified. More than half (58.5%) were targeted therapies, and 61.2% were for the treatment of solid tumors (61.2%). Most had palliative intent (71.4%) and were indicated in relapsed or refractory disease (55.1%). Of the clinical trials, 57.1% were phase III and 63.3% were randomised. The primary endpoint was overall survival in 16.3%, increasing to 25.8% among randomised clinical trials. Regarding licensed drugs based on response rate, the median response rate was 56.4% (IQI 40.0-66.3). In those authorised on the basis of surrogate time-to-event endpoints, the median Hazard Ratio was 0.54 (IQI 0.38-0.57), and among those using overall survival was 0.71 (IQI 0.59-0.77). Globally, 22.4% had shown benefit in overall survival, with a median gain of 4 months (IQI 3.6-16.7). One third (33.3%) of the indications evaluable according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale showed substantial clinical benefit. Of the indications, 75.5% were funded, half (48.6%; 36.7% of the total) with restrictions. The median time to funding was 19.5 months (IQI 11.4-29.3). CONCLUSIONS: Most main clinical trials of new onco-haematology drugs approved in Spain used surrogate primary endpoint and, at the time of authorisation, few had shown to prolong overall survival. More than a third were uncontrolled clinical trials.

Medication reconciliation in hospitalized hematological patient. / Conciliación de la medicación en el paciente hematológico ingresado.

OBJECTIVE: The main objective was to analyze unjustified discrepancies during the medication reconciliation process in patients admitted to the Hematology Service of our hospital and the pharmaceutical interventions. As a secondary objective, to detect possible points of the procedure to be perfected with a view to protocolizing the medication reconciliation process in hematological patients that adapts to the conditions of our center. METHODS: Cross-sectional observational pilot study carried out in a reference hospital in hematology for a population of 800,000 inhabitants. Adult inpatients admitted to the Hematology Service between August and October 2022 whose medication had been reconciled were included. The main variables were: number and type of unjustified discrepancy, proposed pharmaceutical intervention, and acceptance rate. RESULTS: 36 conciliation processes were analyzed, 34 admissions and 2 intrahospital transfer. 58.3% of the patients presented at least one unjustified discrepancy. 38 unjustified discrepancies were detected, with an acceptance of pharmaceutical interventions of 97.4%. The most common types of discrepancy were medication omission (56.8%) and drug interaction (24.3%). The most frequent pharmaceutical interventions were reintroducing medication (48.6%) and treatment discontinuation (16.2%). Polypharmacy and chemotherapy multiplied by 4 the probability of presenting drug interactions. CONCLUSIONS: The most common unjustified discrepancies in the medication reconciliation process in hospitalized hematology patients are: Medication omission and drug interactions. The reintroduction of medication and suspension of the prescription are the most frequent accepted pharmaceutical interventions. Polypharmacy is related to an increase in unjustified discrepancies. The factors that promote the appearance of interactions are admissions to receive chemotherapy treatment and polypharmacy. The main point of improvement detected is the need to create a circuit that allows conciliation to be carried out on discharge. Medication reconciliation contribute to improving patient safety by reducing medication errors.

Megakaryoblastic Acute Myeloid Leukemia Associated with a Testicular Tumour in a Young Adult: a Case Report / Leucemia Mieloide Aguda Megacarioblástica Associada a Tumor de Testículo em Adulto Jovem: um Relato de Caso

Acute megakaryoblastic leukemia (M7 AML) is a rare subtype of acute myeloid leukemia in adults, the incidence of which is higher in children aged 1 to 3 years, especially in patients with Down Syndrome; and in the age group between 60 and 70 years old, with an adverse prognosis. We report the case of a 28-year-old male patient, with a history of non-seminoma germ cell tumour of the testis, diagnosed with M7 AML. Nine months after performing an orchiectomy to remove the testicular tumour, the patient developed dyspnea, dry cough and asthenia, associated with the presence of erythematous-purple lesions on the skin, ascites and pleural effusion. The myelogram demonstrated medullary hypocellularity, with the presence of 53% of blastic, pleomorphic and bulky cells, with positivity for the markers CD34, CD31 and CD117 in immature cells in immunohistochemistry. Despite undergoing cycles of chemotherapy with cisplatin and a BEP regimen (Bleomycin, Etoposide and Cisplatin), the patient presented with chest tomography with the presence of pulmonary nodules and magnetic resonance imaging of the skull and neuraxial with infiltration of the bone marrow in the spine and cranial vault, resulting in with neurological impairment and died. In view of the case presented, we observed agreement with previous reports of the adverse prognosis of M7 AML in young adults and we questioned its relationship with germ cell tumour. (AU)

A leucemia megacarioblástica aguda (LMA M7) é um subtipo raro em adultos de leucemia mielóide aguda, cuja incidência é maior em crianças de 1 a 3 anos, especialmente em pacientes portadores de Síndrome de Down; e na faixa etária entre 60 e 70 anos, com um prognóstico adverso. Relatamos o caso de um paciente, do sexo masculino, 28 anos, com histórico de tumor germinativo não seminoma de testículo, diagnosticado com LMA M7. Nove meses após a realização de uma orquiectomia para a retirada do tumor testicular, o paciente apresentou quadro de dispneia, tosse seca e astenia, associado a presença de lesões eritemato-arroxeadas na pele, ascite e derrame pleural. O mielograma demonstrou hipocelularidade medular, com presença de 53% de células blásticas, pleomórficas e volumosas, com a positividade para os marcadores CD34, CD31 e CD117 em células imaturas na imunohistoquímica. Apesar da realização de ciclos de quimioterapia com cisplatina e esquema BEP (Bleomicina, Etoposídeo e Cisplatina), o paciente apresentou Tomografia de tórax com presença de nódulos pulmonares e ressonância magnética de crânio e neuroeixo com infiltração da medula óssea em coluna vertebral e calota craniana, intercorrendo com comprometimento neurológico e foi a óbito. Diante do caso apresentado observamos a concordância com relatos prévios do prognóstico adverso da LMA M7 em jovens adultos e indagamos a sua relação com o tumor de células germinativas. (AU)

