RESUMO
BACKGROUND: Although there are several predominantly single-center case series in the literature, relatively little prospectively collected data exist regarding the outcomes of open hip reduction (OR) for infantile developmental dysplasia of the hip (DDH). The purpose of this prospective, multi-center study was to determine the outcomes after OR in a diverse patient population. METHODS: The prospectively collected database of an international multicenter study group was queried for all patients treated with OR for DDH. Minimum follow-up was 1 year. Proximal femoral growth disturbance (PFGD) was defined by consensus review using Salter's criteria. Persistent acetabular dysplasia was defined as an acetabular index >90th percentile for age. Statistical analyses were performed to compare preoperative and operative characteristics that predicted re-dislocation, PFGD, and residual acetabular dysplasia. RESULTS: A cohort of 232 hips (195 patients) was identified; median age at OR was 19 months (interquartile range 13 to 28) and median follow-up length was 21 months (interquartile range 16 to 32). Re-dislocation occurred in 7% of hips (n=16/228). The majority (81%; n=13/16) occurred in the first year after initial OR. Excluding patients with repeat dislocation, 94.5% of hips were IHDI 1 at most recent follow-up. On the basis of strict radiographic review, some degree of PFGD was present in 44% of hips (n=101/230) at most recent follow-up. Seventy-eight hips (55%) demonstrated residual dysplasia compared with established normative data. Hips that had a pelvic osteotomy at index surgery had about half the rate of residual dysplasia (39%; n=32/82) versus those without a pelvic osteotomy with at least 2 years follow-up (78%; n=46/59). CONCLUSIONS: In the largest prospective, multicenter study to date, OR for infantile DDH was associated with a 7% risk of re-dislocation, 44% risk of PFGD, and 55% risk of residual acetabular dysplasia at short term follow-up. The incidence of these adverse outcomes is higher than previous reports. Patients treated with concomitant pelvic osteotomy had lower rates of residual dysplasia. These prospectively collected, multicenter data provide better generalizable information to improve family education and appropriately set expectations. LEVEL OF EVIDENCE: Level II, prospective comparative study.
Assuntos
Displasia do Desenvolvimento do Quadril , Luxação Congênita de Quadril , Luxação do Quadril , Humanos , Lactente , Pré-Escolar , Estudos Prospectivos , Displasia do Desenvolvimento do Quadril/cirurgia , Resultado do Tratamento , Acetábulo/cirurgia , Luxação Congênita de Quadril/cirurgia , Osteotomia , Luxação do Quadril/epidemiologia , Luxação do Quadril/cirurgia , Estudos Retrospectivos , Articulação do Quadril/cirurgiaRESUMO
BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic's effects on nephrology fellows' educational experiences, preparedness for practice, and emotional wellbeing are unknown. METHODS: We recruited current adult and pediatric fellows and 2020 graduates of nephrology training programs in the United States to participate in a survey measuring COVID-19's effects on their training experiences and wellbeing. RESULTS: Of 1005 nephrology fellows-in-training and recent graduates, 425 participated (response rate 42%). Telehealth was widely adopted (90% for some or all outpatient nephrology consults), as was remote learning (76% of conferences were exclusively online). Most respondents (64%) did not have in-person consults on COVID-19 inpatients; these patients were managed by telehealth visits (27%), by in-person visits with the attending faculty without fellows (29%), or by another approach (9%). A majority of fellows (84%) and graduates (82%) said their training programs successfully sustained their education during the pandemic, and most fellows (86%) and graduates (90%) perceived themselves as prepared for unsupervised practice. Although 42% indicated the pandemic had negatively affected their overall quality of life and 33% reported a poorer work-life balance, only 15% of 412 respondents who completed the Resident Well-Being Index met its distress threshold. Risk for distress was increased among respondents who perceived the pandemic had impaired their knowledge base (odds ratio [OR], 3.04; 95% confidence interval [CI], 2.00 to 4.77) or negatively affected their quality of life (OR, 3.47; 95% CI, 2.29 to 5.46) or work-life balance (OR, 3.16; 95% CI, 2.18 to 4.71). CONCLUSIONS: Despite major shifts in education modalities and patient care protocols precipitated by the COVID-19 pandemic, participants perceived their education and preparation for practice to be minimally affected.
