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1.
Zhonghua Xue Ye Xue Za Zhi ; 45(2): 178-183, 2024 Feb 14.
Artigo em Chinês | MEDLINE | ID: mdl-38604795

RESUMO

Objective: To investigate the clinical efficacy and safety of ferric derisomaltose injection versus iron sucrose injection in the treatment of iron deficiency anemia (IDA) . Methods: A total of 120 patients with iron deficiency anemia admitted from June 2021 to March 2023 were given intravenous iron supplementation with ferric derisomaltose to assess the efficacy and safety of hemoglobin (HGB) elevation before and after treatment. Simultaneously, the clinical effects of iron supplementation with iron sucrose were compared to those of inpatient patients during the same period. Results: Baseline values were comparable in both groups. Within 12 weeks of treatment, the elevated HGB level in the ferric derisomaltose group was higher than that of the iron sucrose group, with a statistical difference at all time points, and the proportion of HGB increased over 20 g/L in the patients treated for 4 weeks was higher (98.7%, 75.9% ). During the treatment with ferric derisomaltose and iron sucrose, the proportion of mild adverse reactions in the ferric derisomaltose group was slightly lower than that of the iron sucrose group, and neither group experienced any serious adverse reactions. The patients responded well to the infusion treatment, with no reports of pain or pigmentation at the injection site. Conclusion: The treatment of IDA patients with ferric derisomaltose has a satisfactory curative effect, with the advantages of rapidity, accuracy, and safety. Therefore, it is worthy of widespread clinical use.


Assuntos
Anemia Ferropriva , Dissacarídeos , Humanos , Óxido de Ferro Sacarado/uso terapêutico , Anemia Ferropriva/tratamento farmacológico , Anemia Ferropriva/induzido quimicamente , Infusões Intravenosas , Estudos Retrospectivos , Compostos Férricos/uso terapêutico , Compostos Férricos/efeitos adversos , Ferro , Hemoglobinas/análise , Hemoglobinas/uso terapêutico
2.
J Control Release ; 368: 566-579, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38438093

RESUMO

Intravenous (IV) iron-carbohydrate complexes are widely used nanoparticles (NPs) to treat iron deficiency anaemia, often associated with medical conditions such as chronic kidney disease, heart failure and various inflammatory conditions. Even though a plethora of physicochemical characterisation data and clinical studies are available for these products, evidence-based correlation between physicochemical properties of iron-carbohydrate complexes and clinical outcome has not fully been elucidated yet. Studies on other metal oxide NPs suggest that early interactions between NPs and blood upon IV injection are key to understanding how differences in physicochemical characteristics of iron-carbohydrate complexes cause variance in clinical outcomes. We therefore investigated the core-ligand structure of two clinically relevant iron-carbohydrate complexes, iron sucrose (IS) and ferric carboxymaltose (FCM), and their interactions with two structurally different human plasma proteins, human serum albumin (HSA) and fibrinogen, using a combination of cryo-scanning transmission electron microscopy (cryo-STEM), x-ray diffraction (XRD), small-angle x-ray scattering (SAXS) and small-angle neutron scattering (SANS). Using this orthogonal approach, we defined the nano-structure, individual building blocks and surface morphology for IS and FCM. Importantly, we revealed significant differences in the surface morphology of the iron-carbohydrate complexes. FCM shows a localised carbohydrate shell around its core, in contrast to IS, which is characterised by a diffuse and dynamic layer of carbohydrate ligand surrounding its core. We hypothesised that such differences in carbohydrate morphology determine the interaction between iron-carbohydrate complexes and proteins and therefore investigated the NPs in the presence of HSA and fibrinogen. Intriguingly, IS showed significant interaction with HSA and fibrinogen, forming NP-protein clusters, while FCM only showed significant interaction with fibrinogen. We postulate that these differences could influence bio-response of the two formulations and their clinical outcome. In conclusion, our study provides orthogonal characterisation of two clinically relevant iron-carbohydrate complexes and first hints at their interaction behaviour with proteins in the human bloodstream, setting a prerequisite towards complete understanding of the correlation between physicochemical properties and clinical outcome.


Assuntos
Anemia Ferropriva , Maltose/análogos & derivados , Nanopartículas Metálicas , Humanos , Ferro/química , Espalhamento a Baixo Ângulo , Ligantes , Difração de Raios X , Compostos Férricos , Óxido de Ferro Sacarado/uso terapêutico , Anemia Ferropriva/tratamento farmacológico , Nanopartículas Metálicas/química , Fibrinogênio
3.
Indian J Med Res ; 159(1): 62-70, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-38439125