Alteraciones hematológicas en el paciente gran quemado

Introducción: Las quemaduras graves alteran de manera significativa los parámetros hematológicos y de la coagulación. Objetivo: Describir las alteraciones hematológicas en el paciente gran quemado. Métodos: Se realizó un estudio descriptivo, longitudinal y prospectivo, en pacientes ingresados en el servicio de Cirugía Plástica y Caumatología del Hospital Universitario Manuel Ascunce Domenech, de la provincia Camagüey, durante el período comprendido entre mayo de 2020 a abril de 2022. Se estudiaron 38 pacientes, se tuvieron en cuenta las siguientes variables: alteración hematológica, superficie corporal quemada, índice pronóstico, estado al egreso. Resultados: De los pacientes con 30 % o más de superficie corporal quemada (12 en total) el 91,66 % presentó anemia. La anemia se encontró con más frecuencia en los pacientes clasificados como muy graves, 11 pacientes que representan el 28,95 %, es de destacar que los pacientes con este índice de gravedad constituyeron la mayoría en esta serie, 19 para un 50 %. En 23 de los enfermos presentaron alteraciones leucocitarias. Se encontró leucocitosis en el 44,73 % de los pacientes y leucopenia en seis enfermo que representó el 15,79 %. En el 23,68 % de los enfermos se observó la presencia de trombocitopenia. Conclusiones: Las alteraciones hematológicas influyen en la buena evolución de los pacientes quemados, de no tratarse de forma oportuna pueden llevar a estos lesionados a la muerte.

Introduction: The serious burns alter of significant way the hematological and coagulation parameters. Objective: To describe the hematological alterations in the large burned patient. Methods: A descriptive, longitudinal and prospective study was carried out for the sake of describing the main hematological alterations in the large burned patient, once 2020 were deposited in the Manuel Ascunce Domenech's Universitary Hospital service of Plastic Surgery and Caumatology, of the City Camagüey, during the period understood between May, 2020 to April, 2022. They studied 38 patients in those who they had in account variables: hematological alteration, corporal burned-out surface, index forecast, state to the discharge. Results: Of the patients with 30 % or more of corporal burned-out surface (12 in total) the 91.66 % presented anemia. Anemia was found with more frequency in the patient classified as very serious condition, 11 patients that represent the 28.95 %, it is from standing out that the patients with this severity rate constituted the majority in this series, 19 for a 50 %. In 23 of the sick persons of this series they presented leukocytal alterations. Leucocytosis was found in 44.73 % of the patients, and leukopenia in six patients which represented 15.79 %. In 23.68 % of the patients the presence of thrombocytopenia was observed. Conclusions: Hematological alterations influence the good progress of burned patients, and if not treated in a timely manner can lead to death.

Effects of Se nanoparticles supplementation on growth performance, hematological parameters and nutrient digestibility of Labeo rohita fingerling fed sunflower meal based diet

Abstract The aim of the present study is to assess the effects of selenium nanoparticles on the growth, hematology and nutrients digestibility of Labeorohita fingerlings. Fingerlings were fed with seven isocaloric sunflower meal-based diet supplemented with different concentrations of nanoparticles naming T1 to T7 (0, 0.5, 1, 1.5, 2, 2.5, and 3 mg/kg), with 5% wet body weight while chromic oxide was used as an indigestible marker. After experimentation for 90 days T3 treated group (1mg/kg -1Se-nano level) showed the best result in hematological parameters (WBCs 7.97 ×103mm-3, RBCs 2.98 ×106 mm-3 and Platelet count 67), nutrient digestibility (crude protein: 74%, ether extract: 76%, gross energy: 70%) and growth performance (weight gain 13.24 g, weight gain% 198, feed conversion ratio 1.5, survival rate 100%) as compared to the other treatment groups. Specific growth rates were found significantly higher in T5 than in other groups. The present study indicated positive effect of 1 mg/kg Se-nanoparticles on growth advancement, hematological parameters, and nutrients digestibility of L. rohita fingerlings.

Resumo O objetivo do presente estudo é avaliar os efeitos das nanopartículas de selênio no crescimento, hematologia e digestibilidade dos nutrientes de alevinos de Labeo rohita. Os alevinos foram alimentados com sete dietas isocalóricas à base de farinha de girassol suplementada com diferentes concentrações de nanopartículas, nomeando T1 a T7 (0, 0,5, 1, 1,5, 2, 2,5 e 3 mg / kg), com 5% do peso corporal úmido enquanto o óxido crômico foi usado como um marcador indigesto. Após a experimentação por 90 dias, o grupo tratado com T3 (nível 1mg / kg -1Se-nano) mostrou o melhor resultado em parâmetros hematológicos (WBCs 7,97 × 103mm-3, RBCs 2,98 × 106mm-3 e contagem de plaquetas 67), digestibilidade dos nutrientes (proteína bruta: 74%, extrato de éter: 76%, energia bruta: 70%) e desempenho de crescimento (ganho de peso 13,24 g, ganho de peso % 198, taxa de conversão alimentar 1,5, taxa de sobrevivência 100%) em comparação com os outros grupos de tratamento. As taxas de crescimento específicas foram encontradas significativamente mais altas em T5 do que em outros grupos. O presente estudo indicou efeito positivo de 1 mg / kg de nanopartículas de Se no avanço do crescimento, parâmetros hematológicos e digestibilidade de nutrientes de alevinos de L. rohita.

