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1.
Medicine (Baltimore) ; 99(2): e18749, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31914095

RESUMO

A multicenter cohort study.The DialysisNet was previously developed for the management of hemodialysis (HD) patients based on the American Society for Testing and Materials Continuity of Care Records by metadata transformation. DialysisNet is a dialysis patient management program created by using the personal health record care platform to overcome the problems of registry studies, in real-time.Here, we aimed to investigate the pattern of treatment for renal anemia in HD patients using DialysisNet.We performed a multicenter cohort study among HD patients who were treated at one of the three Korean university-affiliated hospitals from January 2016 to December 2016. Subjects were divided into 4 hemoglobin variability groups by quartiles. The variable anemia treatment pattern was reviewed. To determine renal anemia treatment patterns, we automatically collected information on the practice of anemia treatment patterns such as erythropoietin stimulating agent (ESA) doses and administration frequencies, and targeted hemoglobin maintenance rate. Individual hemoglobin variabilities were expressed as (standard deviations)/(√(n/[n-1]).The records of 159 patients were analyzed (Hospital A: 35, Hospital B: 21, Hospital C: 103). Mean patients' age was 65.6 ±â€Š12.8 years, and 61.6% were men. Overall, hemoglobin level was 10.5[7.43;13.93] g/dL. 158 (99.3%) patients were using ESA; and overall, the epoetin alfa dose was 33,000[4000;136,800] U per week. Hemoglobin levels (P = .206) and epoetin alfa doses were similar (P = .924) for patients with different hemoglobin variabilities. The hemoglobin target maintenance rate was lower in the highest hemoglobin variability group than in the lowest variability group (P = .045).In this study, detailed information on the actual anemia treatment patterns were obtained using the DialysisNet. We expect that DialysisNet will simplify and improve the renal anemia management for both dialysis patients and health care providers.


Assuntos
Anemia/etiologia , Anemia/terapia , Bases de Dados Factuais , Epoetina alfa/uso terapêutico , Hematínicos/uso terapêutico , Diálise Renal/efeitos adversos , Idoso , Relação Dose-Resposta a Droga , Registros Eletrônicos de Saúde , Epoetina alfa/administração & dosagem , Feminino , Hematínicos/administração & dosagem , Hemoglobinas , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos
2.
Int J Mol Sci ; 20(16)2019 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-31394818

RESUMO

During the last decade, substantial advances have been made in the understanding of the complex molecular, immunological and cellular disturbances involved in the initiation as well as evolution of myelodysplastic syndromes (MDS). In 85% of the mainly frail and older patient population, anemia is present at the time of diagnosis and is thus a major therapeutic challenge. High rates of primary resistance to erythropoiesis-stimulating agents (ESAs), the currently only approved standard therapy to treat anemia in lower-risk MDS, demand the development of novel and efficient drugs with a good safety profile. Luspatercept, a ligand trap of activin receptor II, is able to promote late stage erythropoiesis even in patients failing prior ESA treatment. The presence of ring sideroblastic phenotype defines a subgroup of patients with higher response rates. Additionally, recent developments in clinical research using HIF-1 or telomerase modulation by roxadustat or imetelstat are promising. Other areas of translational research involve targeting the inflammasome by anti-inflammatory drugs in order to improve anemia. These efforts will hopefully pave the way for new targeted treatment options for anemic low-risk MDS patients.


Assuntos
Resistência a Medicamentos , Hematínicos/uso terapêutico , Síndromes Mielodisplásicas/tratamento farmacológico , Animais , Terapia Combinada , Gerenciamento Clínico , Hematínicos/administração & dosagem , Hematínicos/efeitos adversos , Humanos , Fatores Imunológicos/farmacologia , Fatores Imunológicos/uso terapêutico , Síndromes Mielodisplásicas/diagnóstico , Síndromes Mielodisplásicas/etiologia , Síndromes Mielodisplásicas/metabolismo , Resultado do Tratamento
3.
Life Sci ; 234: 116787, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31445028

RESUMO

Iron deficiency anemia (IDA) is a major worldwide public health problem. This is due to its prevalence among infants, children, adolescents, pregnant and reproductive age women. Ferrous sulfate (FeSO4) is the first line therapy for iron IDA. Unfortunately, it is reported that FeSO4 suffers from low absorption rate in the body and itself exhibits severe side effects. Herein, iron oxide magnetic nanoparticles-loaded liposomes (LMNPs) are prepared, characterized and evaluated as a treatment regimen for IDA in Wistar rats (as an animal model). Iron oxide magnetic nanoparticles (MNPs) are prepared and loaded into liposomes using the thin film hydration method. The size of the prepared formulations is in the range 10-100 nm, thus it can avoid the reticular endothelial system (RES), and increased their blood circulation time. For in vivo assessment, thirty-five Wistar rats are divided into 5 groups (n = 7): negative control group, positive control group, and three groups treated with different iron formulations (FeSO4, MNPs and LMNPs). Anemia is induced in the anemic groups by the bleeding method and then treatment started with different iron compounds administrated orally for 13 days. Hematological parameters are followed up during the treatment period. Results indicate that, in the LMNPs group, the hematological parameters turn to normal values and the histopathological structures of the liver, spleen and kidney remain normal. This proves that liposome increases the bioavailability of MNPs. In conclusion, LMNPs demonstrate superiority as a therapeutic regimen for the treatment of IDA among the tested iron formulations.