RESUMO

BACKGROUND OBJECTIVES: Iron deficiency anaemia (IDA) during pregnancy is treated with oral and parenteral iron. The objective of this review was to compare the clinical effectiveness, safety, pregnancy and neonatal outcomes of intravenous (iv) ferric carboxymaltose (FCM) and iv iron sucrose (IS) in treating IDA in pregnancy. METHODS: The Department of Health Research funded this study. PubMed, Cochrane Library, EMBASE and Scopus were searched to include studies published till November 2022. The protocol was registered in PROSPERO (CRD42022306092). Pregnant women (15-49 yr) in second and third trimesters, diagnosed with moderate-to-severe iron deficiency anaemia, treated with either of the drugs were included. The included studies were critically assessed using appropriate tools. We conducted a qualitative synthesis of the studies and meta-analysis for improvement in haematological parameters and incidence of adverse events. RESULTS: A total of 18 studies were included. The risk of bias was low to moderate. A rise in haemoglobin up to four weeks was higher with FCM than IS by 0.57 (0.24, 0.9) g/dl. Intravenous FCM is associated with fewer adverse events than IS [pooled odds ratio: 0.5 (0.32, 0.79)]. The included studies had limited evidence on pregnancy and neonatal outcomes after iv iron treatment. INTERPRETATION CONCLUSIONS: Intravenous FCM is effective and safer than intravenous IS in terms of haematological parameters, in treating IDA in pregnancy. Further research is required on the effects of iv FCM and iv IS on the pregnancy and neonatal outcomes when used for treating IDA in pregnancy.


Assuntos
Anemia Ferropriva , Compostos Férricos , Maltose/análogos & derivados , Gravidez , Recém-Nascido , Feminino , Humanos , Óxido de Ferro Sacarado , Anemia Ferropriva/tratamento farmacológico , Resultado do Tratamento , Ferro/uso terapêutico
4.
Nutr. clín. diet. hosp ; 44(1): 180-187, Feb. 2024. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-231305

RESUMO

Objetivo: Evaluar el efecto hepatoprotector del consumo de Nostoc commune (cushuro) frente al daño inducido por dietas ricas en sacarosa en ratones. Métodos: El estudio tuvo un enfoque cuantitativo, experimental puro con grupo control y post prueba. Se utilizaron 28 ratones macho con un peso promedio de 30 ± 6,2 g y pulverizado de Nostoc commune. Los animales se dividieron en cuatro grupos y recibieron las siguientes dietas durante 50 días: Grupo I: dieta A (sacarosa 10%), grupo II: dieta B (sacarosa 36,5%), grupo III: dieta C (sacarosa 36,5% + cushuro 1%) y grupo IV: dieta D (sacarosa 36,5% + cushuro 3%). Finalmente se extrajo el hígado y se realizó los análisis bioquímicos e histológicos. El estadístico ANOVA se aplicó para los datos simétricos y para los asimétricos, Kruskall-Wallis. Resultados: En los grupos III y IV se observó que los niveles de triglicéridos (p<0.05) disminuyeron y también se observó una mejor conservación a nivel histológico. Conclusión: El consumo de Nostoc commune (cushuro) presenta efecto hepatoprotector expresado en la disminución de triglicéridos y la conservación a nivel histológico frente al daño inducido por dietas ricas en sacarosa en ratones.(AU)


Objective: To evaluate the hepatoprotective effect of theconsumption of Nostoc commune (cushuro) against the da-mage induced by diets rich in sucrose in mice. Methods: The study had a quantitative, pure experimen-tal approach with control group and post test. Twenty-eightmale mice with an average weight of 30 ± 6.2 g and sprayedwith Nostoc commune were used. The animals were dividedinto four groups and received the following diets for 50 days: Group I: diet A (sucrose 10%), group II: diet B (sucrose36.5%), group III: diet C (sucrose 36.5 % + cushuro 1%)and group IV: diet D (sucrose 36.5% + cushuro 3%). Finally,the liver was extracted and biochemical and histologicalanalyzes were performed. The ANOVA statistic was appliedfor symmetric data and Kruskall-Wallis for asymmetric data. Results: In groups III and IV it was observed that thetriglyceride levels (p<0.05) decreased and a better conserva-tion at the histological level was also observed. Conclusion: The consumption of Nostoc commune (cus-huro) has a hepatoprotective effect expressed in the reduction of triglycerides and conservation at the histological levelagainst the damage induced by diets rich in sucrose in mice.(AU)


Assuntos
Animais , Camundongos , Camundongos , Nostoc commune , Doença Hepática Induzida por Substâncias e Drogas , Óxido de Ferro Sacarado , Fígado Gorduroso , Estudos de Avaliação como Assunto , Estudos de Casos e Controles
5.
Sci Rep ; 13(1): 18919, 2023 11 02.
Artigo em Inglês | MEDLINE | ID: mdl-37919317

RESUMO

With the aging of the population, an increasing number of elderly patients are opting for artificial joint replacement, leading to the exploration of various rapid rehabilitation programs in the perioperative period. In this study, we aimed to investigate the effectiveness of combining recombinant human erythropoietin and iron sucrose in altering the range and trend of postoperative hemoglobin in patients undergoing arthroplasty. Specifically, we will examine whether this combination can effectively alter the rise and fall of postoperative haemoglobin, identify the inflection point of haemoglobin change or recovery after arthroplasty, and assess the effect of treatment on serum iron in postoperative blood. We conducted a retrospective study of 138 patients who underwent unilateral total joint arthroplasty by the same surgeon in the same hospital before July 2022. The results of this study may provide valuable insights for the development of effective rehabilitation programs for patients undergoing arthroplasty.