Sublethal toxicity of carbofuran in cattle egret (Bubulcus ibis coromandus): hematological, biochemical, and histopathological alterations

Abstract This study was aimed to investigate Carbofuran (CF)-induced pathological changes in cattle egret. Two hundred cattle egrets were reared and equally divided into four groups and given different CF concentrations (0.03 mg/L, 0.02 mg/L, 0.01 mg/L and 0 mg/L (control group)). Hematology, serum biochemistry, histopathology, and immunological markers were studied. Our results confirm that CF induces anemic conditions, leukocytosis, elevated liver enzymatic activity, and alterations in renal biomarkers. Moreover, specific microscopic lesions such as multifocal necrosis, pyknotic nuclei, hemorrhages, congestion, and inflammatory cell proliferation were observed in the liver, kidney, spleen, and thymus. These findings suggest that CF can induce harmful effects, so the application of this pesticide in the field must be strictly monitored to mitigate the possibility of exposure to non-target species.

Resumo Este estudo teve como objetivo investigar as alterações patológicas induzidas por carbofurano (CF) em garças-vaqueiras. Duzentas dessas garças foram criadas e divididas igualmente em quatro grupos e receberam diferentes concentrações de CF: 0,03 mg/L; 0,02 mg/L; 0,01 mg/L; e 0 mg/L (grupo controle). Foram realizadas análises de hematologia, bioquímica sérica, histopatologia e marcadores imunológicos. Nossos resultados confirmaram que CF induz condições anêmicas, leucocitose, atividade enzimática hepática elevada e alterações nos biomarcadores renais. Além disso, lesões microscópicas específicas, como necrose multifocal, núcleos picnóticos, hemorragias, congestão e proliferação de células inflamatórias, foram observadas no fígado, rim, baço e timo. Esses achados sugerem que o CF pode causar efeitos nocivos, portanto a aplicação desse agrotóxico no campo deve ser rigorosamente monitorada para mitigar a possibilidade de exposição a espécies não alvo.

Physiological responses of tambaqui (Colossoma macropomum) fed diets supplemented with silage from fish and vegetables residues

Abstract The demand for products to replace high-cost raw materials, such oil and fish meal, in the manufacture of feed for use in aquaculture, while also guaranteeing the nutritional quality of the diets, is increasing. Silage produced with fish and vegetables residues is a low-cost and efficient protein source. The objective of the present study was to evaluate the physiological and biochemical responses of tambaqui fingerlings fed four different levels of silage included in commercial feed with 28% crude protein, over two periods: 45 and 90 days. Each treatment was carried out over three replications, with 10 tambaqui in each 100 L experimental tank. At the end of each established period, blood samples were collected from five animals from each repetition to determine the hematological and biochemical variables. Body weight and total length, hepatosomatic and liposomal indices and hematocrit of specimens fed with diets supplemented with silage did not exhibit significant changes in both assessment period. After 45 days of feeding, the hemoglobin concentration increased when tambaqui were fed a diet including 20% silage. The red blood cell count, mean corpuscular volume and mean corpuscular hemoglobin did not change between treatments in either period. The total protein concentrations increased significantly in the plasma of tambaqui fed with diets with the inclusion of 5 and 10% of silage, evaluated after feeding for 45 days. It was found that the groups which had silage included in their diet did not exhibit significant alterations in the evaluated parameters, and the diet was therefore not consider harmful to the health of tambaqui. Therefore, the use of silage as a feed supplement during tambaqui farming is a sustainable alternative for producers, as it leads to a reduction of impacts of fish and vegetables waste disposal.

Resumo A procura por insumos que substituam produtos de alto custo, como óleo e farinha de peixe, na fabricação de rações para uso na aquicultura é crescente, sendo necessário garantir a qualidade nutricional das dietas. A silagem produzida a partir de resíduos de pescado e de vegetais apresenta-se como uma alternativa de baixo custo e eficiente fonte proteica. O objetivo do presente estudo foi avaliar as respostas fisiológicas e bioquímicas de alevinos de tambaqui alimentados com quatro níveis de inclusão de silagem em ração comercial com 28% de proteína bruta, em dois períodos: 45 e 90 dias. Cada tratamento foi realizado em três repetições, com 10 tambaquis em cada caixa experimental de 100 L. Ao término de cada período estabelecido, amostras sanguíneas foram coletadas de cinco animais de cada repetição para determinação das variáveis hematológicas e bioquímicas. Peso, comprimento total e índices hepatossomático e lipossomático de espécimes alimentados com silagem não mostraram alterações significativas em ambos os períodos de avaliação, bem como os valores de hematócrito. A concentração de hemoglobina de tambaqui após 45 dias de alimentação aumentou quando foi fornecida dieta com inclusão de 20% de silagem. A contagem de eritrócitos, volume corpuscular médio e hemoglobina corpuscular média não apresentaram alterações entre os tratamentos, em ambos os períodos. As proteínas totais aumentaram significativamente no plasma de tambaquis que receberam dietas com inclusão de 5 e 10% de silagem, avaliados após 45 dias de alimentação. Evidenciou-se que os grupos com inclusão de silagem na dieta não apresentaram alterações significativas nos parâmetros avaliados, assim não sendo prejudiciais à higidez do tambaqui. Portanto, o uso da silagem como suplemento alimentar durante o cultivo do tambaqui é uma alternativa sustentável para produtores, por promover a redução do descarte de resíduos de pescado e da agricultura.