Assuntos
Anemia Ferropriva/tratamento farmacológico , Compostos Ferrosos/administração & dosagem , Hematínicos/administração & dosagem , Lipossomos/química , Nanopartículas de Magnetita/química , Anemia Ferropriva/sangue , Animais , Disponibilidade Biológica , Feminino , Compostos Ferrosos/farmacocinética , Compostos Ferrosos/uso terapêutico , Hematínicos/farmacocinética , Hematínicos/uso terapêutico , Hemoglobinas/análise , Lipossomos/ultraestrutura , Nanopartículas de Magnetita/ultraestrutura , Ratos Wistar
4.
Ren Fail ; 41(1): 662-672, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31296086

RESUMO

Background: Soluble transferrin receptor (sTfR) is a biomarker of erythropoiesis, which is often impaired in dialysis patients. The aim of our study was to evaluate sTfR levels in chronically dialyzed patients and assess potential determinants of its levels. Methods: We performed a cross-sectional study by evaluating 246 end-stage renal disease patients undergoing dialysis and 32 healthy controls. Circulating levels of interleukin (IL)-6, C-reactive protein (CRP), tumor necrosis factor (TNF)-α, hepcidin, sTfR, growth differentiation factor 15 (GDF15), and traditional iron metabolism markers were measured, as well as hemogram parameters. Clinical data was obtained from all patients. Results: Compared to controls, patients presented similar values of sTfR, reticulocytes and reticulocyte production index (RPI), and significantly higher levels of IL-6, CRP, ferritin, hepcidin, TNF-α, and GDF15. Iron, transferrin, hemoglobin levels, erythrocyte count, mean cell hemoglobin (MCH), and mean cell hemoglobin concentration (MCHC) values were significantly lower in dialysis group. Within patients, sTfR values were higher in diabetic patients and were positively and significantly correlated with reticulocytes and erythrocytes, RPI, and therapeutic doses of erythropoiesis stimulating agents (ESA) and intravenous iron; and inversely and significantly correlated with circulating iron, ferritin, transferrin saturation, hepcidin, MCH, and MCHC. In multiple linear regression analysis, ESA dose, RPI, serum iron, diabetes, and hepcidin levels were independently associated with sTfR levels in dialysis patients and, thus, with erythropoiesis. Conclusion: Our data suggest that, besides RPI and ESA dose, diabetes and hepcidin are closely related to erythropoiesis in dialysis patients. The influence of diabetes on sTfR levels deserves further investigation.


Assuntos
Anemia Ferropriva/sangue , Diabetes Mellitus/epidemiologia , Hepcidinas/sangue , Falência Renal Crônica/sangue , Receptores da Transferrina/sangue , Diálise Renal , Idoso , Anemia Ferropriva/terapia , Biomarcadores/sangue , Estudos de Casos e Controles , Estudos Transversais , Eritropoese/fisiologia , Eritropoetina/uso terapêutico , Feminino , Hematínicos/administração & dosagem , Humanos , Ferro/sangue , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Transferrina/análise
5.
Metas enferm ; 22(6): 28-32, jul. 2019. tab
Artigo em Espanhol | IBECS | ID: ibc-184045

RESUMO

Objetivo: conocer los problemas en salud que presentan estos pacientes a los 10 años de haber recibido un trasplante alogénico de progenitores hematopoyéticos (alo-TPH). Método: estudio descriptivo transversal de aquellos pacientes pediátricos (0 a 18 años) que recibieron un alo-TPH durante el periodo 2006-2007 en la unidad de trasplante de progenitores hematopoyéticos del Hospital Universitario Vall d'Hebron (Barcelona). Los datos clínicos se recogieron a través de las historias clínicas. Se realizó estadística descriptiva. Resultados: la muestra fue de 28 pacientes con una media de edad de 16 años y rango de edad de 11 a 26 años. Hubo la misma proporción de hombres y mujeres, un 50% (n= 14). El 96,5% (n= 27) vive con sus padres, el 92,8% (n=20) es estudiante. Las principales complicaciones fueron las endocrinas con un 53,5% (n= 15), seguidas de un 28,5% (n= 8) de problemas circulatorios. Un 57% (n= 16) presentó alteraciones en la piel, musculoesqueléticas y enfermedades no malignas, principalmente anemias hemolíticas. En la muestra de estudio únicamente tres (10,7%) casos sufrieron enfermedad injerto contra huésped. Conclusión: la identificación de los problemas de salud más prevalentes en los alo-TPH (endocrinas, circulatorias, piel, musculoesqueléticas) permitirá diseñar recomendaciones específicas a estos pacientes y sus familias para minimizar los riesgos y mejorar el manejo de las mismas


Objective: to understand the health problems presented by these patients 10 years after receiving an allogeneic stem cell transplant (allo-SCT). Method: a descriptive cross-sectional study of those pediatric patients (from 0 to 18-year-old) who received an allo-SCT during the 2006-2007 period at the Stem Cell Transplant Unit of the Hospital Universitario Vall d'Hebron (Barcelona). Clinical data were collected through clinical records. Descriptive statistics was conducted. Results: the sample included 28 patients with 16 years as mean age, and an age range from 11 to 26-year-old. There was an equal proportion of men and women: 50% (n= 14); 96.5% (n= 27) lived with their parents, and 92.8% (n=20) were students. The main complications were endocrinological, with 53.5% (n= 15), followed by circulatory problems with 28.5% (n= 8); 57% (n= 16) presented skin alterations, musculoskeletal alterations, and non-malignant conditions, mainly hemolytic anemia. Only 3 cases (10.7%) from the sample suffered graft versus host disease. Conclusion: the detection of the most prevalent health conditions in allo-SCT (endocrinological, circulatory, skin, and musculoskeletal) will allow to design specific recommendations for these patients and their families, in order to minimize risks and improve their management