Assuntos
Artroplastia de Quadril , Artroplastia de Substituição , Eritropoetina , Humanos , Idoso , Óxido de Ferro Sacarado , Estudos Retrospectivos , Hemoglobinas/análise , Eritropoetina/uso terapêutico
6.
San Salvador; ISSS; oct. 2023.
Não convencional em Espanhol | BRISA/RedTESA | ID: biblio-1537775

RESUMO

ÁREA DESCRIPTIVA DEL PROBLEMA DE SALUD: Definición: La anemia y la ferropenia son dos importantes comorbilidades comunes en pacientes con Insuficiencia Cardíaca (IC) y se asocian a un mal estado clínico y a peores resultados a corto y largo plazo; la anemia y la ferropenia son de hecho, medidores de pobre pronóstico en pacientes con IC, corregir estas comorbilidades sería una diana terapéutica atractiva y novedosa para mejorar los resultados. La anemia se asocia de forma independiente con la gravedad de la IC y la mortalidad, y la deficiencia de hierro parece asociarse de forma exclusiva con una menor capacidad de ejercicio. La deficiencia de hierro suele definirse como un nivel de ferritina <100 µg /L o un nivel de 100 a 300 µg/L, si la saturación de transferrina es <20%. Se ha demostrado que la repleción intravenosa de hierro mejora la capacidad de ejercicio y la calidad de vida. Principales manifestaciones clínicas: la identificación de los síntomas es un paso clave en el diagnóstico; estos incluyen aquellos relacionados a la sobrecarga hídrica (disnea, ortopnea, edema, dolor por la congestión hepática, y discomfort abdominal asociado a la distensión por la ascitis) y aquellos secundarios a la reducción del gasto cardíaco (debilidad, fatiga) que se pronuncian más con el ejercicio.(2) En cuanto a la anemia, definida como la reducción de 1 o más componentes de la línea roja celular (concentración de hemoglobina, hematocrito, o conteo de glóbulos rojos) una concentración baja de hemoglobina o bajo hematocrito son los parámetros ampliamente usados para el diagnóstico, con los siguientes rangos. METODOLOGÍA: Se realizó una búsqueda en las principales bases de datos bibliográficas Pubmed Carboximaltosa férrica; Insuficiencia cardiaca; Deficiencia de hierro; Hierro Sacarosa; Anemia; cirugía cardiovascular. Se filtra la búsqueda a Estudios Clínicos fase 111, controlados randomizados, Revisiones Sistemáticas, Meta-análisis, Guías de Práctica Clínica, además se limitó la búsqueda estudios en humanos. También se realiza búsqueda manual en otras bases de datos bibliográficas (Cochrane, NIH, TRIP 0ATABASE), en buscadores genéricos de internet, agencias de evaluación de tecnologías sanitarias y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas, meta-análisis, estudios clínicos aleatorizados y controlados, guías de práctica clínica, evaluaciones de tecnología sanitaria, evaluaciones económicas y políticas de cobertura de otros sistemas de salud. CONCLUSIONES. Eficacia: Carboximaltosa Férrica es un medicamento propuesto para el tratamiento de pacientes con anemia por déficit de hierro, en quienes no se puede corregir esta afección con hierro oral, o se necesita hacerlo de una manera rápida; La evaluación de este efecto se ha hecho a través de ensayos clínicos controlados y aleatorizados. Estos estudios sugieren que el uso de carboximaltosa férrica puede ser eficaz para corregir la anemia secundaria por déficit de hierro, pero es importante recalcar que los estudios pivotales están hechos comparando su uso con placebo; la utilización se asocia con mejoría en la calidad de vida de estos pacientes y menos tiempo de estancia hospitalaria; sin embargo, estos mismos informes refieren que no hay disminución en la probabilidad de muerte en general para estos pacientes; es muy importante mencionar que a pesar de que la carboximaltosa férrica al momento está siendo muy estudiada para el uso de pacientes con déficit de hierro e insuficiencia cardíaca, los preparados como Hierro Sacarosa también han sido estudiados en esta patología , y faltan más investigaciones donde se comparen estos dos preparados para obtener mayor evidencia sobre el beneficio de usar uno sobre el otro; además, también hay una gran falta de estudios específicos sobre la población preoperatoria que se someterá a cirugía cardiovascular; si bien es cierto se hace un especial énfasis acerca de la importancia de identificar y corregir la anemia preoperatoria, las guías clínicas actualizadas y revisiones de la literatura no especifican a la carboximaltosa férrica como medicamento de primera línea en el manejo de los pacientes sometidos a cirugía cardiovascular. También, es de hacer notar que la mayoría de investigaciones se han realizado en poblaciones específicas que no pueden ser generalizados a otras poblaciones, así como hay heterogeneidad en los parámetros estudiados entre ellos como los valores de hemoglobina en cada estudio siendo un dato importante para esta revisión. Seguridad: De acuerdo a la revisión realizada se puede concluir que la administración de Carboximaltosa férrica es segura; La reacción adversa reportada con mayor frecuencia fue náuseas (que se produce en el 3,2% de los sujetos), seguida por reacciones en el lugar de inyección/perfusión, hipofosfatemia, cefalea, rubefacción, mareos e hipertensión. Las reacciones en el lugar de inyección/perfusión se componen de varias reacciónes adversas que de forma individual son poco frecuentes o raras. La más grave es la reacción anafiláctica (rara); se han notificado muertes con su uso; los estudios también demuestran que ambas terapias presentan reacciones similares, siendo las más comunes los trastornos de hipersensibilidad, gastrointestinales y desequilibrios hidroelectrolíticos. Aunque es cierto que la literatura describe un ligero aumento en la frecuencia de estas reacciones con Hierro Sacarosa, también se menciona que la mayoría de ellas son rápidamente reversibles y no ponen en peligro la vida de los pacientes. Costo: Para el ISSS, el uso de Carboximaltosa Férrica en pacientes con Insuficiencia Cardíaca y anemia podría considerarse una opción rentable a largo plazo. Dado que se requiere una única aplicación y menos personal y espacio hospitalario, el costo de adquisición se puede recuperar a través de la reducción de recursos de salud utilizados y la ocupación de camas hospitalarias. Aunque al comparar el costo de adquisición de este medicamento con Hierro Sacarosa, un medicamento ya disponible en la institución, se observa que, a pesar de que se necesitan dosis mayores de Hierro Sacarosa para lograr el mismo efecto, el costo total de estas dosis no supera la aplicación individual de Carboximaltosa Férrica. Conveniencia: A pesar de lo antes mencionado sobre el beneficio del uso de carboximaltosa de hierro, en pacientes con déficit de hierro e insuficiencia cardíaca; La mayoría de documentos mencionan que el hierro intravenoso podría controlar los niveles de hemoglobina en los pacientes sometidos a cirugía electiva, no está clara la repercusión del hierro intravenoso sobre los resultados (transfusiones sanguíneas, riesgo de infecciones, o supervivencia en general). En la institución se cuenta con Hierro Sacarosa, un preparado endovenoso que también se utiliza para la corrección de la anemia por déficit de hierro; las ventajas que se presentan de la carboximaltosa férrica a este preparado se centran en menor número de dosis y menor estancia hospitalaria, que se traducen en menor uso de recursos y menor tiempo cama hospitalaria; sin embargo, no hay estudios que prueben el beneficio en una rápida corrección de hemoglobina utilizando carboximaltosa férrica sobre hierro sacarosa, por lo que no es posible concluir que sea más conveniente su uso en pacientes preoperatorios que necesiten un rápido restablecimiento de estos valores.