Sublethal toxicity of carbofuran in cattle egret (Bubulcus ibis coromandus): hematological, biochemical, and histopathological alterations / Toxicidade subletal do carbofurano na garça-vaqueira (Bubulcus ibis coromandus): alterações hematológicas, bioquímicas e histopatológicas

Abstract This study was aimed to investigate Carbofuran (CF)-induced pathological changes in cattle egret. Two hundred cattle egrets were reared and equally divided into four groups and given different CF concentrations (0.03 mg/L, 0.02 mg/L, 0.01 mg/L and 0 mg/L (control group)). Hematology, serum biochemistry, histopathology, and immunological markers were studied. Our results confirm that CF induces anemic conditions, leukocytosis, elevated liver enzymatic activity, and alterations in renal biomarkers. Moreover, specific microscopic lesions such as multifocal necrosis, pyknotic nuclei, hemorrhages, congestion, and inflammatory cell proliferation were observed in the liver, kidney, spleen, and thymus. These findings suggest that CF can induce harmful effects, so the application of this pesticide in the field must be strictly monitored to mitigate the possibility of exposure to non-target species.

Resumo Este estudo teve como objetivo investigar as alterações patológicas induzidas por carbofurano (CF) em garças-vaqueiras. Duzentas dessas garças foram criadas e divididas igualmente em quatro grupos e receberam diferentes concentrações de CF: 0,03 mg/L; 0,02 mg/L; 0,01 mg/L; e 0 mg/L (grupo controle). Foram realizadas análises de hematologia, bioquímica sérica, histopatologia e marcadores imunológicos. Nossos resultados confirmaram que CF induz condições anêmicas, leucocitose, atividade enzimática hepática elevada e alterações nos biomarcadores renais. Além disso, lesões microscópicas específicas, como necrose multifocal, núcleos picnóticos, hemorragias, congestão e proliferação de células inflamatórias, foram observadas no fígado, rim, baço e timo. Esses achados sugerem que o CF pode causar efeitos nocivos, portanto a aplicação desse agrotóxico no campo deve ser rigorosamente monitorada para mitigar a possibilidade de exposição a espécies não alvo.

Effects of Se nanoparticles supplementation on growth performance, hematological parameters and nutrient digestibility of Labeo rohita fingerling fed sunflower meal based diet / Efeitos da suplementação de nanopartículas de Se no desempenho de crescimento, parâmetros hematológicos e digestibilidade de nutrientes da dieta baseada em farinha de girassol alimentada com alevinos de Labeo rohita

Abstract The aim of the present study is to assess the effects of selenium nanoparticles on the growth, hematology and nutrients digestibility of Labeorohita fingerlings. Fingerlings were fed with seven isocaloric sunflower meal-based diet supplemented with different concentrations of nanoparticles naming T1 to T7 (0, 0.5, 1, 1.5, 2, 2.5, and 3 mg/kg), with 5% wet body weight while chromic oxide was used as an indigestible marker. After experimentation for 90 days T3 treated group (1mg/kg -1Se-nano level) showed the best result in hematological parameters (WBC's 7.97 ×103mm-3, RBC's 2.98 ×106 mm-3 and Platelet count 67), nutrient digestibility (crude protein: 74%, ether extract: 76%, gross energy: 70%) and growth performance (weight gain 13.24 g, weight gain% 198, feed conversion ratio 1.5, survival rate 100%) as compared to the other treatment groups. Specific growth rates were found significantly higher in T5 than in other groups. The present study indicated positive effect of 1 mg/kg Se-nanoparticles on growth advancement, hematological parameters, and nutrients digestibility of L. rohita fingerlings.

Resumo O objetivo do presente estudo é avaliar os efeitos das nanopartículas de selênio no crescimento, hematologia e digestibilidade dos nutrientes de alevinos de Labeo rohita. Os alevinos foram alimentados com sete dietas isocalóricas à base de farinha de girassol suplementada com diferentes concentrações de nanopartículas, nomeando T1 a T7 (0, 0,5, 1, 1,5, 2, 2,5 e 3 mg / kg), com 5% do peso corporal úmido enquanto o óxido crômico foi usado como um marcador indigesto. Após a experimentação por 90 dias, o grupo tratado com T3 (nível 1mg / kg -1Se-nano) mostrou o melhor resultado em parâmetros hematológicos (WBC's 7,97 × 103mm-3, RBC's 2,98 × 106mm-3 e contagem de plaquetas 67), digestibilidade dos nutrientes (proteína bruta: 74%, extrato de éter: 76%, energia bruta: 70%) e desempenho de crescimento (ganho de peso 13,24 g, ganho de peso % 198, taxa de conversão alimentar 1,5, taxa de sobrevivência 100%) em comparação com os outros grupos de tratamento. As taxas de crescimento específicas foram encontradas significativamente mais altas em T5 do que em outros grupos. O presente estudo indicou efeito positivo de 1 mg / kg de nanopartículas de Se no avanço do crescimento, parâmetros hematológicos e digestibilidade de nutrientes de alevinos de L. rohita.