Assuntos
COVID-19/epidemiologia , Nefrologia/educação , SARS-CoV-2 , Adulto , Competência Clínica , Educação a Distância , Educação de Pós-Graduação em Medicina , Bolsas de Estudo , Feminino , Humanos , Internato e Residência , Masculino , Estresse Ocupacional/epidemiologia , Pandemias , Pediatria/educação , Consulta Remota , Inquéritos e Questionários , Telemedicina , Estados Unidos/epidemiologiaRESUMO
RATIONALE & OBJECTIVE: Outcomes of patients hospitalized with coronavirus disease 2019 (COVID-19) and acute kidney injury (AKI) are not well understood. The goal of this study was to investigate the survival and kidney outcomes of these patients. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Patients (aged≥18 years) hospitalized with COVID-19 at 13 hospitals in metropolitan New York between March 1, 2020, and April 27, 2020, followed up until hospital discharge. EXPOSURE: AKI. OUTCOMES: Primary outcome: in-hospital death. SECONDARY OUTCOMES: requiring dialysis at discharge, recovery of kidney function. ANALYTICAL APPROACH: Univariable and multivariable time-to-event analysis and logistic regression. RESULTS: Among 9,657 patients admitted with COVID-19, the AKI incidence rate was 38.4/1,000 patient-days. Incidence rates of in-hospital death among patients without AKI, with AKI not requiring dialysis (AKI stages 1-3), and with AKI receiving dialysis (AKI 3D) were 10.8, 31.1, and 37.5/1,000 patient-days, respectively. Taking those without AKI as the reference group, we observed greater risks for in-hospital death for patients with AKI 1-3 and AKI 3D (HRs of 5.6 [95% CI, 5.0-6.3] and 11.3 [95% CI, 9.6-13.1], respectively). After adjusting for demographics, comorbid conditions, and illness severity, the risk for death remained higher among those with AKI 1-3 (adjusted HR, 3.4 [95% CI, 3.0-3.9]) and AKI 3D (adjusted HR, 6.4 [95% CI, 5.5-7.6]) compared with those without AKI. Among patients with AKI 1-3 who survived, 74.1% achieved kidney recovery by the time of discharge. Among those with AKI 3D who survived, 30.6% remained on dialysis at discharge, and prehospitalization chronic kidney disease was the only independent risk factor associated with needing dialysis at discharge (adjusted OR, 9.3 [95% CI, 2.3-37.8]). LIMITATIONS: Observational retrospective study, limited to the NY metropolitan area during the peak of the COVID-19 pandemic. CONCLUSIONS: AKI in hospitalized patients with COVID-19 was associated with significant risk for death.
Assuntos
Injúria Renal Aguda , COVID-19 , Mortalidade Hospitalar , Hospitalização/estatística & dados numéricos , Diálise Renal , Injúria Renal Aguda/diagnóstico , Injúria Renal Aguda/epidemiologia , Injúria Renal Aguda/fisiopatologia , Injúria Renal Aguda/terapia , COVID-19/diagnóstico , COVID-19/mortalidade , COVID-19/fisiopatologia , COVID-19/terapia , Feminino , Humanos , Incidência , Testes de Função Renal/métodos , Testes de Função Renal/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , New York/epidemiologia , Avaliação de Processos e Resultados em Cuidados de Saúde , Diálise Renal/métodos , Diálise Renal/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , SARS-CoV-2/isolamento & purificação , Análise de SobrevidaRESUMO
BACKGROUND: Reports show that AKI is a common complication of severe coronavirus disease 2019 (COVID-19) in hospitalized patients. Studies have also observed proteinuria and microscopic hematuria in such patients. Although a recent autopsy series of patients who died with severe COVID-19 in China found acute tubular necrosis in the kidney, a few patient reports have also described collapsing glomerulopathy in COVID-19. METHODS: We evaluated biopsied kidney samples from ten patients at our institution who had COVID-19 and clinical features of AKI, including proteinuria with or without hematuria. We documented clinical features, pathologic findings, and outcomes. RESULTS: Our analysis included ten patients who underwent kidney biopsy (mean age: 65 years); five patients were black, three were Hispanic, and two were white. All patients had proteinuria. Eight patients had severe AKI, necessitating RRT. All biopsy samples showed varying degrees of acute tubular necrosis, and one patient had associated widespread myoglobin casts. In addition, two patients had findings of thrombotic microangiopathy, one had pauci-immune crescentic GN, and another had global as well as segmental glomerulosclerosis with features of healed collapsing glomerulopathy. Interestingly, although the patients had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by RT-PCR, immunohistochemical staining of kidney biopsy samples for SARS-CoV-2 was negative in all ten patients. Also, ultrastructural examination by electron microscopy showed no evidence of viral particles in the biopsy samples. CONCLUSIONS: The most common finding in our kidney biopsy samples from ten hospitalized patients with AKI and COVID-19 was acute tubular necrosis. There was no evidence of SARS-CoV-2 in the biopsied kidney tissue.