Assuntos
Humanos , Procedimentos Cirúrgicos Cardiovasculares , Insuficiência Cardíaca Diastólica/fisiopatologia , Óxido de Ferro Sacarado/uso terapêutico , Deficiências de Ferro/tratamento farmacológico , Anemia/tratamento farmacológico , Avaliação em Saúde/economia , Eficácia
7.
Adv Ther ; 40(11): 4877-4888, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37702931

RESUMO

INTRODUCTION: Intravenous (IV) administration of iron is considered a safe and efficacious treatment for iron deficiency anemia (IDA), recommended in patients requiring rapid replenishment of iron, or intolerant or unresponsive to oral administration of iron. Recent randomized controlled trials (RCTs) have shown high incidence of hypophosphatemia after administration of two IV iron preparations: saccharated ferric oxide (SFO) and ferric carboxymaltose (FCM). The present study aimed to conduct matching-adjusted indirect comparison (MAIC) of hypophosphatemia incidence with these iron formulations and ferric derisomaltose (FDI) based on data from head-to-head RCTs conducted in Japan. METHODS: A MAIC of hypophosphatemia incidence was conducted on the basis of data from two head-to-head RCTs. The relative odds of hypophosphatemia with FDI versus SFO were obtained from patient-level data from a recent RCT and adjusted for cumulative iron dose, while parametric models of serum phosphate levels from a separate RCT were used to estimate the relative odds of hypophosphatemia with FCM with SFO. An anchored MAIC was then conducted comparing FDI with FCM. RESULTS: The adjusted odds of experiencing hypophosphatemia were significantly lower with FDI than SFO [odds ratio (OR) of 0.02; 95% confidence interval (CI) 0.01-0.05]. The parametric models of serum phosphate from the RCT comparing FCM with SFO provided an estimated OR of 1.17 for the incidence of hypophosphatemia with FCM versus SFO. Combining the two estimates in the MAIC showed that the odds of experiencing hypophosphatemia would be 52.5 (95% CI 27.7-99.4) times higher with FCM than FDI in patients with IDA associated with heavy menstrual bleeding in Japan. CONCLUSIONS: Direct comparison of patient-level data and a MAIC from two RCTs in Japanese patients with heavy menstrual bleeding indicated that hypophosphatemia is less frequent in patients treated with FDI than those with FCM or SFO. Results are in agreement with RCTs comparing FDI and FCM in patients with various etiologies conducted in the USA and Europe.