Assuntos
Humanos , Masculino , Feminino , Recém-Nascido , Lactente , Pré-Escolar , Criança , Adolescente , Adulto Jovem , Adulto , Transplante Homólogo/métodos , Hematínicos/administração & dosagem , Transplante Homólogo/efeitos adversos , Estudos Transversais , Epidemiologia Descritiva
6.
Trials ; 20(1): 194, 2019 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-30947751

RESUMO

BACKGROUND: Intravenous (IV) iron is frequently used to treat iron deficiency/anemia in patients who are unable to tolerate oral iron or the oral iron is not sufficient toreplete iron requirements. However, safety concerns regarding the potential increase in oxidative stress and other adverse effects persist and it remains unclear whether all iron preparations are equivalent. Indeed, the comparative risk of adverse events with IV iron preparations has not been extensively assessed. We hypothesize that IV iron leads to changes in oxidative stress, endothelial function, and potential renal damage depending on the iron formulation (related to the generation of "free" or catalytic labile iron) and this may result in more tubular and glomerular injury manifested as increased proteinuria and raised neutrophil gelatinase-associated lipocalin (NGAL) levels in patients with chronic kidney disease (CKD). METHODS: IRON-CKD is a prospective, open-label, explorative, randomized, single-center study designed to compare the safety and efficacy of three parenteral iron preparations: low-molecular-weight iron dextran-Cosmofer, iron sucrose-Venofer, and iron isomaltoside-Monofer. The study includes 40 adults who have established CKD stages 3-5 and serum ferritin (SF) of less than 200 µg/L or transferrin saturation (TS) of less than 20% (or both); they were randomly assigned in a 1:1:1:1 ratio to 200 mg iron dextran, 200 mg iron sucrose, 200 mg iron isomaltoside, or 1000 mg iron isomaltoside. After randomization, participants undergo baseline assessments and then an iron infusion. Each participant is followed up at 2 h, day 1, week 1, and months 1 and 3. At each follow-up visit, patients undergo clinical review, measurement of pulse wave velocity (PWV), blood tests for renal function, and collection of serum/plasma samples for oxidative stress and inflammatory markers. The primary outcomes are measures of oxidative stress, inflammatory markers, and markers of acute renal injury in comparison with baseline measures of each iron preparation and between each of the iron preparations. Secondary objectives include effects on hematinic profiles and hemoglobin concentrations, changes in arterial stiffness, incidence of significant side effects, and change in patients' quality of life. RESULTS: Between October 2015 and April 2018, 521 individuals were identified as potential participants; 216 were contacted, 56 expressed an interest, 49 attended a screening visit, and 40 were confirmed to meet the eligibility criteria and were randomly assigned. The mean age was 58.3 (standard error of the mean 4.4) years, and 23 (58%) were male. All patients were white and English-speaking. The mean SF was 66.6 µg/L, TS was 21.2%, and hemoglobin was 121.6 g/L at randomization for the whole group. The mean estimated glomerular filtration rate was 27.8 mL/min, the urinary protein/creatinine ratio was 104.3 mg/mmol, and CRP was 6.65 mg/L. DISCUSSION: IRON-CKD will provide important information on the short-term effects of three preparations of IV iron in CKD patients with biochemical functional or absolute iron deficiency on measures of oxidative stress, inflammation, endothelial function, and renal injury. TRIAL REGISTRATION: European Clinical Trials Database (EudraCT) number 2010-020452-64 .


Assuntos
Lesão Renal Aguda/induzido quimicamente , Anemia Ferropriva/tratamento farmacológico , Dissacarídeos/administração & dosagem , Compostos Férricos/administração & dosagem , Óxido de Ferro Sacarado/administração & dosagem , Hematínicos/efeitos adversos , Complexo Ferro-Dextran/administração & dosagem , Rim/efeitos dos fármacos , Estresse Oxidativo/efeitos dos fármacos , Insuficiência Renal Crônica/complicações , Lesão Renal Aguda/sangue , Lesão Renal Aguda/diagnóstico , Lesão Renal Aguda/urina , Anemia Ferropriva/sangue , Anemia Ferropriva/complicações , Anemia Ferropriva/diagnóstico , Biomarcadores/sangue , Biomarcadores/urina , Dissacarídeos/efeitos adversos , Inglaterra , Feminino , Compostos Férricos/efeitos adversos , Óxido de Ferro Sacarado/efeitos adversos , Hematínicos/administração & dosagem , Hemoglobinas/metabolismo , Humanos , Mediadores da Inflamação/sangue , Infusões Intravenosas , Complexo Ferro-Dextran/efeitos adversos , Rim/metabolismo , Rim/patologia , Lipocalina-2/urina , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Proteinúria/induzido quimicamente , Proteinúria/urina , Ensaios Clínicos Controlados Aleatórios como Assunto , Insuficiência Renal Crônica/sangue , Insuficiência Renal Crônica/diagnóstico , Fatores de Tempo , Resultado do Tratamento
7.
Contrib Nephrol ; 198: 135-143, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30991408

RESUMO

The results of previous large clinical trials have revealed that low hemoglobin (Hb) levels are significantly associated with adverse events (cardiovascular disease, infection, hospitalization, and mortality) in patients with chronic kidney disease (CKD). However, in the general population, the mean Hb levels differ by sex and age. Furthermore, the comorbidities and activities of daily living of elderly patients are markedly different from those of nonelderly patients. CKD in elderly patients is accompanied by not only chronic inflammation, which is more severe than that in nonelderly patients, but also changes in the secretion of sex hormones with aging and decreases in erythropoiesis in the bone marrow. Thus, it is presumed that compared with nonelderly CKD patients, elderly CKD patients are hyporesponsive to erythropoiesis-stimulating agents (ESAs) and show the dysutilization of iron for erythropoiesis. However, in these patients, the target Hb levels and the appropriate doses of ESA and iron preparations are not indicated clearly. Recent clinical trials have reported that higher Hb levels, the same as those in nonelderly CKD patients, might not necessarily improve the quality of life or survival of elderly CKD patients. We have also revealed that hyporesponsiveness to ESAs and higher doses of intravenous iron affect the adverse events occurring in elderly patients undergoing maintenance hemodialysis compared with nonelderly CKD patients. Therefore, before the administration of ESAs and iron preparations to elderly CKD patients, the pathophysiological characteristics of these patients should be considered.