Physiological responses of tambaqui (Colossoma macropomum) fed diets supplemented with silage from fish and vegetables residues / Respostas fisiológicas de tambaqui (Colossoma macropomum) alimentado com dietas suplementadas com silagem de resíduos de pescado e vegetais

The demand for products to replace high-cost raw materials, such oil and fish meal, in the manufacture of feed for use in aquaculture, while also guaranteeing the nutritional quality of the diets, is increasing. Silage produced with fish and vegetables residues is a low-cost and efficient protein source. The objective of the present study was to evaluate the physiological and biochemical responses of tambaqui fingerlings fed four different levels of silage included in commercial feed with 28% crude protein, over two periods: 45 and 90 days. Each treatment was carried out over three replications, with 10 tambaqui in each 100 L experimental tank. At the end of each established period, blood samples were collected from five animals from each repetition to determine the hematological and biochemical variables. Body weight and total length, hepatosomatic and liposomal indices and hematocrit of specimens fed with diets supplemented with silage did not exhibit significant changes in both assessment period. After 45 days of feeding, the hemoglobin concentration increased when tambaqui were fed a diet including 20% silage. The red blood cell count, mean corpuscular volume and mean corpuscular hemoglobin did not change between treatments in either period. The total protein concentrations increased significantly in the plasma of tambaqui fed with diets with the inclusion of 5 and 10% of silage, evaluated after feeding for 45 days. It was found that the groups which had silage included in their diet did not exhibit significant alterations in the evaluated parameters, and the diet was therefore not consider harmful to the health of tambaqui. Therefore, the use of silage as a feed supplement during tambaqui farming is a sustainable alternative for producers, as it leads to a reduction of impacts of fish and vegetables waste disposal.

A procura por insumos que substituam produtos de alto custo, como óleo e farinha de peixe, na fabricação de rações para uso na aquicultura é crescente, sendo necessário garantir a qualidade nutricional das dietas. A silagem produzida a partir de resíduos de pescado e de vegetais apresenta-se como uma alternativa de baixo custo e eficiente fonte proteica. O objetivo do presente estudo foi avaliar as respostas fisiológicas e bioquímicas de alevinos de tambaqui alimentados com quatro níveis de inclusão de silagem em ração comercial com 28% de proteína bruta, em dois períodos: 45 e 90 dias. Cada tratamento foi realizado em três repetições, com 10 tambaquis em cada caixa experimental de 100 L. Ao término de cada período estabelecido, amostras sanguíneas foram coletadas de cinco animais de cada repetição para determinação das variáveis hematológicas e bioquímicas. Peso, comprimento total e índices hepatossomático e lipossomático de espécimes alimentados com silagem não mostraram alterações significativas em ambos os períodos de avaliação, bem como os valores de hematócrito. A concentração de hemoglobina de tambaqui após 45 dias de alimentação aumentou quando foi fornecida dieta com inclusão de 20% de silagem. A contagem de eritrócitos, volume corpuscular médio e hemoglobina corpuscular média não apresentaram alterações entre os tratamentos, em ambos os períodos. As proteínas totais aumentaram significativamente no plasma de tambaquis que receberam dietas com inclusão de 5 e 10% de silagem, avaliados após 45 dias de alimentação. Evidenciou-se que os grupos com inclusão de silagem na dieta não apresentaram alterações significativas nos parâmetros avaliados, assim não sendo prejudiciais à higidez do tambaqui. Portanto, o uso da silagem como suplemento alimentar durante o cultivo do tambaqui é uma alternativa sustentável para produtores, por promover a redução do descarte de resíduos de pescado e da agricultura.

Perfil sociodemográfico e laboratorial dos pacientes submetidos à hemodiálise em um centro de referência do Estado do Ceará / Sociodemographic and laboratory profile of patients undergoing hemodialysis in a reference center in the State of Ceará / Perfil sociodemográfico y de laboratorio de dos pacientes sometidos a hemodiálisis en un centro de referencia del Estado de Ceará

A Doença Renal Crônica (DRC) é uma importante redução da função renal que causa alterações no metabolismo dos indivíduos. Para acompanhar a progressão da DRC e prevenir possíveis complicações, foi realizada uma pesquisa para avaliar o perfil sociodemográfico, bioquímico e hematológico de pacientes com Insuficiência Renal Crônica (IRC) submetidos a hemodiálise. Esta pesquisa foi quantitativa, descritiva e transversal de caráter retrospectivo, realizada por meio da análise de dados secundários contidos nos prontuários dos pacientes. A coleta de dados ocorreu no Centro de Hemodiálise da cidade de Russas, no Ceará. A amostra foi constituída por 161 pacientes com DRC, sendo 63,35% do sexo masculino e 85,71% pardos, com uma idade média de 54,39 anos. Desses, 63,97% tinham entre 2 e 10 anos de tratamento e 57,76% possuíam ensino fundamental incompleto. 19,25% residiam em Russas. Resultados: Após a hemodiálise, os resultados mostraram 44 mg/dL de Ureia, 48,44% dos pacientes com valores normais. A hemoglobina e hematócrito médios foram 11,8 g/dL e 33,7%, respectivamente, sendo que 63,35% tiveram valores reduzidos. 85,10% dos pacientes tiveram contagem de plaquetas normal, 72,04% níveis adequados de ferro e albumina, 52,79% tiveram níveis elevados de ferritina, 23,61% redução de transferrina e níveis lipídicos satisfatórios. 79,50% apresentaram níveis séricos de potássio dentro da normalidade, 12,42% de fósforo acima do normal, 85,09% de cálcio dentro dos valores normais, 39,13% de PTHi normais e 86,33% de glicose dentro dos valores considerados normais. Com base nos resultados, concluiu-se que todos os pacientes em tratamento hemodialítico apresentam diversas alterações em decorrência da DRC e do próprio processo de tratamento. Portanto, a realização de exames para avaliar ou monitorar possíveis complicações da IRC é essencial para criar estratégias e intervenções mais eficazes, que melhorem a assistência prestada a esses pacientes e, consequentemente, da qualidade e expectativa de vida dos mesmos.