Assuntos
Anemia Ferropriva , Hipofosfatemia , Menorragia , Feminino , Humanos , Ferro/efeitos adversos , Incidência , Menorragia/tratamento farmacológico , População do Leste Asiático , Ensaios Clínicos Controlados Aleatórios como Assunto , Administração Intravenosa , Hipofosfatemia/induzido quimicamente , Hipofosfatemia/epidemiologia , Óxido de Ferro Sacarado/efeitos adversos , Anemia Ferropriva/tratamento farmacológico , Anemia Ferropriva/epidemiologia , Fosfatos
8.
Biomed Pharmacother ; 167: 115510, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37757490

RESUMO

The study evaluated the safety and effectiveness of the generic intravenous (IV) iron treatment (Feriv®), in a Spanish cohort with absolute iron deficiency (ID) (serum ferritin <50 ng/ml, with or without anaemia) (n = 122; 91% women; median age of 44 years [IQR: 33.7-54]). Iron-related biomarkers were measured before treatment (baseline), 2 weeks after beginning the protocol (intermediate control, IC) and between 7 and 10 days after treatment completion (final time-point). Primary efficacy endpoints were ferritin levels ≥ 50 ng/ml, anaemia restoration or an increase in haemoglobin (Hb) of at least one point in patients without baseline anaemia. After treatment, iron-related biomarkers improved, including ferritin, Hb, sideremia, transferrin, transferrin saturation index, soluble transferrin receptor (sTfR), and hepcidin. Baseline ferritin concentration (13.5 ng/ml [IQR: 8-24.2]) increased at the IC and continued rising at the final time-point, reaching a median ferritin of 222 ng/ml and 97.3% of patients ≥ 50 ng/ml. At the final time-point, anaemia prevalence decreased from 26.2% to 5%, while the 34.1% without baseline anaemia showed an increase in Hb of at least one point. Headache was the only drug-adverse event recorded in 2.3% of patients. At a late time-point (27.5 median weeks after ending therapy [IQR: 22-40]), evaluated in a subgroup of 66 patients, 18% had ferritin levels < 50 ng/ml. Multivariate analysis showed that low baseline ferritin and high sTfR/hepcidin ratio tended to be independently associated with ID recurrence. Feriv® is a safe, effective first-line treatment for absolute ID, with improvement of serum ferritin and Hb. ID recurrence was associated with the baseline degree of iron stores depletion, indicated by serum ferritin, and sTfR/hepcidin ratio.


Assuntos
Óxido de Ferro Sacarado , Deficiências de Ferro , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anemia Ferropriva/tratamento farmacológico , Anemia Ferropriva/etiologia , Biomarcadores/sangue , Suplementos Nutricionais , Óxido de Ferro Sacarado/administração & dosagem , Óxido de Ferro Sacarado/efeitos adversos , Ferritinas/sangue , Hemoglobinas/metabolismo , Hepcidinas/sangue , Ferro/metabolismo , Receptores da Transferrina , Transferrina , Administração Intravenosa , Deficiências de Ferro/complicações , Deficiências de Ferro/tratamento farmacológico
9.
Biomed Pharmacother ; 166: 115404, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37657262

RESUMO

Iron-carbohydrate complexes are widely used to treat iron deficiencies. Macrophages play a crucial role in the uptake and fate of these nanomedicines, however, how complexed iron carbohydrates are taken up and metabolized by macrophages is still not fully understood. Using a (phospho-)proteomics approach, we assessed differences in protein expression and phosphorylation in M2 macrophages triggered by iron sucrose (IS). Our results show that IS alters the expression of multiple receptors, indicative of a complex entry mechanism. Besides, IS induced an increase in intracellular ferritin, the loss of M2 polarization, protective mechanisms against ferroptosis, and an autophagic response. These data indicate that macrophages can use IS as a source of iron for its storage and later release, however, the excess of iron can cause oxidative stress, which can be successfully regulated by the cells. When comparing IS with ferric carboxymaltose (FCM) and iron isomaltoside-1000 (IIM), complexes with a higher carbohydrate ligand stability, we observed that FCM and IIM are metabolized at a slower rate, and trigger M2 polarization loss to a lower extent. These results indicate that the surface characteristics of the iron-carbohydrate complexes may influence the cell responses. Our data show that the application of (phospho-)proteomics can lead to a better understanding of metabolic processes, including the uptake, biodegradation and bioavailability of nanomedicines.