Assuntos
Anemia/tratamento farmacológico , Insuficiência Renal Crônica/fisiopatologia , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Envelhecimento , Anemia/etiologia , Anemia/fisiopatologia , Gerenciamento Clínico , Feminino , Hematínicos/administração & dosagem , Humanos , Ferro/administração & dosagem , Masculino , Qualidade de Vida , Insuficiência Renal Crônica/complicações
8.
J Obstet Gynaecol Res ; 45(4): 858-864, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30932300

RESUMO

AIM: To compare ferric carboxymaltose (FCM) with iron sucrose (IS) for the effective and timely treatment of preoperative iron deficiency anemia (IDA) in women with menorrhagia. METHODS: This open-label, multicenter, two-arm study randomized patients to receive either a single dose of FCM or multiple doses of IS. The primary endpoint was the proportion of patients who achieved hemoglobin (Hb) levels ≥10 g/dL within 2 weeks after the first administration. Secondary endpoints included mean Hb levels, time to reach Hb ≥10 g/dL and quality of life (QoL). RESULTS: In total, 101 patients (FCM n = 52; IS n = 49) were randomized to the study treatments. FCM was as effective as IS in achieving Hb ≥10 g/dL within 2 weeks after the first administration (78.8% vs 72.3%). The time to reach Hb ≥10 g/dL was significantly shorter in the FCM group than in the IS group (7.7 days vs 10.5 days). Mean Hb levels were higher in the FCM-treated patients than in the IS-treated patients with borderline significance. QoL scores did not differ between the two groups. CONCLUSION: Ferric carboxymaltose is as effective as IS in correcting preoperative IDA among patients with menorrhagia. The added benefits of FCM over IS included significant rapid correction of IDA, replenishment of iron stores and reduced hospital visits.


Assuntos
Anemia Ferropriva/tratamento farmacológico , Compostos Férricos/farmacologia , Óxido de Ferro Sacarado/farmacologia , Hematínicos/farmacologia , Hemoglobinas , Maltose/análogos & derivados , Menorragia/cirurgia , Adulto , Feminino , Compostos Férricos/administração & dosagem , Óxido de Ferro Sacarado/administração & dosagem , Hematínicos/administração & dosagem , Humanos , Maltose/administração & dosagem , Maltose/farmacologia , Menorragia/sangue , Pessoa de Meia-Idade , Adulto Jovem
9.
J Med Econ ; 22(8): 736-741, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30915883

RESUMO

Objectives: There is a lack of data in Panama on the potential differences in total healthcare professional (HCP) time between routine administrations of short-acting erythropoietin simulating agents (ESAs) (i.e. epoetin alfa) and continuous erythropoietin receptor activator (CERA) (i.e. methoxy polyethylene glycol-epoetin beta). This study aimed to quantify the HCP time associated with a single administration of epoetin alfa and CERA for the treatment of anemic patients with chronic kidney disease (CKD) on hemodialysis. Methods: This was a multi-center, cross-sectional study, using a time-and-motion methodology. Costs related to HCP time and consumables usage associated with administration of epoetin alfa and CERA were estimated. Results: Based on 60 administrations of either CERA or epoetin alfa, the estimated savings in mean total active HCP time were 2.34 (95% confidence interval = 1.87-2.81) min (-30%) per administration. When extrapolating to a full year's treatment with intravenous ESA, it would require a total of 20.3 (95% CI = 19.90-20.71) h of HCP time for epoetin alfa vs 1.1 (95% CI = 1.01-1.19) h for CERA per patient per year. Estimated savings in active HCP time per patient per year were 19.20 (95% CI = 19.20-19.21) h (-95%). This, in turn, translates into staff cost efficiency that favors Mircera with an estimated annual saving of $78.24 (95% CI = 78.24-78.28) (-95%) per patient. Conclusions: Data from a real-world setting showed that the adoption of CERA could potentially lead to a reduction in active HCP time. Highlights Few comparative data have explored the costs and potential savings of using long-acting erythropoietin-stimulating agents (ESA) instead of short-acting ESAs to treat anemia in CKD patients on hemodialysis. This time-and-motion study shows that use of CERA reduces total healthcare professional time and could represent a save for an institution in a real-world setting in Panama.