Assuntos
Injúria Renal Aguda/patologia , Betacoronavirus , Infecções por Coronavirus/complicações , Rim/patologia , Pneumonia Viral/complicações , Idoso , Biópsia , COVID-19 , Infecções por Coronavirus/patologia , Feminino , Humanos , Rim/ultraestrutura , Necrose Tubular Aguda/patologia , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/patologia , SARS-CoV-2RESUMO
The rate of acute kidney injury (AKI) associated with patients hospitalized with Covid-19, and associated outcomes are not well understood. This study describes the presentation, risk factors and outcomes of AKI in patients hospitalized with Covid-19. We reviewed the health records for all patients hospitalized with Covid-19 between March 1, and April 5, 2020, at 13 academic and community hospitals in metropolitan New York. Patients younger than 18 years of age, with end stage kidney disease or with a kidney transplant were excluded. AKI was defined according to KDIGO criteria. Of 5,449 patients admitted with Covid-19, AKI developed in 1,993 (36.6%). The peak stages of AKI were stage 1 in 46.5%, stage 2 in 22.4% and stage 3 in 31.1%. Of these, 14.3% required renal replacement therapy (RRT). AKI was primarily seen in Covid-19 patients with respiratory failure, with 89.7% of patients on mechanical ventilation developing AKI compared to 21.7% of non-ventilated patients. 276/285 (96.8%) of patients requiring RRT were on ventilators. Of patients who required ventilation and developed AKI, 52.2% had the onset of AKI within 24 hours of intubation. Risk factors for AKI included older age, diabetes mellitus, cardiovascular disease, black race, hypertension and need for ventilation and vasopressor medications. Among patients with AKI, 694 died (35%), 519 (26%) were discharged and 780 (39%) were still hospitalized. AKI occurs frequently among patients with Covid-19 disease. It occurs early and in temporal association with respiratory failure and is associated with a poor prognosis.
Assuntos
Injúria Renal Aguda/virologia , Infecções por Coronavirus/complicações , Pneumonia Viral/complicações , Insuficiência Respiratória/complicações , Injúria Renal Aguda/epidemiologia , Idoso , COVID-19 , Infecções por Coronavirus/epidemiologia , Feminino , Humanos , Pacientes Internados/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque/epidemiologia , Pandemias , Pneumonia Viral/epidemiologia , Insuficiência Respiratória/virologia , Estudos RetrospectivosRESUMO
OBJECTIVES: Patient-reported outcomes (PRO) assessing health-related quality of life (HRQoL) are important outcome measures, especially in Legg-Calvé-Perthes disease (LCPD) where symptoms (pain and limping), activity restrictions, and treatments vary depending on the stage of the disease. The purpose of this study was to investigate the validity of the Patient-reported Outcomes Measurement Information System (PROMIS) for measuring HRQoL of patients with LCPD in various stages of the disease. METHODS: This is a multicenter validity study. Patients with LCPD between 4 and 18 years old were included and classified into modified Waldenström stages of disease: Early (1 or 2A), Late (2B or 3), or Healed (4). Seven PROMIS domains were collected, including Pain Interference, Fatigue, Mobility, Depression, Anger, Anxiety, and Peer Relationships. Convergent, discriminant, and known group validity was determined. RESULTS: A total of 190 patients were included (mean age: 10.4±3.1 y). All 7 domains showed the worst scores in patients in the Early stage (known group validity). Within each domain, all domains positively correlated to each other (convergent validity). Patients who reported more anxiety, depression, and anger were associated with decreased mobility and increased fatigue and pain. Peer relationships had no to weak associations with other domains (discriminant validity). CONCLUSIONS: PROMIS has construct validity in measuring the HRQoL of patients in different stages of LCPD, suggesting that PROMIS has potential to serve as a patient-reported outcome tool for this population. LEVEL OF EVIDENCE: Diagnostic level III study.