Assuntos
Hematínicos , Proteômica , Humanos , Óxido de Ferro Sacarado , Ferro
10.
J Vis Exp ; (197)2023 07 07.
Artigo em Inglês | MEDLINE | ID: mdl-37486118

RESUMO

Intravenously administered iron-carbohydrate nanoparticle complexes are widely used to treat iron deficiency. This class includes several structurally heterogeneous nanoparticle complexes, which exhibit varying sensitivity to the conditions required for the methodologies available to physicochemically characterize these agents. Currently, the critical quality attributes of iron-carbohydrate complexes have not been fully established. Dynamic light scattering (DLS) has emerged as a fundamental method to determine intact particle size and distribution. However, challenges still remain regarding the standardization of methodologies across laboratories, specific modifications required for individual iron-carbohydrate products, and how the size distribution can be best described. Importantly, the diluent and serial dilutions used must be standardized. The wide variance in approaches for sample preparation and data reporting limit the use of DLS for the comparison of iron-carbohydrate agents. Herein, we detail a robust and easily reproducible protocol to measure the size and size distribution of the iron-carbohydrate complex, iron sucrose, using the Z-average and polydispersity index.


Assuntos
Nanopartículas , Difusão Dinâmica da Luz , Tamanho da Partícula , Óxido de Ferro Sacarado , Nanopartículas/química , Ferro
11.
Ann Hematol ; 102(10): 2645-2650, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37432415

RESUMO

Iron deficiency anemia is the most common and preventable cause of anemia. Oral and parenteral iron preparations can be used for treatment. There are some concerns about the effect on oxidative stress of parenteral preparations. In this study, we aimed to investigate the effect of ferric carboxymaltose and iron sucrose on short- and long-term oxidant-antioxidant status. The study was designed as a prospective, single-center, observational study. Patients diagnosed with iron deficiency anemia and receiving intravenous iron therapy were included. Patients were divided into 3 groups as those receiving 1000 mg iron sucrose, 1000 mg ferric carboxymaltose, and 1500 mg ferric carboxymaltose. Blood samples were collected for blood tests before treatment, at the 1st hour of the first infusion, and at the 1st month of follow-up. The total oxidant and total antioxidant status were analyzed to evaluate oxidative stress and antioxidant status. Fifty-eight patients are included. Nineteen patients received iron sucrose 1000 mg (G1), 21 patients received ferric carboxymaltose 1000 mg (G2), and 18 patients received ferric carboxymaltose 1500 mg (G3). First hour total antioxidant status was higher in the iron sucrose group than in the ferric carboxymaltose group [G1 and G2 (p = 0.027), G1 and G3 (p = 0.004)]. At the 1st hour, total oxidant status was higher in iron sucrose group than in ferric carboxymaltose group [G1 and G2 (p = 0.016), G1 and G3 (p = 0.011)]. There was no difference in total oxidant and antioxidant stress between the three treatment groups at the 1st month evaluation [p: 0.19 and p: 0.12]. Total oxidant and antioxidant status in iron sucrose and ferric carboxymaltose formulations were found to be higher in the iron sucrose group in the acute period at the 1st hour after infusion. There was no significant difference between antioxidant and oxidant total status in all three treatment groups at the 1st month of long-term control. The fact that total oxidant status was lower in the ferric carboxymaltose group containing high-dose treatment compared to iron sucrose according to the 1st hour change showed that high-dose iron did not significantly affect oxidant stress in the short term. In addition, long-term oxidant stress evaluation at the 1st month did not show any difference between iron preparations. In conclusion, it has been shown that high-dose intravenous iron therapy, which is easier to use in clinical practice, has no effect on the oxidant-antioxidant system.


Assuntos
Anemia Ferropriva , Humanos , Óxido de Ferro Sacarado/uso terapêutico , Anemia Ferropriva/tratamento farmacológico , Antioxidantes , Oxidantes , Estudos Prospectivos , Compostos Férricos , Ferro/uso terapêutico
13.
Soins Gerontol ; 28(162): 42-46, 2023.
Artigo em Francês | MEDLINE | ID: mdl-37481291

RESUMO

The proper use and economic impact of carboxymaltose iron were evaluated for patients hospitalized in the geriatric wards of a French university hospital from November 2019 to April 2020. Martial supplementation was recommended for 75.7% of the 173 patients who received carboxymaltose iron: 43.4% had a real indication for carboxymaltose iron, while 14.4% could have received sucrose iron and 17.9% could have received per os iron. Compliance with the recommendations would have generated savings of 10,345.80 euros (32.1%).