Assuntos
Epoetina alfa/economia , Eritropoetina/economia , Pessoal de Saúde/economia , Hematínicos/economia , Polietilenoglicóis/economia , Anemia/tratamento farmacológico , Anemia/etiologia , Estudos Transversais , Custos de Medicamentos , Epoetina alfa/administração & dosagem , Eritropoetina/administração & dosagem , Feminino , Pessoal de Saúde/estatística & dados numéricos , Hematínicos/administração & dosagem , Humanos , Masculino , Panamá , Polietilenoglicóis/administração & dosagem , Diálise Renal/efeitos adversos , Insuficiência Renal Crônica/terapia , Fatores de Tempo
11.
Crit Rev Oncol Hematol ; 136: 37-47, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30878127

RESUMO

Anemic patients with lower risk myelodysplastic syndromes are frequently treated with erythropoiesis stimulating agents (ESA), eventually in combination with granulocyte colony stimulating factor (G-CSF). However, the evidence for the efficacy of a combined treatment remains controversial. The goal of our analysis was to assess the available evidence for a combined treatment. We performed a systematic review and identified only nine eligible studies. In two randomized controlled trials (n = 98), erythroid response rates were 33% and 40% after low-/standard-doses of ESA alone (10,000-30,000 rHuEPO equivalents/week) versus 65% and 73% after combination treatment. In seven trials with sequential drug administration (n = 393), erythroid response rates ranged from 12% to 71% after full-doses of ESA alone (60,000-80,000 rHuEPO equivalents/week) and from 35% to 74% after combination therapy. Our analysis supports an additional efficacy of G-CSF added to low-/standard-dose ESA, but the available data remains controversial, if G-CSF is added to full-dose ESA.


Assuntos
Anemia/tratamento farmacológico , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Hematínicos/administração & dosagem , Síndromes Mielodisplásicas/tratamento farmacológico , Anemia/epidemiologia , Anemia/etiologia , Sinergismo Farmacológico , Quimioterapia Combinada , Eritropoetina/administração & dosagem , Humanos , Síndromes Mielodisplásicas/complicações , Síndromes Mielodisplásicas/epidemiologia , Síndromes Mielodisplásicas/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Proteínas Recombinantes/administração & dosagem , Resultado do Tratamento
12.
Perit Dial Int ; 39(2): 192-195, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30858290

RESUMO

Safety of parenteral iron therapy is critical and has been demonstrated in several studies, but concerns persist on safety. We performed a retrospective single-center study investigating the safety and efficacy of parenteral iron administration using 2 iron preparations-Monofer and Cosmofer (Pharmacosmos A/S, Holbaek, Denmark)-in patients with chronic kidney disease (CKD), on peritoneal dialysis (PD) and non-dialysis. A database of CKD patients receiving intravenous (IV) iron was analyzed. Side effects were recorded during infusion, post-infusion, and after 48 hours. In a population of CKD patients (non-dialysis and PD), IV iron is safe with few major adverse effects for these 2 IV iron preparations studied with similar dosing schedules. These data provide reassurance on the relative short-term safety of IV iron preparations regarding acute infusion-related hypersensitivity reactions.


Assuntos
Dissacarídeos/administração & dosagem , Compostos Férricos/administração & dosagem , Hematínicos/administração & dosagem , Complexo Ferro-Dextran/administração & dosagem , Diálise Peritoneal , Insuficiência Renal Crônica/terapia , Dissacarídeos/efeitos adversos , Compostos Férricos/efeitos adversos , Hematínicos/efeitos adversos , Humanos , Infusões Intravenosas , Complexo Ferro-Dextran/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento
13.
Int Heart J ; 60(2): 255-263, 2019 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-30799375

RESUMO

Previous clinical studies have shown inconsistent results regarding the effect of erythropoietin in ST-segment elevation myocardial infarction (STEMI). This study investigated whether directed intracoronary infusion of darbepoetin-α into ischemic myocardium before reperfusion would reduce infarct size or post-infarct remodeling in STEMI patients.Eighty STEMI patients received one of the following treatments simultaneously with the first balloon inflation: intracoronary darbepoetin-α 300 µg (n = 40) or saline (n = 40), administered via the over-the-wire balloon system. The primary endpoint was infarct size estimated by serial cardiac enzyme levels after procedure. The secondary endpoints were (1) infarct size and proportion of salvaged myocardium measured with cardiac magnetic resonance (CMR) at baseline; (2) post-infarct remodeling (PIR), defined as an increase in left ventricular end-diastolic volume more than 20% at 4 months compared to the baseline on CMR; and (3) composite cardiovascular endpoints assessed at 4 months.The peak CK-MB [median 270.0 (interquartile range 139.8-356.3) versus 231.5 (131.0-408.5) ng/mL, P = 0.55] and troponin-I [128.5 (63.5-227.8) versus 109.0 (43.8-220.0) ng/mL, P = 0.52) ] did not differ between the darbepoetin-α and control group. Fifty-seven patients completed the baseline and 4-month follow-up CMR. There were no differences in infarct size [30.6 (18.1-49.8) versus 31.5 (22.5-47.3) cm3, P = 0.91), proportion of salvaged myocardium [26.7% (15.9-42.6%) versus 35.8% (22.4-48.8%), P = 0.12) or PIR (8.0% versus 6.7%, P = 0.62) between the two groups. Composite cardiovascular outcomes did not differ between the two groups.In conclusion, administration of intracoronary darbepoetin-α before reperfusion did not reduce infarct size or post-infarct remodeling in STEMI patients.