Assuntos
Doença de Legg-Calve-Perthes/complicações , Doença de Legg-Calve-Perthes/psicologia , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Adolescente , Ira , Ansiedade/etiologia , Criança , Pré-Escolar , Depressão/etiologia , Fadiga/etiologia , Feminino , Humanos , Masculino , Limitação da Mobilidade , Dor/etiologia , AutorrelatoRESUMO
BACKGROUND: Interest in nephrology careers is declining, possibly due to perceptions of the field and/or training aspects. Understanding practices of medical schools successfully instilling nephrology interest could inform efforts to attract leading candidates to the specialty. METHODS: The American Society of Nephrology Workforce Committee's Best Practices Project was one of several initiatives to increase nephrology career interest. Board-certified nephrologists graduating medical school between 2002 and 2009 were identified in the American Medical Association Masterfile and their medical schools ranked by production. Renal educators from the top 10 producing institutions participated in directed focus groups inquiring about key factors in creating nephrology career interest, including aspects of their renal courses, clinical rotations, research activities, and faculty interactions. Thematic content analysis of the transcripts (with inductive reasoning implementing grounded theory) was performed to identify factors contributing to their programs' success. RESULTS: The 10 schools identified were geographically representative, with similar proportions of graduates choosing internal medicine (mean 26%) as the national graduating class (26% in the 2017 residency Match). Eighteen educators from 9 of these 10 institutions participated. Four major themes were identified contributing to these schools' success: (1) nephrology faculty interaction with medical students; (2) clinical exposure to nephrology and clinical relevance of renal pathophysiology materials; (3) use of novel educational modalities; and (4) exposure, in particular early exposure, to the breadth of nephrology practice. CONCLUSION: Early and consistent exposure to a range of clinical nephrology experiences and nephrology faculty contact with medical students are important to help generate interest in the specialty.
Assuntos
Escolha da Profissão , Educação de Graduação em Medicina/métodos , Nefrologia/educação , Estudantes de Medicina/psicologia , Currículo , Docentes , Grupos Focais , Humanos , Faculdades de Medicina , Estados UnidosRESUMO
Waldenström macroglobulinemia (WM) is a rare B-cell lymphoma characterized by lymphoplasmacytic cell infiltration in the bone marrow and other organs and the presence of a monoclonal immunoglobulin M protein in the serum. Although uncommon, several kidney diseases have been associated with WM. In addition to kidney diseases related to lymphoplasmacytic lymphoma infiltration, a variety of glomerular and tubular lesions have been described in patients with WM. Immunoglobulin light chain (AL) amyloidosis and cryoglobulinemic glomerulonephritis are the two predominant glomerular pathologies seen in WM. In this article we review the kidney diseases associated with WM. We also briefly review some nephrotoxicities of novel chemotherapeutic and targeted therapies used for the treatment of WM.
Assuntos
Nefropatias/etiologia , Nefropatias/terapia , Macroglobulinemia de Waldenstrom/complicações , Gerenciamento Clínico , HumanosAssuntos
Anemia , Insuficiência Renal Crônica , Glicina/análogos & derivados , Humanos , Isoquinolinas , Diálise RenalRESUMO
Anemia is a common complication of advanced chronic kidney disease (CKD). Treatment with erythropoiesis-stimulating agents (ESAs) remains a common approach in managing anemia of CKD. The 2012 Kidney Disease Improving Global Outcomes Clinical Practice Guideline for Anemia in CKD suggests avoiding ESA therapy use to maintain Hb level above 11.5 g/dL. However, optimal Hb target range in adult patients undergoing chronic dialysis remains unknown. Clinical studies suggest risks associated with normalization of Hb levels in adult patients with CKD. In this article, we briefly review some of these studies and the concerns associated with higher Hb targets in this patient population. We also suggest a target Hb range for adult chronic dialysis patients receiving ESAs. It is currently undetermined if this target Hb range would apply to newer agents that are being studied for anemia management in this population.