Assuntos
Hospitais , Ferro , Humanos , Idoso , Óxido de Ferro Sacarado
14.
Nutrients ; 15(12)2023 Jun 09.
Artigo em Inglês | MEDLINE | ID: mdl-37375595

RESUMO

The association between intravenous iron substitution therapy and hypophosphatemia was previously reported in patients with iron deficiency anemia. However, the extent of hypophosphatemia is thought to depend on the type of iron supplementation. We hypothesized that the intravenous application of ferric carboxymaltose and iron sucrose leads to a different longitudinal adaptation in serum phosphate levels. In this open-label pilot study, a total of 20 patients with inflammatory bowel diseases or iron deficiency anemia were randomly assigned to one of two study groups (group 1: ferric carboxymaltose, n = 10; group 2: iron sucrose, n = 10). Serum values were controlled before iron substitution therapy, as well as 2, 4, and 12 weeks after the last drug administration. The primary objective of the study was the longitudinal evaluation of serum phosphate levels after iron substitution therapy with ferric carboxymaltose and iron sucrose. The secondary objective was the longitudinal investigation of calcium, 25-hydroxyvitamin D (25(OH)D), intact parathyroid hormone, procollagen type 1 amino-terminal propeptide (P1NP), beta-CrossLaps (CTX), hemoglobin (Hb), iron, ferritin, and transferrin saturation levels. Two weeks after drug administration, phosphate levels were significantly lower (p < 0.001) in group 1 and ferritin levels were significantly higher (p < 0.001) in group 1. Phosphate levels (0.8-1.45 mmol/L) were below the therapeutic threshold and ferritin levels (10-200 ng/mL for women and 30-300 ng/mL for men) were above the therapeutic threshold in group 1. P1NP (15-59 µg/L) and CTX (<0.57 ng/mL) levels were above the therapeutic threshold in group 2. Four weeks after drug administration, significant differences were still observed between both study groups for phosphate (p = 0.043) and ferritin (p = 0.0009). All serum values except for Hb were within the therapeutic thresholds. Twelve weeks after drug administration, no differences were observed in all serum values between both study groups. Hb values were within the therapeutic threshold in both study groups. Serum 25(OH)D levels did not differ between both study groups throughout the whole study period and remained within the therapeutic threshold.


Assuntos
Anemia Ferropriva , Hipofosfatemia , Masculino , Humanos , Feminino , Ferro/uso terapêutico , Óxido de Ferro Sacarado , Projetos Piloto , Compostos Férricos , Ferritinas , Hipofosfatemia/complicações , Hipofosfatemia/tratamento farmacológico , Fosfatos , Hemoglobinas , Remodelação Óssea
15.
Obstet Gynecol ; 141(6): 1049-1051, 2023 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-37141585

RESUMO

BACKGROUND: Iron infusions have become increasingly common in the treatment of iron-deficiency anemia during pregnancy. Although iron infusions are generally well tolerated, adverse reactions have been reported. CASE: A pregnant patient was diagnosed with rhabdomyolysis after receiving a second dose of intravenous (IV) iron sucrose at 32 6/7 weeks of gestation. On admission to the hospital, creatine kinase was 2,437 units/L, sodium was 132 mEq/L, and potassium was 2.1 mEq/L. Intravenous fluids and electrolyte repletion were administered, with improvement of symptoms within 48 hours. Creatinine kinase normalized 1 week after hospital discharge. CONCLUSION: Rhabdomyolysis can be associated with IV iron infusion during pregnancy.


Assuntos
Anemia Ferropriva , Rabdomiólise , Gravidez , Feminino , Humanos , Óxido de Ferro Sacarado , Ferro , Infusões Intravenosas , Anemia Ferropriva/tratamento farmacológico , Rabdomiólise/induzido quimicamente
16.
JPEN J Parenter Enteral Nutr ; 47(5): 670-676, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37199058

RESUMO

BACKGROUND: Iron deficiency and iron deficiency anemia are common in pediatric inflammatory bowel disease and often require supplementation with iron. There is a paucity of literature regarding optimal iron formulation. The aim of this study is to compare outcomes in pediatric patients with inflammatory bowel disease receiving either iron sucrose or ferric carboxymaltose during inpatient hospitalizations. METHODS: This was a single-center retrospective study of pediatric patients with inflammatory bowel disease admitted for newly diagnosed disease or flare who received either iron sucrose or ferric carboxymaltose. Linear regression was used to assess differences in iron repletion. Longitudinal linear mixed-effects models and generalized estimating equations compared hematologic and iron outcomes 6 months post-iron repletion. RESULTS: Thirty patients received ferric carboxymaltose. Sixty-nine patients received iron sucrose. Baseline hemoglobin and iron deficits were similar in both groups. A larger percentage of iron deficit was repleted in the ferric carboxymaltose group (81.4%) compared with iron sucrose (25.9%) (P < 0.001) with fewer infusions. Cumulative doses of ferric carboxymaltose administered (18.7 mg/kg) were higher than iron sucrose (6.1 mg/kg) (P < 0.001). Hemoglobin increased more quickly with ferric carboxymaltose compared with iron sucrose (P = 0.04 and P = 0.02, respectively). Total iron binding capacity and red cell distribution width levels decreased more over time with ferric carboxymaltose vs iron sucrose (P < 0.01 and P = 0.01, respectively). No adverse effects were seen. CONCLUSIONS: Hematologic and iron parameters responded more quickly with fewer infusions in patients who received ferric carboxymaltose vs iron sucrose. Patients who received ferric carboxymaltose achieved a higher percentage of iron deficit repleted.