Assuntos
Angioplastia Coronária com Balão/métodos , Darbepoetina alfa , Miocárdio/patologia , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Remodelação Ventricular/efeitos dos fármacos , Idoso , Vasos Coronários , Darbepoetina alfa/administração & dosagem , Darbepoetina alfa/efeitos adversos , Monitoramento de Medicamentos/métodos , Feminino , Hematínicos/administração & dosagem , Hematínicos/efeitos adversos , Humanos , Infusões Intra-Arteriais , Imagem Cinética por Ressonância Magnética/métodos , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Volume Sistólico/efeitos dos fármacos , Resultado do Tratamento
14.
Cochrane Database Syst Rev ; 2: CD004868, 2019 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-30776084

RESUMO

BACKGROUND: Preterm infants have low plasma levels of erythropoietin (EPO), providing a rationale for the use of erythropoiesis-stimulating agents (ESAs) to prevent or treat anaemia. Darbepoetin (Darbe) and EPO are currently available ESAs. OBJECTIVES: To assess the effectiveness and safety of late initiation of ESAs, between eight and 28 days after birth, in reducing the use of red blood cell (RBC) transfusions in preterm or low birth weight infants. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 5), MEDLINE via PubMed (1966 to 5 June 2018), Embase (1980 to 5 June 2018), and CINAHL (1982 to 5 June 2018). We searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials of late initiation of EPO treatment (started at ≥ eight days of age) versus placebo or no intervention in preterm (< 37 weeks) or low birth weight (< 2500 grams) neonates. DATA COLLECTION AND ANALYSIS: We performed data collection and analyses in accordance with the methods of the Cochrane Neonatal Review Group. We used the GRADE approach to assess the quality of the evidence. MAIN RESULTS: We include 31 studies (32 comparisons) randomising 1651 preterm infants. Literature searches in 2018 identified one new study for inclusion. No new on-going trials were identified and no studies used darbepoetin.Most included trials were of small sample size. The meta-analysis showed a significant effect on the use of one or more RBC transfusions (21 studies (n = 1202); typical risk ratio (RR) 0.72, 95% confidence interval (CI) 0.65 to 0.79; typical risk difference (RD) -0.17, 95% CI -0.22 to -0.12; typical number needed to treat for an additional beneficial outcome (NNTB) 6, 95% CI 5 to 8). There was moderate heterogeneity for this outcome (RR I² = 66%; RD I² = 58%). The quality of the evidence was very low. We obtained similar results in secondary analyses based on different combinations of high/low doses of EPO and iron supplementation. There was no significant reduction in the total volume (mL/kg) of blood transfused per infant (typical mean difference (MD) -1.6 mL/kg, 95% CI -5.8 to 2.6); 5 studies, 197 infants). There was high heterogeneity for this outcome (I² = 92%). There was a significant reduction in the number of transfusions per infant (11 studies enrolling 817 infants; typical MD -0.22, 95% CI -0.38 to -0.06). There was high heterogeneity for this outcome (I² = 94%).Three studies including 404 infants reported on retinopathy of prematurity (ROP) (all stages or stage not reported), with a typical RR 1.27 (95% CI 0.99 to 1.64) and a typical RD of 0.09 (95% CI -0.00 to 0.18). There was high heterogeneity for this outcome for both RR (I² = 83%) and RD (I² = 82%). The quality of the evidence was very low.Three trials enrolling 442 infants reported on ROP (stage ≥ 3). The typical RR was 1.73 (95% CI 0.92 to 3.24) and the typical RD was 0.05 (95% CI -0.01 to 0.10). There was no heterogeneity for this outcome for RR (I² = 18%) but high heterogeneity for RD (I² = 79%). The quality of the evidence was very low.There were no significant differences in other clinical outcomes including mortality and necrotising enterocolitis. For the outcomes of mortality and necrotising enterocolitis, the quality of the evidence was moderate. Long-term neurodevelopmental outcomes were not reported. AUTHORS' CONCLUSIONS: Late administration of EPO reduces the use of one or more RBC transfusions, the number of RBC transfusions per infant (< 1 transfusion per infant) but not the total volume (mL/kg) of RBCs transfused per infant. Any donor exposure is likely not avoided as most studies included infants who had received RBC transfusions prior to trial entry. Late EPO does not significantly reduce or increase any clinically important adverse outcomes except for a trend in increased risk for ROP. Further research of the use of late EPO treatment, to prevent donor exposure, is not indicated. Research efforts should focus on limiting donor exposure during the first few days of life in sick neonates, when RBC requirements are most likely to be required and cannot be prevented by late EPO treatment. The use of satellite packs (dividing one unit of donor blood into many smaller aliquots) may reduce donor exposure.


Assuntos
Anemia Neonatal/prevenção & controle , Transfusão de Eritrócitos/estatística & dados numéricos , Eritropoetina/administração & dosagem , Hematínicos/administração & dosagem , Recém-Nascido de Baixo Peso/sangue , Recém-Nascido Prematuro/sangue , Fatores Etários , Displasia Broncopulmonar/etiologia , Causas de Morte , Esquema de Medicação , Eritropoetina/sangue , Mortalidade Hospitalar , Humanos , Recém-Nascido , Ensaios Clínicos Controlados Aleatórios como Assunto , Retinopatia da Prematuridade/etiologia , Fatores de Tempo
15.
PLoS One ; 14(2): e0212795, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30794672