Chronic Kidney Disease (CKD) is an important reduction in kidney function that causes changes in the metabolism of individuals. To monitor the progression of CKD and prevent possible complications, a survey was carried out to assess the sociodemographic, biochemical and hematological profile of patients with Chronic Renal Failure (CRF) undergoing hemodialysis. This research was quantitative, descriptive and cross-sectional with a retrospective character, carried out through the analysis of secondary data contained in the patients' medical records. Data collection took place at the Hemodialysis Center in the city of Russas, Ceará. The sample consisted of 161 patients with CKD, 63.35% male and 85.71% brown, with an average age of 54.39 years. Of these, 63.97% had between 2 and 10 years of treatment and 57.76% had incomplete primary education. 19.25% resided in Russas. Results: After hemodialysis, the results showed 44 mg/dL of Urea, 48.44% of patients with normal values. Average hemoglobin and hematocrit were 11.8 g/dL and 33.7%, respectively, with 63.35% having reduced values. 85.10% of the patients had normal platelet counts, 72.04% had adequate levels of iron and albumin, 52.79% had high levels of ferritin, 23.61% had reduced transferrin and satisfactory lipid levels. 79.50% had serum levels of potassium within the normal range, 12.42% of phosphorus above normal, 85.09% of calcium within normal values, 39.13% of PTHi normal and 86.33% of glucose within the values considered normal. Based on the results, it was concluded that all patients on hemodialysis have several changes due to CKD and the treatment process itself. Therefore, carrying out tests to assess or monitor possible complications of CRF is essential to create more effective strategies and interventions that improve the care provided to these patients and, consequently, their quality and life expectancy.

La Enfermedad Renal Crónica (ERC) es una reducción importante de la función renal que provoca cambios en el metabolismo de los individuos. Para monitorizar la evolución de la ERC y prevenir posibles complicaciones, se realizó una encuesta para evaluar el perfil sociodemográfico, bioquímico y hematológico de los pacientes con Insuficiencia Renal Crónica (IRC) en hemodiálisis. Esta investigación fue cuantitativa, descriptiva y transversal con carácter retrospectivo, realizada a través del análisis de datos secundarios contenidos en las historias clínicas de los pacientes. La recolección de datos ocurrió en el Centro de Hemodiálisis de la ciudad de Russas, Ceará. La muestra estuvo constituida por 161 pacientes con ERC, 63,35% del sexo masculino y 85,71% pardos, con una edad media de 54,39 años. De estos, 63,97% tenían entre 2 y 10 años de tratamiento y 57,76% tenían primaria incompleta. El 19,25% residía en Russas. Resultados: Posterior a la hemodiálisis los resultados arrojaron 44 mg/dL de Urea, 48,44% de los pacientes con valores normales. La hemoglobina y el hematocrito medios fueron 11,8 g/dl y 33,7 %, respectivamente, con un 63,35 % con valores reducidos. El 85,10% de los pacientes presentaba plaquetas normales, el 72,04% presentaba niveles adecuados de hierro y albúmina, el 52,79% presentaba niveles elevados de ferritina, el 23,61% presentaba transferrina reducida y niveles satisfactorios de lípidos. El 79,50% presentaba niveles séricos de potasio dentro de la normalidad, el 12,42% de fósforo por encima de lo normal, el 85,09% de calcio dentro de los valores normales, el 39,13% de PTHi normal y el 86,33% de glucosa dentro de los valores considerados normales. Con base en los resultados, se concluyó que todos los pacientes en hemodiálisis tienen varios cambios debido a la ERC y al propio proceso de tratamiento. Por tanto, la realización de pruebas para evaluar o monitorizar las posibles complicaciones de la IRC es fundamental para crear estrategias e intervenciones más eficaces que mejoren la atención a estos pacientes y, en consecuencia, su calidad y esperanza de vida.

[Comparative analysis of bleed volume with visual technique]. / Análisis comparativo de volumen de sangrado mediante técnica visual.

Background: Blood loss estimation in a surgery is made by anesthesiologists by means of visual technique, which is not reliable because it can change depending on the judgement of every person, or his/her work experience, which is why it is considered something subjective. Therefore, the results obtained could lead to make mistakes with the exact amount of bleeding, mismanaging unnecessary hemoderived transfusions or administering unnecessary drugs. Objective: To compare the blood volume and its visual calculation between Anesthesiology residents and anesthesiologists. Material and methods: Prolective cross-sectional study which included 85 Anesthesiology residents and anesthesiologists. Diverse scenarios of bleeding were set, divided into gauze pads, compresses and jars, and each participant was asked to answer the poll. Results: There is no significant difference in the estimate of bleeding between the estimation made by residents and anesthesiologists. Conclusions: The grade of studies or experience is not significant for the exact estimation of bleeding with visual technique.

Introducción: la estimación de sangrado en las cirugías se realiza por medio de la técnica de cálculo visual, que es llevada a cabo por parte del servicio de anestesiología. Se trata de una técnica poco confiable, que puede variar dependiendo del juicio de cada persona y de su experiencia laboral, por lo que es considerada algo subjetivo. Por lo tanto, los datos arrojados hacen que se cometan errores en la cantidad exacta del sangrado y llevan a transfusiones de paquetes globulares o a la administración probablemente innecesaria de medicamentos. Objetivo: comparar la cantidad de un volumen de sangrado determinado y su cálculo visual realizada por residentes de Anestesiología y anestesiólogos. Material y métodos: estudio transversal prolectivo en el cual se incluyeron 85 médicos residentes de Anestesiología y anestesiólogos. Se dispusieron diversos escenarios con sangrado, los cuales se dividieron en gasas, compresas y frascos, y se le pidió a cada médico que contestara la encuesta correspondiente según su criterio. Resultados: de acuerdo con los resultados, no hay diferencia significativa en la estimación realizada del sangrado entre residentes y anestesiólogos para las muestras estudiadas. Conclusiones: el grado de estudios o experiencia no es significativo para la exacta estimación de sangrado con técnica visual.