Assuntos
Doenças Inflamatórias Intestinais , Ferro , Humanos , Criança , Óxido de Ferro Sacarado , Ferro/uso terapêutico , Estudos Retrospectivos , Compostos Férricos/uso terapêutico , Doenças Inflamatórias Intestinais/complicações , Hemoglobinas/metabolismo
19.
Ann Pharm Fr ; 81(5): 790-800, 2023 Sep.
Artigo em Francês | MEDLINE | ID: mdl-36963655

RESUMO

Hypophosphatemia is a recognized side effect of treatment of iron deficiency anemias with injectable iron. We analyzed 35 clinical trials that used ferric carboxymaltose (FCM) or iron sucrose (IS). Hypophosphatemia prevalence ranged from 0 to 91.7%. FCM-induced a significant (P<0.001) greater hypophosphatemia prevalence and phosphatemia decrease than IS (52.0% [95% CI: 42.2-61.8%] vs. 7.7% [95% CI: -2.8 to 18.2%] and -1.12mmol/L [95% CI: -1.36 to -0.89mmol/L] vs. -0.13mmol/L [95% CI: -0.59 to 0.32mmol/L]). FCM-induced hypophosphatemia was dose-dependent. The nadir of hypophosphatemia was reached in almost all studies after 7 and 14days. Hypophosphatemia persisted at the end of the study in 53.8% of the reported studies that used FCM and lasted up to 6months. FCM-induced an increase in intact circulating fibroblast growth factor 23 and in renal phosphorus excretion while serum 1-25 dihydroxyvitamin D was decreased. Risk factors for hypophosphatemia after FCM therapy were low basal circulating phosphate or ferritin, low body weight, high glomerular filtration rate, serum parathyroid hormone or hemoglobin and age, whereas renal insufficiency was associated with a lower risk. In conclusion, hypophosphatemia is common after treatment with injectable iron, FCM being associated with a higher risk than IS and with disorders of phosphocalcium metabolism. Monitoring of blood phosphate and 1-25 dihydroxyvitamin D could be considered during FCM therapy.


Assuntos
Hipofosfatemia , Ferro , Adulto , Humanos , Ferro/efeitos adversos , Óxido de Ferro Sacarado/efeitos adversos , Hipofosfatemia/induzido quimicamente , Hipofosfatemia/epidemiologia , Fosfatos/efeitos adversos
20.
Ren Fail ; 45(1): 2164305, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36688811

RESUMO

INTRODUCTION: It has been observed that intravenous iron administration may suppress endogenous production of erythropoietin (EPO). We postulate that this effect may be mediated by increased FGF-23 secretion. AIM OF THE STUDY: To evaluate the short-term effect of intravenous iron sucrose administration on endogenous EPO secretion in patients with chronic kidney disease (CKD). MATERIALS AND METHODS: The cohort comprised 35 nondialysis patients with CKD stages 3-5. All received 100 mg of intravenous iron (III)-hydroxide sucrose complex daily for five consecutive days. Plasma EPO, iFGF-23, cFGF-23, PTH, bone alkaline phosphatase (BAP), phosphorus (PO4), calcium (Ca), and high-sensitive C-reactive protein (CRP) were measured before, and two hours after, the first and third iron infusions, and after completing iron therapy. RESULTS: EPO concentration at the end of iron treatment was significantly lower than two hours after the first iron infusion (p = 0.0003) and before the third dose (p = 0.0006) (12.6 [10.2, 41.4] mIU/mL. vs. 30.9 [15.9, 54.2] mIU/mL and 33.4 [15.4, 56.7] mIU/mL, respectively). Conversely, plasma iFGF-23 was significantly higher before the third dose (61.1 [18.6, 420.1 4] pg/mL; p = 0.025) and after the course of treatment (92.1 [28.4, 878.1] pg/mL; p = 0.004) compared to pretreatment value (48.4 [16.2, 420] pg/mL). cFGF-23 concentration was significantly lower than baseline after the first iron dose (491.8 [257.7, 1086.3] vs. 339.2 [75.4, 951.2] RU/mL; p = 0.005) and after treatment (398.7 [90.4, 1022.3] RU/mL; p = 0.025). No significant linear correlation was found between changes in plasma EPO and FGF-23. CONCLUSIONS: Although intravenous iron therapy causes parallel increase of FGF-23 and supression of endogenous EPO, these two effects seem to be independent.


Assuntos
Eritropoetina , Insuficiência Renal Crônica , Humanos , Ferro/metabolismo , Óxido de Ferro Sacarado , Epoetina alfa
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