RESUMO

BACKGROUND: Anemia is a major comorbidity of patients with end-stage renal disease and poses an enormous economic burden to health-care systems. High dose erythropoiesis-stimulating agents (ESAs) have been associated with unfavorable clinical outcomes. We explored whether mixed-dilution hemodiafiltration (Mixed-HDF), based on its innovative substitution modality, may improve anemia outcomes compared to the traditional post-dilution hemodiafiltration (Post-HDF). METHODS: We included 174 adult prevalent dialysis patients (87 on Mixed-HDF, 87 on Post-HDF) treated in 24 NephroCare dialysis centers between January 2010 and August 2016 into this retrospective cohort study. All patients were dialyzed three times per week and had fistula/graft as vascular access. Patients were matched at baseline and followed over a one-year period. The courses of hemoglobin levels (Hb) and monthly ESA consumption were compared between the two groups with linear mixed models. RESULTS: Mean baseline Hb was 11.9±1.3 and 11.8±1.1g/dl in patients on Mixed- and Post-HDF, respectively. While Hb remained stable in patients on Mixed-HDF, it decreased slightly in patients on Post-HDF (at month 12: 11.8±1.2 vs 11.1±1.2g/dl). This tendency was confirmed by our linear mixed model (p = 0.0514 for treatment x time interaction). Baseline median ESA consumption was 6000 [Q1:0;Q3:16000] IU/4 weeks in both groups. Throughout the observation period ESA doses tended to be lower in the Mixed-HDF group (4000 [Q1:0;Q3:16000] vs 8000 [Q1:0;Q3:20000] IU/4 weeks at month 12; p = 0.0791 for treatment x time interaction). Sensitivity analyses, adjusting for differences not covered by matching at baseline, strengthened our results (Hb: p = 0.0124; ESA: p = 0.0687). CONCLUSIONS: Results of our explorative study suggest that patients on Mixed-HDF may have clinical benefits in terms of anemia management. This may also have a beneficial economic impact. Future studies are needed to confirm our hypothesis-generating results and to provide additional evidence on the potential beneficial effects of Mixed-HDF.


Assuntos
Anemia , Hematínicos/administração & dosagem , Hemodiafiltração , Falência Renal Crônica , Modelos Biológicos , Adulto , Idoso , Anemia/sangue , Anemia/complicações , Anemia/terapia , Feminino , Seguimentos , Hemoglobinas/metabolismo , Humanos , Falência Renal Crônica/sangue , Falência Renal Crônica/complicações , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
17.
BMC Pregnancy Childbirth ; 19(1): 54, 2019 Feb 04.
Artigo em Inglês | MEDLINE | ID: mdl-30717690

RESUMO

BACKGROUND: To evaluate the efficacy and safety of intravenous Ferric Carboxymaltose. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy. METHODS: A randomized clinical trial was conducted from (January 2016-August 2017). at a tertiary hospital. Pregnant women diagnosed with moderate to severe iron deficiency anaemia were screened for the study. One hundred patients were randomized to receive either intravenous FCM or ISC. Primary outcome was rise in hemoglobin (Hb) from baseline after 12 weeks. Secondary outcomes were change in RBC indices, serum iron studies, improvement in fatigue scores, number of visits and perinatal outcome. RESULTS: Mean rise in Hb at 12 weeks was significantly higher in FCM group (29 g/L vs 22 g/L; p value < 0.01). FCM was associated with greater improvement in fatigue scores. Number of visits were significantly less in FCM group. No serious adverse events were noted in either group. CONCLUSION: Treatment with FCM resulted in rapid replenishment of iron stores in pregnant women with significantly higher Hb rise over a 12 week period. The convenient dosing with lesser number of total doses to complete the treatment will lead to better compliance in community setting. CLINICAL TRIAL REGISTRATION ( WWW.CTRI.NIC.IN ): CTRI/2015/09/006224. Registered on 21/07/2017 (Trial registered retrospectively).


Assuntos
Anemia Ferropriva/tratamento farmacológico , Compostos Férricos/administração & dosagem , Óxido de Ferro Sacarado/administração & dosagem , Hematínicos/administração & dosagem , Maltose/análogos & derivados , Complicações na Gravidez/tratamento farmacológico , Administração Intravenosa , Adulto , Anemia Ferropriva/sangue , Contagem de Eritrócitos , Feminino , Hemoglobinas/metabolismo , Humanos , Índia , Ferro/sangue , Maltose/administração & dosagem , Gravidez , Complicações na Gravidez/sangue , Cuidado Pré-Natal/métodos , Resultado do Tratamento , Adulto Jovem
18.
Anesth Analg ; 128(5): 981-992, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30649068

RESUMO

BACKGROUND: Erythropoietic-stimulating agents such as erythropoietin have been used as part of patient blood management programs to reduce or even avoid the use of allogeneic blood transfusions. We review the literature to evaluate the effect of preoperative erythropoietin use on the risk of exposure to perioperative allogeneic blood transfusions. METHODS: The study involved a systematic review and meta-analysis of randomized controlled trials evaluating the use of preoperative erythropoietin. The primary outcome was the reported incidence of allogeneic red blood cell transfusions during inpatient hospitalizations. Secondary outcomes included phase-specific allogeneic red blood cell transfusions (ie, intraoperative, postoperative), intraoperative estimated blood loss, perioperative hemoglobin levels, length of stay, and thromboembolic events. RESULTS: A total of 32 randomized controlled trials (n = 4750 patients) were included, comparing preoperative erythropoietin (n = 2482 patients) to placebo (n = 2268 patients). Preoperative erythropoietin is associated with a significant decrease in incidence of allogeneic blood transfusions among all patients (n = 28 studies; risk ratio, 0.59; 95% CI, 0.47-0.73; P < .001) as well as patients undergoing cardiac (n = 9 studies; risk ratio, 0.55; 95% CI, 0.37-0.81; P = .003) and elective orthopedic (n = 5 studies; risk ratio, 0.36; 95% CI, 0.28-0.46; P < .001) surgery compared to placebo, respectively. Preoperative erythropoietin was also associated with fewer phase-specific red blood cell transfusions. There was no difference between groups in incidence of thromboembolic events (n = 28 studies; risk ratio, 1.02; 95% CI, 0.78-1.33; P = .68). CONCLUSIONS: Preoperative erythropoietin is associated with a significant reduction in perioperative allogeneic blood transfusions. This finding is also confirmed among the subset of patients undergoing cardiac and orthopedic surgery. Furthermore, our study demonstrates no significant increase in risk of thromboembolic complications with preoperative erythropoietin administration.