Assuntos
Anemia/diagnóstico , Hemoglobinas/metabolismo , Diálise Renal , Insuficiência Renal Crônica/sangue , Insuficiência Renal Crônica/terapia , Adulto , Anemia/tratamento farmacológico , Anemia/etiologia , Hematínicos/uso terapêutico , Humanos , Insuficiência Renal Crônica/complicaçõesRESUMO
BACKGROUND: Outcomes for patients with late-stage chronic kidney disease (CKD) in the United States are suboptimal. There is poor education and preparation for end-stage kidney disease, as well as a high rate of hospitalization in this group of patients. STUDY DESIGN: A randomized, parallel-group, 2-arm, controlled trial. SETTING & PARTICIPANTS: The study was conducted at 3 sites: a clinic of an academic medical center, a public hospital academic clinic, and a community-based private practice. All participants had late-stage CKD (stages 4-5 CKD). Patients were excluded only if they had significant cognitive impairment. INTERVENTION: The care management intervention involved nurse care manager coordination aided by the use of a disease-based informatics system for monitoring patients' clinical status, enhancing CKD education, and facilitating preparation for end-stage kidney disease. The comparison control group received usual late-stage CKD care alone. OUTCOMES: The primary outcome was rate of hospitalization. MEASUREMENTS: Rates of preemptive transplantation, home dialysis, hemodialysis (HD) starts without a hospitalization, and HD therapy initiation rates with catheters or with functioning accesses. RESULTS: 130 patients were randomly assigned. The hospitalization rate was significantly lower in the intervention group versus controls: 0.61 versus 0.92 per year, respectively (incidence rate ratio, 0.66; 95% CI, 0.43-0.99; P=0.04). Peritoneal dialysis or preemptive transplantation was the initial end-stage kidney disease treatment in 11 of 30 (37%) participants receiving the intervention versus 3 of 29 (10%) receiving usual care. Among HD starts, treatment was initiated without hospitalization in 11 of 19 (58%) participants in the intervention group versus 6 of 26 (23%) in the control group. At the time of HD therapy initiation, a catheter was present in 7 of 19 (37%) participants in the intervention group versus 18 of 26 (69%) in the control group. A functioning arteriovenous access was in place in 10 of 19 (53%) participants in the intervention group and 7 of 26 (27%) in the control group LIMITATIONS: Moderate sample size, limited geographic scope. CONCLUSIONS: The augmented nurse care management intervention resulted in reduced hospitalizations in late-stage CKD and there were suggestions of improved end-stage kidney disease preparation. Given suboptimal outcomes in late-stage CKD, care management interventions could potentially improve patient outcomes.
Assuntos
Insuficiência Renal Crônica/enfermagem , Idoso , Feminino , Humanos , Falência Renal Crônica/enfermagem , Masculino , Pessoa de Meia-Idade , Processo de Enfermagem , Índice de Gravidade de DoençaRESUMO
The Kidney Tutored Research and Education for Kidney Students (TREKS) Program is a product of the American Society of Nephrology (ASN) Workforce Committee that seeks to connect medical and graduate students to nephrology. This program starts with a weeklong camp-like course introducing participants to renal physiology through classic and modern experiments. Next, each student is matched with a nephrology mentor at his or her home institution to foster a better understanding of a nephrology career. Lastly, the students are encouraged to participate in scholarly activities and attend the ASN Kidney Week. Now in its third year, with a total of 84 participants, survey data suggest early success of the program, with a self-reported 40% increased interest in nephrology fellowship and/or research careers. In addition, students give high ratings to the course components and mentorship pairings. Continued student tracking will be necessary to determine the long-term program effect.