[Translated article] Medication reconciliation in pediatric hemato-oncologic patients: A multicenter study.

OBJECTIVE: To determine the prevalence of reconciliation errors on admission to hospital in the pediatric onco-hematological population in order to check whether they are similarly susceptible to these reconciliation errors as adults and to describe the characteristics of the patients who suffer them. METHODS: A 12-month prospective, multicentre study of medication reconciliation on admission in the pediatric onco-hematological population to assess the incidence of reconciliation errors and to describe the characteristics of the patients. RESULTS: Medication reconciliation was performed in 157 patients. At least a medication discrepancy was detected in 96 patients. Of the discrepancies detected, 52.1% were related to patient's new clinical situation or by the physician, while 48.9% were determined to be reconciliation errors. The most frequent type of reconciliation error was the "omission of a medication", followed by "a different dose, frequency or route of administration". A total of 77 pharmaceutical interventions were carried out, 94.2% of which were accepted. In the group of patients with a number equal to or greater than 4 drugs in home treatment, there was a 2.1-fold increase in the probability of suffering a reconciliation error. CONCLUSIONS: In order to avoid or reduce errors in one of the critical safety points such as transitions of care, there are measures such as medication reconciliation. In the case of complex chronic pediatric patients, such as onco-hematological patients, the number of drugs as part of home treatment is the variable that has been associated with the presence of medication reconciliation errors on admission to hospital, and the omission of some medication was the main cause of these errors.

Multicentre study of medication reconciliation in paediatric onco-hematology. / Estudio multicéntrico de conciliación de la medicación en onco-hematología pediátrica.

OBJECTIVE: To determine the prevalence of reconciliation errors (RE) on admission to hospital in the paediatric onco-haematological population in order to check whether they are similarly susceptible to these RE as adults and to describe the characteristics of the patients who suffer them. METHODS: A 12-month prospective, multicentre study of medication reconciliation on admission in the paediatric onco-haematological population to assess the incidence of RE and describe the characteristics of the patients in whom they occur. RESULTS: Medication reconciliation was performed in 157 patients. At least 1 medication discrepancy was detected in 96 patients. Of the discrepancies detected, 52.1% were justified by the patient's new clinical situation or by the physician, while 48.9% were determined to be RE. The most frequent type of RE was the "omission of a medication", followed by "a different dose, frequency or route of administration". A total of 77 pharmaceutical interventions were carried out, 94.2% of which were accepted. In the group of patients with a number equal to or greater than 4 drugs in home treatment, there was a 2.1-fold increase in the probability of suffering a RE. CONCLUSIONS: In order to avoid or reduce errors in one of the critical safety points such as transitions of care, there are measures such as medication reconciliation. In the case of complex chronic paediatric patients, such as onco-haematological patients, the number of drugs as part of home treatment is the variable that has been associated with the presence of medication RE on admission to hospital, with the omission of some medication being the main cause of these errors.

[Translated article] Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

OBJECTIVE: Define consensus recommendations to improve care coordination between Hospital Pharmacy, Hematology and Nursing, inter- and intra-center, in the care of hemophilia patients. METHOD: Recommendations for the improvement of care coordination in the management of hemophilia patients were identified and assessed by a multidisciplinary panel of professionals with experience in this field (Hospital Pharmacy, Hematology and Nursing) and supported by scientific evidence. The identified recommendations were assessed by Rand/UCLA consensus methodology (Delphi-adapted) based on their appropriateness and, subsequently, on their necessity. In both cases, it was used ordinal Likert scale. Data were statistically analyzed through different metrics. RESULTS: Fifty-three recommendations for the improvement of care coordination between Hospital Pharmacy, Hematology and Nursing in the management of hemophilia patients were identified, grouped into eight areas of action: i) Hemophilia units, reference centers and multidisciplinary care; ii) Role of Hematology, Hospital Pharmacy and Nursing in the patient journey of hemophilia patients; iii) Telepharmacy and telemedicine; iv) Pharmacokinetic monitoring; v) Transition to adult patient regimen; vi) Patient health education; vii) Surgery, emergency room and hospital admission; and viii) Outcome evaluation. All recommendations were assessed as appropriate and necessary by the external expert panel. CONCLUSIONS: Hemophilia patient journey is complex and depends on different variables. It also requires the involvement of different healthcare professionals who must act in a coordinated and integrated manner at all stages of the patient's life, adapted to their individual needs. On this matter, the identified and agreed recommendations may improve continuity and quality of care, as they facilitate the integration and coordination of the professionals involved in the management of this pathology, especially Hospital Pharmacy, Hematology and Nursing.

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia. / Consenso de recomendaciones para la mejora de la coordinación asistencial inter e intra-centros en el abordaje de la hemofilia.