Assuntos
Perda Sanguínea Cirúrgica , Transfusão de Sangue/estatística & dados numéricos , Transfusão de Eritrócitos/estatística & dados numéricos , Eritropoetina/administração & dosagem , Hematínicos/administração & dosagem , Transplante de Células-Tronco Hematopoéticas , Hemoglobinas/análise , Hospitalização , Humanos , Pacientes Internados , Período Pré-Operatório , Risco , Sensibilidade e Especificidade , Tromboembolia/terapia , Transplante Homólogo , Resultado do Tratamento
19.
PLoS One ; 14(1): e0210086, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30615646

RESUMO

INTRODUCTION: Nutritional anemia is a major public health problem throughout the world, particularly in developing countries. Iron with folic acid supplementation (IFAS) is recommended to mitigate anemia and its resulting complications during pregnancy. There has been limited study on IFAS adherence of pregnant women in the study area. The aim of this study was to assess adherence to IFAS and its associated factors among pregnant women attending antenatal care service in Debre Tabor General Hospital, Ethiopia. METHODS: An institution-based cross-sectional study was conducted from January 9 to April 8, 2017, at Debre Tabor General Hospital. A total of 262 study participants were included and selected by systematic random sampling. The entire interviewed questionnaire was checked and entered into EpiData version 3.1 and then exported to SPSS version 20 for windows for analysis. IFAS adherence status was defined as, if pregnant mothers took 65% or more of the IFAS which is equivalent to taking IFAS at least 4 days a week during the 1-month period preceding the study. Regressions were fitted to identify independent predictors of IFAS adherence. A P-value of less than 0.05 was used to declare statistical significance. RESULTS: A total of 241 pregnant women were included (92% response rate), of which 107 (44%) were adherent to IFAS. Only 39% received IFAS counseling, and 52% had some knowledge of IFAS. Gravidity (AOR = 2.92 95% CI (1.61, 5.30)), gestational age at first ANC visit (AOR = 3.67, 95% CI (1.94, 6.97)), pregnant women who got advice about IFAS (AOR = 2.04, 95%CI (1.12, 3.75)), current anemia (AOR = 2.22, 95%CI (1.45, 4.29)), and had knowledge about IFAS (AOR = 3.27, 95% CI (1.80, 5.95)) were statistically associated with adherence to IFAS among pregnant women. CONCLUSION: Overall, IFAS adherence among pregnant women was low. The associated factors with adherence of IFAS were counseling and knowledge, early ANC attendance, pregnancy history, and current anemia diagnosis. IFAS counseling by health workers was low but, when given, was associated with improved IFAS adherence. Health workers and health extension workers should consistently counsel on IFAS benefits during ANC visit, to improve IFAS adherence during the current and subsequent pregnancies.


Assuntos
Anemia Ferropriva/prevenção & controle , Suplementos Nutricionais , Hematínicos/administração & dosagem , Adesão à Medicação/estatística & dados numéricos , Complicações na Gravidez/prevenção & controle , Adolescente , Adulto , Estudos Transversais , Etiópia , Feminino , Ácido Fólico/administração & dosagem , Seguimentos , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Ferro/administração & dosagem , Estado Nutricional , Gravidez , Gestantes/psicologia , Adulto Jovem
20.
Int Urol Nephrol ; 51(2): 325-334, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30600440

RESUMO

PURPOSE: Anaemia and resistance to erythropoiesis-stimulating agents (ESAs) are common complications in haemodialysis (HD) patients. We investigated the role of hepcidin in the development of anaemia and ESA resistance/hyporesponsiveness and its relation to the plasma levels of the inflammatory markers interleukin 6 (IL-6) and high-sensitivity C-reactive protein (hsCRP). METHODS: This study included 60 maintenance HD patients attending Ain Shams University Hospital and 30 age- and sex-matched healthy subjects as a control group. Serum hepcidin, IL-6, hsCRP and haemoglobin (Hb) levels were measured in all subjects. The erythropoietin resistance index (ERI) was calculated in the patient group only. RESULTS: There was a significant difference between the patients and controls; the patients had higher hepcidin, IL-6, and hsCRP levels and a lower Hb level. Patients were classified according to their response to ESAs into responder and non-responder groups. Those in the non-responder group had higher hepcidin, IL-6, and hsCRP levels, a higher ERI, and a lower Hb level. Hepcidin showed a positive correlation with IL-6 and hsCRP but a negative correlation with Hb. Upon performing a ROC curve analysis, a cut-off of ≥ 280 ng/ml for hepcidin and ≥ 7.5 for ERI was able to discriminate the responder and non-responder groups with a prognostic accuracy of 83% and 77.3%, respectively. In addition, upon classifying the patients into tertiles according to the ERI, hepcidin significantly increased with increasing ERI. CONCLUSION: Our findings demonstrate an association between the hepcidin level, anaemia and ESA resistance/hyporesponsiveness in HD patients, suggesting its possible role as a candidate marker for ESA resistance.


Assuntos
Anemia , Proteína C-Reativa/análise , Eritropoese , Hematínicos , Hepcidinas/sangue , Interleucina-6/sangue , Falência Renal Crônica , Diálise Renal/efeitos adversos , Idoso , Anemia/diagnóstico , Anemia/tratamento farmacológico , Anemia/etiologia , Biomarcadores/sangue , Correlação de Dados , Resistência a Medicamentos/imunologia , Eritropoese/efeitos dos fármacos , Eritropoese/imunologia , Feminino , Hematínicos/administração & dosagem , Hematínicos/efeitos adversos , Humanos , Ferro/metabolismo , Falência Renal Crônica/sangue , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade
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