Assuntos
Escolha da Profissão , Nefrologia/educação , Educação de Pós-Graduação em Medicina , Feminino , Humanos , Masculino , Mentores , Sociedades Médicas , Estados UnidosRESUMO
Procedures are a key component to the practice of nephrology. The Accreditation Council for Graduate Medical Education (ACGME) requires nephrology fellows to acquire skills and demonstrate competency in the performance of several procedures during fellowship training, including temporary hemodialysis catheter placement, biopsy of native and transplanted kidneys, and various dialytic therapies. It is also required that fellows acquire competency in the interpretation of renal imaging, including renal ultrasound, during their training. To gain a more recent perspective of nephrology fellows' experiences regarding renal ultrasonography, dialysis catheter placement, and kidney biopsies, we carried out a national survey of nephrology fellows in May 2014. A majority of the programs did not offer formal clinical training in renal ultrasonography. In addition, a significant percentage of fellows in adult nephrology may not be acquiring the required procedural skills and competency during fellowship training. In this perspective, we explore some of the reasons for this occurrence and propose some measures that the nephrology training community can take to enhance procedural skills and competency of fellows.
Assuntos
Cateterismo , Cateteres de Demora , Competência Clínica , Bolsas de Estudo , Rim/diagnóstico por imagem , Rim/patologia , Nefrologia/educação , Diálise Renal , Ultrassonografia , Biópsia , Humanos , Diálise Renal/instrumentação , Estados UnidosRESUMO
BACKGROUND: Strategies used to teach nephrology to medical students are not well studied. This study assesses the published literature on medical student education in nephrology. METHODS: A review of the published literature on nephrology education for medical students was conducted on two major online search engines (PubMed and ERIC). In addition, references of the manuscripts discovered in these searches were reviewed. The empirical studies were categorized by subject within nephrology and research design. RESULTS: We found 26 original studies in which a method of teaching nephrology to medical students was described. The studies dated from 1977 to 2015. The focus of these nephrology teaching experiences was as follows: anatomy (6.5%), physiology (22.6%), pathophysiology (29.0%), pathology (6.5%), treatment (25.8%), and general nephrology (9.7%). The studies were also categorized into various types of research design. 6.9% had either no assessment of the educational experience or had a description too vague to categorize it; 3.4% involved a survey about the existing educational approach before a curriculum change was implemented; 55.2% used surveys or tests after an educational course was carried out; 10.3% sought feedback from students before and after the educational experience; 13.8% were case studies; and 10.3% included a randomized controlled trial. The randomized controlled trials involved teaching techniques focused on the pathophysiology of renal disease. CONCLUSIONS: Rigor was lacking in most empirical studies on medical student education in nephrology. Well-designed randomized controlled studies are needed to accurately assess the effectiveness of the educational techniques introduced into medical school curricula.
Assuntos
Educação Médica/métodos , Nefrologia/educação , Currículo , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Inquéritos e Questionários , Estados UnidosRESUMO
PURPOSE OF REVIEW: Management of hyperphosphatemia remains an integral component in the care of patients with chronic kidney disease on dialysis. In addition to dietary restriction and dialysis, oral phosphate binders remain a key strategy in the control of serum phosphorus levels in this population. We review two new oral phosphate binders that are currently marketed in the United States. RECENT FINDINGS: Sucroferric oxyhydroxide was approved by the U.S. Food and Drug Administration (FDA) in November 2013. A recent international, multicenter study found the drug to be efficacious and noninferior to sevelamer carbonate in magnitude of serum phosphate control. This was achieved with a significantly reduced daily pill burden for sucroferric oxyhydroxide. A second novel agent, ferric citrate was approved by the FDA in September, 2014. The drug was found to have similar phosphate control efficacy to active comparators and was superior to placebo. In addition, the drug delivers a significant amount of iron, resulting in improved erythropoietic parameters. Both drugs had diarrhea as a fairly frequent side-effect. SUMMARY: These new phosphate binders offer alternatives to currently available agents. Both have interesting properties that may make them particularly useful in clinical practice.