OBJECTIVE: Define consensus recommendations to improve care coordination between Hospital Pharmacy, Haematology and Nursing, inter- and intra-center, in the care of haemophilia patients. METHOD: Recommendations for the improvement of care coordination in the management of haemophilia patients were identified and assessed by a multidisciplinary panel of professionals with experience in this field (Hospital Pharmacy, Haematology and Nursing) and supported by scientific evidence. The identified recommendations were assessed by Rand/UCLA consensus methodology (Delphi-adapted) based on their appropriateness and, subsequently, on their necessity. In both cases, it was used ordinal Likert scale. Data were statistically analysed through different metrics. RESULTS: Fifty-three recommendations for the improvement of care coordination between Hospital Pharmacy, Haematology and Nursing in the management of haemophilia patients were identified, grouped into eight areas of action: i) Haemophilia units, reference centers and multidisciplinary care; ii) Role of Haematology, Hospital Pharmacy and Nursing in the patient journey of haemophilia patients; iii) Telepharmacy and telemedicine; iv) Pharmacokinetic monitoring; v) Transition to adult patient regimen; vi) Patient health education; vii) Surgery, emergency room and hospital admission; and viii) Outcome evaluation. All recommendations were assessed as appropriate and necessary by the external expert panel. CONCLUSIONS: Haemophilia patient journey is complex and depends on different variables. It also requires the involvement of different healthcare professionals who must act in a coordinated and integrated manner at all stages of the patient's life, adapted to their individual needs. On this matter, the identified and agreed recommendations may improve continuity and quality of care, as they facilitate the integration and coordination of the professionals involved in the management of this pathology, especially Hospital Pharmacy, Haematology and Nursing.

Antimicrobial stewardship in hospitals: Expert recommendation guidance document for activities in specific populations, syndromes and other aspects (PROA-2) from SEIMC, SEFH, SEMPSPGS, SEMICYUC and SEIP.

In 2012, The Spanish Societies of Infectious Diseases and Clinical Microbiology (SEIMC), Hospital Pharmacy (SEFH), and Preventive Medicine, Public Health and Healthcare Management (SEMPSGS) lead a consensus document including recommendations for the implementation of antimicrobial stewardship (AMS) programs (AMSP; PROA in Spanish) in acute care hospitals in Spain. While these recommendations were critical for the development of these programs in many centres, there is a need for guidance in the development of AMS activities for specific patient populations, syndromes or other specific aspects which were not included in the previous document or have developed significantly since then. The objective of this expert recommendation guidance document is to review the available information about these activities in these patient populations or circumstances, and to provide guidance recommendations about them. With this objective the SEIMC, SEFH, SEMPSPGS, the Spanish Society of Intensive Care Medicine (SEMICYUC) and the Spanish Pediatric Infectious Disease Society (SEIP) selected a panel of experts who chose the different aspects to include in the document. Because of the lack of high-level evidence in the implementation of the activities, the panel opted to perform a narrative review of the literature for the different topics for which recommendations were agreed by consensus. The document was open to public consultation for the members of these societies for their comments and suggestions, which were reviewed and considered by the panel.

Revision of some mensural measurements, food preference, and haematological parameters in breeding pairs of blue rock pigeon, Columba livia sampled from punjab Pakistan / Revisão de algumas medidas mensurais, preferência alimentar e parâmetros hematológicos em pares de criação de pombo blue rock (Columba livia), amostragem de punjab, Paquistão

Abstract The present study describes the haematological profile, feeding preference, and comparison of morphometric characters of blue rock pigeon (Columba livia) breeding pairs. For this purpose, 25 pairs (25 samples per sex) were sampled through Mist nets from district Okara and Bahawalnagar, Punjab, Pakistan. Birds were then anaesthetized with a combination of ketamine HCL (10 mg/kg) and diazepam (0.2 mg/kg) and subjected to morphometric measurements. 5µL blood also was taken from the jugular vein of each anaesthetized bird for haematological analysis. Few pairs were also dissected to remove gastrointestinal tracts (GITs) for food preferences. Results revealed that there are no significant differences in the haematological parameters and feeding preference of breeding pairs of Columba livia. The gut analysis further revealed, the major portion of gut contents consisted of pea and corn in most of the pairs. Regarding the mensural measurements, significant differences were recorded in the body weight, length of the longest primary feather, and chest circumference, whereas the rest of the studied parameters remain nonsignificant between sexes. So, it is concluded that apart from 3 morphometric parameters (body weight, length of longest primary feather and chest circumference), both sexes are alike in term of morphometry, haematology and food preference.

Resumo O presente estudo descreve o perfil hematológico, a preferência alimentar e a comparação de caracteres morfométricos de casais reprodutores de pombo-rocha (Columba livia). Para tanto, 25 pares (25 amostras por sexo) foram amostrados por meio de redes de névoa do distrito de Okara e Bahawalnagar, Punjab, Paquistão. As aves foram então anestesiadas com uma combinação de cetamina HCL (10 mg/kg) e diazepam (0,2 mg/kg) e submetidas a medidas morfométricas; 5 µL de sangue também foram retirados da veia jugular de cada ave anestesiada para análise hematológica. Poucos pares também foram dissecados para remover o trato gastrointestinal (GITs) para preferências alimentares. Os resultados revelaram que não há diferenças significativas nos parâmetros hematológicos e na preferência alimentar dos casais reprodutores de Columba livia. A análise intestinal revelou ainda que a maior parte do conteúdo intestinal consistia em ervilha e milho na maioria dos pares. Em relação às medidas mensurais, foram registradas diferenças significativas no peso corporal, comprimento da pena primária mais longa e circunferência torácica, enquanto os demais parâmetros estudados permanecem não significativos entre os sexos. Assim, conclui-se que além de três parâmetros morfométricos (peso corporal, comprimento da pena primária mais longa e circunferência torácica), ambos os sexos são semelhantes em termos de morfometria, hematologia e preferência alimentar.