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Quelantes/uso terapêutico , Hiperfosfatemia/tratamento farmacológico , Ferro/metabolismo , Fosfatos/sangue , Insuficiência Renal Crônica/tratamento farmacológico , Humanos , Diálise Renal/métodosRESUMO
Biologic drugs, including epoetin, continue to play an important role in the management of medical conditions. However, biologics are costly and soon many of the patents on these drugs will expire, making way for non-brand name products (ie, biosimilars). It is only by introducing competition to the marketplace that costs will de-escalate. In Europe, a specific regulatory pathway for approving biosimilars has been in place since 2005. A similar review pathway in the United States has been developed by the US Food and Drug Administration. These guidelines for approving biosimilars are stringent, requiring preclinical pharmacodynamic and toxicologic studies, clinical studies to demonstrate bioequivalence and efficacy, and long-term postmarketing studies to monitor drug safety. Biosimilar epoetin has been used in Europe since 2007, and a wealth of data has been collected. These studies and reports indicate that the efficacy and safety profiles of biosimilar epoetin are similar to those of originator epoetin alfa. Biosimilars of epoetin alfa are expected to be among the first biosimilar agents to be approved for use in the United States. The availability of lower cost epoetins may have significant impact on the treatment of anemia of chronic kidney disease.
Assuntos
Medicamentos Biossimilares/uso terapêutico , Eritropoetina/uso terapêutico , Hematínicos/uso terapêutico , Nefrologia/tendências , Anemia/tratamento farmacológico , Anemia/etiologia , Medicamentos Biossimilares/economia , Aprovação de Drogas/legislação & jurisprudência , Epoetina alfa , Custos de Cuidados de Saúde , Humanos , Proteínas Recombinantes/uso terapêutico , Insuficiência Renal Crônica/complicações , Estados Unidos , United States Food and Drug AdministrationRESUMO
This study updates assessment of post-transplant outcomes in IgAN patients in the modern era of immunosuppression. Using UNOS/OPTN data, patients ≥18 yr of age with first kidney transplant (1/1/1999 to 12/31/2008) were analyzed. Multivariable Cox regression models and propensity score-based matching techniques were used to estimate hazard ratios (HRs) for death-censored allograft survival (DCGS) and patient survival in IgAN compared to non-IgAN. Results of multivariable regression were stratified by donor type (living vs. deceased). A total of 107, 747 recipients were included (4589 with IgAN and 103 158 with non-IgAN). Adjusted HR for DCGS showed no significant difference between IgAN and non-IgAN. IgAN had higher patient survival compared to non-IgAN (HR 0.54, 95% CI 0.47-0.62, p < 0.0001 for deceased donors; HR 0.42, 95% CI 0.33-0.54, p < 0.0001 for living donors). Propensity score-matched analysis was similar, with no significant difference in DCGS between matched groups and higher patient survival in IgAN patients compared to non-IgAN group (HR 0.54, 95% CI 0.47, 0.63; p-value <0.0001). IgAN patients with first kidney transplant have superior patient survival and similar graft survival compared to non-IgAN recipients. Results can be used in prognostication and informed decision-making about kidney transplantation in patients with IgAN.
Assuntos
Glomerulonefrite por IGA/cirurgia , Transplante de Rim , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Feminino , Seguimentos , Glomerulonefrite por IGA/mortalidade , Sobrevivência de Enxerto , Humanos , Estimativa de Kaplan-Meier , Transplante de Rim/mortalidade , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Transplante Homólogo , Resultado do Tratamento , Estados Unidos , Adulto JovemRESUMO
Interest in nephrology careers continues to decline in the United States. The reasons for this declining interest are not fully understood but it is plausible that inadequate exposure to the full spectrum of what a career in nephrology encompasses may be part of the explanation. Inpatient-based nephrology electives have been a common venue for residents to gain exposure to nephrology but little is known regarding the details of such electives and how often they include outpatient experiences. We carried out a national survey of nephrology fellowship training program directors to obtain data on the content of nephrology elective experiences as well as their ideas on how to promote interest in the field. The survey revealed the majority of elective experiences to be either exclusively or heavily inpatient based, with only a small percentage having a substantial outpatient component, particularly in outpatient dialysis or transplantation. Training program directors felt that providing greater outpatient experiences to residents during elective rotations would be an effective means to promote interest in nephrology, along with structured faculty mentoring. Our findings suggest that current approaches to the nephrology elective experience are heavily inpatient-based and might benefit from incorporating much more of the rich spectrum of activities a career in nephrology entails. Hopefully such efforts can create and enhance interest in careers in nephrology and potentially begin a sustained reversal of an unfortunate and serious decline in interest.